I

104TH CONGRESS

1ST SESSION H. R. 1742

To amend the Federal Food, Drug, and Cosmetic Act to revise the process

for the approval of drugs and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JUNE 6, 1995

Mr. WYDEN introduced the following bill; which was referred to the Committee

on Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

revise the process for the approval of drugs and for

other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON4 TENTS.

5 (A) SHORT TITLE.—This Act may be cited as the

6 ‘‘FDA Modernization Act of 1995’’.

7 (b) REFERENCE.—Whenever in this Act an amend8 ment or repeal is expressed in terms of an amendment

9 to, or repeal of, a section or other provision, the reference
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1 shall be considered to be made to a section or other provi2 sion of the Federal Food, Drug, and Cosmetic Act.

3 (c) TABLE OF CONTENTS.—The table of contents of

4 this Act is as follows:

Sec. 1. Short title; reference; table of contents.

Sec. 2. Findings.

Sec. 3. Responsibility of the Secretary.

Sec. 4. Conditional approval.

Sec. 5. Use of institutional review boards.

Sec. 6. Review by independent testing organizations.

Sec. 7. Limitations on authority over legitimate labeling and advertising.

Sec. 8. Review by expert advisory panel.

Sec. 9. Rationalizing good manufacturing practices.

Sec. 10. Export of drugs and devices.

Sec. 11. Regulation of biological products.

Sec. 12. Initial reporting of devices.

Sec. 13. FDA response to G.M.P. violations.

5 SEC. 2. FINDINGS.

6 The Congress finds the following:

7 (1) The Food and Drug Administration has pri8 mary responsibility to ensure the safety and effec9 tiveness of drugs and medical devices.

10 (2) Within the scope of that mission, the Food

11 and Drug Administration also has a public mandate

12 to help speed the introduction of life-saving and life13 enhancing new products to the marketplace.

14 (3) The United States medical products indus15 try is a nationally important employer, and a major,

16 positive balance-of-trade factor in our economy.

17 (4) It is apparent to persons both within and

18 outside of the agency that certain Food and Drug
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1 Administration practices, policies, and systems

2 may—

3 (A) needlessly delay the introduction of

4 new products,

5 (B) withhold new health care benefits to

6 American citizens,

7 (C) erode job development in an important

8 United States industry, and

9 (D) reduce our effective competitiveness in

10 international markets.

11 (5) These problems are compounded by the

12 twin pressures of an increasing agenda of regulatory

13 mandates for which the Food and Drug Administra14 tion has been made responsible, and budget limita15 tions which have restricted the agency’s ability to

16 properly address all functions in an expeditious man17 ner.

18 (6) The agency is hamstrung by some regu19 latory processes which are outdated, and by systems,

20 policies, technical knowledge, and philosophies which

21 have not, in every case, kept up with revolutionary

22 changes in the underlying science now creating 21st

23 century drug and medical device breakthroughs.

24 Among other problems, these policies and philoso25 phies may unnecessarily restrict the appropriate and
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1 free flow of credible scientific knowledge between cli2 nicians, researchers, and manufacturers.

3 (7) Better health care for all Americans is the

4 ultimate goal as the Food and Drug Administration

5 is reshaped to meet the challenges of regulating a

6 rapidly growing, and changing, health care products

7 industry.

8 SEC. 3. RESPONSIBILITY OF THE SECRETARY.

9 Section 903(b)(2) (21 U.S.C. 393(b)(2)) is amended

10 by redesignating subparagraphs (A), (B), (C), (D), and

11 (E) as subparagraphs (B), (C), (D), (E), and (F), respec12 tively and by adding before subparagraph (B) (as so redes13 ignated) the following:

14 ‘‘(A) consistent with the public health, rap15 idly making decisions on the approval of drugs

16 and devices in accordance with this Act and bio17 logical products in accordance with section 351

18 of the Public Health Service Act;’’.

19 SEC. 4. CONDITIONAL APPROVAL.

20 (a) DRUGS AND BIOLOGICAL PRODUCTS.—Section

21 505 (21 U.S.C. 355) is amended by adding at the end

22 the following:

23 ‘‘(n) A new drug to treat life-threatening or serious

24 conditions for which an application has been submitted

25 under subsection (b) may, if the new drug is otherwise
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1 approvable, receive a conditional approval on the basis of

2 valid scientific evidence demonstrating a reasonable assur3 ance of safety and effectiveness. A conditional approval

4 shall become a final section 505 approval unless conditions

5 set forth in such approval have not been met within a time

6 certain as set by the Secretary in consultation with the

7 applicant. If such conditions have not been fulfilled within

8 such time, the conditional approval shall terminate. A new

9 drug which has a conditional approval shall for purposes

10 of this Act be considered an approved new drug. A condi11 tional approval shall terminate upon the expiration of the

12 period applicable to such approval.’’.

13 (b) MEDICAL DEVICES.—Section 515 (21 U.S.C

14 360e) is amended by adding at the end the following:

15 ‘‘CONDITIONAL APPROVAL

16 ‘‘(j) A a class III device to treat life-threatening or

17 serious health conditions for which an application for pre18 market approval has been submitted under subsection (c)

19 may, if the device is otherwise approvable, receive a condi20 tional approval on the basis of valid scientific evidence

21 demonstrating a reasonable assurance of safety and effec22 tiveness. A conditional approval shall be for such period

23 as the Secretary designates in granting such approval. A

24 device which has a conditional approval shall for purposes

25 of this Act be considered an approved device. A conditional
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1 approval shall terminate upon the expiration of the period

2 applicable to such approval.’’.

