89–006 

116TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 116–47 

ORANGE BOOK TRANSPARENCY ACT OF 2019 

MAY 2, 2019.—Committed to the Committee of the Whole House on the State of the 

Union and ordered to be printed 

Mr. PALLONE, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 1503] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 1503) to amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act, and for other purposes, having considered the same, report favorably thereon with an amendment and 

recommend that the bill as amended do pass. 

CONTENTS 

Page 

I. Purpose and Summary ............................................................................... 3 

II. Background and Need for the Legislation ................................................ 4 

III. Committee Hearings ................................................................................... 4 

IV. Committee Consideration ........................................................................... 5 

V. Committee Votes ......................................................................................... 5 

VI. Oversight Findings ...................................................................................... 5 

VII. New Budget Authority, Entitlement Authority, and Tax Expenditures 5 

VIII. Congressional Budget Office Estimate ...................................................... 6 

IX. Federal Mandates Statement ..................................................................... 7 

X. Statement of General Performance Goals and Objectives ....................... 7 

XI. Duplication of Federal Programs ............................................................... 7 

XII. Committee Cost Estimate ........................................................................... 8 

XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits ............... 8 

XIV. Advisory Committee Statement ................................................................. 8 

XV. Applicability to Legislative Branch ........................................................... 8 

XVI. Section-by-Section Analysis of the Legislation ......................................... 8 

XVII. Changes in Existing Law Made by the Bill, as Reported ........................ 9 

The amendment is as follows: 

Strike all after the enacting clause and insert the following: 


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SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Orange Book Transparency Act of 2019’’. 

SEC. 2. ORANGE BOOK. 

(a) SUBMISSION OF PATENT INFORMATION FOR BRAND NAME DRUGS.—Paragraph 

(1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 

is amended to read as follows: 

‘‘(b)(1) Any person may file with the Secretary an application with respect to any 

drug subject to the provisions of subsection (a). Such persons shall submit to the 

Secretary as part of the application— 

‘‘(A) full reports of investigations which have been made to show whether or 

not such drug is safe for use and whether such drug is effective in use; 

‘‘(B) a full list of the articles used as components of such drug; 

‘‘(C) a full statement of the composition of such drug; 

‘‘(D) a full description of the methods used in, and the facilities and controls 

used for, the manufacture, processing, and packing of such drug; 

‘‘(E) such samples of such drug and of the articles used as components thereof 

as the Secretary may require; 

‘‘(F) specimens of the labeling proposed to be used for such drug; 

‘‘(G) any assessments required under section 505B; and 

‘‘(H) patent information, with respect to each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the 

owner engaged in the manufacture, use, or sale of the drug, and consistent with 

the following requirements: 

‘‘(i) The applicant shall file with the application the patent number and 

the expiration date of— 

‘‘(I) any patent which claims the drug for which the applicant submitted the application and is a drug substance (including active ingredient) patent or a drug product (including formulation and composition) 

patent; and 

‘‘(II) any patent which claims the method of using such drug. 

‘‘(ii) If an application is filed under this subsection for a drug and a patent of the type described in clause (i) which claims such drug or a method 

of using such drug is issued after the filing date but before approval of the 

application, the applicant shall amend the application to include such patent information. 

Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (H). The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of 

women and minorities in clinical trials required by subparagraph (A).’’. 

(b) CONFORMING CHANGES TO REQUIREMENTS FOR SUBSEQUENT SUBMISSION OF

PATENT INFORMATION.—Section 505(c)(2) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(j)(7)) is amended— 

(1) by inserting after ‘‘the patent number and the expiration date of any patent which’’ the following: ‘‘fulfills the criteria in subsection (b) and’’; 

(2) by inserting after the first sentence the following: ‘‘Patent information that 

is not the type of patent information required by subsection (b) shall not be submitted.’’; and 

(3) by inserting after ‘‘could not file patent information under subsection (b) 

because no patent’’ the following: ‘‘of the type required to be submitted in subsection (b)’’. 

(c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the 

end the following: 

‘‘(iv) For each drug included on the list, the Secretary shall specify each exclusivity period that is applicable and has not concluded under— 

‘‘(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) of this section; 

‘‘(II) clause (iv) or (v) of paragraph (5)(B) of this subsection; 

‘‘(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of this subsection; 

‘‘(IV) section 505A; 

‘‘(V) section 505E; or 

‘‘(VI) section 527(a).’’. 

(d) REMOVAL OF INVALID PATENTS.— 

(1) IN GENERAL.—Section 505(j)(7) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following: 

‘‘(D)(i) The holder of an application approved under subsection (c) for a drug on 

the list shall notify within 14 days the Secretary in writing if either of the following 

occurs: 


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‘‘(I) The Patent Trial and Appeals Board issues a decision from which no appeal has been or can be taken that a patent for such drug is invalid. 

‘‘(II) A court issues a decision from which no appeal has been or can be taken 

that a patent for such drug is invalid. 

‘‘(ii) The holder of an approved application shall include in any notification under 

clause (i) a copy of the decision described in subclause (I) or (II) of clause (i). 

‘‘(iii) The Secretary shall remove from the list any patent that is determined to 

be invalid in a decision described in subclause (I) or (II) of clause (i)— 

‘‘(I) promptly; but 

‘‘(II) not before the expiration of any 180-day exclusivity period under paragraph (5)(B)(iv) that relies on a certification described in paragraph 

(2)(A)(vii)(IV) that such patent was invalid.’’. 

(2) APPLICABILITY.—Subparagraph (D) of section 505(j)(7) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), as added by paragraph (1), applies 

only with respect to a decision described in such subparagraph that is issued 

on or after the date of enactment of this Act. 

(e) REVIEW AND REPORT.—Not later than one year after the date of enactment of 

this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— 

(1) solicit public comment regarding the types of patent information that 

should be included on the list under section 507(j)(7) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(j)(7)); and 

(2) transmit to the Congress an evaluation of such comments, including any 

recommendations about the types of patent information that should be included 

on or removed from such list. 

SEC. 3. GAO REPORT TO CONGRESS. 

(a) IN GENERAL.—Not later than one year after the date of enactment of this Act, 

the Comptroller General of the United States (referred to in this section as the 

‘‘Comptroller General’’) shall submit to the Committee on Energy and Commerce of 

the House of Representatives a report on the patents included in the list published 

under section 505(j)(7) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 

355(j)(7)), including an analysis and evaluation of the types of patents included in 

such list and the claims such patents make about the products they claim. 

(b) CONTENTS.—The Comptroller General shall include in the report under subsection (a)— 

(1) data on the number of— 

(A) patents included in the list published under paragraph (7) of section 

505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)), that 

claim the active ingredient or formulation of a drug in combination with a 

device that is used for delivery of the drug, together comprising the finished 

dosage form of the drug; and 

(B) claims in each patent that claim a device that is used for the delivery 

of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug; 

(2) data on the date of inclusion in the list under paragraph (7) of such section 505(j) for all patents under such list, as compared to patents that claim 

a method of using the drug in combination with a device; 

(3) an analysis regarding the impact of including on the list under paragraph 

(7) of such section 505(j) certain types of patent information for drug product 

applicants and approved application holders, including an analysis of whether— 

(A) the listing of the patents described in paragraph (1)(A) delayed the 

market entry of one or more drugs approved under such section 505(j); and 

(B) not listing the patents described in paragraph (1)(A) would delay the 

market entry of one or more such drugs; and 

(4) recommendations about which kinds of patents relating to devices described in paragraph (1)(A) should be submitted to the Secretary of Health and 

Human Services for inclusion on the list under paragraph (7) of such section 

505(j) and which patents should not be required to be so submitted. 

PURPOSE AND SUMMARY

H.R. 1503, the ‘‘Orange Book Transparency Act of 2019’’, was introduced on March 5, 2019, by Rep. Kelly (D–IL), and referred to 

the Committee on Energy and Commerce. H.R. 1503 would require 

manufacturers to share complete and timely patent information 

with the Food and Drug Administration (FDA), ensure that periods 

of exclusivity listed in the Orange Book are promptly updated, and 


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1Food and Drug Administration, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (https://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm). 2 21 C.F.R. 314.53 

3 Reed F Bell & Aaron S Kesselheim, Tertiary patenting on drug—device combination products 

in the United States, (https://www.nature.com/articles/nbt.4078.epdf?author_access_token=k19w_ 

aka6yYXhVtkaCGFOdRgN0jAjWel9jnR3ZoTv0MGOAdGITA-e4st1uwIqL0ZGE0-17DL5n2Qg8u7 

csdohGlFGwUWdjvieJtiDwzfoldY3_E4HS6rf7YbpkcyvI2u). 

clarify that patents found to be invalid through a court decision or 

a decision by the Patent Trial and Appeal Board would be required 

to be removed from the Orange Book promptly, but not before time 

for appeal has expired. The bill would also direct the U.S. General 

Accountability Office (GAO) to study which types of patents should 

be listed in the Orange Book. 

BACKGROUND AND NEED FOR LEGISLATION

Approved branded and generic drug products currently marketed 

are included on a list commonly referred to as the ‘‘Orange Book,’’ 1

which is published on the FDA’s website and includes, among other 

details, the patents that protect each product, the product’s application number, and some related exclusivities. Drug manufacturers 

are required to list with FDA patent information related to their 

drug.2 This listing in the Orange Book is used by generic manufacturers to make development decisions as it provides information 

about when patents or exclusivities associated with an approved 

drug will expire. 

While FDA has issued regulations clarifying certain types of patents that must be submitted to the agency and certain types that 

must not be submitted, many patents are complex and may not fall 

clearly into the types identified by FDA. As a result, some branded 

drug manufacturers may choose not to submit every patent on a 

product to the FDA, and others are submitting patents potentially 

for the purpose of blocking generic competition.3 Further, some 

stakeholders have been critical that the patent information included in the Orange Book is not as accurate or up-to-date as it 

could be. 

This legislation would help to ensure that the Orange Book is accurate and up-to-date, by specifying what information must be submitted to FDA and what information should be listed, clarifying 

that invalid patents must be removed in a timely manner, directing 

FDA to solicit public comment on the types of information that 

should be listed in the Orange Book an evaluation of such comments to Congress, and the GAO to study whether certain patents 

should, or should not be listed in the Orange Book. 

COMMITTEE HEARINGS

For the purposes of section 103(i) of H. Res. 6 of the 116th Congress, the following hearing was used to develop or consider H.R. 

1503: 

The Subcommittee on Health held a legislative hearing on March 

13, 2019, to consider H.R. 1503, the ‘‘Orange Book Transparency 

Act of 2019’’ and six other bills. The hearing was entitled, ‘‘Lowing 

the Cost of Prescription Drugs: Reducing Barriers to Market Competition.’’ The Subcommittee received testimony from: • Lou Kennedy, Chief Executive Officer and Owner, 

Nephron Pharmaceuticals; 


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• Anthony Barrueta, Senior Vice President for Government 

Relations, Kaiser Permanente; 

• Michael Carrier, Distinguished Professor, Rutgers Law 

School; 

• Kurt Karst, Director, Hyman, Phelps & McNamara, P.C.; 

• Jeff Kushan, Partner, Sidley Austin LLP; 

• Marc M. Boutin, JD, Chief Executive Officer, National 

Health Council; and 

• Chester ‘‘Chip’’ Davis, Jr., President and Chief Executive 

Officer, Association for Accessible Medicines. 

COMMITTEE CONSIDERATION

H.R. 1503, the ‘‘Orange Book Transparency Act of 2019’’, was introduced on March 5, 2019, by Rep. Kelly (D–IL), and referred to 

the Committee on Energy and Commerce. The bill was subsequently referred to the Subcommittee on Health on March 6, 2019. 

Following legislative hearings, the Subcommittee met in open 

markup session on H.R. 1503 on March 27, 2019, pursuant to notice, for consideration of the bill. A manager’s amendment offered 

by Ms. Kelly was adopted by a voice vote. Subsequently, the Subcommittee on Health agreed to a motion by Ms. Eshoo, Chairwoman of the Subcommittee, to favorably forward H.R. 1503 to the 

full Committee on Energy and Commerce, amended. 

The full Committee on Energy and Commerce met in open markup session, pursuant to notice, on April 3, 2019, to consider H.R. 

1503, as amended by the subcommittee. An amendment by Ms. 

Kelly and Mr. Guthrie was adopted by a voice vote. At the conclusion of consideration and markup of the bill, the Committee agreed 

to a motion by Mr. Pallone, Chairman of the Committee, to order 

H.R. 1503 favorably reported to the House, amended, by a voice 

vote. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list each record vote on the motion 

to report legislation and amendments thereto. The Committee advises that there were no record votes taken on H.R. 1503. A motion 

by Mr. Pallone to order H.R. 1503 favorably reported to the House, 

amended, was agreed to by a voice vote. 

OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) of rule 

X of the Rules of the House of Representatives, the oversight findings and recommendations of the Committee are reflected in the 

descriptive portion of the report. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND

TAX EXPENDITURES

Pursuant to 3(c)(2) of rule XIII of the Rules of the House of Representatives, the Committee adopts as its own the estimate of new 

budget authority, entitlement authority, or tax expenditures or revenues contained in the cost estimate prepared by the Director of 


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the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

With respect to the requirements of clause (3)(c)(3) of rule XIII 

of the Rules of the House of Representatives and section 402 of the 

Congressional Budget Act of 1974, the Committee has received the 

following cost estimate for H.R. 1503 from the Director of Congressional Budget Office: 

U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, May 1, 2019. 

Hon. FRANK PALLONE, Jr., 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 1503, the Orange Book 

Transparency Act of 2019. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Julia Christensen. 

Sincerely, 

KEITH HALL, Director. 

Enclosure. 

Under current law, the Food and Drug Administration (FDA) 

publishes a compendium entitled, Approved Drug Products with 

Therapeutic Equivalence Evaluations, commonly referred to as the 

‘‘Orange Book.’’ The Orange Book identifies drug products approved 

on the basis of safety and effectiveness by FDA and provides associated patent and exclusivity information. FDA updates the Orange 

Book on a regular basis. H.R. 1503 would codify current regulations and practice regarding the types of patent and exclusivity-related information listed in the Orange Book. 

H.R. 1503 also would require the prompt removal of certain patents from the Orange Book that have been invalidated by a ruling 


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of the Patent Trial and Appeal Board at the United States Patent 

and Trademark Office. 

The bill would require FDA to solicit public comments regarding 

the types of patent information that should be listed in the Orange 

Book. Within one year of enactment, FDA would be required to 

transmit to the Congress an evaluation of such comments, including any recommendations about the types of patent information 

that should be included on or removed from such list. 

In addition, H.R. 1503 would direct the General Accountability 

Office (GAO) to conduct a study that analyzes certain patents with 

claims relating to devices listed in the Orange Book and evaluates 

the extent to which listing such patents has affected the timing for 

the entry of generic drugs into the market. The bill would require 

GAO to submit the report to the Congress within one year of enactment. 

Based on the costs of similar activities, CBO estimates that implementing the bill would cost $1 million, primarily for FDA’s personnel-related expenses to comply with the bill’s reporting requirements. Any such spending would be subject to the availability of 

appropriated funds. 

H.R. 1503 would impose a private-sector mandate as defined in 

the Unfunded Mandates Reform Act (UMRA) by requiring drug 

manufacturers to notify the FDA when the Patent Trial and Appeals Board or another court finds a drug patent to be invalid. 

CBO estimates the cost of the mandate would fall well below the 

private-sector threshold established in UMRA ($164 million in 

2019, adjusted annually for inflation). 

The CBO staff contacts for this estimate are Julia Christensen 

(for federal costs) and Andrew Laughlin (for mandates). The estimate was reviewed by Leo Lex, Deputy Assistant Director for 

Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

Pursuant to clause 3(c)(4) of rule XIII, the general performance 

goal or objective of this legislation is to amend the Food, Drug, and 

Cosmetic Act to clarify which patents should be submitted to FDA, 

that exclusivity periods should be included on the list under 

505(j)(7)(A) of the Act, and when invalid patents should be removed 

from that list. The bill also directs the Comptroller General to conduct a study about the types of patents that are currently included 

on this list and whether they should continue to be included on this 

list. 

DUPLICATION OF FEDERAL PROGRAMS

Pursuant to clause 3(c)(5) of rule XIII, no provision of H.R. 1503 

is known to be duplicative of another Federal program, including 

any program that was included in a report to Congress pursuant 

to section 21 of Public Law 111–139 or the most recent Catalog of 

Federal Domestic Assistance. 


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COMMITTEE COST ESTIMATE

Pursuant to clause 3(d)(1) of rule XIII, the Committee adopts as 

its own the cost estimate prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional 

Budget Act of 1974. 

