I

104TH CONGRESS

2D SESSION H. R. 3199

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health

Service Act to facilitate the development and approval of new drugs

and biological products, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MARCH 29, 1996

Mr. BURR (for himself, Mr. GREENWOOD, Mr. RICHARDSON, Mr. BILIRAKIS,

Mr. TOWNS, Mr. BARTON of Texas, Mr. HALL of Texas, Mr. KLUG, Ms.

ESHOO, Mr. UPTON, Mr. GORDON, Mr. BILBRAY, Mr. BREWSTER, Mr.

COBURN, Mr. DOOLEY of California, Mr. GANSKE, Mr. MCHALE, Mr.

OXLEY, Mr. PAYNE of Virginia, Mr. FIELDS of Texas, Mr. ROSE, Mr.

PAXON, Mr. HOLDEN, Mr. TAUZIN, Mr. SCHAEFER, Mr. FOX of Pennsylvania, Mr. FUNDERBURK, Mr. CAMPBELL, Mr. MCINTOSH, Mr. COX

of California, Mr. DREIER, Mr. HEINEMAN, Mr. WELDON of Florida, Mr.

SHAYS, Mr. HASTERT, Mr. NORWOOD, Mr. BURTON of Indiana, Mr.

FRAZER, Mr. STEARNS, Mr. FRISA, Mr. RAMSTAD, Mr. MARTINI, and

Ms. DUNN of Washington) introduced the following bill; which was referred to the Committee on Commerce

A BILL

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

the Public Health Service Act to facilitate the development and approval of new drugs and biological products,

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,
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1 SECTION 1. SHORT TITLE, REFERENCE, AND TABLE OF

2 CONTENTS.

3 (a) SHORT TITLE.—This Act may be cited as the

4 ‘‘Drug and Biological Products Reform Act of 1996’’.

5 (b) REFERENCE.—Whenever in this Act (other than

6 in sections 13 and 24) an amendment is expressed in

7 terms of an amendment to a section or other provision,

8 the reference shall be considered to be made to a section

9 or other provision of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 321) et seq.) except as otherwise

11 specified.

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

13 as follows:

Sec. 1. Short title, reference, and table of contents.

Sec. 2. FDA mission and annual report.

Sec. 3. Streamlining clinical research on drugs and biological products.

Sec. 4. The content and review of a new drug application.

Sec. 5. Effectiveness determination.

Sec. 6. Scientific review groups.

Sec. 7. Marketing approval.

Sec. 8. Accreditation of third parties.

Sec. 9. Dispute resolution.

Sec. 10. Good manufacturing practice inspections.

Sec. 11. Good manufacturing practices.

Sec. 12. Pilot and small scale manufacture.

Sec. 13. Manufacturing changes.

Sec. 14. Insulin and antibiotics.

Sec. 15. Nonprescription drugs.

Sec. 16. Information system.

Sec. 17. Environmental impact review.

Sec. 18. Application of State and Federal law to the practice of pharmacy

compounding.

Sec. 19. Harmonization.

Sec. 20. Use of scientific and medical information.

Sec. 21. Informal agency statements.

Sec. 22. Research and education; practice of medicine.

Sec. 23. Delegation of authority.

Sec. 24. Judicial review.

Sec. 25. Publication of notice of deviation.

Sec. 26. Biological products.
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1 SEC. 2. FDA MISSION AND ANNUAL REPORT.

2 (a) MISSION.—Section 903 (21 U.S.C. 393) is

3 amended by redesignating subsections (b) and (c) as sub4 sections (c) and (d), respectively, and by adding after sub5 section (a) the following:

6 ‘‘(b) MISSION.—The Food and Drug Administration

7 shall protect the public health and safety and promptly

8 and efficiently review and approve clinical research and

9 marketing of products in a manner that does not unduly

10 impede innovation or product availability. The Food and

11 Drug Administration shall participate with other countries

12 to reduce the burden of regulation, harmonize regulatory

13 requirements, and achieve appropriate reciprocal arrange14 ments.’’.