3 SEC. 5. USE OF INSTITUTIONAL REVIEW BOARDS.

4 (a) APPROVAL OF I.N.D. FOR DRUGS.—Section

5 505(i) (21 U.S.C. 355(i) is amended by inserting ‘‘(1)’’

6 after ‘‘(i)’’ and by adding at the end the following:

7 ‘‘(2)(A) An application (including an amendment or

8 supplement thereto) for an exemption for a new drug for

9 investigational use shall be deemed approved on the 30th

10 day after the submission of the application to the Sec11 retary unless on or before such day—

12 ‘‘(i) the Secretary, or

13 ‘‘(ii) the Secretary acting upon the rec14 ommendation of an institutional review board cer15 tified under paragraph (3)(C),

16 by order disapproves the application and notifies the appli17 cant in writing of the disapproval and the reasons for dis18 approval and affords the applicant an opportunity for an

19 informal hearing on the disapproval.

20 ‘‘(B) Personnel of the Secretary shall meet with any

21 person who wishes to submit an application for a drug

22 under paragraph (1) for the purpose of reaching agree23 ment on the design and size of clinical trials in order to

24 facilitate expeditious review of an application under sub25 section (b). Meetings shall be held within 30 days of any
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1 reasonable request therefor. Minutes of any such meeting

2 shall be exchanged.’’.

3 (b) INVESTIGATIONAL DEVICES.—Section

4 520(g)(4)(A) (21 U.S.C. 360j(g)(4)(A)) is amended by

5 striking ‘‘unless’’ and all that follows and inserting ‘‘un6 less on or before such day—

7 ‘‘(i) the Secretary, or

8 ‘‘(ii) the Secretary acting upon the rec9 ommendation of an institutional review board cer10 tified under section 505(i)(3)(C),

11 by order disapproves the application and notifies the appli12 cant in writing of the disapproval and the reasons for dis13 approval and affords the applicant an opportunity for an

14 informal hearing on the disapproval. Personnel of the Sec15 retary shall meet with any person who wishes to submit

16 an application for a device under paragraph (1) for the

17 purpose of reaching agreement on the design and size of

18 clinical trials in order to facilitate expeditious review of

19 an application under section 515(c). Meetings shall be held

20 within 30 days of any reasonable request therefor. Minutes

21 of any such meeting shall be exchanged.’’.

22 (c) REVIEW OF CERTAIN CLINICAL INVESTIGA23 TIONS.—Section 505(i) (21 U.S.C. 355(i), as amended by

24 subsection (a), is amended by adding at the end the

25 following:
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1 ‘‘(3)(A) The Secretary shall use institutional review

2 boards, approved by the Secretary, to review and approve

3 the initiation and conduct of Phase I clinical investigations

4 under paragraph (1). The Secretary shall certify an insti5 tutional review board as qualified to review and approve

6 a Phase I clinical investigation upon a determination that

7 the board meets the criteria established under subpara8 graph (C).

9 ‘‘(B)(i) The Secretary shall require private sponsors

10 to submit proposed Phase I clinical investigations to be

11 conducted under an exemption under this subsection to

12 an institutional review board certified under subparagraph

13 (A) in lieu of submission to the Secretary.

14 ‘‘(ii) The Secretary may, upon request, authorize

15 commercial sponsors to submit proposed Phase I clinical

16 investigations to be conducted under an exemption under

17 this subsection to an institutional review board certified

18 under subparagraph (A) in lieu of submission to the Sec19 retary.

20 ‘‘(C) The Secretary, acting through the Commis21 sioner of Food and Drugs and the Director of the National

22 Institutes of Health, shall establish criteria for certifi23 cation by the Commissioner of institutional review boards

24 as qualified to approve the initiation and conduct of Phase

25 I clinical investigations. Applicants shall apply to a cer-
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1 tified institutional review board for approval to conduct

2 a Phase I clinical investigation.

3 ‘‘(D) An institutional review board may approve a

4 Phase I clinical investigation if it determines the investiga5 tion meets the requirements of paragraph (1) and is to

6 be conducted in accordance with standards which provide

7 reasonable protection of human subjects, including in8 formed consent procedures.

9 ‘‘(E) For purposes of this paragraph, the term ‘Phase

10 I clinical investigations’ means one or more clinical inves11 tigations that involve the introduction of an investigational

12 new drug into human beings. Such an investigation shall

13 be designed to determine parameters such as the follow14 ing: the safety profile of the drug, the metabolism and

15 pharmacologic actions of the drug in humans, the side ef16 fects associated with increasing doses of the drug, early

17 evidence of effectiveness of the drug, and information

18 about the drug’s rate and extent to absorption.

19 ‘‘(4)(A) The Secretary (or an institutional review

20 board with respect to a Phase I clinical investigation which

21 it has approved) may place a clinical hold on any proposed

22 or ongoing clinical investigation if the Secretary deter23 mines that such action is necessary for the protection of

24 human subjects or that the clinical investigations are poor25 ly supervised or executed, produce inaccurate or materially
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1 insufficient data, or are based on clearly deficient proto2 cols.

3 ‘‘(B) If an institutional review board places a clinical

4 hold on an investigation under subparagraph (A), it shall

5 immediately notify the Secretary of such action.

6 ‘‘(5)(A) Information otherwise protected from disclo7 sure to the public under section 301(j) or 520(c) may be

8 disclosed, under such conditions as the Secretary may

9 specify, to members of an institutional review board and

10 its staff if, in the opinion of the Secretary, such disclosure

11 is necessary to protect the public safety and for the satis12 factory performance by the institutional review board of

13 its functions under paragraph (3).

14 ‘‘(B) The Secretary shall, in writing, require as a con15 dition to the disclosure of information under this para16 graph that the person receiving such information take

17 such security precautions respecting the information as

18 the Secretary shall by regulation prescribe. Disclosure by

19 such person of such information to a person not author20 ized to receive it shall constitute a violation of section

21 301(j) and of section 1905 of title 18, United States Code.