EARMARKS, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the Committee 

finds that H.R. 1503 contains no earmarks, limited tax benefits, or 

limited tariff benefits. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1: Short title 

This Act may be cited as the ‘‘Orange Book Transparency Act of 

2019’’. 

Section 2: Orange Book 

Subsection (a) amends section 505(b) of the Federal Food, Drug, 

and Cosmetic Act (FDCA) to require FDA to include the following 

patent information for a drug in the Orange Book: drug substance 

patents, drug product patents, and method of use patents. 

Subsection (b) amends the requirements for subsequent submissions of patent information in Section 505(c)(2) to conform to the 

clarified requirements in 505(b). 

Subsection (c) requires the Secretary to specify each exclusivity 

period for drugs listed in the Orange Book. 

Subsection (d) requires that approved drug application holders 

promptly notify FDA if one of their listed patents is found invalid 

in a decision from either the Patent Trial and Appeals Board or a 

court issues a decision from which no appeal has been or can be 

taken. The legislation further requires that FDA remove a patent 

from this list promptly if it is found to be invalid, but not before 

the expiration of any 180-day exclusivity period. 

Subsection (e) requires FDA to solicit public comment regarding 

the types of patent information that should be included on the ‘‘Orange Book’’ and transmit to Congress an evaluation of such comments, including any recommendations about the types of information that should be included or removed from the list. 

Section 3: GAO report to Congress 

Section 3 directs GAO to analyze and evaluate the types of patents included in the Orange Book and the claims such patents 


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make about the products they claim, and to include in such analysis specific data and recommendations about the types of patents 

that should be listed. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

and existing law in which no change is proposed is shown in 

roman): 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * * 

CHAPTER V—DRUGS AND DEVICES 

SUBCHAPTER A—DRUGS AND DEVICES

* * * * * * * 

NEW DRUGS

SEC. 505. (a) No person shall introduce or deliver for introduction 

into interstate commerce any new drug, unless an approval of an 

application filed pursuant to subsection (b) or (j) is effective with 

respect to such drug. 

(b)ø(1) Any person may file with the Secretary an application 

with respect to any drug subject to the provisions of subsection (a). 

Such persons shall submit to the Secretary as a part of the application (A) full reports of investigations which have been made to 

show whether or not such drug is safe for use and whether such 

drug is effective in use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such 

drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles 

used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug, and (G) any 

assessments required under section 505B. The applicant shall file 

with the application the patent number and the expiration date of 

any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug 

and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged 

in the manufacture use, or sale of the drug. If a application is filed 

under this subsection for a drug and a patent which claims such 

drug or a method of using such drug is issued after the filing date 

but before approval of the application, the applicant shall amend 

the application to include the information required by the preceding sentence. Upon approval of the application, the Secretary 

shall publish information submitted under the two preceding sentences. The Secretary shall, in consultation with the Director of the 

National Institutes of Health and with representatives of the drug 

manufacturing industry, review and develop guidance, as approVerDate Sep 11 2014 05:32 May 04, 2019 Jkt 089006 PO 00000 Frm 00009 Fmt 6659 Sfmt 6601 E:\HR\OC\HR047.XXX HR047

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priate, on the inclusion of women and minorities in clinical trials 

required by clause (A).¿(1) Any person may file with the Secretary 

an application with respect to any drug subject to the provisions of 

subsection (a). Such persons shall submit to the Secretary as part 

of the application— 

(A) full reports of investigations which have been made to 

show whether or not such drug is safe for use and whether such 

drug is effective in use; 

(B) a full list of the articles used as components of such drug; 

(C) a full statement of the composition of such drug; 

(D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and 

packing of such drug; 

(E) such samples of such drug and of the articles used as 

components thereof as the Secretary may require; 

(F) specimens of the labeling proposed to be used for such 

drug; 

(G) any assessments required under section 505B; and 

(H) patent information, with respect to each patent for which 

a claim of patent infringement could reasonably be asserted if 

a person not licensed by the owner engaged in the manufacture, 

use, or sale of the drug, and consistent with the following requirements: 

(i) The applicant shall file with the application the patent number and the expiration date of— 

(I) any patent which claims the drug for which the 

applicant submitted the application and is a drug substance (including active ingredient) patent or a drug 

product (including formulation and composition) patent; and 

(II) any patent which claims the method of using 

such drug. 

(ii) If an application is filed under this subsection for a 

drug and a patent of the type described in clause (i) which 

claims such drug or a method of using such drug is issued 

after the filing date but before approval of the application, 

the applicant shall amend the application to include such 

patent information. 

Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (H). The Secretary shall, 

in consultation with the Director of the National Institutes of Health 

and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of 

women and minorities in clinical trials required by subparagraph 

(A). 

(2) An application submitted under paragraph (1) for a drug for 

which the investigations described in clause (A) of such paragraph 

and relied upon by the applicant for approval of the application 

were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person 

by or for whom the investigations were conducted shall also include— 

(A) a certification, in the opinion of the applicant and to the 

best of his knowledge, with respect to each patent which claims 

the drug for which such investigations were conducted or 


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which claims a use for such drug for which the applicant is 

seeking approval under this subsection and for which information is required to be filed under paragraph (1) or subsection 

(c)— 

(i) that such patent information has not been filed, 

(ii) that such patent has expired, 

(iii) of the date on which such patent will expire, or 

(iv) that such patent is invalid or will not be infringed 

by the manufacture, use, or sale of the new drug for which 

the application is submitted; and 

(B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted information was 

filed under paragraph (1) or subsection (c) for a method of use 

patent which does not claim a use for which the applicant is 

seeking approval under this subsection, a statement that the 

method of use patent does not claim such a use. 

(3) NOTICE OF OPINION THAT PATENT IS INVALID OR WILL NOT BE

INFRINGED.— 

(A) AGREEMENT TO GIVE NOTICE.—An applicant that makes 

a certification described in paragraph (2)(A)(iv) shall include in 

the application a statement that the applicant will give notice 

as required by this paragraph. 

(B) TIMING OF NOTICE.—An applicant that makes a certification described in paragraph (2)(A)(iv) shall give notice as required under this paragraph— 

(i) if the certification is in the application, not later than 

20 days after the date of the postmark on the notice with 

which the Secretary informs the applicant that the application has been filed; or 

(ii) if the certification is in an amendment or supplement 

to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether 

the applicant has already given notice with respect to another such certification contained in the application or in 

an amendment or supplement to the application. 

(C) RECIPIENTS OF NOTICE.—An applicant required under 

this paragraph to give notice shall give notice to— 

(i) each owner of the patent that is the subject of the certification (or a representative of the owner designated to 

receive such a notice); and 

(ii) the holder of the approved application under this 

subsection for the drug that is claimed by the patent or a 

use of which is claimed by the patent (or a representative 

of the holder designated to receive such a notice). 

(D) CONTENTS OF NOTICE.—A notice required under this 

paragraph shall— 

(i) state that an application that contains data from bioavailability or bioequivalence studies has been submitted 

under this subsection for the drug with respect to which 

the certification is made to obtain approval to engage in 

the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and 


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(ii) include a detailed statement of the factual and legal 

basis of the opinion of the applicant that the patent is invalid or will not be infringed. 

(4)(A) An applicant may not amend or supplement an application 

referred to in paragraph (2) to seek approval of a drug that is a 

different drug than the drug identified in the application as submitted to the Secretary. 

(B) With respect to the drug for which such an application is submitted, nothing in this subsection or subsection (c)(3) prohibits an 

applicant from amending or supplementing the application to seek 

approval of a different strength. 

(5)(A) The Secretary shall issue guidance for the individuals who 

review applications submitted under paragraph (1) or under section 

351 of the Public Health Service Act, which shall relate to promptness in conducting the review, technical excellence, lack of bias and 

conflict of interest, and knowledge of regulatory and scientific 

standards, and which shall apply equally to all individuals who review such applications. 

(B) The Secretary shall meet with a sponsor of an investigation 

or an applicant for approval for a drug under this subsection or section 351 of the Public Health Service Act if the sponsor or applicant 

makes a reasonable written request for a meeting for the purpose 

of reaching agreement on the design and size— 

(i)(I) of clinical trials intended to form the primary basis of 

an effectiveness claim; or 

(II) in the case where human efficacy studies are not ethical 

or feasible, of animal and any associated clinical trials which, 

in combination, are intended to form the primary basis of an 

effectiveness claim; or 

(ii) with respect to an application for approval of a biological 

product under section 351(k) of the Public Health Service Act, 

of any necessary clinical study or studies. 

The sponsor or applicant shall provide information necessary for 

discussion and agreement on the design and size of the clinical 

trials. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant upon request. 

(C) Any agreement regarding the parameters of the design and 

size of clinical trials of a new drug under this paragraph that is 

reached between the Secretary and a sponsor or applicant shall be 

reduced to writing and made part of the administrative record by 

the Secretary. Such agreement shall not be changed after the testing begins, except— 

(i) with the written agreement of the sponsor or applicant; 

or 

(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or 

effectiveness of the drug has been identified after the testing 

has begun. 

(D) A decision under subparagraph (C)(ii) by the director shall be 

in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the 

sponsor or applicant will be present and at which the director will 

document the scientific issue involved. 


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(E) The written decisions of the reviewing division shall be binding upon, and may not directly or indirectly be changed by, the 

field or compliance division personnel unless such field or compliance division personnel demonstrate to the reviewing division why 

such decision should be modified. 

(F) No action by the reviewing division may be delayed because 

of the unavailability of information from or action by field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe and effective drug. 

(G) For purposes of this paragraph, the reviewing division is the 

division responsible for the review of an application for approval of 

a drug under this subsection or section 351 of the Public Health 

Service Act (including all scientific and medical matters, chemistry, 

manufacturing, and controls). 

(6) An application submitted under this subsection shall be 

accompanied by the certification required under section 

402(j)(5)(B) of the Public Health Service Act. Such certification 

shall not be considered an element of such application. 

(c)(1) Within one hundred and eighty days after the filing of an 

application under subsection (b), or such additional period as may 

be agreed upon by the Secretary and the applicant, the Secretary 

shall either— 

(A) approve the application if he then finds that none of the 

grounds for denying approval specified in subsection (d) applies, or 

(B) give the applicant notice of an opportunity for a hearing 

before the Secretary under subsection (d) on the question 

whether such application is approvable. If the applicant elects 

to accept the opportunity for hearing by written request within 

thirty days after such notice, such hearing shall commence not 

more than ninety days after the expiration of such thirty days 

unless the Secretary and the applicant otherwise agree. Any 

such hearing shall thereafter be conducted on an expedited 

basis and the Secretary’s order thereon shall be issued within 

ninety days after the date fixed by the Secretary for filing final 

briefs. 

(2) If the patent information described in subsection (b) could not 

be filed with the submission of an application under subsection (b) 

because the application was filed before the patent information was 

required under subsection (b) or a patent was issued after the application was approved under such subsection, the holder of an approved application shall file with the Secretary, the patent number 

and the expiration date of any patent which fulfills the criteria in 

subsection (b) and claims the drug for which the application was 

submitted or which claims a method of using such drug and with 

respect to which a claim of patent infringement could reasonably 

be asserted if a person not licensed by the owner engaged in the 

manufacture, use, or sale of the drug. Patent information that is 

not the type of patent information required by subsection (b) shall 

not be submitted. If the holder of an approved application could not 

file patent information under subsection (b) because it was not required at the time the application was approved, the holder shall 

file such information under this subsection not later than thirty 

days after the date of the enactment of this sentence, and if the 

holder of an approved application could not file patent information 


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under subsection (b) because no patent of the type required to be 

submitted in subsection (b) had been issued when an application 

was filed or approved, the holder shall file such information under 

this subsection not later than thirty days after after the date the 

patent involved is issued. Upon the submission of patent information under this subsection, the Secretary shall publish it. 

(3) The approval of an application filed under subsection (b) 

which contains a certification required by paragraph (2) of such 

subsection shall be made effective on the last applicable date determined by applying the following to each certification made under 

subsection (b)(2)(A): 

(A) If the applicant only made a certification described in 

clause (i) or (ii) of subsection (b)(2)(A) or in both such clauses, 

the approval may be made effective immediately. 

(B) If the applicant made a certification described in clause 

(iii) of subsection (b)(2)(A), the approval may be made effective 

on the date certified under clause (iii). 

(C) If the applicant made a certification described in clause 

(iv) of subsection (b)(2)(A), the approval shall be made effective 

immediately unless, before the expiration of 45 days after the 

date on which the notice described in subsection (b)(3) is received, an action is brought for infringement of the patent that 

is the subject of the certification and for which information was 

submitted to the Secretary under paragraph (2) or subsection 

(b)(1) before the date on which the application (excluding an 

amendment or supplement to the application) was submitted. 

If such an action is brought before the expiration of such days, 

the approval may be made effective upon the expiration of the 

thirty-month period beginning on the date of the receipt of the 

notice provided under subsection (b)(3) or such shorter or 

longer period as the court may order because either party to 

the action failed to reasonably cooperate in expediting the action, except that— 

(i) if before the expiration of such period the district 

court decides that the patent is invalid or not infringed (including any substantive determination that there is no 

cause of action for patent infringement or invalidity), the 

approval shall be made effective on— 

(I) the date on which the court enters judgment reflecting the decision; or 

(II) the date of a settlement order or consent decree 

signed and entered by the court stating that the patent that is the subject of the certification is invalid or 

not infringed; 

(ii) if before the expiration of such period the district 

court decides that the patent has been infringed— 

(I) if the judgment of the district court is appealed, 

the approval shall be made effective on— 

(aa) the date on which the court of appeals decides that the patent is invalid or not infringed 

(including any substantive determination that 

there is no cause of action for patent infringement 

or invalidity); or 

(bb) the date of a settlement order or consent 

decree signed and entered by the court of appeals 


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stating that the patent that is the subject of the 

certification is invalid or not infringed; or 

(II) if the judgment of the district court is not appealed or is affirmed, the approval shall be made effective on the date specified by the district court in a 

court order under section 271(e)(4)(A) of title 35, 

United States Code; 

(iii) if before the expiration of such period the court 

grants a preliminary injunction prohibiting the applicant 

from engaging in the commercial manufacture or sale of 

the drug until the court decides the issues of patent validity and infringement and if the court decides that such 

patent is invalid or not infringed, the approval shall be 

made effective as provided in clause (i); or 

(iv) if before the expiration of such period the court 

grants a preliminary injunction prohibiting the applicant 

from engaging in the commercial manufacture or sale of 

the drug until the court decides the issues of patent validity and infringement and if the court decides that such 

patent has been infringed, the approval shall be made effective as provided in clause (ii). 

In such an action, each of the parties shall reasonably cooperate in expediting the action. 

(D) CIVIL ACTION TO OBTAIN PATENT CERTAINTY.— (i) DECLARATORY JUDGMENT ABSENT INFRINGEMENT AC- TION.— 

(I) IN GENERAL.—No action may be brought under 

section 2201 of title 28, United States Code, by an applicant referred to in subsection (b)(2) for a declaratory 

judgment with respect to a patent which is the subject 

of the certification referred to in subparagraph (C) unless— 

(aa) the 45-day period referred to in such subparagraph has expired; 

(bb) neither the owner of such patent nor the 

holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent 

brought a civil action against the applicant for infringement of the patent before the expiration of 

such period; and 

(cc) in any case in which the notice provided 

under paragraph (2)(B) relates to noninfringement, the notice was accompanied by a document 

described in subclause (III). 

(II) FILING OF CIVIL ACTION.—If the conditions described in items (aa), (bb), and as applicable, (cc) of 

subclause (I) have been met, the applicant referred to 

in such subclause may, in accordance with section 

2201 of title 28, United States Code, bring a civil action under such section against the owner or holder referred to in such subclause (but not against any owner 

or holder that has brought such a civil action against 

the applicant, unless that civil action was dismissed 

without prejudice) for a declaratory judgment that the 


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patent is invalid or will not be infringed by the drug 

for which the applicant seeks approval, except that 

such civil action may be brought for a declaratory 

judgment that the patent will not be infringed only in 

a case in which the condition described in subclause 

(I)(cc) is applicable. A civil action referred to in this 

subclause shall be brought in the judicial district 

where the defendant has its principal place of business 

or a regular and established place of business. 