15 (b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),

16 as amended by subsection (a), is amended by adding at

17 the end the following:

18 ‘‘(e) ANNUAL REPORT.—The Secretary shall, simul19 taneously with the submission each year of the budget for

20 the Food and Drug Administration, submit to the Com21 mittee on Commerce of the House of Representatives and

22 the Committee on Labor and Human Resources of the

23 Senate an annual report which shall—

24 ‘‘(1) review the performance of the Food and

25 Drug Administration in meeting its mission and the
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1 development of Food and Drug Administration poli2 cies to implement such mission;

3 ‘‘(2) review the performance of the Food and

4 Drug Administration in meeting its own perform5 ance standards, including its own outcome measure6 ments and statutory deadlines for the approval of

7 products or for other purposes contained in this Act;

8 ‘‘(3) describe the staffing and resources of the

9 Food and Drug Administration and list those per10 sons and organizations accredited to conduct inves11 tigations under section 505(i), product approvals

12 under sections 505 and 506, and to perform good

13 manufacturing practice reviews under sections

14 505(d)(3) and 520(f);

15 ‘‘(4) describe the goals, activities, and accom16 plishments of the Food and Drug Administration in

17 bilateral and multinational meetings that addressed

18 methods and approaches to reduce the burden of

19 regulation, harmonize regulation, and to seek appro20 priate reciprocal arrangements, list each such meet21 ing, and list pending issues specifying those that are

22 not consistent with or are contrary to the provisions

23 of this Act; and

24 ‘‘(5) compare the performance of the Food and

25 Drug Administration in approving innovative prod-
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1 ucts with that of the most successful agencies per2 forming similar functions in other countries and

3 compare the resources used by such agencies.’’.

4 SEC. 3. STREAMLINING CLINICAL RESEARCH ON DRUGS

5 AND BIOLOGICAL PRODUCTS.

6 Section 505(i) (21 U.S.C. 355(i)) is amended by add7 ing ‘‘(1)’’ prior to the first sentence, by redesignating

8 paragraphs (1), (2), and (3) as subparagraphs (A), (B),

9 and (C), respectively, and by adding the following new

10 paragraphs at the end thereof:

11 ‘‘(2) A clinical investigation of a new drug may begin

12 21 days after the Secretary has received from the sponsor

13 of the investigation a submission containing information

14 about the drug and the clinical investigation as follows:

15 The submission shall contain—

16 ‘‘(A) adequate reports of basic information, cer17 tified by the applicant to be accurate reports, nec18 essary to assess the safety of the drug for use in

19 clinical investigation; and

20 ‘‘(B) adequate information on the chemistry of

21 the drug, manufacturing of the drug, controls avail22 able for the drug, and primary data tabulations for

23 the drug from animal or human studies, except that

24 for phase I or phase II clinical investigations de25 tailed information shall not be required unless the
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1 director of the office responsible for the review of

2 the drug makes a request within 21 days after the

3 submission regarding such detailed information in

4 writing and specifies the reasons for the request.

5 ‘‘(3)(A) At any time, the Secretary may issue to the

6 sponsor of an investigation a clinical hold in writing pro7 hibiting the sponsor from conducting the investigation and

8 specifying the basis for the clinical hold. The Secretary

9 may issue a clinical hold upon a demonstration, based on

10 specific information available to the Secretary, that the

11 drug to be investigated represents an unreasonable risk

12 to the safety of the persons who are the subject of the

13 clinical investigation, taking into account the design of the

14 clinical investigation, the condition for which the drug is

15 to be investigated, and the health status of the subjects

16 involved.

17 ‘‘(B) Any response from the sponsor of an investiga18 tion to the Secretary requesting that a clinical hold be re19 moved shall receive a decision, in writing and specifying

20 the reasons therefor, within 15 days after receipt of such

21 response or the clinical hold shall be deemed to be with22 drawn.