22 ‘‘(6)(A) Any member of an institutional review board

23 certified by the Secretary under paragraph (3)(C) shall,

24 by reason of the member’s performance of any duty, func25 tion, or activity required of, or authorized to be under-
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1 taken by, the institutional review board under this sub2 section, be considered to be an employee of the Govern3 ment under section 2671 of title 28, United States Code.

4 ‘‘(B) Any personnel of a hospital, university, or other

5 institution under which an institutional review board cer6 tified by the Secretary under paragraph (3)(C) was orga7 nized shall, by reason of the personnel’s performance of

8 any duty, function, or activity required of, or authorized

9 to be undertaken by, the institutional review board under

10 this subsection, be considered to be an employee of the

11 Government under section 2671 of title 28, United States

12 Code.

13 ‘‘(7) The Secretary may make grants to institutional

14 review boards to defray, in whole or in part, the costs asso15 ciated with the approval of Phase I clinical investiga16 tions.’’.

17 (b) REPORT.—Not later than the expiration of 5

18 years from the date of the enactment of this Act, the Sec19 retary of Health and Human Services shall report to the

20 Congress on the use the Secretary has made under para21 graphs (3) through (7) of section 505(i) of the Federal

22 Food, Drug, and Cosmetic Act of institutional review

23 boards and any difficulties the Secretary has encountered

24 in using such boards.
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1 (c) EFFECTIVE DATE.—The amendments made by

2 subsections (a), (b), and (c) with respect to review of clini3 cal investigations under section 505(i) of the Federal

4 Food, Drug, and Cosmetic Act by institutional review

5 boards shall take effect upon the expiration of 36 months

6 after the date of the enactment of this Act

7 SEC. 6. REVIEW BY INDEPENDENT TESTING ORGANIZA8 TIONS.

9 (a) AMENDMENT.—Chapter IX is amended by adding

10 after section 905 (21 U.S.C. 395) the following:

11 ‘‘PRIVATIZATION OF APPROVAL FUNCTIONS

12 ‘‘SEC. 906. (a) The Secretary, acting through the

13 Commissioner of Food and Drugs, may establish and im14 plement a program under which the Commissioner will

15 contract, in whole or in significant part, with individuals

16 and laboratories certified under subsection (b) to conduct,

17 under such conditions as the Secretary may specify to as18 sure unbiased scientifically valid results, the following ac19 tivities and responsibilities of the Food and Drug Adminis20 tration in connection with the approval of drugs and de21 vices under sections 505 and 515 and with reviewing noti22 fications required under section 510(k) and making writ23 ten recommendations of initial classification under section

24 513(f)(1) of devices:

25 ‘‘(1) Toxicology reviews to determine if applica26 ble requirements are being met.
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1 ‘‘(2) Chemistry reviews to determine if applica2 ble requirements are being met.

3 ‘‘(3) Statistical analysis to determine if applica4 ble requirements are being met.

5 ‘‘(4) Preapproval manufacturing practice in6 spections to determine if applicable requirements are

7 being met.

8 ‘‘(5) Any other function of the Food and Drug

9 Administration relating to the review and approval

10 of drugs or devices that the Secretary determines

11 can be adequately performed under contract with

12 qualified individuals and laboratories.

13 ‘‘(b) The Secretary, acting through the Commissioner

14 of Food and Drugs, shall certify individuals and labora15 tories as qualified to carry out the functions described in

16 paragraphs (1) through (6) of subsection (a) under a con17 tract with the Commissioner of Food and Drugs.

18 ‘‘(c)(1) Information otherwise protected from disclo19 sure to the public under section 301(j) or 520(c) may be

20 disclosed to—

21 ‘‘(A) contractors certified under subsection (b),

22 and

23 ‘‘(B) employees of such contractors,
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1 if, in the opinion of the Secretary, such disclosure is nec2 essary for the satisfactory performance by the contractor

3 of work under a contract under subsection (a).

4 ‘‘(2) The Secretary shall, in writing, require as a con5 dition to the disclosure of information under paragraph

6 (1) that the person receiving such information take such

7 security precautions respecting the information as the Sec8 retary shall by regulation prescribe. Disclosure by such

9 person of such information to a person not authorized to

10 receive it shall constitute a violation of section 301(j) and

11 of section 1905 of title 18, United States Code.

12 ‘‘(e) The review of an application for approval of a

13 new drug or device under this Act or a biological product

14 under section 351 of the Public Health Service Act shall

15 not include the review of the environmental impact of such

16 drug, device, or biological product under the Environ17 mental Quality Improvement Act of 1970 (42 U.S.C. 4371

18 et seq.).’’.

19 (b) REPORT.—Not later than the expiration of one

20 year from the date of the enactment of this Act, the Sec21 retary of Health and Human Services shall report to the

22 Congress on—

23 (1) the use the Secretary has made under sec24 tion 906 of the Federal Food, Drug, and Cosmetic

25 Act of the authority to contract for individuals and
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1 laboratories to perform duties of the Food and Drug

2 Administration, and

3 (2) any difficulties encountered in contracting

4 under such section 906.

5 SEC. 7. LIMITATIONS ON AUTHORITY OVER LEGITIMATE

6 LABELING AND ADVERTISING.

7 (a) SECTION 201(m).—Section 201(m) (21 U.S.C.

8 321(m)) is amended to read as follows:

9 ‘‘(m)(1) The term ‘labeling’ means all labels and

10 other written, printed, or graphic material upon any arti11 cle or any of its containers or wrappers, or accompanying

12 any such article.