(III) OFFER OF CONFIDENTIAL ACCESS TO APPLICA- TION.—For purposes of subclause (I)(cc), the document 

described in this subclause is a document providing an 

offer of confidential access to the application that is in 

the custody of the applicant referred to in subsection 

(b)(2) for the purpose of determining whether an action referred to in subparagraph (C) should be 

brought. The document providing the offer of confidential access shall contain such restrictions as to persons 

entitled to access, and on the use and disposition of 

any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business 

information. A request for access to an application 

under an offer of confidential access shall be considered acceptance of the offer of confidential access with 

the restrictions as to persons entitled to access, and on 

the use and disposition of any information accessed, 

contained in the offer of confidential access, and those 

restrictions and other terms of the offer of confidential 

access shall be considered terms of an enforceable contract. Any person provided an offer of confidential access shall review the application for the sole and limited purpose of evaluating possible infringement of the 

patent that is the subject of the certification under 

subsection (b)(2)(A)(iv) and for no other purpose, and 

may not disclose information of no relevance to any 

issue of patent infringement to any person other than 

a person provided an offer of confidential access. Further, the application may be redacted by the applicant 

to remove any information of no relevance to any issue 

of patent infringement. 

(ii) COUNTERCLAIM TO INFRINGEMENT ACTION.— 

(I) IN GENERAL.—If an owner of the patent or the 

holder of the approved application under subsection 

(b) for the drug that is claimed by the patent or a use 

of which is claimed by the patent brings a patent infringement action against the applicant, the applicant 

may assert a counterclaim seeking an order requiring 

the holder to correct or delete the patent information 

submitted by the holder under subsection (b) or this 

subsection on the ground that the patent does not 

claim either— 

(aa) the drug for which the application was approved; or 

(bb) an approved method of using the drug. 


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(II) NO INDEPENDENT CAUSE OF ACTION.—Subclause 

(I) does not authorize the assertion of a claim described in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I). 

(iii) NO DAMAGES.—An applicant shall not be entitled to 

damages in a civil action under clause (i) or a counterclaim 

under clause (ii). 

(E)(i) If an application (other than an abbreviated new drug 

application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application 

under subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment 

of this subsection, the Secretary may not make the approval of 

another application for a drug for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the 

applicant for approval of the application were not conducted by 

or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for 

whom the investigations were conducted effective before the 

expiration of ten years from the date of the approval of the application previously approved under subsection (b). 

(ii) If an application submitted under subsection (b) for a 

drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved after the date of the 

enactment of this clause, no application which refers to the 

drug for which the subsection (b) application was submitted 

and for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of 

the application were not conducted by or for the applicant and 

for which the applicant has not obtained a right of reference 

or use from the person by or for whom the investigations were 

conducted may be submitted under subsection (b) before the 

expiration of five years from the date of the approval of the application under subsection (b), except that such an application 

may be submitted under subsection (b) after the expiration of 

four years from the date of the approval of the subsection (b) 

application if it contains a certification of patent invalidity or 

noninfringement described in clause (iv) of subsection (b)(2)(A). 

The approval of such an application shall be made effective in 

accordance with this paragraph except that, if an action for 

patent infringement is commenced during the one-year period 

beginning forty-eight months after the date of the approval of 

the subsection (b) application, the thirty-month period referred 

to in subparagraph (C) shall be extended by such amount of 

time (if any) which is required for seven and one-half years to 

have elapsed from the date of approval of the subsection (b) application. 

(iii) If an application submitted under subsection (b) for a 

drug, which includes an active ingredient (including any ester 

or salt of the active ingredient) that has been approved in another application approved under subsection (b), is approved 

after the date of the enactment of this clause and if such appliVerDate Sep 11 2014 05:32 May 04, 2019 Jkt 089006 PO 00000 Frm 00017 Fmt 6659 Sfmt 6601 E:\HR\OC\HR047.XXX HR047

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cation contains reports of new clinical investigations (other 

than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted 

under subsection (b) for the conditions of approval of such drug 

in the approved subsection (b) application effective before the 

expiration of three years from the date of the approval of the 

application under subsection (b) if the investigations described 

in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or 

for the applicant and if the applicant has not obtained a right 

of reference or use from the person by or for whom the investigations were conducted. 

(iv) If a supplement to an application approved under subsection (b) is approved after the date of enactment of this 

clause and the supplement contains reports of new clinical investigations (other than bioavailabilty studies) essential to the 

approval of the supplement and conducted or sponsored by the 

person submitting the supplement, the Secretary may not 

make the approval of an application submitted under subsection (b) for a change approved in the supplement effective 

before the expiration of three years from the date of the approval of the supplement under subsection (b) if the investigations described in clause (A) of subsection (b)(1) and relied 

upon by the applicant for approval of the application were not 

conducted by or for the applicant and if the applicant has not 

obtained a right of reference or use from the person by or for 

whom the investigations were conducted. 

(v) If an application (or supplement to an application) submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application under 

subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this 

clause, the Secretary may not make the approval of an application submitted under this subsection and for which the investigations described in clause (A) of subsection (b)(1) and relied 

upon by the applicant for approval of the application were not 

conducted by or for the applicant and for which the applicant 

has not obtained a right of reference or use from the person 

by or for whom the investigations were conducted and which 

refers to the drug for which the subsection (b) application was 

submitted effective before the expiration of two years from the 

date of enactment of this clause. 

(4) A drug manufactured in a pilot or other small facility may be 

used to demonstrate the safety and effectiveness of the drug and 

to obtain approval for the drug prior to manufacture of the drug 

in a larger facility, unless the Secretary makes a determination 

that a full scale production facility is necessary to ensure the safety 

or effectiveness of the drug. 

(5)(A) The Secretary may rely upon qualified data summaries to 

support the approval of a supplemental application, with respect to 

a qualified indication for a drug, submitted under subsection (b), if 

such supplemental application complies with subparagraph (B). 


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(B) A supplemental application is eligible for review as described 

in subparagraph (A) only if— 

(i) there is existing data available and acceptable to the Secretary demonstrating the safety of the drug; and 

(ii) all data used to develop the qualified data summaries are 

submitted to the Secretary as part of the supplemental application. 

(C) The Secretary shall post on the Internet website of the Food 

and Drug Administration and update annually— 

(i) the number of applications reviewed solely under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service 

Act; 

(ii) the average time for completion of review under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service 

Act; 

(iii) the average time for review of supplemental applications 

where the Secretary did not use review flexibility under subparagraph (A) or section 351(a)(2)(E) of the Public Health Service Act; and 

(iv) the number of applications reviewed under subparagraph 

(A) or section 351(a)(2)(E) of the Public Health Service Act for 

which the Secretary made use of full data sets in addition to 

the qualified data summary. 

(D) In this paragraph— 

(i) the term ‘‘qualified indication’’ means an indication for a 

drug that the Secretary determines to be appropriate for summary level review under this paragraph; and 

(ii) the term ‘‘qualified data summary’’ means a summary of 

clinical data that demonstrates the safety and effectiveness of 

a drug with respect to a qualified indication. 

(d) If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a 

hearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by 

all methods reasonably applicable to show whether or not such 

drug is safe for use under the conditions prescribed, recommended, 

or suggested in the proposed labeling thereof; (2) the results of 

such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls 

used for, the manufacture, processing, and packing of such drug 

are inadequate to preserve its identity, strength, quality, and purity; (4) upon the basis of the information submitted to him as part 

of the application, or upon the basis of any other information before 

him with respect to such drug, he has insufficient information to 

determine whether such drug is safe for use under such conditions; 

or (5) evaluated on the basis of the information submitted to him 

as part of the application and any other information before him 

with respect to such drug, there is a lack of substantial evidence 

that the drug will have the effect it purports or is represented to 

have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) the application failed 

to contain the patent information prescribed by subsection (b); or 

(7) based on a fair evaluation of all material facts, such labeling is 


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false or misleading in any particular; he shall issue an order refusing to approve the application. If, after such notice and opportunity 

for hearing, the Secretary finds that clauses (1) through (6) do not 

apply, he shall issue an order approving the application. As used 

in this subsection and subsection (e), the term ‘‘substantial evidence’’ means evidence consisting of adequate and well-controlled 

investigations, including clinical investigations, by experts qualified 

by scientific training and experience to evaluate the effectiveness 

of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the 

effect it purports or is represented to have under the conditions of 

use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or 

after such investigation) are sufficient to establish effectiveness, 

the Secretary may consider such data and evidence to constitute 

substantial evidence for purposes of the preceding sentence. The 

Secretary shall implement a structured risk-benefit assessment 

framework in the new drug approval process to facilitate the balanced consideration of benefits and risks, a consistent and systematic approach to the discussion and regulatory decisionmaking, and 

the communication of the benefits and risks of new drugs. Nothing 

in the preceding sentence shall alter the criteria for evaluating an 

application for marketing approval of a drug. 

(e) The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds (1) that 

clinical or other experience, tests, or other scientific data show that 

such drug is unsafe for use under the conditions of use upon the 

basis of which the application was approved; (2) that new evidence 

of clinical experience, not contained in such application or not 

available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed 

reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the 

application was approved, shows that such drug is not shown to be 

safe for use under the conditions of use upon the basis of which the 

application was approved; or (3) on the basis of new information 

before him with respect to such drug, evaluated together with the 

evidence available to him when the application was approved, that 

there is a lack of substantial evidence that the drug will have the 

effect it purports or is represented to have under the conditions of 

use prescribed, recommended, or suggested in the labeling thereof; 

or (4) the patent information prescribed by subsection (c) was not 

filed within thirty days after the receipt of written notice from the 

Secretary specifying the failure to file such information; or (5) that 

the application contains any untrue statement of a material fact: 

Provided, That if the Secretary (or in his absence the officer acting 

as Secretary) finds that there is an imminent hazard to the public 

health, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under 

this subsection; but the authority conferred by this proviso to suspend the approval of an application shall not be delegated. The 


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Secretary may also, after due notice and opportunity for hearing to 

the applicant, withdraw the approval of an application submitted 

under subsection (b) or (j) with respect to any drug under this section if the Secretary finds (1) that the applicant has failed to establish a system for maintaining required records, or has repeatedly 

or deliberately failed to maintain such records or to make required 

reports, in accordance with a regulation or order under subsection 

(k) or to comply with the notice requirements of section 510(k)(2), 

or the applicant has refused to permit access to, or copying or 

verification of, such records as required by paragraph (2) of such 

subsection; or (2) that on the basis of new information before him, 

evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such 

drug are inadequate to assure and preserve its identity, strength, 

quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) that on the basis of new information before him, evaluated together with the evidence before 

him when the application was approved, the labeling of such drug, 

based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. Any order under this subsection 

shall state the findings upon which it is based. The Secretary may 

withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided 

under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation 

strategy for the drug under section 505–1(g)(2)(D). 

(f) Whenever the Secretary finds that the facts so require, he 

shall revoke any previous order under subsection (d) or (e) refusing, 

withdrawing, or suspending approval of an application and shall 

approve such application or reinstate such approval, as may be appropriate. 

(g) Orders of the Secretary issued under this section shall be 

served (1) in person by any officer or employee of the Department 

designated by the Secretary or (2) by mailing the order by registered mail or by certified mail addressed to the applicant or respondent at his last-known address in the records of the Secretary. 

(h) An appeal may be taken by the applicant from an order of 

the Secretary refusing or withdrawing approval of an application 

under this section. Such appeal shall be taken by filing in the 

United States court of appeals for the circuit wherein such applicant resides or has his principal place of business, or in the United 

States Court of Appeals for the District of Columbia Circuit, within 

sixty days after the entry of such order, a written petition praying 

that the order of the Secretary be set aside. A copy of such petition 

shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and 

thereupon the Secretary shall certify and file in the court the 

record upon which the order complained of was entered, as provided in section 2112 of title 28, United States Code. Upon the filing of such petition such court shall have exclusive jurisdiction to 

affirm or set aside such order, except that until the filing of the 


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record the Secretary may modify or set aside his order. No objection to the order of the Secretary shall be considered by the court 

unless such objection shall have been urged before the Secretary or 

unless there were reasonable grounds for failure so to do. The finding of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive. If any person shall apply to the court 

for leave to adduce additional evidence, and shall show to the satisfaction of the court that such additional evidence is material and 

that there were reasonable grounds for failure to adduce such evidence in the proceeding before the Secretary, the court may order 

such additional evidence to be taken before the Secretary and to be 

adduced upon the hearing in such manner and upon such terms 

and conditions as to the court may seem proper. The Secretary may 

modify his findings as to the facts by reason of the additional evidence so taken, and he shall file with the court such modified findings which, if supported by substantial evidence, shall be conclusive, and his recommendation, if any, for the setting aside of the 

original order. The judgment of the court affirming or setting aside 

any such order of the Secretary shall be final, subject to review by 

the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28 of the United States 

Code. The commencement of proceedings under this subsection 

shall not, unless specifically ordered by the court to the contrary, 

operate as a stay of the Secretary’s order. 

(i)(1) The Secretary shall promulgate regulations for exempting 

from the operation of the foregoing subsections of this section drugs 

intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Such regulations may, within the discretion of 

the Secretary, among other conditions relating to the protection of 

the public health, provide for conditioning such exemption upon— 

(A) the submission to the Secretary, before any clinical testing of a new drug is undertaken, of reports, by the manufacturer or the sponsor of the investigation of such drug, or preclinical tests (including tests on animals) of such drug adequate to justify the proposed clinical testing; 

(B) the manufacturer or the sponsor of the investigation of 

a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will 

be under his personal supervision, or under the supervision of 

investigators responsible to him, and that he will not supply 

such drug to any other investigator, or to clinics, for administration to human beings; 

(C) the establishment and maintenance of such records, and 

the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such drug, of data 

(including but not limited to analytical reports by investigators) obtained as the result of such investigational use of such 

drug, as the Secretary finds will enable him to evaluate the 

safety and effectiveness of such drug in the event of the filing 

of an application pursuant to subsection (b); and 

(D) the submission to the Secretary by the manufacturer 

or the sponsor of the investigation of a new drug of a statement of intent regarding whether the manufacturer or 


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sponsor has plans for assessing pediatric safety and efficacy. 

(2) Subject to paragraph (3), a clinical investigation of a new 

drug may begin 30 days after the Secretary has received from the 

manufacturer or sponsor of the investigation a submission containing such information about the drug and the clinical investigation, including— 

(A) information on design of the investigation and adequate 

reports of basic information, certified by the applicant to be accurate reports, necessary to assess the safety of the drug for 

use in clinical investigation; and 

(B) adequate information on the chemistry and manufacturing of the drug, controls available for the drug, and primary 

data tabulations from animal or human studies. 

(3)(A) At any time, the Secretary may prohibit the sponsor of an 

investigation from conducting the investigation (referred to in this 

paragraph as a ‘‘clinical hold’’) if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the 

basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical 

hold, and confirm such determination in writing. 

(B) For purposes of subparagraph (A), a determination described 

in this subparagraph with respect to a clinical hold is that— 

(i) the drug involved represents an unreasonable risk to the 

safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical 

investigators, information about the drug, the design of the 

clinical investigation, the condition for which the drug is to be 

investigated, and the health status of the subjects involved; or 

(ii) the clinical hold should be issued for such other reasons 

as the Secretary may by regulation establish (including reasons established by regulation before the date of the enactment 

of the Food and Drug Administration Modernization Act of 

1997). 

(C) Any written request to the Secretary from the sponsor of an 

investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days 

after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold. 

(4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for 

investigational purposes certify to such manufacturer or sponsor 

that they will inform any human beings to whom such drugs, or 

any controls used in connection therewith, are being administered, 

or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human 

beings or their representatives, except where it is not feasible, it 

is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such 

human beings and includes appropriate safeguards as prescribed to 

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tions to require inclusion in the informed consent documents and 

process a statement that clinical trial information for such clinical 

investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act. 

(j)(1) Any person may file with the Secretary an abbreviated application for the approval of a new drug. 