23 ‘‘(4) As an alternative to the procedure established

24 in paragraph (2), a Phase I or Phase II clinical investiga25 tion may begin after an accredited institution has ap-
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1 proved the investigation and the sponsor of the investiga2 tion has submitted to the Secretary a notification setting

3 forth the name and address of the sponsor, the identity

4 of the drug, and the uses of the drug that the sponsor

5 intends to investigate. Data and information developed

6 through such an investigation may be submitted in sup7 port of an application for approval of a new drug and shall

8 be considered by the Secretary to the same extent as data

9 and information developed through an investigation under

10 paragraph (2). Paragraph (3) shall apply to such an inves11 tigation. The Secretary shall establish by regulation the

12 requirements and qualifications that an accredited institu13 tion shall meet to be eligible to approve an investigation

14 for purposes of this paragraph.

15 ‘‘(5) The Food and Drug Administration shall have

16 exclusive regulatory jurisdiction in the Department of

17 Health and Human Services over the use of a new drug

18 in any clinical investigation.’’.

19 SEC. 4. THE CONTENT AND REVIEW OF A NEW DRUG APPLI20 CATION.

21 (a) SECTION 505(b).—Section 505(b) (21 U.S.C.

22 355(b)) is amended by adding at the end the following:

23 ‘‘(4)(A) An application submitted under paragraph

24 (1) shall include adequate reports of clinical and pre25 clinical investigations on safety and effectiveness certified
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1 by the applicant to be accurate and supported by tables

2 of the relevant data, and forms and tabulations related

3 to deaths and dropouts due to adverse reactions. The di4 rector of the office responsible for review of the drug may

5 request, in writing and specifying the reasons for the re6 quest for a particular application, the submission of spe7 cific primary data tabulations or case report forms or tab8 ulations for a specific investigation.

9 ‘‘(B) The Secretary shall establish standards for the

10 review of applications submitted under paragraph (1) re11 lating to promptness, technical excellence, lack of bias and

12 conflict of interest, and a knowledge of regulatory and sci13 entific standards which shall apply equally to outside re14 viewers and to employees of the Secretary who review such

15 applications.

16 ‘‘(C) Food and Drug Administration employees shall

17 meet with a sponsor of an investigation or an applicant

18 under an application submitted under paragraph (1) with19 in 30 days of any reasonable request for a meeting by the

20 sponsor or applicant for the purpose of reaching agree21 ment on the design and size of clinical trials. Minutes of

22 any such meeting shall be exchanged. Advice provided to

23 a sponsor or applicant at its request by a Food and Drug

24 Administration employee, which is reduced to writing and

25 made part of the administrative record by the sponsor or
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1 applicant or by the Food and Drug Administration, re2 garding appropriate testing of a new drug shall not be

3 changed after such testing begins, except with the written

4 agreement of the sponsor or applicant or by a decision

5 in writing, after an informal hearing, by the director of

6 the office in which the drug is reviewed where such change

7 is needed because there is a demonstrated need to protect

8 the public health.

9 ‘‘(D) The written decisions of the office responsible

10 for the review of a drug on all aspects of scientific and

11 medical matters relating to a new drug shall be binding

12 upon, and may not directly or indirectly be changed by,

13 the field personnel or the offices of compliance of the office

14 responsible for the review.

15 ‘‘(E) No action by the office responsible for the re16 view of a drug on any matter relating to a new drug for

17 which an application has been submitted under paragraph

18 (1) may at any time, or under any circumstance other

19 than a demonstrable extraordinary circumstance, be de20 layed because of the unavailability of information from or

21 action by field personnel.’’.

22 (b) SECTION 735(7).—Section 735(7) is amended—

23 (1) by striking ‘‘applications for’’ and inserting

24 ‘‘applications’’ and by inserting ‘‘for’’ after ‘‘(A)’’,

25 ‘‘(B)’’, and ‘‘(C)’’;
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1 (2) by striking ‘‘and’’ at the end of subpara2 graph (C),

3 (3) by striking the period at the end of sub4 paragraph (D) and inserting ‘‘, and’’, and

5 (4) by inserting the following after subpara6 graph (D):

7 ‘‘(E) by outside organizations and individ8 uals.’’.