13 ‘‘(2) Such term does not include scientifically valid—

14 ‘‘(A) reprints of articles published in peer-re15 viewed scientific publications, other generally recog16 nized scientific materials such as medical textbooks,

17 official compendia, abstracts and proceedings of sci18 entific meetings, or information concerning decisions

19 about drug utilization review or formulary decisions

20 if—

21 ‘‘(i) such reprints, materials, or informa22 tion are disseminated in a meeting to health

23 professionals or to persons involved in the in24 surance of, or reimbursement for, drugs and de-
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1 vices approved under this Act and section 351

2 of the Public Health Service Act, and

3 ‘‘(ii) the dissemination of such reprints,

4 materials, or information was not required, di5 rectly or indirectly, by a pharmaceutical com6 pany or device manufacturer as a condition of

7 financial support of the development of such

8 materials or of such meeting;

9 ‘‘(B) materials used to fulfill the disclosure re10 quirements of the Securities and Exchange Commis11 sion; or

12 ‘‘(C) other information intended primarily for

13 distribution to shareholders (and potential share14 holders);

15 if such information is reported to the Secretary at least

16 60 days before its dissemination.

17 ‘‘(3) If labeling contains information described in

18 paragraph (2)(A) along with related data as may be

19 deemed appropriate by the Secretary, the Secretary may

20 require that persons disseminating such labeling include

21 in the labeling a statement prescribed by the Secretary

22 concerning such information if the Secretary finds that the

23 information is scientifically insufficient, inaccurate, or

24 misleading.’’.
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1 (b) SECTION 201(n).—Section 201(n) (21 U.S.C.

2 321(n)) is amended—

3 (1) by inserting ‘‘(1)’’ after ‘‘(n)’’; and

4 (2) by inserting the following at the end there5 of:

6 ‘‘(2) For purposes of this subsection, the term ‘adver7 tising’ does not include scientifically valid—

8 ‘‘(A) reprints of articles published in peer-re9 viewed scientific publications, other generally recog10 nized scientific materials such as medical textbooks,

11 official compendia, abstracts, and proceedings of sci12 entific meetings, or information concerning decisions

13 about drug utilization review of formulary decision

14 if—

15 ‘‘(i) such reprints, materials, or informa16 tion are disseminated in a meeting to health

17 professionals or persons involved in the insur18 ance of, or reimbursement for, drugs and de19 vices regulated under this Act and section 351

20 of the Public Health Service Act, and

21 ‘‘(ii) the dissemination of such reprints,

22 materials, or information was not required, di23 rectly or indirectly, by a pharmaceutical com24 pany or device manufacturer as a condition of
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1 financial support of the development of such

2 materials or of such meeting;

3 ‘‘(B) materials used to fulfill the disclosure re4 quirements of the Securities and Exchange Commis5 sion or the Securities Act of 1933 and the Securities

6 Exchange Act of 1934 and regulations promulgated

7 thereunder; or

8 ‘‘(C) other information intended primarily for

9 distribution to shareholders (and potential share10 holders);

11 if such information is reported to the Secretary at least

12 60 days before its dissemination.

13 ‘‘(3) If advertising contains information described in

14 paragraph (2)(A) along with related data as may be

15 deemed appropriate by the Secretary, the Secretary may

16 require that persons disseminating such advertising in17 clude in the advertising a statement prescribed by the Sec18 retary concerning such information if the Secretary finds

19 that the information is scientifically insufficient, inac20 curate, or misleading.’’.

21 (c) SECTION 201(p).—Section 201(p)(1) (21 U.S.C.

22 321(p)(1)) is amended by striking ‘‘labeling thereof’’ and

23 inserting ‘‘drug’s labeling (as defined in paragraph (m))’’.
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1 (d) SECTION 502(a).—Section 502(a) (21 U.S.C.

2 352(a)) is amended by inserting ‘‘(1)’’ after ‘‘(a)’’ and in3 serting at the end thereof the following:

4 ‘‘(2) The Secretary does not have authority to require

5 approval of promotional labeling prior to use or dissemina6 tion of such labeling. This paragraph does not apply to

7 the regulation of tobacco products.

8 ‘‘(3) The dissemination of scientifically valid informa9 tion as defined in section 201(m)(2)(A) is not a violation

10 of this section, provided that (a) it is reported to the Sec11 retary 60 days prior to dissemination, and (b) subject to

12 provisions of Section 201(m)(3).’’

13 (e) SECTION 502(n).—The first sentence of section

14 502(n) (21 U.S.C. 352(n) is amended by striking ‘‘, and

15 (B)’’ and inserting before the period at the end the follow16 ing: ‘‘, and (C) no advertising shall be subject to approval

17 prior to use or dissemination’’.

18 (f) APPLICATION.—The amendments made by this

19 section apply to the labeling and advertising of drugs, bio20 logical products, and devices which have been approved for

21 at least one indication.

22 SEC. 8. REVIEW BY EXPERT ADVISORY PANEL.

23 Chapter IX is amended by adding at the end the fol24 lowing:

25 ‘‘REVIEW BY EXPERT ADVISORY PANEL

26 ‘‘SEC. 906. (a)(1) In the case of—
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1 ‘‘(A) any person who has submitted an applica2 tion under section 505(a) for approval of a new

3 drug, or

4 ‘‘(B) any person who has submitted a product

5 license application for a biological product under sec6 tion 351(a) of the Public Health Service Act,

7 which the Secretary determines is to be used for the pur8 pose of treating a serious or life-threatening disease or

9 other health condition, such person (hereinafter in this

10 section referred to as the ‘applicant’) may, not sooner than

11 90 days after submitting such application, request review

12 of such application by an expert advisory panel under this

13 section.