(2)(A) An abbreviated application for a new drug shall contain— 

(i) information to show that the conditions of use prescribed, 

recommended, or suggested in the labeling proposed for the 

new drug have been previously approved for a drug listed 

under paragraph (7) (hereinafter in this subsection referred to 

as a ‘‘listed drug’’); 

(ii)(I) if the listed drug referred to in clause (i) has only one 

active ingredient, information to show that the active ingredient of the new drug is the same as that of the listed drug; 

(II) if the listed drug referred to in clause (i) has more than 

one active ingredient, information to show that the active ingredients of the new drug are the same as those of the listed 

drug, or 

(III) if the listed drug referred to in clause (i) has more than 

one active ingredient and if one of the active ingredients of the 

new drug is different and the application is filed pursuant to 

the approval of a petition filed under subparagraph (C), information to show that the other active ingredients of the new 

drug are the same as the active ingredients of the listed drug, 

information to show that the different active ingredient is an 

active ingredient of a listed drug or of a drug which does not 

meet the requirements of section 201(p), and such other information respecting the different active ingredient with respect 

to which the petition was filed as the Secretary may require; 

(iii) information to show that the route of administration, the 

dosage form, and the strength of the new drug are the same 

as those of the listed drug referred to in clause (i) or, if the 

route of administration, the dosage form, or the strength of the 

new drug is different and the application is filed pursuant to 

the approval of a petition filed under subparagraph (C), such 

information respecting the route of administration, dosage 

form, or strength with respect to which the petition was filed 

as the Secretary may require; 

(iv) information to show that the new drug is bioequivalent 

to the listed drug referred to in clause (i), except that if the application is filed pursuant to the approval of a petition filed 

under subparagraph (C), information to show that the active 

ingredients of the new drug are of the same pharmacological 

or therapeutic class as those of the listed drug referred to in 

clause (i) and the new drug can be expected to have the same 

therapeutic effect as the listed drug when administered to patients for a condition of use referred to in clause (i); 

(v) information to show that the labeling proposed for the 

new drug is the same as the labeling approved for the listed 

drug referred to in clause (i) except for changes required because of differences approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are 

produced or distributed by different manufacturers; 


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(vi) the items specified in clauses (B) through (F) of subsection (b)(1); 

(vii) a certification, in the opinion of the applicant and to the 

best of his knowledge, with respect to each patent which claims 

the listed drug referred to in clause (i) or which claims a use 

for such listed drug for which the applicant is seeking approval 

under this subsection and for which information is required to 

be filed under subsection (b) or (c)— 

(I) that such patent information has not been filed, 

(II) that such patent has expired, 

(III) of the date on which such patent will expire, or 

(IV) that such patent is invalid or will not be infringed 

by the manufacture, use, or sale of the new drug for which 

the application is submitted; and 

(viii) if with respect to the listed drug referred to in clause 

(i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement 

that the method of use patent does not claim such a use. 

The Secretary may not require that an abbreviated application contain information in addition to that required by clauses (i) through 

(viii). 

(B) NOTICE OF OPINION THAT PATENT IS INVALID OR WILL NOT BE

INFRINGED.— (i) AGREEMENT TO GIVE NOTICE.—An applicant that makes a 

certification described in subparagraph (A)(vii)(IV) shall include in the application a statement that the applicant will 

give notice as required by this subparagraph. 

(ii) TIMING OF NOTICE.—An applicant that makes a certification described in subparagraph (A)(vii)(IV) shall give notice 

as required under this subparagraph— 

(I) if the certification is in the application, not later than 

20 days after the date of the postmark on the notice with 

which the Secretary informs the applicant that the application has been filed; or 

(II) if the certification is in an amendment or supplement to the application, at the time at which the applicant 

submits the amendment or supplement, regardless of 

whether the applicant has already given notice with respect to another such certification contained in the application or in an amendment or supplement to the application. 

(iii) RECIPIENTS OF NOTICE.—An applicant required under 

this subparagraph to give notice shall give notice to— 

(I) each owner of the patent that is the subject of the 

certification (or a representative of the owner designated 

to receive such a notice); and 

(II) the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a 

use of which is claimed by the patent (or a representative 

of the holder designated to receive such a notice). 

(iv) CONTENTS OF NOTICE.—A notice required under this subparagraph shall— 

(I) state that an application that contains data from bioavailability or bioequivalence studies has been submitted 

under this subsection for the drug with respect to which 


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the certification is made to obtain approval to engage in 

the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and 

(II) include a detailed statement of the factual and legal 

basis of the opinion of the applicant that the patent is invalid or will not be infringed. 

(C) If a person wants to submit an abbreviated application for a 

new drug which has a different active ingredient or whose route of 

administration, dosage form, or strength differ from that of a listed 

drug, such person shall submit a petition to the Secretary seeking 

permission to file such an application. The Secretary shall approve 

or disapprove a petition submitted under this subparagraph within 

ninety days of the date the petition is submitted. The Secretary 

shall approve such a petition unless the Secretary finds— 

(i) that investigations must be conducted to show the safety 

and effectiveness of the drug or of any of its active ingredients, 

the route of administration, the dosage form, or strength which 

differ from the listed drug; or 

(ii) that any drug with a different active ingredient may not 

be adequately evaluated for approval as safe and effective on 

the basis of the information required to be submitted in an abbreviated application. 

(D)(i) An applicant may not amend or supplement an application 

to seek approval of a drug referring to a different listed drug from 

the listed drug identified in the application as submitted to the 

Secretary. 

(ii) With respect to the drug for which an application is submitted, nothing in this subsection prohibits an applicant from 

amending or supplementing the application to seek approval of a 

different strength. 

(iii) Within 60 days after the date of the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 

2003, the Secretary shall issue guidance defining the term ‘‘listed 

drug’’ for purposes of this subparagraph. 

(3)(A) The Secretary shall issue guidance for the individuals who 

review applications submitted under paragraph (1), which shall relate to promptness in conducting the review, technical excellence, 

lack of bias and conflict of interest, and knowledge of regulatory 

and scientific standards, and which shall apply equally to all individuals who review such applications. 

(B) The Secretary shall meet with a sponsor of an investigation 

or an applicant for approval for a drug under this subsection if the 

sponsor or applicant makes a reasonable written request for a 

meeting for the purpose of reaching agreement on the design and 

size of bioavailability and bioequivalence studies needed for approval of such application. The sponsor or applicant shall provide 

information necessary for discussion and agreement on the design 

and size of such studies. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant. 

(C) Any agreement regarding the parameters of design and size 

of bioavailability and bioequivalence studies of a drug under this 

paragraph that is reached between the Secretary and a sponsor or 

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istrative record by the Secretary. Such agreement shall not be 

changed after the testing begins, except— 

(i) with the written agreement of the sponsor or applicant; 

or 

(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or 

effectiveness of the drug has been identified after the testing 

has begun. 

(D) A decision under subparagraph (C)(ii) by the director shall be 

in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the 

sponsor or applicant will be present and at which the director will 

document the scientific issue involved. 

(E) The written decisions of the reviewing division shall be binding upon, and may not directly or indirectly be changed by, the 

field or compliance office personnel unless such field or compliance 

office personnel demonstrate to the reviewing division why such decision should be modified. 

(F) No action by the reviewing division may be delayed because 

of the unavailability of information from or action by field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe and effective drug. 

(G) For purposes of this paragraph, the reviewing division is the 

division responsible for the review of an application for approval of 

a drug under this subsection (including scientific matters, chemistry, manufacturing, and controls). 

(4) Subject to paragraph (5), the Secretary shall approve an application for a drug unless the Secretary finds— 

(A) the methods used in, or the facilities and controls used 

for, the manufacture, processing, and packing of the drug are 

inadequate to assure and preserve its identity, strength, quality, and purity; 

(B) information submitted with the application is insufficient 

show that each of the proposed conditions of use have been 

previously approved for the listed drug referred to in the application; 

(C)(i) if the listed drug has only one active ingredient, information submitted with the application is insufficient to show 

that the active ingredient is the same as that of the listed 

drug; 

(ii) if the listed drug has more than one active ingredient, information submitted with the application is insufficient to 

show that the active ingredients are the same as the active ingredients of the listed drug, or 

(iii) if the listed drug has more than one active ingredient 

and if the application is for a drug which has an active ingredient different from the listed drug, information submitted 

with the application is insufficient to show— 

(I) that the other active ingredients are the same as the 

active ingredients of the listed drug, or 

(II) that the different active ingredient is an active ingredient of a listed drug or a drug which does not meet the 

requirements of section 201(p), 


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or no petition to file an application for the drug with the different ingredient was approved under paragraph (2)(C); 

(D)(i) if the application is for a drug whose route of administration, dosage form, or strength of the drug is the same as the 

route of administration, dosage form, or strength of the listed 

drug referred to in the application, information submitted in 

the application is insufficient to show that the route of administration, dosage form, or strength is the same as that of the 

listed drug, or 

(ii) if the application is for a drug whose route of administration, dosage form, or strength of the drug is different from that 

of the listed drug referred to in the application, no petition to 

file an application for the drug with the different route of administration, dosage form, or strength was approved under 

paragraph (2)(C); 

(E) if the application was filed pursuant to the approval of 

a petition under paragraph (2)(C), the application did not contain the information required by the Secretary respecting the 

active ingredient, route of administration, dosage form, or 

strength which is not the same; 

(F) information submitted in the application is insufficient to 

show that the drug is bioequivalent to the listed drug referred 

to in the application or, if the application was filed pursuant 

to a petition approved under paragraph (2)(C), information 

submitted in the application is insufficient to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in paragraph (2)(A)(i) and that the new drug can be 

expected to have the same therapeutic effect as the listed drug 

when administered to patients for a condition of use referred 

to in such paragraph; 

(G) information submitted in the application is insufficient to 

show that the labeling proposed for the drug is the same as the 

labeling approved for the listed drug referred to in the application except for changes required because of differences approved under a petition filed under paragraph (2)(C) or because 

the drug and the listed drug are produced or distributed by different manufacturers; 

(H) information submitted in the application or any other information available to the Secretary shows that (i) the inactive 

ingredients of the drug are unsafe for use under the conditions 

prescribed, recommended, or suggested in the labeling proposed for the drug, or (ii) the composition of the drug is unsafe 

under such conditions because of the type or quantity of inactive ingredients included or the manner in which the inactive 

ingredients are included; 

(I) the approval under subsection (c) of the listed drug referred to in the application under this subsection has been 

withdrawn or suspended for grounds described in the first sentence of subsection (e), the Secretary has published a notice of 

opportunity for hearing to withdraw approval of the listed drug 

under subsection (c) for grounds described in the first sentence 

of subsection (e), the approval under this subsection of the listed drug referred to in the application under this subsection has 

been withdrawn or suspended under paragraph (6), or the SecVerDate Sep 11 2014 05:32 May 04, 2019 Jkt 089006 PO 00000 Frm 00028 Fmt 6659 Sfmt 6601 E:\HR\OC\HR047.XXX HR047

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retary has determined that the listed drug has been withdrawn 

from sale for safety or effectiveness reasons; 

(J) the application does not meet any other requirement of 

paragraph (2)(A); or 

(K) the application contains an untrue statement of material 

fact. 

(5)(A) Within one hundred and eighty days of the initial receipt 

of an application under paragraph (2) or within such additional period as may be agreed upon by the Secretary and the applicant, the 

Secretary shall approve or disapprove the application. 

(B) The approval of an application submitted under paragraph 

(2) shall be made effective on the last applicable date determined 

by applying the following to each certification made under paragraph (2)(A)(vii): 

(i) If the applicant only made a certification described in subclause (I) or (II) of paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective immediately. 

(ii) If the applicant made a certification described in subclause (III) of paragraph (2)(A)(vii), the approval may be made 

effective on the date certified under subclause (III). 

(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made 

effective immediately unless, before the expiration of 45 days 

after the date on which the notice described in paragraph 

(2)(B) is received, an action is brought for infringement of the 

patent that is the subject of the certification and for which information was submitted to the Secretary under subsection 

(b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which 

the Secretary later determines to be substantially complete, 

was submitted. If such an action is brought before the expiration of such days, the approval shall be made effective upon 

the expiration of the thirty-month period beginning on the date 

of the receipt of the notice provided under paragraph (2)(B)(i) 

or such shorter or longer period as the court may order because 

either party to the action failed to reasonably cooperate in expediting the action, except that— 

(I) if before the expiration of such period the district 

court decides that the patent is invalid or not infringed (including any substantive determination that there is no 

cause of action for patent infringement or invalidity), the 

approval shall be made effective on— 

(aa) the date on which the court enters judgment reflecting the decision; or 

(bb) the date of a settlement order or consent decree 

signed and entered by the court stating that the patent that is the subject of the certification is invalid or 

not infringed; 

(II) if before the expiration of such period the district 

court decides that the patent has been infringed— 

(aa) if the judgment of the district court is appealed, 

the approval shall be made effective on— 

(AA) the date on which the court of appeals decides that the patent is invalid or not infringed 

(including any substantive determination that 


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there is no cause of action for patent infringement 

or invalidity); or 

(BB) the date of a settlement order or consent 

decree signed and entered by the court of appeals 

stating that the patent that is the subject of the 

certification is invalid or not infringed; or 

(bb) if the judgment of the district court is not appealed or is affirmed, the approval shall be made effective on the date specified by the district court in a 

court order under section 271(e)(4)(A) of title 35, 

United States Code; 

(III) if before the expiration of such period the court 

grants a preliminary injunction prohibiting the applicant 

from engaging in the commercial manufacture or sale of 

the drug until the court decides the issues of patent validity and infringement and if the court decides that such 

patent is invalid or not infringed, the approval shall be 

made effective as provided in subclause (I); or 

(IV) if before the expiration of such period the court 

grants a preliminary injunction prohibiting the applicant 

from engaging in the commercial manufacture or sale of 

the drug until the court decides the issues of patent validity and infringement and if the court decides that such 

patent has been infringed, the approval shall be made effective as provided in subclause (II). 

In such an action, each of the parties shall reasonably cooperate in expediting the action. 

(iv) 180-DAY EXCLUSIVITY PERIOD.— (I) EFFECTIVENESS OF APPLICATION.—Subject to subparagraph (D), if the application contains a certification described in paragraph (2)(A)(vii)(IV) and is for a drug for 

which a first applicant has submitted an application containing such a certification, the application shall be made 

effective on the date that is 180 days after the date of the 

first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant. 

(II) DEFINITIONS.—In this paragraph: 

(aa) 180-DAY EXCLUSIVITY PERIOD.—The term ‘‘180- 

day exclusivity period’’ means the 180-day period ending on the day before the date on which an application 

submitted by an applicant other than a first applicant 

could become effective under this clause. 

(bb) FIRST APPLICANT.—As used in this subsection, 

the term ‘‘first applicant’’ means an applicant that, on 

the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a 

drug, submits a substantially complete application 

that contains and lawfully maintains a certification 

described in paragraph (2)(A)(vii)(IV) for the drug. 

(cc) SUBSTANTIALLY COMPLETE APPLICATION.—As 

used in this subsection, the term ‘‘substantially complete application’’ means an application under this 

subsection that on its face is sufficiently complete to 


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permit a substantive review and contains all the information required by paragraph (2)(A). 

(dd) TENTATIVE APPROVAL.— 

(AA) IN GENERAL.—The term ‘‘tentative approval’’ means notification to an applicant by the 

Secretary that an application under this subsection meets the requirements of paragraph 

(2)(A), but cannot receive effective approval because the application does not meet the requirements of this subparagraph, there is a period of 

exclusivity for the listed drug under subparagraph 

(F) or section 505A, or there is a 7-year period of 

exclusivity for the listed drug under section 527. 

(BB) LIMITATION.—A drug that is granted tentative approval by the Secretary is not an approved drug and shall not have an effective approval until the Secretary issues an approval after 

any necessary additional review of the application. 

(v) 180-DAY EXCLUSIVITY PERIOD FOR COMPETITIVE GENERIC

THERAPIES.— 

(I) EFFECTIVENESS OF APPLICATION.—Subject to subparagraph (D)(iv), if the application is for a drug that is the 

same as a competitive generic therapy for which any first 

approved applicant has commenced commercial marketing, 

the application shall be made effective on the date that is 

180 days after the date of the first commercial marketing 

of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant. 

(II) LIMITATION.—The exclusivity period under subclause 

(I) shall not apply with respect to a competitive generic 

therapy that has previously received an exclusivity period 

under subclause (I). 

(III) DEFINITIONS.—In this clause and subparagraph 

(D)(iv): 

(aa) The term ‘‘competitive generic therapy’’ means 

a drug— 

(AA) that is designated as a competitive generic 

therapy under section 506H; and 

(BB) for which there are no unexpired patents 

or exclusivities on the list of products described in 

section 505(j)(7)(A) at the time of submission. 

(bb) The term ‘‘first approved applicant’’ means any 

applicant that has submitted an application that— 

(AA) is for a competitive generic therapy that is 

approved on the first day on which any application for such competitive generic therapy is approved; 

(BB) is not eligible for a 180-day exclusivity period under clause (iv) for the drug that is the subject of the application for the competitive generic 

therapy; and 

(CC) is not for a drug for which all drug 

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clusivity period under clause (iv) pursuant to subparagraph (D). 