9 SEC. 5. EFFECTIVENESS DETERMINATION.

10 Section 505(d) (21 U.S.C. 355(d)) is amended—

11 (1) in the last sentence, by adding ‘‘one or

12 more’’ before ‘‘clinical investigations’’;

13 (2) by adding at the end the following: ‘‘For

14 purposes of the preceding sentence, a well-controlled

15 investigation shall only include methods of control

16 that are appropriate to the disease or condition for

17 which a drug is intended as prescribed, rec18 ommended, or suggested in its labeling. The Sec19 retary may waive the requirement to conduct any

20 well-controlled investigation, as defined in the pre21 ceding sentence.’’; and

22 (3) by inserting ‘‘(1)’’ after ‘‘(d)’’, by redesig23 nating clauses (1) through (6) as clauses (A)

24 through (F), by striking ‘‘(1) through (6)’’ and in-
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1 serting ‘‘(A) through (F)’’, and by adding at the end

2 the following:

3 ‘‘(2) For purposes of clause (E) of paragraph (1)—

4 ‘‘(A) an application for a new drug for a serious

5 or life-threatening condition shall be considered to

6 have substantial evidence if it could be fairly and re7 sponsibly concluded by the experts referred to in

8 paragraph (1) that there is a reasonable likelihood

9 that the drug will be effective in a significant num10 ber of patients and that the risk from the drug is

11 no greater than the risk from the condition; and

12 ‘‘(B) if an application has been submitted for a

13 new use of a previously approved new drug, such

14 drug shall be considered to have substantial evidence

15 by a demonstration that the new use is common

16 among clinicians experienced in the field and rep17 resents reasonable clinical practice based upon reli18 able clinical experience and confirmatory informa19 tion.

20 ‘‘(3) For purposes of paragraph (1), the determina21 tion of effectiveness shall not include—

22 ‘‘(A) relative effectiveness, unless the effective23 ness of the drug is explicitly compared in the label24 ing to the effectiveness of another drug;
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1 ‘‘(B) any potential use not explicitly included in

2 the labeling; and

3 ‘‘(C) the cost-effectiveness of the drug as com4 pared to the cost-effectiveness of another drug un5 less the labeling explicitly includes a representation

6 about cost-effectiveness.’’.

7 SEC. 6. SCIENTIFIC ADVISORY PANELS.

8 Section 505 (21 U.S.C. 355) is amended by adding

9 at the end the following:

10 ‘‘(n)(1) For the purpose of providing expert scientific

11 advice and recommendations to the Secretary regarding

12 a clinical investigation of a drug or biological product or

13 the approval for marketing of a drug or biological product

14 under section 505 or 506, the Secretary shall establish

15 panels of experts or use panels of experts established be16 fore the date of the enactment of this subsection, or both.

17 Scientific advisory panels shall consider scientific issues

18 and shall not include considerations of cost, economic as19 pects, comparative effectiveness, or legal matters.

20 ‘‘(2) The Secretary may delegate the appointment

21 and oversight authority granted under section 904 to a

22 director of a center or successor entity within the Food

23 and Drug Administration.

24 ‘‘(3) The Secretary shall appoint to each panel estab25 lished under paragraph (1) persons who are qualified by
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1 training and experience to evaluate the safety and effec2 tiveness of the drugs and biological products to be referred

3 to the panel and who, to the extent feasible, possess skill

4 in the use of, or experience in, the development, manufac5 ture, or utilization of, such drugs or biological products.

6 The Secretary shall make appointments to each panel so

7 that each panel shall consist of members with adequately

8 diversified expertise in such fields as clinical and adminis9 trative medicine, engineering, biological and physical

10 sciences, and other related professions. In addition, each

11 panel shall include as nonvoting members a representative

12 of consumer interests and a representative of interests of

13 the drug and biological product manufacturing industry.