14 ‘‘(2) If an expert advisory panel appointed by the Sec15 retary under subsection (b) recommends under subsection

16 (d) that the drug reviewed should be approved under sec17 tion 505 or that the biological product reviewed should

18 have a product license issued for it under section 351 of

19 the Public Health Service Act, then, within 45 days of re20 ceipt of the recommendation, the drug shall be deemed ap21 proved or the biological product shall be deemed to have

22 a product license issued for it unless the Secretary deter23 mines that the applicant has not met standards of section

24 505 or 351, whichever is applicable.
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1 ‘‘(b)(1) The Secretary may appoint expert advisory

2 panels for review of applications under this section accord3 ing to the various fields of clinical medicine and fun4 damental sciences in which drugs or biological products

5 are used.

6 ‘‘(2)(A) Members of an advisory panel shall be se7 lected from a list of persons submitted to the Secretary

8 under subsection (e), and the Secretary shall designate the

9 chairperson of each panel. Each advisory panel shall con10 sist of 5 or more persons with training and experience in

11 the fields of medicine and science applicable to the drug

12 which is the subject of the application to be reviewed and

13 who are otherwise qualified to review such applications.

14 ‘‘(B) Members of advisory panels appointed under

15 this subsection shall be compensated at a rate not to ex16 ceed the daily equivalent of the rate in effect for GS–18

17 of the General Schedule for each day (including travel

18 time) they are engaged in the performance of their duties

19 as members of the advisory panel. All members, while so

20 serving away from their homes or regular places of busi21 ness, may be allowed travel expenses, including per diem

22 in lieu of subsistence, in the same manner as such ex23 penses are authorized by section 5703, title 5, United

24 States Code, for employees serving intermittently.
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1 ‘‘(c)(1) The Secretary shall, within 60 days of the re2 ceipt of a request under subsection (a)(1), refer an eligible

3 application to an advisory panel, appointed under sub4 section (b), for the purpose of reviewing such application

5 and shall provide to the panel such information as the Sec6 retary determines will facilitate review of such application

7 by the panel.

8 ‘‘(2)(A) Information provided under paragraph (1)

9 which is otherwise protected from disclosure to the public

10 under section 301(j) or 520(c) shall be disclosed to mem11 bers of advisory panels only under the conditions specified

12 in subparagraph (B).

13 ‘‘(B) The Secretary shall, in writing, require as a con14 dition to the disclosure of information under subparagraph

15 (A) that the person receiving it take such security pre16 cautions respecting the information as the Secretary shall

17 by regulation prescribe. Disclosure by such person of such

18 information to a person not authorized to receive it shall

19 constitute a violation of section 301(j) and of section 1905

20 of title 18, United States Code.

21 ‘‘(d)(1) Within 60 days of the date information is

22 provided to the expert advisory panel under subsection

23 (c)(1), the expert advisory panel shall complete its review

24 of the information received under subsection (c) with re25 spect to an application being reviewed by the panel and
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1 shall submit to the Secretary and the applicant a rec2 ommendation as to whether the drug included in the appli3 cation should be approved in accordance with section 505

4 or whether a product license should be issued under sec5 tion 351 of the Public Health Service Act for the biological

6 product included in the application. A recommendation for

7 approval of the drug or issuance of a license for a biologi8 cal product shall specify the indication for which the drug

9 or biological product is recommended for approval.

10 ‘‘(2) A summary of the recommendation submitted

11 to the Secretary under paragraph (1) shall be made avail12 able to the public on the day it is so submitted, but no

13 information which is described in section 552(b)(4) of title

14 5, United States Code, shall be included in the summary

15 or otherwise released to the public.

16 ‘‘(e)(1) The Secretary shall request a nongovern17 mental scientific body to submit to the Secretary a list

18 of names of persons, together with their qualifications,

19 who such body believes to be qualified to serve on expert

20 advisory panels appointed under subsection (f). Such list

21 shall be revised on an annual basis.

22 ‘‘(2) Any person may submit to such nongovern23 mental body recommendations of persons to be included

24 on the list submitted under paragraph (1).
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1 (c) REPORT.—Not later than the expiration of one

2 year from the date of the enactment of this Act, the Sec3 retary of Health and Human Services shall report to the

4 Congress on the Secretary’s implementation of sections

5 505(i)(7) and 520(g)(6) of the Federal Food, Drug, and

6 Cosmetic Act and the use the Secretary has made of insti7 tutional review boards. Such report shall include any dif8 ficulties the Secretary has encountered in the implementa9 tion of such sections and the use of institutional review

10 boards.

11 SEC. 9. RATIONALIZING GOOD MANUFACTURING PRAC12 TICES.

13 Section 501 (21 U.S.C. 351(a)) is amended—

14 (1) by inserting ‘‘(A)’’ after ‘‘(a)(1)’’ and redes15 ignating ‘‘(2)(A)’’ as ‘‘(B)(i)’’, ‘‘(B)’’ as ‘‘(ii)’’ both

16 times it appears, ‘‘(3)’’ as ‘‘(C)’’, ‘‘(4)’’ as ‘‘(D)’’,

17 ‘‘(5)’’ as ‘‘(E)’’, ‘‘(6)’’ as ‘‘(F)’’, and ‘‘(A)’’ as ‘‘(i)’’

18 the second time it appears; and

19 (2) by inserting the following at the end of sub20 section (a):

21 ‘‘(B) The Secretary shall by regulation establish good

22 manufacturing practices applicable to drugs subject to sec23 tion 505 of this Act and biological products (other than

24 blood, blood products and blood components, and vaccines

25 that cannot adequately be characterized by physical or
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1 chemical methods) subject to section 351 of the Public

2 Health Service Act as follows:

3 ‘‘(i) One set of regulations shall apply only to

4 drugs and biological products which cannot be char5 acterized adequately by physical or chemical meth6 ods.