(C) CIVIL ACTION TO OBTAIN PATENT CERTAINTY.— (i) DECLARATORY JUDGMENT ABSENT INFRINGEMENT AC- TION.— 

(I) IN GENERAL.—No action may be brought under 

section 2201 of title 28, United States Code, by an applicant under paragraph (2) for a declaratory judgment with respect to a patent which is the subject of 

the certification referred to in subparagraph (B)(iii) 

unless— 

(aa) the 45-day period referred to in such subparagraph has expired; 

(bb) neither the owner of such patent nor the 

holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent 

brought a civil action against the applicant for infringement of the patent before the expiration of 

such period; and 

(cc) in any case in which the notice provided 

under paragraph (2)(B) relates to noninfringement, the notice was accompanied by a document 

described in subclause (III). 

(II) FILING OF CIVIL ACTION.—If the conditions described in items (aa), (bb), and as applicable, (cc) of 

subclause (I) have been met, the applicant referred to 

in such subclause may, in accordance with section 

2201 of title 28, United States Code, bring a civil action under such section against the owner or holder referred to in such subclause (but not against any owner 

or holder that has brought such a civil action against 

the applicant, unless that civil action was dismissed 

without prejudice) for a declaratory judgment that the 

patent is invalid or will not be infringed by the drug 

for which the applicant seeks approval, except that 

such civil action may be brought for a declaratory 

judgment that the patent will not be infringed only in 

a case in which the condition described in subclause 

(I)(cc) is applicable. A civil action referred to in this 

subclause shall be brought in the judicial district 

where the defendant has its principal place of business 

or a regular and established place of business. 

(III) OFFER OF CONFIDENTIAL ACCESS TO APPLICATION.—For purposes of subclause (I)(cc), the document 

described in this subclause is a document providing an 

offer of confidential access to the application that is in 

the custody of the applicant under paragraph (2) for 

the purpose of determining whether an action referred 

to in subparagraph (B)(iii) should be brought. The document providing the offer of confidential access shall 

contain such restrictions as to persons entitled to access, and on the use and disposition of any information 

accessed, as would apply had a protective order been 

entered for the purpose of protecting trade secrets and 


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other confidential business information. A request for 

access to an application under an offer of confidential 

access shall be considered acceptance of the offer of 

confidential access with the restrictions as to persons 

entitled to access, and on the use and disposition of 

any information accessed, contained in the offer of confidential access, and those restrictions and other terms 

of the offer of confidential access shall be considered 

terms of an enforceable contract. Any person provided 

an offer of confidential access shall review the application for the sole and limited purpose of evaluating possible infringement of the patent that is the subject of 

the certification under paragraph (2)(A)(vii)(IV) and 

for no other purpose, and may not disclose information 

of no relevance to any issue of patent infringement to 

any person other than a person provided an offer of 

confidential access. Further, the application may be 

redacted by the applicant to remove any information 

of no relevance to any issue of patent infringement. 

(ii) COUNTERCLAIM TO INFRINGEMENT ACTION.— 

(I) IN GENERAL.—If an owner of the patent or the 

holder of the approved application under subsection 

(b) for the drug that is claimed by the patent or a use 

of which is claimed by the patent brings a patent infringement action against the applicant, the applicant 

may assert a counterclaim seeking an order requiring 

the holder to correct or delete the patent information 

submitted by the holder under subsection (b) or (c) on 

the ground that the patent does not claim either— 

(aa) the drug for which the application was approved; or 

(bb) an approved method of using the drug. 

(II) NO INDEPENDENT CAUSE OF ACTION.—Subclause 

(I) does not authorize the assertion of a claim described in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I). 

(iii) NO DAMAGES.—An applicant shall not be entitled to 

damages in a civil action under clause (i) or a counterclaim 

under clause (ii). 

(D) FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.— 

(i) DEFINITION OF FORFEITURE EVENT.—In this subparagraph, the term ‘‘forfeiture event’’, with respect to an application under this subsection, means the occurrence of 

any of the following: 

(I) FAILURE TO MARKET.—The first applicant fails to 

market the drug by the later of— 

(aa) the earlier of the date that is— 

(AA) 75 days after the date on which the 

approval of the application of the first applicant is made effective under subparagraph 

(B)(iii); or 

(BB) 30 months after the date of submission 

of the application of the first applicant; or 


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(bb) with respect to the first applicant or any 

other applicant (which other applicant has received tentative approval), the date that is 75 

days after the date as of which, as to each of the 

patents with respect to which the first applicant 

submitted and lawfully maintained a certification 

qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at 

least 1 of the following has occurred: 

(AA) In an infringement action brought 

against that applicant with respect to the patent or in a declaratory judgment action 

brought by that applicant with respect to the 

patent, a court enters a final decision from 

which no appeal (other than a petition to the 

Supreme Court for a writ of certiorari) has 

been or can be taken that the patent is invalid or not infringed. 

(BB) In an infringement action or a declaratory judgment action described in subitem 

(AA), a court signs a settlement order or consent decree that enters a final judgment that 

includes a finding that the patent is invalid or 

not infringed. 

(CC) The patent information submitted 

under subsection (b) or (c) is withdrawn by 

the holder of the application approved under 

subsection (b). 

(II) WITHDRAWAL OF APPLICATION.—The first applicant withdraws the application or the Secretary considers the application to have been withdrawn as a result of a determination by the Secretary that the application does not meet the requirements for approval 

under paragraph (4). 

(III) AMENDMENT OF CERTIFICATION.—The first applicant amends or withdraws the certification for all of 

the patents with respect to which that applicant submitted a certification qualifying the applicant for the 

180-day exclusivity period. 

(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The 

first applicant fails to obtain tentative approval of the 

application within 30 months after the date on which 

the application is filed, unless the failure is caused by 

a change in or a review of the requirements for approval of the application imposed after the date on 

which the application is filed. 

(V) AGREEMENT WITH ANOTHER APPLICANT, THE LIST- ED DRUG APPLICATION HOLDER, OR A PATENT OWNER.— 

The first applicant enters into an agreement with another applicant under this subsection for the drug, the 

holder of the application for the listed drug, or an 

owner of the patent that is the subject of the certification under paragraph (2)(A)(vii)(IV), the Federal 

Trade Commission or the Attorney General files a 

complaint, and there is a final decision of the Federal 


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35 

Trade Commission or the court with regard to the 

complaint from which no appeal (other than a petition 

to the Supreme Court for a writ of certiorari) has been 

or can be taken that the agreement has violated the 

antitrust laws (as defined in section 1 of the Clayton 

Act (15 U.S.C. 12), except that the term includes section 5 of the Federal Trade Commission Act (15 U.S.C. 

45) to the extent that that section applies to unfair 

methods of competition). 

(VI) EXPIRATION OF ALL PATENTS.—All of the patents 

as to which the applicant submitted a certification 

qualifying it for the 180-day exclusivity period have 

expired. 

(ii) FORFEITURE.—The 180-day exclusivity period described in subparagraph (B)(iv) shall be forfeited by a first 

applicant if a forfeiture event occurs with respect to that 

first applicant. 

(iii) SUBSEQUENT APPLICANT.—If all first applicants forfeit the 180-day exclusivity period under clause (ii)— 

(I) approval of any application containing a certification described in paragraph (2)(A)(vii)(IV) shall be 

made effective in accordance with subparagraph 

(B)(iii); and 

(II) no applicant shall be eligible for a 180-day exclusivity period. 

(iv) SPECIAL FORFEITURE RULE FOR COMPETITIVE GENERIC

THERAPY.—The 180-day exclusivity period described in 

subparagraph (B)(v) shall be forfeited by a first approved 

applicant if the applicant fails to market the competitive 

generic therapy within 75 days after the date on which the 

approval of the first approved applicant’s application for 

the competitive generic therapy is made effective. 

(E) If the Secretary decides to disapprove an application, the Secretary shall give the applicant notice of an opportunity for a hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity 

for hearing by written request within thirty days after such notice, 

such hearing shall commence not more than ninety days after the 

expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon 

shall be issued within ninety days after the date fixed by the Secretary for filing final briefs. 

(F)(i) If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of 

which has been approved in any other application under subsection 

(b), was approved during the period beginning January 1, 1982, 

and ending on the date of the enactment of this subsection, the 

Secretary may not make the approval of an application submitted 

under this subsection which refers to the drug for which the subsection (b) application was submitted effective before the expiration 

of ten years from the date of the approval of the application under 

subsection (b). 


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(ii) If an application submitted under subsection (b) for a drug, 

no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under 

subsection (b), is approved after the date of the enactment of this 

subsection, no application may be submitted under this subsection 

which refers to the drug for which the subsection (b) application 

was submitted before the expiration of five years from the date of 

the approval of the application under subsection (b), except that 

such an application may be submitted under this subsection after 

the expiration of four years from the date of the approval of the 

subsection (b) application if it contains a certification of patent invalidity or noninfringement described in subclause (IV) of paragraph (2)(A)(vii). The approval of such an application shall be made 

effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of 

the subsection (b) application, the thirty-month period referred to 

in subparagraph (B)(iii) shall be extended by such amount of time 

(if any) which is required for seven and one-half years to have 

elapsed from the date of approval of the subsection (b) application. 

(iii) If an application submitted under subsection (b) for a drug, 

which includes an active ingredient (including any ester or salt of 

the active ingredient) that has been approved in another application approved under subsection (b), is approved after the date of 

enactment of this subsection and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or 

sponsored by the applicant, the Secretary may not make the approval of an application submitted under this subsection for the 

conditions of approval of such drug in the subsection (b) application 

effective before the expiration of three years from the date of the 

approval of the application under subsection (b) for such drug. 

(iv) If a supplement to an application approved under subsection 

(b) is approved after the date of enactment of this subsection and 

the supplement contains reports of new clinical investigations 

(other than bioavailability studies) essential to the approval of the 

supplement and conducted or sponsored by the person submitting 

the supplement, the Secretary may not make the approval of an 

application submitted under this subsection for a change approved 

in the supplement effective before the expiration of three years 

from the date of the approval of the supplement under subsection 

(b). 

(v) If an application (or supplement to an application) submitted 

under subsection (b) for a drug, which includes an active ingredient 

(including any ester or salt of the active ingredient) that has been 

approved in another application under subsection (b), was approved 

during the period beginning January 1, 1982, and ending on the 

date of the enactment of this subsection, the Secretary may not 

make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted or which refers to a change approved in a 

supplement to the subsection (b) application effective before the expiration of two years from the date of enactment of this subsection. 

(6) If a drug approved under this subsection refers in its approved application to a drug the approval of which was withdrawn 


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or suspended for grounds described in the first sentence of subsection (e) or was withdrawn or suspended under this paragraph 

or which, as determined by the Secretary, has been withdrawn 

from sale for safety or effectiveness reasons, the approval of the 

drug under this subsection shall be withdrawn or suspended— 

(A) for the same period as the withdrawal or suspension 

under subsection (e) or this paragraph, or 

(B) if the listed drug has been withdrawn from sale, for the 

period of withdrawal from sale or, if earlier, the period ending 

on the date the Secretary determines that the withdrawal from 

sale is not for safety or effectiveness reasons. 

(7)(A)(i) Within sixty days of the date of the enactment of this 

subsection, the Secretary shall publish and make available to the 

public— 

(I) a list in alphabetical order of the official and proprietary 

name of each drug which has been approved for safety and effectiveness under subsection (c) before the date of the enactment of this subsection; 

(II) the date of approval if the drug is approved after 1981 

and the number of the application which was approved; and 

(III) whether in vitro or in vivo bioequivalence studies, or 

both such studies, are required for applications filed under this 

subsection which will refer to the drug published. 

(ii) Every thirty days after the publication of the first list under 

clause (i) the Secretary shall revise the list to include each drug 

which has been approved for safety and effectiveness under subsection (c) or approved under this subsection during the thirty-day 

period. 

(iii) When patent information submitted under subsection (b) or 

(c) respecting a drug included on the list is to be published by the 

Secretary, the Secretary shall, in revisions made under clause (ii), 

include such information for such drug. 

(iv) For each drug included on the list, the Secretary shall specify 

each exclusivity period that is applicable and has not concluded 

under— 

(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) of this section; 

(II) clause (iv) or (v) of paragraph (5)(B) of this subsection; 

(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of this subsection; 

(IV) section 505A; 

(V) section 505E; or 

(VI) section 527(a). 

(B) A drug approved for safety and effectiveness under subsection 

(c) or approved under this subsection shall, for purposes of this 

subsection, be considered to have been published under subparagraph (A) on the date of its approval or the date of enactment, 

whichever is later. 

(C) If the approval of a drug was withdrawn or suspended for 

grounds described in the first sentence of subsection (e) or was 

withdrawn or suspended under paragraph (6) or if the Secretary 

determines that a drug has been withdrawn from sale for safety or 

effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its 


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publication in such list, it shall be immediately removed from such 

list— 

(i) for the same period as the withdrawal or suspension 

under subsection (e) or paragraph (6), or 

(ii) if the listed drug has been withdrawn from sale, for the 

period of withdrawal from sale or, if earlier, the period ending 

on the date the Secretary determines that the withdrawal from 

sale is not for safety or effectiveness reasons. 

A notice of the removal shall be published in the Federal Register. 

(D)(i) The holder of an application approved under subsection (c) 

for a drug on the list shall notify within 14 days the Secretary in 

writing if either of the following occurs: 

(I) The Patent Trial and Appeals Board issues a decision 

from which no appeal has been or can be taken that a patent 

for such drug is invalid. 

(II) A court issues a decision from which no appeal has been 

or can be taken that a patent for such drug is invalid. 

(ii) The holder of an approved application shall include in any 

notification under clause (i) a copy of the decision described in subclause (I) or (II) of clause (i). 

(iii) The Secretary shall remove from the list any patent that is 

determined to be invalid in a decision described in subclause (I) or 

(II) of clause (i)— 

(I) promptly; but 

(II) not before the expiration of any 180-day exclusivity period 

under paragraph (5)(B)(iv) that relies on a certification described in paragraph (2)(A)(vii)(IV) that such patent was invalid. 

(8) For purposes of this subsection: 

(A)(i) The term ‘‘bioavailability’’ means the rate and extent 

to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug 

action. 

(ii) For a drug that is not intended to be absorbed into the 

bloodstream, the Secretary may assess bioavailability by scientifically valid measurements intended to reflect the rate and 

extent to which the active ingredient or therapeutic ingredient 

becomes available at the site of drug action. 

(B) A drug shall be considered to be bioequivalent to a listed 

drug if— 

(i) the rate and extent of absorption of the drug do not 

show a significant difference from the rate and extent of 

absorption of the listed drug when administered at the 

same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or 

(ii) the extent of absorption of the drug does not show a 

significant difference from the extent of absorption of the 

listed drug when administered at the same molar dose of 

the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses and the 

difference from the listed drug in the rate of absorption of 

the drug is intentional, is reflected in its proposed labeling, 

is not essential to the attainment of effective body drug 


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39 

concentrations on chronic use, and is considered medically 

insignificant for the drug. 

(C) For a drug that is not intended to be absorbed into the 

bloodstream, the Secretary may establish alternative, scientifically valid methods to show bioequivalence if the alternative 

methods are expected to detect a significant difference between 

the drug and the listed drug in safety and therapeutic effect. 

(9) The Secretary shall, with respect to each application submitted under this subsection, maintain a record of— 

(A) the name of the applicant, 

(B) the name of the drug covered by the application, 

(C) the name of each person to whom the review of the chemistry of the application was assigned and the date of such assignment, and 

(D) the name of each person to whom the bioequivalence review for such application was assigned and the date of such assignment. 

The information the Secretary is required to maintain under this 

paragraph with respect to an application submitted under this subsection shall be made available to the public after the approval of 

such application. 

(10)(A) If the proposed labeling of a drug that is the subject of 

an application under this subsection differs from the listed drug 

due to a labeling revision described under clause (i), the drug that 

is the subject of such application shall, notwithstanding any other 

provision of this Act, be eligible for approval and shall not be considered misbranded under section 502 if— 

(i) the application is otherwise eligible for approval under 

this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph 

(5)(B)(iii), and a revision to the labeling of the listed drug has 

been approved by the Secretary within 60 days of such expiration; 

(ii) the labeling revision described under clause (i) does not 

include a change to the ‘‘Warnings’’ section of the labeling; 

(iii) the sponsor of the application under this subsection 

agrees to submit revised labeling of the drug that is the subject 

of such application not later than 60 days after the notification 

of any changes to such labeling required by the Secretary; and 

(iv) such application otherwise meets the applicable requirements for approval under this subsection. 

(B) If, after a labeling revision described in subparagraph (A)(i), 

the Secretary determines that the continued presence in interstate 

commerce of the labeling of the listed drug (as in effect before the 

revision described in subparagraph (A)(i)) adversely impacts the 

safe use of the drug, no application under this subsection shall be 

eligible for approval with such labeling. 