14 Scientific, trade, and consumer organizations shall be af15 forded an opportunity to nominate individuals for appoint16 ment to the panels. No individual who is in the regular

17 full-time employ of the United States and engaged in the

18 administration of this Act may be a member of any panel.

19 The Secretary shall designate one of the members of each

20 panel to serve as chairman thereof.

21 ‘‘(4) Each member of a panel shall publically disclose

22 all conflicts of interest that member may have with the

23 work to be undertaken by the panel. No member of a panel

24 may vote on any matter where the member could gain fi25 nancially from the advice given to the Secretary. The Sec-
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1 retary may grant a waiver of any conflict of interest upon

2 public disclosure of such conflict of interest if such waiver

3 contributes to the ability of a panel to contribute to the

4 public health, except that the Secretary may not grant a

5 waiver for a member of a panel when the member’s own

6 scientific work is involved.

7 ‘‘(5) The Secretary shall provide education and train8 ing to each new panel member before such member partici9 pates in a panel’s activities. Such education and training

10 shall include a familiarization with certain requirements

11 under this Act and any related regulation of the Secretary

12 and the administrative process and procedures related to

13 panel meetings.

14 ‘‘(6) Panel members (other than officers or employees

15 of the United States), while attending meetings or con16 ferences of a panel or otherwise engaged in its business,

17 shall be entitled to receive compensation at rates to be

18 fixed by the Secretary, but not at rates exceeding the daily

19 equivalent of the rate in effect for grade GS–18 of the

20 General Schedule, for each day so engaged, including trav21 eltime. While so serving away from their homes or regular

22 places of business, each member may be allowed travel ex23 penses (including per diem in lieu of subsistence) as au24 thorized by section 5703 of title 5, United States Code,
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1 for persons in the Government service employed intermit2 tently.

3 ‘‘(7) The Secretary shall take whatever action is nec4 essary to ensure that regular meetings are held by sci5 entific advisory panels, at appropriate intervals and for a

6 sufficient length of time, so that any matter to be reviewed

7 by any such panel shall be presented to the panel not more

8 than 60 days after the matter is ready for review by the

9 panel. The meetings shall occur not less than 6 times each

10 year unless there are compelling reasons for fewer meet11 ings. Such meetings shall be held with the physical pres12 ence of panel members at least 3 times each calendar year.

13 Other meetings of the panel may be held using electronic

14 communication to convene the meeting.

15 ‘‘(8)(A) All persons, including employees of the Sec16 retary, shall have the same rights and responsibilities re17 garding—

18 ‘‘(i) the submission of data and information to,

19 and contact and discussion with, a scientific advisory

20 panel;

21 ‘‘(ii) the participation of the persons at meet22 ings of the panel; and

23 ‘‘(iii) access to data and information submitted

24 to a scientific advisory panel (except for data and in-
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1 formation that are not available for public disclosure

2 under section 552 of title 5, United States Code).

3 ‘‘(B) In a case in which a scientific advisory panel

4 reviews an application submitted under section 505 or 506

5 (including a petition, notification, or other similar re6 quest), all related data and information that are not avail7 able for public disclosure under section 552 of title 5,

8 United States Code, shall be exchanged between the appli9 cant and the Food and Drug Administration at the time

10 the data and information are submitted to such panel but

11 shall not otherwise be publicly disclosed.

12 ‘‘(C) Any meetings of a scientific advisory panel shall

13 provide adequate time for initial presentations and for re14 sponse to any differing views and shall encourage free and

15 open participation by all interested persons.

16 ‘‘(9) Within 30 days after the date a scientific advi17 sory panel makes its conclusions and recommendations on

18 any matter under review by the panel, the Food and Drug

19 Administration official responsible for the matter shall re20 view the conclusions and recommendations of the panel,

21 shall make a final decision on the matter, and shall notify

22 the affected persons of the decision in writing and, if the

23 decision differs from the conclusions and recommendations

24 of the panel, shall include the reasons for the difference.
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1 ‘‘(10) A scientific advisory panel under this sub2 section shall not be subject to the annual chartering and

3 annual report requirements of the Federal Advisory Com4 mittee Act. Such a panel shall make an annual report of

5 its activities to the Secretary.’’.