7 ‘‘(ii) A second set of regulations shall apply

8 only to drugs and biological products which can be

9 characterized adequately by physical or chemical

10 methods.

11 ‘‘(C) Regulations established under subparagraph

12 (B) shall establish requirements for submissions to the

13 Secretary of changes in manufacturing practices by the

14 applicant or holder. Such regulations shall provide as fol15 lows:

16 ‘‘(i) In the case of drugs and biological products

17 which can adequately be characterized by physical or

18 chemical methods, approval of manufacturing

19 changes shall be required prior to implementation of

20 such changes only if such manufacturing changes

21 are specified in regulations as substantially affecting

22 the safety or efficacy of such drugs and biological

23 products.

24 ‘‘(ii) In the case of drugs and biological prod25 ucts which cannot be characterized adequately by
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1 physical or chemical methods, approval of such man2 ufacturing changes before implementation shall be

3 required—

4 ‘‘(I) in the case of a drug or a biological

5 product which is required under section

6 351(a)(1)(B) of the Public Health Service Act

7 to have a product license, only if such manufac8 turing changes are specified in regulations as

9 potentially affecting the safety or efficacy of

10 such drug or biological product; or

11 ‘‘(II) in the case of a biological product

12 which is subject to standards as determined

13 under section 351(a)(1)(B) of the Public

14 Health Service Act, only if such manufacturing

15 changes are specified in the regulations as sub16 stantially affecting the safety, purity, or po17 tency (or, in the case of tissue, safety, and in18 tegrity) of such biological products.

19 ‘‘(iii) Such regulations shall specify the types of

20 manufacturing changes that must be submitted in

21 writing to the Secretary (but not required to be ap22 proved prior to implementation). A request to make

23 such changes must be submitted by the applicant or

24 holder at least 30 days prior to implementation of

25 such changes. Such request may be implemented on
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1 the 31st day after submission unless on or before

2 such day the Secretary disapproves such request and

3 notifies the applicant or holder in writing of such

4 disapproval. Such notification shall include a com5 plete statement of the reasons for not allowing im6 plementation.

7 ‘‘(iv) If upon further review, the Secretary iden8 tifies problems that would affect product safety, effi9 cacy, purity, or potency or tissue integrity, the Sec10 retary may disapprove the manufacturing changes.

11 Taking into consideration risks involved, reasonable

12 time shall be given the applicant or holder to comply

13 with the disapproval.

14 ‘‘(v) A description of manufacturing changes

15 not covered by clauses (i) or (iii) shall be submitted

16 by the applicant or holder to the Secretary on an an17 nual basis.

18 ‘‘(D)(i) The Secretary shall, after notice and oppor19 tunity for public comment pursuant to section 553 of title

20 5, United States Code, establish not later than December

21 31. 1998, regulations to be used in determining whether

22 a drug or a biological product can adequately be character23 ized by physical or chemical methods.

24 ‘‘(ii) If the applicant disagrees with a determination

25 by the Secretary that the drug or biological product which
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1 is the subject of an application cannot be adequately char2 acterized by physical or chemical methods, such applicant

3 may contest such determination by requesting an informal

4 hearing.

5 ‘‘(E) For purposes of subparagraphs (B) through

6 (D)—

7 ‘‘(i) the term ‘changes in manufacturing prac8 tices’ means—

9 ‘‘(I) changes in manufacturing procedures

10 generally applicable throughout the facility,

11 such as changes in recordkeeping procedures,

12 validation processes, methods of training of per13 sonnel, and methods of qualification of equip14 ment;

15 ‘‘(II) changes in the manufacturing facility

16 or equipment; and

17 ‘‘(III) changes in manufacturing proce18 dures of specific applicability to a biological

19 product;

20 ‘‘(ii) the term ‘holder’ means a person whose

21 drug application submitted under section 505 or

22 product license application submitted under section

23 351 of the Public Health Service Act has been ap24 proved; and
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1 ‘‘(iii) the term ‘applicant’ means a person

2 whose application described under clause (ii) has

3 been submitted to, but not approved by, the Sec4 retary.’’.

5 SEC. 10. EXPORT OF DRUGS AND DEVICES.

6 (a) SECTION 801(e).—Section 801(e) (21 U.S.C.

7 381(e)) is amended—

8 (1) in paragraph (1), by inserting after ‘‘under

9 this Act’’ the following: ‘‘or in violation of section

10 505 or section 351 of the Public Health Service

11 Act’’;

12 (2) in paragraph (1), by amending subpara13 graph (B) to read as follows:

14 ‘‘(B) has been accepted or requested for

15 import by the country to which it is intended

16 for export and will be sold, tested, or otherwise

17 used in such country’’;

18 (3) in paragraph (1), by striking the last sen19 tence;

20 (4) by amending paragraph (2) to read as fol21 lows:

22 ‘‘(2) Paragraph (1) does not apply to the export of—

23 ‘‘(A) any device—

24 ‘‘(i) which does not comply with an appli25 cable requirement under section 514 or 515; or
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1 ‘‘(ii) which under section 520(g) is exempt

2 from either such section, or

3 ‘‘(B) any drug which does not comply with an

4 applicable requirement under section 505 or 512 or

5 section 351 of the Public Health Service Act,

6 unless the device or drug is in compliance with the require7 ments of paragraph (1) and if the device or drug is to

8 be exported to a country which is not a member of the

9 World Trade Organization, the person exporting it has no10 tified the Secretary of the export at least 30 days before

11 the export and has included in such notice the name of

12 the product, the country to which the product is being ex13 ported and a brief description of the medical need for such