(11)(A) Subject to subparagraph (B), the Secretary shall prioritize 

the review of, and act within 8 months of the date of the submission of, an original abbreviated new drug application submitted for 

review under this subsection that is for a drug— 

(i) for which there are not more than 3 approved drug products listed under paragraph (7) and for which there are no 

blocking patents and exclusivities; or 

(ii) that has been included on the list under section 506E. 


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(B) To qualify for priority review under this paragraph, not later 

than 60 days prior to the submission of an application described in 

subparagraph (A) or that the Secretary may prioritize pursuant to 

subparagraph (D), the applicant shall provide complete, accurate 

information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application, 

including facilities in corresponding Type II active pharmaceutical 

ingredients drug master files referenced in an application and sites 

or organizations involved in bioequivalence and clinical studies 

used to support the application, to enable the Secretary to make a 

determination regarding whether an inspection of a facility is necessary. Such information shall include the relevant (as determined 

by the Secretary) sections of such application, which shall be unchanged relative to the date of the submission of such application, 

except to the extent that a change is made to such information to 

exclude a facility that was not used to generate data to meet any 

application requirements for such submission and that is not the 

only facility intended to conduct one or more unit operations in 

commercial production. Information provided by an applicant under 

this subparagraph shall not be considered the submission of an application under this subsection. 

(C) The Secretary may expedite an inspection or reinspection 

under section 704 of an establishment that proposes to manufacture a drug described in subparagraph (A). 

(D) Nothing in this paragraph shall prevent the Secretary from 

prioritizing the review of other applications as the Secretary determines appropriate. 

(12) The Secretary shall publish on the internet website of the 

Food and Drug Administration, and update at least once every 6 

months, a list of all drugs approved under subsection (c) for which 

all patents and periods of exclusivity under this Act have expired 

and for which no application has been approved under this subsection. 

(13) Upon the request of an applicant regarding one or more 

specified pending applications under this subsection, the Secretary 

shall, as appropriate, provide review status updates indicating the 

categorical status of the applications by each relevant review discipline. 

(k)(1) In the case of any drug for which an approval of an application filed under subsection (b) or (j) is in effect, the applicant 

shall establish and maintain such records, and make such reports 

to the Secretary, of data relating to clinical experience and other 

data or information, received or otherwise obtained by such applicant with respect to such drug, as the Secretary may by general 

regulation, or by order with respect to such application, prescribe 

on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate 

a determination, whether there is or may be ground for invoking 

subsection (e) of this section. Regulations and orders issued under 

this subsection and under subsection (i) shall have due regard for 

the professional ethics of the medical profession and the interests 

of patients and shall provide, where the Secretary deems it to be 

appropriate, for the examination, upon request, by the persons to 

whom such regulations or orders are applicable, of similar information received or otherwise obtained by the Secretary. 


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(2) Every person required under this section to maintain records, 

and every person in charge or custody thereof, shall, upon request 

of an officer or employee designated by the Secretary, permit such 

officer or employee at all reasonable times to have access to and 

copy and verify such records. 

(3) ACTIVE POSTMARKET RISK IDENTIFICATION.— (A) DEFINITION.—In this paragraph, the term ‘‘data’’ refers to information with respect to a drug approved under 

this section or under section 351 of the Public Health Service Act, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, and any 

other data deemed appropriate by the Secretary. 

(B) DEVELOPMENT OF POSTMARKET RISK IDENTIFICATION

AND ANALYSIS METHODS.—The Secretary shall, not later 

than 2 years after the date of the enactment of the Food 

and Drug Administration Amendments Act of 2007, in collaboration with public, academic, and private entities— 

(i) develop methods to obtain access to disparate 

data sources including the data sources specified in 

subparagraph (C); 

(ii) develop validated methods for the establishment 

of a postmarket risk identification and analysis system 

to link and analyze safety data from multiple sources, 

with the goals of including, in aggregate— 

(I) at least 25,000,000 patients by July 1, 2010; 

and 

(II) at least 100,000,000 patients by July 1, 

2012; and 

(iii) convene a committee of experts, including individuals who are recognized in the field of protecting 

data privacy and security, to make recommendations 

to the Secretary on the development of tools and methods for the ethical and scientific uses for, and communication of, postmarketing data specified under subparagraph (C), including recommendations on the development of effective research methods for the study 

of drug safety questions. 

(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTI- FICATION AND ANALYSIS SYSTEM.— 

(i) IN GENERAL.—The Secretary shall, not later than 

1 year after the development of the risk identification 

and analysis methods under subparagraph (B), establish and maintain procedures— 

(I) for risk identification and analysis based on 

electronic health data, in compliance with the regulations promulgated under section 264(c) of the 

Health Insurance Portability and Accountability 

Act of 1996, and in a manner that does not disclose individually identifiable health information 

in violation of paragraph (4)(B); 

(II) for the reporting (in a standardized form) of 

data on all serious adverse drug experiences (as 

defined in section 505–1(b)) submitted to the Secretary under paragraph (1), and those adverse 


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events submitted by patients, providers, and drug 

sponsors, when appropriate; 

(III) to provide for active adverse event surveillance using the following data sources, as available: 

(aa) Federal health-related electronic data 

(such as data from the Medicare program and 

the health systems of the Department of Veterans Affairs); 

(bb) private sector health-related electronic 

data (such as pharmaceutical purchase data 

and health insurance claims data); and 

(cc) other data as the Secretary deems necessary to create a robust system to identify 

adverse events and potential drug safety signals; 

(IV) to identify certain trends and patterns with 

respect to data accessed by the system; 

(V) to provide regular reports to the Secretary 

concerning adverse event trends, adverse event 

patterns, incidence and prevalence of adverse 

events, and other information the Secretary determines appropriate, which may include data on 

comparative national adverse event trends; and 

(VI) to enable the program to export data in a 

form appropriate for further aggregation, statistical analysis, and reporting. 

(ii) TIMELINESS OF REPORTING.—The procedures established under clause (i) shall ensure that such data 

are accessed, analyzed, and reported in a timely, routine, and systematic manner, taking into consideration 

the need for data completeness, coding, cleansing, and 

standardized analysis and transmission. 

(iii) PRIVATE SECTOR RESOURCES.—To ensure the establishment of the active postmarket risk identification and analysis system under this subsection not 

later than 1 year after the development of the risk 

identification and analysis methods under subparagraph (B), as required under clause (i), the Secretary 

may, on a temporary or permanent basis, implement 

systems or products developed by private entities. 

(iv) COMPLEMENTARY APPROACHES.—To the extent 

the active postmarket risk identification and analysis 

system under this subsection is not sufficient to gather 

data and information relevant to a priority drug safety 

question, the Secretary shall develop, support, and 

participate in complementary approaches to gather 

and analyze such data and information, including— 

(I) approaches that are complementary with respect to assessing the safety of use of a drug in 

domestic populations not included, or underrepresented, in the trials used to approve the drug 

(such as older people, people with comorbidities, 

pregnant women, or children); and 


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(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine 

Safety Datalink or successor databases. 

(v) AUTHORITY FOR CONTRACTS.—The Secretary may 

enter into contracts with public and private entities to 

fulfill the requirements of this subparagraph. 

(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.— (A) PURPOSE.—The Secretary shall establish collaborations with public, academic, and private entities, which 

may include the Centers for Education and Research on 

Therapeutics under section 912 of the Public Health Service Act, to provide for advanced analysis of drug safety 

data described in paragraph (3)(C) and other information 

that is publicly available or is provided by the Secretary, 

in order to— 

(i) improve the quality and efficiency of postmarket 

drug safety risk-benefit analysis; 

(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety questions; and 

(iii) enhance the ability of the Secretary to make 

timely assessments based on drug safety data. 

(B) PRIVACY.—Such analysis shall not disclose individually identifiable health information when presenting such 

drug safety signals and trends or when responding to inquiries regarding such drug safety signals and trends. 

(C) PUBLIC PROCESS FOR PRIORITY QUESTIONS.—At least 

biannually, the Secretary shall seek recommendations 

from the Drug Safety and Risk Management Advisory 

Committee (or any successor committee) and from other 

advisory committees, as appropriate, to the Food and Drug 

Administration on— 

(i) priority drug safety questions; and 

(ii) mechanisms for answering such questions, including through— 

(I) active risk identification under paragraph 

(3); and 

(II) when such risk identification is not sufficient, postapproval studies and clinical trials 

under subsection (o)(3). 

(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY

COLLABORATIONS.— 

(i) IN GENERAL.—Not later than 180 days after the 

date of the establishment of the active postmarket risk 

identification and analysis system under this subsection, the Secretary shall establish and implement 

procedures under which the Secretary may routinely 

contract with one or more qualified entities to— 

(I) classify, analyze, or aggregate data described 

in paragraph (3)(C) and information that is publicly available or is provided by the Secretary; 

(II) allow for prompt investigation of priority 

drug safety questions, including— 

(aa) unresolved safety questions for drugs 

or classes of drugs; and 


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(bb) for a newly-approved drugs, safety signals from clinical trials used to approve the 

drug and other preapproval trials; rare, serious drug side effects; and the safety of use in 

domestic populations not included, or underrepresented, in the trials used to approve the 

drug (such as older people, people with 

comorbidities, pregnant women, or children); 

(III) perform advanced research and analysis on 

identified drug safety risks; 

(IV) focus postapproval studies and clinical 

trials under subsection (o)(3) more effectively on 

cases for which reports under paragraph (1) and 

other safety signal detection is not sufficient to resolve whether there is an elevated risk of a serious adverse event associated with the use of a 

drug; and 

(V) carry out other activities as the Secretary 

deems necessary to carry out the purposes of this 

paragraph. 

(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The procedures described in clause (i) shall permit the Secretary to request that a specific methodology be used 

by the qualified entity. The qualified entity shall work 

with the Secretary to finalize the methodology to be 

used. 

(E) USE OF ANALYSES.—The Secretary shall provide the 

analyses described in this paragraph, including the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug. 

(F) QUALIFIED ENTITIES.— 

(i) IN GENERAL.—The Secretary shall enter into contracts with a sufficient number of qualified entities to 

develop and provide information to the Secretary in a 

timely manner. 

(ii) QUALIFICATION.—The Secretary shall enter into 

a contract with an entity under clause (i) only if the 

Secretary determines that the entity has a significant 

presence in the United States and has one or more of 

the following qualifications: 

(I) The research, statistical, epidemiologic, or 

clinical capability and expertise to conduct and 

complete the activities under this paragraph, including the capability and expertise to provide the 

Secretary de-identified data consistent with the 

requirements of this subsection. 

(II) An information technology infrastructure in 

place to support electronic data and operational 

standards to provide security for such data. 

(III) Experience with, and expertise on, the development of drug safety and effectiveness research using electronic population data. 

(IV) An understanding of drug development or 

risk/benefit balancing in a clinical setting. 


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(V) Other expertise which the Secretary deems 

necessary to fulfill the activities under this paragraph. 

(G) CONTRACT REQUIREMENTS.—Each contract with a 

qualified entity under subparagraph (F)(i) shall contain 

the following requirements: 

(i) ENSURING PRIVACY.—The qualified entity shall 

ensure that the entity will not use data under this 

subsection in a manner that— 

(I) violates the regulations promulgated under 

section 264(c) of the Health Insurance Portability 

and Accountability Act of 1996; 

(II) violates sections 552 or 552a of title 5, 

United States Code, with regard to the privacy of 

individually-identifiable beneficiary health information; or 

(III) discloses individually identifiable health information when presenting drug safety signals 

and trends or when responding to inquiries regarding drug safety signals and trends. 

Nothing in this clause prohibits lawful disclosure for 

other purposes. 

(ii) COMPONENT OF ANOTHER ORGANIZATION.—If a 

qualified entity is a component of another organization— 

(I) the qualified entity shall establish appropriate security measures to maintain the confidentiality and privacy of such data; and 

(II) the entity shall not make an unauthorized 

disclosure of such data to the other components of 

the organization in breach of such confidentiality 

and privacy requirement. 

(iii) TERMINATION OR NONRENEWAL.—If a contract 

with a qualified entity under this subparagraph is terminated or not renewed, the following requirements 

shall apply: 

(I) CONFIDENTIALITY AND PRIVACY PROTECTIONS.—The entity shall continue to comply with 

the confidentiality and privacy requirements 

under this paragraph with respect to all data disclosed to the entity. 

(II) DISPOSITION OF DATA.—The entity shall return any data disclosed to such entity under this 

subsection to which it would not otherwise have 

access or, if returning the data is not practicable, 

destroy the data. 

(H) COMPETITIVE PROCEDURES.—The Secretary shall use 

competitive procedures (as defined in section 4(5) of the 

Federal Procurement Policy Act) to enter into contracts 

under subparagraph (G). 

(I) REVIEW OF CONTRACT IN THE EVENT OF A MERGER OR

ACQUISITION.—The Secretary shall review the contract 

with a qualified entity under this paragraph in the event 

of a merger or acquisition of the entity in order to ensure 


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that the requirements under this paragraph will continue 

to be met. 

(J) COORDINATION.—In carrying out this paragraph, the 

Secretary shall provide for appropriate communications to 

the public, scientific, public health, and medical communities, and other key stakeholders, and to the extent practicable shall coordinate with the activities of private entities, professional associations, or other entities that may 

have sources of drug safety data. 

(5) The Secretary shall— 

(A) conduct regular screenings of the Adverse Event Reporting System database and post a quarterly report on 

the Adverse Event Reporting System Web site of any new 

safety information or potential signal of a serious risk 

identified by Adverse Event Reporting System within the 

last quarter; and 

(B) on an annual basis, review the entire backlog of 

postmarket safety commitments to determine which commitments require revision or should be eliminated, report 

to the Congress on these determinations, and assign start 

dates and estimated completion dates for such commitments; and 

(C) make available on the Internet website of the Food and 

Drug Administration— 

(i) guidelines, developed with input from experts qualified by scientific training and experience to evaluate the 

safety and effectiveness of drugs, that detail best practices 

for drug safety surveillance using the Adverse Event Reporting System; and 

(ii) criteria for public posting of adverse event signals. 

(l)(1) Safety and effectiveness data and information which has 

been submitted in an application under subsection (b) for a drug 

and which has not previously been disclosed to the public shall be 

made available to the public, upon request, unless extraordinary 

circumstances are shown— 

(A) if no work is being or will be undertaken to have the application approved, 

(B) if the Secretary has determined that the application is 

not approvable and all legal appeals have been exhausted, 

(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, 

(D) if the Secretary has determined that such drug is not a 

new drug, or 

(E) upon the effective date of the approval of the first application under subsection (j) which refers to such drug or upon 

the date upon which the approval of an application under subsection (j) which refers to such drug could be made effective if 

such an application had been submitted. 

(2) ACTION PACKAGE FOR APPROVAL.— (A) ACTION PACKAGE.—The Secretary shall publish the action 

package for approval of an application under subsection (b) or 

section 351 of the Public Health Service Act on the Internet 

Web site of the Food and Drug Administration— 

(i) not later than 30 days after the date of approval of 

such application for a drug no active ingredient (including 


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47 

any ester or salt of the active ingredient) of which has 

been approved in any other application under this section 

or section 351 of the Public Health Service Act; and 

(ii) not later than 30 days after the third request for 

such action package for approval received under section 

552 of title 5, United States Code, for any other drug. 

(B) IMMEDIATE PUBLICATION OF SUMMARY REVIEW.—Notwithstanding subparagraph (A), the Secretary shall publish, on the 

Internet Web site of the Food and Drug Administration, the 

materials described in subparagraph (C)(iv) not later than 48 

hours after the date of approval of the drug, except where such 

materials require redaction by the Secretary. 

(C) CONTENTS.—An action package for approval of an application under subparagraph (A) shall be dated and shall include 

the following: 

(i) Documents generated by the Food and Drug Administration related to review of the application. 

(ii) Documents pertaining to the format and content of 

the application generated during drug development. 

(iii) Labeling submitted by the applicant. 

(iv) A summary review that documents conclusions from 

all reviewing disciplines about the drug, noting any critical 

issues and disagreements with the applicant and within 

the review team and how they were resolved, recommendations for action, and an explanation of any nonconcurrence 

with review conclusions. 

(v) The Division Director and Office Director’s decision 

document which includes— 

(I) a brief statement of concurrence with the summary review; 

(II) a separate review or addendum to the review if 

disagreeing with the summary review; and 

(III) a separate review or addendum to the review to 

add further analysis. 

(vi) Identification by name of each officer or employee of 

the Food and Drug Administration who— 

(I) participated in the decision to approve the application; and 

(II) consents to have his or her name included in the 

package. 

(D) REVIEW.—A scientific review of an application is considered the work of the reviewer and shall not be altered by management or the reviewer once final. 