6 SEC. 7. MARKETING APPROVAL.

7 Section 505(b) (21 U.S.C. 355(b)), as amended by

8 section 4(a), is amended—

9 (1) in the first sentence of paragraph (1), by

10 inserting immediately after ‘‘the Secretary’’ the fol11 lowing: ‘‘or may file such application with a person

12 authorized to review applications for marketing ap13 proval under section 712’’; and

14 (2) by adding after paragraph (4) the following:

15 ‘‘(5)(A) The scope of review responsibilities of accred16 ited persons authorized to conduct reviews of marketing

17 approval applications under section 712 shall include the

18 review of applications to determine whether there is a rea19 sonable assurance that a drug is safe and effective under

20 the conditions prescribed, recommended, or suggested in

21 the proposed labeling. The review shall be conducted under

22 the standards and requirements of this Act applicable to

23 reviews by the Secretary. Prior to 60 days before the end

24 of the period prescribed by subsection (c), the accredited

25 person shall submit a report of its review to the Secretary
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1 and its recommendations. Recommendations to the Sec2 retary shall specify whether an application should be ap3 proved or denied and shall state the basis for the rec4 ommendation.

5 ‘‘(B) The recommendation of the accredited person

6 shall be deemed to be approved by the Secretary unless

7 the Secretary finds that there is a reasonable probability

8 that the drug is not safe or effective. Upon receipt of the

9 recommendation from an accredited person to approve or

10 deny an application, the Secretary shall evaluate the rec11 ommendation within 60 days of such receipt. In the event

12 that the Secretary makes such a finding, the Secretary

13 shall provide a detailed explanation of the basis of the dif14 ference.’’.

15 SEC. 8. ACCREDITATION OF THIRD PARTIES.

16 (a) AMENDMENT.—Subchapter A of chapter VII is

17 amended by adding at the end the following:

18 ‘‘SEC. 712. ACCREDITED PERSONS.

19 ‘‘(a) IN GENERAL.—The Secretary shall, within 180

20 days of the date of the enactment of this section, by regu21 lation establish procedures for the accreditation of persons

22 for the purposes of—

23 ‘‘(1) reviewing applications under section

24 505(b) or 506, providing written reviews to the Sec25 retary for the Secretary’s consideration, and making
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1 recommendations on whether or not such applica2 tions should be approved; and

3 ‘‘(2) conducting good manufacturing practice

4 inspections to determine the conformance of a facil5 ity with regulations promulgated under sections

6 501(a)(2), 505(d)(3), and 520(f).

7 ‘‘(b) ACCREDITATION.—

8 ‘‘(1) PROGRAMS.—The Secretary shall provide

9 for such accreditation through programs adminis10 tered by government agencies or by other qualified

11 organizations.

12 ‘‘(2) IMPLEMENTATION.—The Secretary may

13 designate one or more qualified non-government or14 ganizations to implement such programs. Such orga15 nizations shall implement such programs from fees

16 charged to applicants for accreditation.

17 ‘‘(3) QUALIFICATIONS.—An accredited person

18 shall meet the following requirements:

19 ‘‘(A) Such person shall be an independent

20 organization which is not owned or controlled

21 by manufacturer, supplier or vendor of drugs

22 and which has no organizational, material, or

23 financial affiliation with such a manufacturer,

24 supplier, or vendor.
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1 ‘‘(B) Such person shall be a legally con2 stituted entity permitted to conduct the activi3 ties for which it seeks accreditation.

4 ‘‘(C) Such person shall not engage in the

5 development, manufacture, promotion, or sale

6 of drugs.

7 ‘‘(D) Such person shall be operated in ac8 cordance with generally accepted professional

9 and ethical business practices and shall agree in

10 writing that as a minimum it will—

11 ‘‘(i) certify that reported information

12 accurately reflects data reviewed;

13 ‘‘(ii) limit work to that for which com14 petence and capacity are available;

15 ‘‘(iii) treat information received,

16 records, reports, and recommendations as

17 proprietary information; and

18 ‘‘(iv) promptly respond and attempt to

19 resolve complaints regarding its activities

20 for which it is accredited.’’.