14 device or drug in such country. In the case of a device

15 or drug for which an export notice is required under this

16 paragraph, the Secretary may prohibit the export of such

17 device or drug if the Secretary determines that the possi18 bility of the reimportation of the device or drug into the

19 United States presents an imminent hazard to the public

20 health and safety of the United States and the only means

21 of limiting the hazard is to prohibit the export of the de22 vice or drug.’’; and

23 (5) by adding the following at the end thereof:

24 ‘‘(f) The Secretary shall not exercise jurisdiction.—
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1 ‘‘(1) over the labeling of drugs or devices in2 tended for export in order to comply with require3 ments of foreign countries’’; or

4 ‘‘(2) over drugs or devices not subject to sub5 section (e) which are intended for export and which

6 are not intended for commercial sale or are intended

7 for investigational use only.’’.

8 (b) SECTION 802.—Section 802 (21 U.S.C. 382) is

9 repealed.

10 SEC. 11. REGULATION OF BIOLOGICAL PRODUCTS.

11 Section 351(a) of the Public Health Service Act (42

12 U.S.C. 262(a)) is amended by inserting ‘‘(1)(A)’’ after

13 ‘‘(a)’’ and by striking ‘‘any virus’’ and all that appears

14 thereafter and inserting in lieu thereof the following: ‘‘a

15 biological product to which this section applies unless—

16 ‘‘(i) such biological product has been propa17 gated, manufactured, or prepared in accordance with

18 good manufacturing practices;

19 ‘‘(ii) such biological product is the subject of an

20 approved product license or complies with a stand21 ard established by the Secretary; and

22 ‘‘(iii) each package of such biological product is

23 plainly marked with the proper name of the biologi24 cal product contained therein, the name, address,

25 and establishment number of the manufacturer, and
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1 the date beyond which the contents cannot be ex2 pected to yield their specific results.

3 ‘‘(B) The Secretary shall by regulation specify which

4 biological products shall be required to have a product li5 cense or shall be subject to standards established under

6 subparagraph (A)(ii), except that tissue, blood and blood

7 components and derivatives (other than blood test kits)

8 shall be subject to standards under paragraph (4).

9 ‘‘(2)(A) The Secretary shall establish, by regulation,

10 requirements for product license applications. The Sec11 retary shall approve a product license application upon a

12 demonstration that there exists reasonable assurance that

13 the biological product which is the subject of the applica14 tion is safe and effective.

15 ‘‘(B)(i) The Secretary shall establish, by regulation,

16 standards for biological products subject to such stand17 ards under paragraph (1)(B), except that tissue, blood,

18 and blood components or derivatives (other than blood test

19 kits) shall be subject to standards established under para20 graph (4). Standards shall, as appropriate, reasonably as21 sure the safety, purity, and potency of the biological prod22 uct or class of biological products subject to such stand23 ard.

24 ‘‘(3)(A) A product license approved by the Secretary

25 under paragraph (2)(A) and regulations established by the
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1 Secretary under paragraph (2)(B) may require that lots

2 or batches of a biological product be released only after

3 certification that such lots or batches have the characteris4 tics of safety, purity, and potency which the biological

5 product purports or is represented to possess.

6 ‘‘(B)(i) A product license shall specify whether certifi7 cation under subparagraph (A) will be by the manufac8 turer of the biological product, by the Secretary, or by a

9 certified individual or independent laboratory under sec10 tion 906 of the Federal Food, Drug, and Cosmetic Act.

11 ‘‘(ii) Certification of lots or batches by the Secretary

12 or independent laboratory shall be required only for a pe13 riod of not more than 6 months or until satisfactory his14 tory of consistent acceptable production has been estab15 lished, which period will not be extended unless the Sec16 retary determines in writing that continuing such certifi17 cation is required to assure the safety and efficacy of the

18 biological product.’’.

19 ‘‘(iii) The Secretary may at any time, upon petition

20 by the manufacturer or upon the Secretary’s own initia21 tive, terminate any requirement for certification.

22 ‘‘(4)(A) The Secretary shall by regulation establish

23 standards for tissue, blood, and blood components or blood

24 derivatives (other than blood test kits). Such standards

25 shall assure the safety and integrity of the tissue, blood,
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1 and blood components or derivatives (other than blood test

2 kits). The Secretary shall solicit the submission of one or

3 more proposed standards, applicable to tissue, blood, and

4 blood components or derivatives (other than blood test

5 kits) and approved by the Secretary as appropriate for

6 purposes of this section, from professional and scientific

7 organizations. The Secretary shall publish such standards

8 as a notice of proposed rulemaking in accordance with

9 paragraph (2)(B)(ii).

10 ‘‘(B) Tissue subject to this paragraph shall be proc11 essed in accordance with good manufacturing practices es12 tablished by the Secretary under section 501.

13 ‘‘(C) The Secretary may use—

14 ‘‘(i) professional and scientific organizations,

15 and

16 ‘‘(ii) accrediting bodies used to assure compli17 ance with the standards of such organizations,

18 to assist in the implementation of subparagraph (A) and

19 to assure that tissue meets the requirements of subpara20 graph (B).

21 ‘‘(D) For blood, blood products and blood compo22 nents, and vaccines which cannot be adequately character23 ized by physical or chemical methods, the Secretary shall

24 continue to implement the existing requirements for facili25 ties where such blood, blood products, and blood compo-
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1 nents are drawn processed, stored, or otherwise main2 tained for distribution or in which such vaccines are man3 ufactured or propagated.