(E) CONFIDENTIAL INFORMATION.—This paragraph does not 

authorize the disclosure of any trade secret, confidential commercial or financial information, or other matter listed in section 552(b) of title 5, United States Code. 

(m) For purposes of this section, the term ‘‘patent’’ means a patent issued by the United States Patent and Trademark Office. 

(n)(1) For the purpose of providing expert scientific advice and 

recommendations to the Secretary regarding a clinical investigation 

of a drug or the approval for marketing of a drug under section 505 

or section 351 of the Public Health Service Act, the Secretary shall 

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fore the date of enactment of the Food and Drug Administration 

Modernization Act of 1997, or both. 

(2) The Secretary may delegate the appointment and oversight 

authority granted under section 1004 to a director of a center or 

successor entity within the Food and Drug Administration. 

(3) The Secretary shall make appointments to each panel established under paragraph (1) so that each panel shall consist of— 

(A) members who are qualified by training and experience to 

evaluate the safety and effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess 

skill and experience in the development, manufacture, or utilization of such drugs; 

(B) members with diverse expertise in such fields as clinical 

and administrative medicine, pharmacy, pharmacology, 

pharmacoeconomics, biological and physical sciences, and other 

related professions; 

(C) a representative of consumer interests, and a representative of interests of the drug manufacturing industry not directly affected by the matter to be brought before the panel; 

and 

(D) two or more members who are specialists or have other 

expertise in the particular disease or condition for which the 

drug under review is proposed to be indicated. 

Scientific, trade, and consumer organizations shall be afforded an 

opportunity to nominate individuals for appointment to the panels. 

No individual who is in the regular full-time employ of the United 

States and engaged in the administration of this Act may be a voting member of any panel. The Secretary shall designate one of the 

members of each panel to serve as chairman thereof. 

(4) The Secretary shall, as appropriate, provide education and 

training to each new panel member before such member participates in a panel’s activities, including education regarding requirements under this Act and related regulations of the Secretary, and 

the administrative processes and procedures related to panel meetings. 

(5) Panel members (other than officers or employees of the 

United States), while attending meetings or conferences of a panel 

or otherwise engaged in its business, shall be entitled to receive 

compensation for each day so engaged, including traveltime, at 

rates to be fixed by the Secretary, but not to exceed the daily 

equivalent of the rate in effect for positions classified above grade 

GS–15 of the General Schedule. While serving away from their 

homes or regular places of business, panel members may be allowed travel expenses (including per diem in lieu of subsistence) as 

authorized by section 5703 of title 5, United States Code, for persons in the Government service employed intermittently. 

(6) The Secretary shall ensure that scientific advisory panels 

meet regularly and at appropriate intervals so that any matter to 

be reviewed by such a panel can be presented to the panel not 

more than 60 days after the matter is ready for such review. Meetings of the panel may be held using electronic communication to 

convene the meetings. 

(7) Within 90 days after a scientific advisory panel makes recommendations on any matter under its review, the Food and Drug 

Administration official responsible for the matter shall review the 


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49 

conclusions and recommendations of the panel, and notify the affected persons of the final decision on the matter, or of the reasons 

that no such decision has been reached. Each such final decision 

shall be documented including the rationale for the decision. 

(o) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING.— (1) IN GENERAL.—A responsible person may not introduce or 

deliver for introduction into interstate commerce the new drug 

involved if the person is in violation of a requirement established under paragraph (3) or (4) with respect to the drug. 

(2) DEFINITIONS.—For purposes of this subsection: 

(A) RESPONSIBLE PERSON.—The term ‘‘responsible person’’ means a person who— 

(i) has submitted to the Secretary a covered application that is pending; or 

(ii) is the holder of an approved covered application. 

(B) COVERED APPLICATION.—The term ‘‘covered application’’ means— 

(i) an application under subsection (b) for a drug 

that is subject to section 503(b); and 

(ii) an application under section 351 of the Public 

Health Service Act. 

(C) NEW SAFETY INFORMATION; SERIOUS RISK.—The 

terms ‘‘new safety information’’, ‘‘serious risk’’, and ‘‘signal 

of a serious risk’’ have the meanings given such terms in 

section 505–1(b). 

(3) STUDIES AND CLINICAL TRIALS.— (A) IN GENERAL.—For any or all of the purposes specified 

in subparagraph (B), the Secretary may, subject to subparagraph (D), require a responsible person for a drug to 

conduct a postapproval study or studies of the drug, or a 

postapproval clinical trial or trials of the drug, on the basis 

of scientific data deemed appropriate by the Secretary, including information regarding chemically-related or pharmacologically-related drugs. 

(B) PURPOSES OF STUDY OR CLINICAL TRIAL.—The purposes referred to in this subparagraph with respect to a 

postapproval study or postapproval clinical trial are the 

following: 

(i) To assess a known serious risk related to the use 

of the drug involved. 

(ii) To assess signals of serious risk related to the 

use of the drug. 

(iii) To identify an unexpected serious risk when 

available data indicates the potential for a serious 

risk. 

(C) ESTABLISHMENT OF REQUIREMENT AFTER APPROVAL

OF COVERED APPLICATION.—The Secretary may require a 

postapproval study or studies or postapproval clinical trial 

or trials for a drug for which an approved covered application is in effect as of the date on which the Secretary seeks 

to establish such requirement only if the Secretary becomes aware of new safety information. 

(D) DETERMINATION BY SECRETARY.— 

(i) POSTAPPROVAL STUDIES.—The Secretary may not 

require the responsible person to conduct a study 


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under this paragraph, unless the Secretary makes a 

determination that the reports under subsection (k)(1) 

and the active postmarket risk identification and analysis system as available under subsection (k)(3) will 

not be sufficient to meet the purposes set forth in subparagraph (B). 

(ii) POSTAPPROVAL CLINICAL TRIALS.—The Secretary 

may not require the responsible person to conduct a 

clinical trial under this paragraph, unless the Secretary makes a determination that a postapproval 

study or studies will not be sufficient to meet the purposes set forth in subparagraph (B). 

(E) NOTIFICATION; TIMETABLES; PERIODIC REPORTS.— 

(i) NOTIFICATION.—The Secretary shall notify the responsible person regarding a requirement under this 

paragraph to conduct a postapproval study or clinical 

trial by the target dates for communication of feedback 

from the review team to the responsible person regarding proposed labeling and postmarketing study 

commitments as set forth in the letters described in 

section 101(c) of the Food and Drug Administration 

Amendments Act of 2007. 

(ii) TIMETABLE; PERIODIC REPORTS.—For each study 

or clinical trial required to be conducted under this 

paragraph, the Secretary shall require that the responsible person submit a timetable for completion of 

the study or clinical trial. With respect to each study 

required to be conducted under this paragraph or otherwise undertaken by the responsible person to investigate a safety issue, the Secretary shall require the 

responsible person to periodically report to the Secretary on the status of such study including whether 

any difficulties in completing the study have been encountered. With respect to each clinical trial required 

to be conducted under this paragraph or otherwise undertaken by the responsible person to investigate a 

safety issue, the Secretary shall require the responsible person to periodically report to the Secretary on 

the status of such clinical trial including whether enrollment has begun, the number of participants enrolled, the expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information with respect to 

the requirements under section 402(j) of the Public 

Health Service Act. If the responsible person fails to 

comply with such timetable or violates any other requirement of this subparagraph, the responsible person shall be considered in violation of this subsection, 

unless the responsible person demonstrates good cause 

for such noncompliance or such other violation. The 

Secretary shall determine what constitutes good cause 

under the preceding sentence. 

(F) DISPUTE RESOLUTION.—The responsible person may 

appeal a requirement to conduct a study or clinical trial 


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51 

under this paragraph using dispute resolution procedures 

established by the Secretary in regulation and guidance. 

(4) SAFETY LABELING CHANGES REQUESTED BY SECRETARY.— (A) NEW SAFETY OR NEW EFFECTIVENESS INFORMATION.— If the Secretary becomes aware of new information, including any new safety information or information related to 

reduced effectiveness, that the Secretary determines 

should be included in the labeling of the drug, the Secretary shall promptly notify the responsible person or, if 

the same drug approved under section 505(b) is not currently marketed, the holder of an approved application 

under 505(j). 

(B) RESPONSE TO NOTIFICATION.—Following notification 

pursuant to subparagraph (A), the responsible person or 

the holder of the approved application under section 505(j) 

shall within 30 days— 

(i) submit a supplement proposing changes to the 

approved labeling to reflect the new safety information, including changes to boxed warnings, contraindications, warnings, precautions, or adverse reactions, or new effectiveness information; or 

(ii) notify the Secretary that the responsible person 

or the holder of the approved application under section 

505(j) does not believe a labeling change is warranted 

and submit a statement detailing the reasons why 

such a change is not warranted. 

(C) REVIEW.—Upon receipt of such supplement, the Secretary shall promptly review and act upon such supplement. If the Secretary disagrees with the proposed changes 

in the supplement or with the statement setting forth the 

reasons why no labeling change is necessary, the Secretary 

shall initiate discussions to reach agreement on whether 

the labeling for the drug should be modified to reflect the 

new safety or new effectiveness information, and if so, the 

contents of such labeling changes. 

(D) DISCUSSIONS.—Such discussions shall not extend for 

more than 30 days after the response to the notification 

under subparagraph (B), unless the Secretary determines 

an extension of such discussion period is warranted. 

(E) ORDER.—Within 15 days of the conclusion of the discussions under subparagraph (D), the Secretary may issue 

an order directing the responsible person or the holder of 

the approved application under section 505(j) to make such 

a labeling change as the Secretary deems appropriate to 

address the new safety or new effectiveness information. 

Within 15 days of such an order, the responsible person or 

the holder of the approved application under section 505(j) 

shall submit a supplement containing the labeling change. 

(F) DISPUTE RESOLUTION.—Within 5 days of receiving an 

order under subparagraph (E), the responsible person or 

the holder of the approved application under section 505(j) 

may appeal using dispute resolution procedures established by the Secretary in regulation and guidance. 

(G) VIOLATION.—If the responsible person or the holder 

of the approved application under section 505(j) has not 


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submitted a supplement within 15 days of the date of such 

order under subparagraph (E), and there is no appeal or 

dispute resolution proceeding pending, the responsible person or holder shall be considered to be in violation of this 

subsection. If at the conclusion of any dispute resolution 

procedures the Secretary determines that a supplement 

must be submitted and such a supplement is not submitted within 15 days of the date of that determination, 

the responsible person or holder shall be in violation of 

this subsection. 

(H) PUBLIC HEALTH THREAT.—Notwithstanding subparagraphs (A) through (F), if the Secretary concludes that 

such a labeling change is necessary to protect the public 

health, the Secretary may accelerate the timelines in such 

subparagraphs. 

(I) RULE OF CONSTRUCTION.—This paragraph shall not 

be construed to affect the responsibility of the responsible 

person or the holder of the approved application under section 505(j) to maintain its label in accordance with existing 

requirements, including subpart B of part 201 and sections 

314.70 and 601.12 of title 21, Code of Federal Regulations 

(or any successor regulations). 

(5) NON-DELEGATION.—Determinations by the Secretary 

under this subsection for a drug shall be made by individuals 

at or above the level of individuals empowered to approve a 

drug (such as division directors within the Center for Drug 

Evaluation and Research). 

(p) RISK EVALUATION AND MITIGATION STRATEGY.— 

(1) IN GENERAL.—A person may not introduce or deliver for 

introduction into interstate commerce a new drug if— 

(A)(i) the application for such drug is approved under 

subsection (b) or (j) and is subject to section 503(b); or 

(ii) the application for such drug is approved under section 351 of the Public Health Service Act; and 

(B) a risk evaluation and mitigation strategy is required 

under section 505–1 with respect to the drug and the person fails to maintain compliance with the requirements of 

the approved strategy or with other requirements under 

section 505–1, including requirements regarding assessments of approved strategies. 

(2) CERTAIN POSTMARKET STUDIES.—The failure to conduct a 

postmarket study under section 506, subpart H of part 314, or 

subpart E of part 601 of title 21, Code of Federal Regulations 

(or any successor regulations), is deemed to be a violation of 

paragraph (1). 

(q) PETITIONS AND CIVIL ACTIONS REGARDING APPROVAL OF CERTAIN APPLICATIONS.— 

(1) IN GENERAL.— 

(A) DETERMINATION.—The Secretary shall not delay approval of a pending application submitted under subsection 

(b)(2) or (j) of this section or section 351(k) of the Public 

Health Service Act because of any request to take any 

form of action relating to the application, either before or 

during consideration of the request, unless— 


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53 

(i) the request is in writing and is a petition submitted to the Secretary pursuant to section 10.30 or 

10.35 of title 21, Code of Federal Regulations (or any 

successor regulations); and 

(ii) the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public 

health. 

Consideration of the petition shall be separate and apart 

from review and approval of any application. 

(B) NOTIFICATION.—If the Secretary determines under 

subparagraph (A) that a delay is necessary with respect to 

an application, the Secretary shall provide to the applicant, not later than 30 days after making such determination, the following information: 

(i) Notification of the fact that a determination 

under subparagraph (A) has been made. 

(ii) If applicable, any clarification or additional data 

that the applicant should submit to the docket on the 

petition to allow the Secretary to review the petition 

promptly. 

(iii) A brief summary of the specific substantive 

issues raised in the petition which form the basis of 

the determination. 

(C) FORMAT.—The information described in subparagraph (B) shall be conveyed via either, at the discretion of 

the Secretary— 

(i) a document; or 

(ii) a meeting with the applicant involved. 

(D) PUBLIC DISCLOSURE.—Any information conveyed by 

the Secretary under subparagraph (C) shall be considered 

part of the application and shall be subject to the disclosure requirements applicable to information in such application. 

(E) DENIAL BASED ON INTENT TO DELAY.—If the Secretary determines that a petition or a supplement to the 

petition was submitted with the primary purpose of delaying the approval of an application and the petition does 

not on its face raise valid scientific or regulatory issues, 

the Secretary may deny the petition at any point based on 

such determination. The Secretary may issue guidance to 

describe the factors that will be used to determine under 

this subparagraph whether a petition is submitted with 

the primary purpose of delaying the approval of an application. 

(F) FINAL AGENCY ACTION.—The Secretary shall take 

final agency action on a petition not later than 150 days 

after the date on which the petition is submitted. The Secretary shall not extend such period for any reason, including— 

(i) any determination made under subparagraph (A); 

(ii) the submission of comments relating to the petition or supplemental information supplied by the petitioner; or 

(iii) the consent of the petitioner. 


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(G) EXTENSION OF 30-MONTH PERIOD.—If the filing of an 

application resulted in first-applicant status under subsection (j)(5)(D)(i)(IV) and approval of the application was 

delayed because of a petition, the 30-month period under 

such subsection is deemed to be extended by a period of 

time equal to the period beginning on the date on which 

the Secretary received the petition and ending on the date 

of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether the 

Secretary grants, in whole or in part, or denies, in whole 

or in part, the petition. 

(H) CERTIFICATION.—The Secretary shall not consider a 

petition for review unless the party submitting such petition does so in written form and the subject document is 

signed and contains the following certification: ‘‘I certify 

that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition 

relies; (b) this petition includes representative data and/or 

information known to the petitioner which are unfavorable 

to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information 

which are unfavorable to the petition were disclosed to me. 

I further certify that the information upon which I have 

based the action requested herein first became known to 

the party on whose behalf this petition is submitted on or 

about the following date: llllllllll. If I received or expect to receive payments, including cash and 

other forms of consideration, to file this information or its 

contents, I received or expect to receive those payments 

from the following persons or organizations: 

lllllllllllll. I verify under penalty of perjury that the foregoing is true and correct as of the date 

of the submission of this petition.’’, with the date on which 

such information first became known to such party and the 

names of such persons or organizations inserted in the 

first and second blank space, respectively. 

(I) VERIFICATION.—The Secretary shall not accept for review any supplemental information or comments on a petition unless the party submitting such information or comments does so in written form and the subject document 

is signed and contains the following verification: ‘‘I certify 

that, to my best knowledge and belief: (a) I have not intentionally delayed submission of this document or its contents; and (b) the information upon which I have based the 

action requested herein first became known to me on or 

about llllllllll. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received 

or expect to receive those payments from the following persons or organizations: lllll. I verify under penalty of 

perjury that the foregoing is true and correct as of the date 

of the submission of this petition.’’, with the date on which 

such information first became known to the party and the 

names of such persons or organizations inserted in the 

first and second blank space, respectively. 