4 ‘‘(5) The requirements of paragraph (1) do not apply

5 to a biological product—

6 ‘‘(A) for which there is in effect an investiga7 tional new drug application under section 505(i) of

8 the Federal Food, Drug, and Cosmetic Act, or

9 ‘‘(B) for which there is in effect under para10 graph (6) a provisional standards license.

11 ‘‘(6)(A) Each person who proposes to begin the intro12 duction or delivery for introduction into interstate com13 merce for commercial distribution of a biological product

14 which will require a standards license shall, at least 30

15 days before making such introduction or delivery submit

16 to the Secretary (in such form and manner as the Sec17 retary shall by regulation prescribe) a report that in18 cludes—

19 ‘‘(i) a description of the biological product;

20 ‘‘(ii) a statement of reasons satisfactory to the

21 Secretary that the biological product will require a

22 standards license (and not a product license);

23 ‘‘(iii) assurances by such person which are sat24 isfactory to the Secretary that such biological prod25 uct will be manufactured in accordance with good
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1 manufacturing practices described in paragraph

2 (1)(A)(i); and

3 ‘‘(iv) such other information as the Secretary

4 may by regulation require.

5 ‘‘(B) Upon the expiration of 30 days after the receipt

6 by the Secretary of a report under subparagraph (A), the

7 biological product for which the report was submitted shall

8 be deemed to have a provisional standards license unless

9 before the expiration of such days the Secretary deter10 mines that a requirement of such subparagraph (A) has

11 not been met. If the Secretary determines that such a re12 quirement has not been met, the Secretary shall provide

13 to the person who submitted the report on which such de14 termination was made an opportunity for an informal

15 hearing.

16 ‘‘(C) A provisional standards license under subpara17 graph (A) shall expire upon the issuance of a standards

18 license under paragraph (2).

19 ‘‘(7) For purposes of this subsection—

20 ‘‘(A) the term ‘tissue’ means a collection of

21 human cells which are similar or the intercellular

22 substances surrounding them, or both, which—

23 ‘‘(i) are intended for administration to a

24 human being for the diagnosis, cure, mitigation,
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1 treatment, or prevention of any disease or con2 dition;

3 ‘‘(ii) are procured, processed, stored, or

4 distributed by methods to prevent the trans5 mission of infectious disease and to preserve or

6 enhance clinical usefulness;

7 ‘‘(iii) may be processed to remove some of

8 its constituents but have not been modified

9 chemically;

10 ‘‘(iv) may be combined with substances

11 such as excipients, fillers, or carriers that are

12 not devices or pharmacologically active;

13 ‘‘(v) if subjected to expansion, manipula14 tion, or other processing (which may include

15 modification of physical form or structure) be16 fore being transplanted or implanted, are not

17 thereby substantially altered in their inherent

18 structural or functional characteristics; and

19 ‘‘(vi) achieve their principal intended pur20 poses through structural or functional support

21 and not systemic action;

22 but such term does not include vascularized human

23 organs.

24 ‘‘(B) the term ‘biological product to which this

25 section applies’ means a virus, therapeutic serum,
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1 toxin, antitoxin, tissue, blood, component or deriva2 tive, allergenic biological product, or an other analo3 gous biological product or arsphenamine or its deriv4 ative applicable to the prevention, treatment, or cure

5 of diseases or conditions of human beings.’’.

6 SEC. 12. INITIAL REPORTING OF DEVICES.

7 (a) CLASS I DEVICES.—Section 510(k) (21 U.S.C.

8 360(k)) is amended by adding after paragraph (2) the fol9 lowing: ‘‘No person shall be required to make a report

10 under this subsection with respect to a class I device or

11 a class II device which the Secretary has designated after

12 notice and comment rulemaking to be exempt from such

13 requirement.’’.

14 (b) RULEMAKING.—Within 30 days of the date of the

15 enactment of this Act, the Secretary of Health and

16 Human Services shall publish a notice requesting identi17 fication of class II devices which should be placed in class

18 I. Upon the expiration of 30 days after the date of such

19 notice, the Secretary shall publish a proposal to exempt

20 from the notification required under section 510(k) of the

21 Federal Food, Drug, and Cosmetic Act the class II devices

22 identified in response to the notice. Within 60 days of such

23 publication, the Secretary shall publish a final regulation

24 exempting the specified class II devices from such notifica25 tion requirement. If the Secretary does not publish a final
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1 regulation, the devices contained in the proposed regula2 tion shall be deemed exempt from such notification re3 quirement.

4 (c) DEVICE MODIFICATIONS.—Section 510(k) (21

5 U.S.C. 360(k)), as amended by subsection (a), is amended

6 by adding at the end the following: ‘‘A person who modi7 fies a device in such a manner that has no substantive

8 effect on the character, utility, or therapeutic nature of

9 the device shall not be required to make a report under

10 this subsection because of such modification and shall

11 maintain data or information that demonstrates that a re12 port under this subsection is not required in such person’s

13 good manufacturing practice document file. Such data or

14 information shall be available upon request to the Sec15 retary.’’.

16 SEC. 13. FDA RESPONSE TO G.M.P. VIOLATIONS.

17 Section 520(f) (21 U.S.C. 360j) is amended by add18 ing at the end the following:

19 ‘‘(4) The Secretary may not delay the approval of a

20 device under a section 510(k) report because the person

21 who made the report is in violation of a requirement pre22 scribed under paragraph (1) unless the Secretary deter23 mines that the violation is reasonably related to such de24 vice or is related to all the operations of such person. If

25 the Secretary delays such approval because of such a viola-
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1 tion, the Secretary shall, within 60 days of being notified

2 that corrective actions have been taken, reinspect for such

3 violations or remove the delay. The Secretary shall prepare

4 information for persons making reports under section

5 510(k) to inform them of the provisions of this

6 paragraph.’’.

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