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(2) EXHAUSTION OF ADMINISTRATIVE REMEDIES.— (A) FINAL AGENCY ACTION WITHIN 150 DAYS.—The Secretary shall be considered to have taken final agency action on a petition if— 

(i) during the 150-day period referred to in paragraph (1)(F), the Secretary makes a final decision 

within the meaning of section 10.45(d) of title 21, Code 

of Federal Regulations (or any successor regulation); 

or 

(ii) such period expires without the Secretary having 

made such a final decision. 

(B) DISMISSAL OF CERTAIN CIVIL ACTIONS.—If a civil action is filed against the Secretary with respect to any issue 

raised in the petition before the Secretary has taken final 

agency action on the petition within the meaning of subparagraph (A), the court shall dismiss without prejudice 

the action for failure to exhaust administrative remedies. 

(C) ADMINISTRATIVE RECORD.—For purposes of judicial 

review related to the approval of an application for which 

a petition under paragraph (1) was submitted, the administrative record regarding any issue raised by the petition 

shall include— 

(i) the petition filed under paragraph (1) and any 

supplements and comments thereto; 

(ii) the Secretary’s response to such petition, if 

issued; and 

(iii) other information, as designated by the Secretary, related to the Secretary’s determinations regarding the issues raised in such petition, as long as 

the information was considered by the agency no later 

than the date of final agency action as defined under 

subparagraph (2)(A), and regardless of whether the 

Secretary responded to the petition at or before the 

approval of the application at issue in the petition. 

(3) ANNUAL REPORT ON DELAYS IN APPROVALS PER PETI- TIONS.—The Secretary shall annually submit to the Congress 

a report that specifies— 

(A) the number of applications that were approved during the preceding 12-month period; 

(B) the number of such applications whose effective 

dates were delayed by petitions referred to in paragraph 

(1) during such period; 

(C) the number of days by which such applications were 

so delayed; and 

(D) the number of such petitions that were submitted 

during such period. 

(4) EXCEPTIONS.— 

(A) This subsection does not apply to— 

(i) a petition that relates solely to the timing of the 

approval of an application pursuant to subsection 

(j)(5)(B)(iv); or 

(ii) a petition that is made by the sponsor of an application and that seeks only to have the Secretary 

take or refrain from taking any form of action with respect to that application. 


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(B) Paragraph (2) does not apply to a petition addressing 

issues concerning an application submitted pursuant to 

section 351(k) of the Public Health Service Act. 

(5) DEFINITIONS.— (A) APPLICATION.—For purposes of this subsection, the 

term ‘‘application’’ means an application submitted under 

subsection (b)(2) or (j) of this section or section 351(k) of 

the Public Health Service Act. 

(B) PETITION.—For purposes of this subsection, other 

than paragraph (1)(A)(i), the term ‘‘petition’’ means a request described in paragraph (1)(A)(i). 

(r) POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND

PROVIDERS.— (1) ESTABLISHMENT.—Not later than 1 year after the date of 

the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall improve the transparency of information about drugs and allow patients and 

health care providers better access to information about drugs 

by developing and maintaining an Internet Web site that— 

(A) provides links to drug safety information listed in 

paragraph (2) for prescription drugs that are approved 

under this section or licensed under section 351 of the 

Public Health Service Act; and 

(B) improves communication of drug safety information 

to patients and providers. 

(2) INTERNET WEB SITE.—The Secretary shall carry out paragraph (1) by— 

(A) developing and maintaining an accessible, consolidated Internet Web site with easily searchable drug safety 

information, including the information found on United 

States Government Internet Web sites, such as the United 

States National Library of Medicine’s Daily Med and 

Medline Plus Web sites, in addition to other such Web 

sites maintained by the Secretary; 

(B) ensuring that the information provided on the Internet Web site is comprehensive and includes, when available and appropriate— 

(i) patient labeling and patient packaging inserts; 

(ii) a link to a list of each drug, whether approved 

under this section or licensed under such section 351, 

for which a Medication Guide, as provided for under 

part 208 of title 21, Code of Federal Regulations (or 

any successor regulations), is required; 

(iii) a link to the registry and results data bank provided for under subsections (i) and (j) of section 402 of 

the Public Health Service Act; 

(iv) the most recent safety information and alerts 

issued by the Food and Drug Administration for drugs 

approved by the Secretary under this section, such as 

product recalls, warning letters, and import alerts; 

(v) publicly available information about implemented RiskMAPs and risk evaluation and mitigation 

strategies under subsection (o); 

(vi) guidance documents and regulations related to 

drug safety; and 


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(vii) other material determined appropriate by the 

Secretary; 

(C) providing access to summaries of the assessed and 

aggregated data collected from the active surveillance infrastructure under subsection (k)(3) to provide information 

of known and serious side-effects for drugs approved under 

this section or licensed under such section 351; 

(D) preparing and making publicly available on the 

Internet website established under paragraph (1) best 

practices for drug safety surveillance activities for drugs 

approved under this section or section 351 of the Public 

Health Service Act; 

(E) enabling patients, providers, and drug sponsors to 

submit adverse event reports through the Internet Web 

site; 

(F) providing educational materials for patients and providers about the appropriate means of disposing of expired, 

damaged, or unusable medications; and 

(G) supporting initiatives that the Secretary determines 

to be useful to fulfill the purposes of the Internet Web site. 

(3) POSTING OF DRUG LABELING.—The Secretary shall post on 

the Internet Web site established under paragraph (1) the approved professional labeling and any required patient labeling 

of a drug approved under this section or licensed under such 

section 351 not later than 21 days after the date the drug is 

approved or licensed, including in a supplemental application 

with respect to a labeling change. 

(4) PRIVATE SECTOR RESOURCES.—To ensure development of 

the Internet Web site by the date described in paragraph (1), 

the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities. 

(5) AUTHORITY FOR CONTRACTS.—The Secretary may enter 

into contracts with public and private entities to fulfill the requirements of this subsection. 

(6) REVIEW.—The Advisory Committee on Risk Communication under section 567 shall, on a regular basis, perform a comprehensive review and evaluation of the types of risk communication information provided on the Internet Web site established under paragraph (1) and, through other means, shall 

identify, clarify, and define the purposes and types of information available to facilitate the efficient flow of information to 

patients and providers, and shall recommend ways for the 

Food and Drug Administration to work with outside entities to 

help facilitate the dispensing of risk communication information to patients and providers. 

(s) REFERRAL TO ADVISORY COMMITTEE.—Prior to the approval of 

a drug no active ingredient (including any ester or salt of the active 

ingredient) of which has been approved in any other application 

under this section or section 351 of the Public Health Service Act, 

the Secretary shall— 

(1) refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee; or 

(2) if the Secretary does not refer such a drug to a Food and 

Drug Administration advisory committee prior to the approval 


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of the drug, provide in the action letter on the application for 

the drug a summary of the reasons why the Secretary did not 

refer the drug to an advisory committee prior to approval. 

(t) DATABASE FOR AUTHORIZED GENERIC DRUGS.— (1) IN GENERAL.— (A) PUBLICATION.—The Commissioner shall— 

(i) not later than 9 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, publish a complete list on the 

Internet Web site of the Food and Drug Administration of all authorized generic drugs (including drug 

trade name, brand company manufacturer, and the 

date the authorized generic drug entered the market); 

and 

(ii) update the list quarterly to include each authorized generic drug included in an annual report submitted to the Secretary by the sponsor of a listed drug 

during the preceding 3-month period. 

(B) NOTIFICATION.—The Commissioner shall notify relevant Federal agencies, including the Centers for Medicare 

& Medicaid Services and the Federal Trade Commission, 

when the Commissioner first publishes the information described in subparagraph (A) that the information has been 

published and that the information will be updated quarterly. 

(2) INCLUSION.—The Commissioner shall include in the list 

described in paragraph (1) each authorized generic drug included in an annual report submitted to the Secretary by the 

sponsor of a listed drug after January 1, 1999. 

(3) AUTHORIZED GENERIC DRUG.—In this section, the term 

‘‘authorized generic drug’’ means a listed drug (as that term is 

used in subsection (j)) that— 

(A) has been approved under subsection (c); and 

(B) is marketed, sold, or distributed directly or indirectly 

to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister 

packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade 

mark than the listed drug. 

(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.— 

(1) IN GENERAL.—For purposes of subsections (c)(3)(E)(ii) and 

(j)(5)(F)(ii), if an application is submitted under subsection (b) 

for a non-racemic drug containing as an active ingredient (including any ester or salt of the active ingredient) a single 

enantiomer that is contained in a racemic drug approved in another application under subsection (b), the applicant may, in 

the application for such non-racemic drug, elect to have the 

single enantiomer not be considered the same active ingredient 

as that contained in the approved racemic drug, if— 

(A)(i) the single enantiomer has not been previously approved except in the approved racemic drug; and 

(ii) the application submitted under subsection (b) for 

such non-racemic drug— 

(I) includes full reports of new clinical investigations 

(other than bioavailability studies)— 


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59 

(aa) necessary for the approval of the application under subsections (c) and (d); and 

(bb) conducted or sponsored by the applicant; 

and 

(II) does not rely on any clinical investigations that 

are part of an application submitted under subsection 

(b) for approval of the approved racemic drug; and 

(B) the application submitted under subsection (b) for 

such non-racemic drug is not submitted for approval of a 

condition of use— 

(i) in a therapeutic category in which the approved 

racemic drug has been approved; or 

(ii) for which any other enantiomer of the racemic 

drug has been approved. 

(2) LIMITATION.— 

(A) NO APPROVAL IN CERTAIN THERAPEUTIC CATEGORIES.—Until the date that is 10 years after the date of 

approval of a non-racemic drug described in paragraph (1) 

and with respect to which the applicant has made the election provided for by such paragraph, the Secretary shall 

not approve such non-racemic drug for any condition of use 

in the therapeutic category in which the racemic drug has 

been approved. 

(B) LABELING.—If applicable, the labeling of a non-racemic drug described in paragraph (1) and with respect to 

which the applicant has made the election provided for by 

such paragraph shall include a statement that the non-racemic drug is not approved, and has not been shown to be 

safe and effective, for any condition of use of the racemic 

drug. 

(3) DEFINITION.— 

(A) IN GENERAL.—For purposes of this subsection, the 

term ‘‘therapeutic category’’ means a therapeutic category 

identified in the list developed by the United States Pharmacopeia pursuant to section 1860D–4(b)(3)(C)(ii) of the 

Social Security Act and as in effect on the date of the enactment of this subsection. 

(B) PUBLICATION BY SECRETARY.—The Secretary shall 

publish the list described in subparagraph (A) and may 

amend such list by regulation. 

(4) AVAILABILITY.—The election referred to in paragraph (1) 

may be made only in an application that is submitted to the 

Secretary after the date of the enactment of this subsection 

and before October 1, 2022. 

(v) ANTIBIOTIC DRUGS SUBMITTED BEFORE NOVEMBER 21, 1997.— 

(1) ANTIBIOTIC DRUGS APPROVED BEFORE NOVEMBER 21, 

1997.— 

(A) IN GENERAL.—Notwithstanding any provision of the 

Food and Drug Administration Modernization Act of 1997 

or any other provision of law, a sponsor of a drug that is 

the subject of an application described in subparagraph 

(B)(i) shall be eligible for, with respect to the drug, the 3- 

year exclusivity period referred to under clauses (iii) and 

(iv) of subsection (c)(3)(E) and under clauses (iii) and (iv) 


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60 

of subsection (j)(5)(F), subject to the requirements of such 

clauses, as applicable. 

(B) APPLICATION; ANTIBIOTIC DRUG DESCRIBED.— 

(i) APPLICATION.—An application described in this 

clause is an application for marketing submitted 

under this section after the date of the enactment of 

this subsection in which the drug that is the subject 

of the application contains an antibiotic drug described 

in clause (ii). 

(ii) ANTIBIOTIC DRUG.—An antibiotic drug described 

in this clause is an antibiotic drug that was the subject of an application approved by the Secretary under 

section 507 of this Act (as in effect before November 

21, 1997). 

(2) ANTIBIOTIC DRUGS SUBMITTED BEFORE NOVEMBER 21, 1997, 

BUT NOT APPROVED.— 

(A) IN GENERAL.—Notwithstanding any provision of the 

Food and Drug Administration Modernization Act of 1997 

or any other provision of law, a sponsor of a drug that is 

the subject of an application described in subparagraph 

(B)(i) may elect to be eligible for, with respect to the 

drug— 

(i)(I) the 3-year exclusivity period referred to under 

clauses (iii) and (iv) of subsection (c)(3)(E) and under 

clauses (iii) and (iv) of subsection (j)(5)(F), subject to 

the requirements of such clauses, as applicable; and 

(II) the 5-year exclusivity period referred to under 

clause (ii) of subsection (c)(3)(E) and under clause (ii) 

of subsection (j)(5)(F), subject to the requirements of 

such clauses, as applicable; or 

(ii) a patent term extension under section 156 of 

title 35, United States Code, subject to the requirements of such section. 

(B) APPLICATION; ANTIBIOTIC DRUG DESCRIBED.— 

(i) APPLICATION.—An application described in this 

clause is an application for marketing submitted 

under this section after the date of the enactment of 

this subsection in which the drug that is the subject 

of the application contains an antibiotic drug described 

in clause (ii). 

(ii) ANTIBIOTIC DRUG.—An antibiotic drug described 

in this clause is an antibiotic drug that was the subject of 1 or more applications received by the Secretary 

under section 507 of this Act (as in effect before November 21, 1997), none of which was approved by the 

Secretary under such section. 

(3) LIMITATIONS.— 

(A) EXCLUSIVITIES AND EXTENSIONS.—Paragraphs (1)(A) 

and (2)(A) shall not be construed to entitle a drug that is 

the subject of an approved application described in subparagraphs (1)(B)(i) or (2)(B)(i), as applicable, to any market exclusivities or patent extensions other than those 

exclusivities or extensions described in paragraph (1)(A) or 

(2)(A). 


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61 

(B) CONDITIONS OF USE.—Paragraphs (1)(A) and (2)(A)(i) 

shall not apply to any condition of use for which the drug 

referred to in subparagraph (1)(B)(i) or (2)(B)(i), as applicable, was approved before the date of the enactment of this 

subsection. 

(4) APPLICATION OF CERTAIN PROVISIONS.—Notwithstanding 

section 125, or any other provision, of the Food and Drug Administration Modernization Act of 1997, or any other provision 

of law, and subject to the limitations in paragraphs (1), (2), 

and (3), the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 shall apply to any drug subject to paragraph (1) or any drug with respect to which an election is made under paragraph (2)(A). 

(w) DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.—The 

Secretary shall issue a final, substantive determination on a petition submitted pursuant to subsection (b) of section 314.161 of title 

21, Code of Federal Regulations (or any successor regulations), no 

later than 270 days after the date the petition is submitted. 

(x) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CONTROLS

UNDER THE CSA.— 

(1) IN GENERAL.—In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue 

a scientific and medical evaluation and recommend controls 

under the Controlled Substances Act, approval of such application shall not take effect until the interim final rule controlling 

the drug is issued in accordance with section 201(j) of the Controlled Substances Act. 

(2) DATE OF APPROVAL.—For purposes of this section, with 

respect to an application described in paragraph (1), the term 

‘‘date of approval’’ shall mean the later of— 

(A) the date an application under subsection (b) is approved under subsection (c); or 

(B) the date of issuance of the interim final rule controlling the drug. 

(y) CONTRAST AGENTS INTENDED FOR USE WITH APPLICABLE

MEDICAL IMAGING DEVICES.— (1) IN GENERAL.—The sponsor of a contrast agent for which 

an application has been approved under this section may submit a supplement to the application seeking approval for a new 

use following the authorization of a premarket submission for 

an applicable medical imaging device for that use with the contrast agent pursuant to section 520(p)(1). 

(2) REVIEW OF SUPPLEMENT.—In reviewing a supplement 

submitted under this subsection, the agency center charged 

with the premarket review of drugs may— 

(A) consult with the center charged with the premarket 

review of devices; and 

(B) review information and data submitted to the Secretary by the sponsor of an applicable medical imaging device pursuant to section 515, 510(k), or 513(f)(2) so long as 

the sponsor of such applicable medical imaging device has 

provided to the sponsor of the contrast agent a right of reference. 

(3) DEFINITIONS.—For purposes of this subsection— 


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(A) the term ‘‘new use’’ means a use of a contrast agent 

that is described in the approved labeling of an applicable 

medical imaging device described in section 520(p), but 

that is not described in the approved labeling of the contrast agent; and 

(B) the terms ‘‘applicable medical imaging device’’ and 

‘‘contrast agent’’ have the meanings given such terms in 

section 520(p). 

* * * * * * * 

Æ 


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