21 (b) CONFORMING AMENDMENT.—Section 301 (21

22 U.S.C. 321) is amended by redesignating the second para23 graph (u) as paragraph (v) and by adding after that para24 graph the following:

25 ‘‘(w) in the case of a drug, device, or food—
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1 ‘‘(A) the submission of a report or rec2 ommendation by a person accredited under section

3 712 that is false or misleading in any material re4 spect;

5 ‘‘(B) the disclosure by a person accredited

6 under section 712 of confidential commerical infor7 mation or any trade secret without the express writ8 ten consent of the person who submitted such infor9 mation or secret to such person; or

10 ‘‘(C) the receipt by a person accredited under

11 section 712 of a bribe in any form or the doing of

12 any corrupt act by such person associated with a re13 sponsibility delegated to such person under this

14 Act.’’.

15 SEC. 9. DISPUTE RESOLUTION.

16 Chapter V, as amended by section 14(b)(1), is

17 amended by adding after section 506 the following:

18 ‘‘DISPUTE RESOLUTION

19 ‘‘SEC. 507. (a) At any time before the issuance of

20 the notice under section 505(c)(1)(B) or an exemption for

21 investigational use under section 505(i) for a drug subject

22 to section 505 or 506, the applicant may, in writing, notify

23 the Secretary that an impasse exists in the review of the

24 application for a drug under section 505(b) or the submis25 sion for such an exemption with respect to a specifically

26 identified issue.
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1 ‘‘(b) On receipt of the notification from the applicant,

2 the Secretary shall refer the disputed issue—

3 ‘‘(1) to an existing (as of the date of the notifi4 cation) scientific advisory panel having expertise re5 lated to the issue;

6 ‘‘(2) to a special Government employee, as de7 fined in section 202(a) of title 18, United States

8 Code, or to a non-governmental person qualified to

9 mediate or arbitrate the substance of such impasse

10 who is acceptable to the Secretary and the applicant.

11 ‘‘(c) The applicant and representatives of the Sec12 retary may consult with the panel, special Government em13 ployee, or non-governmental person on the matter re14 ferred. The panel, special Governmental employee, or non15 governmental person shall submit to the Secretary and the

16 applicant a report containing recommendations (including

17 a statement of reasons for the recommendations) regard18 ing the matter not later than 60 days after the date of

19 the referral, or not later than 90 days after the date of

20 the referral if the panel, special Governmental employee,

21 or non-governmental person considers the additional 30

22 days to be necessary. Not later than 30 days after the

23 date of receiving the report, the Secretary shall, in writing,

24 confirm or modify the recommendations received, provid25 ing reasons and reference to data before the panel, special
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1 Governmental employee, or non-governmental person for

2 any modification. If the Secretary fails to act on such a

3 recommendation within 30 days of its receipt, the rec4 ommendation of the panel, special Government employee,

5 or non-governmental person shall be deemed to be the rec6 ommendation of the Secretary.

7 ‘‘(d) The Federal Advisory Committee Act shall not

8 apply to any scientific advisory panel acting under this

9 section.’’.

10 SEC. 10. GOOD MANUFACTURING PRACTICE INSPECTIONS.

11 (a) Section 704 (21 U.S.C. 374) is amended—

12 (1) in subsection (a)(1), by inserting ‘‘, or an

13 accredited person to conduct good manufacturing

14 practice inspections under section 712’’ after ‘‘Sec15 retary’’;

16 (2) in subsection (a)(3), by inserting ‘‘, or an

17 accredited organization or individual under section

18 712,’’ after ‘‘employee’’;

19 (3) in subsection (b), by inserting ‘‘, or an ac20 credited person under section 712,’’ after ‘‘em21 ployee’’;

22 (4) in subsection (b), by inserting ‘‘(1)’’ after

23 ‘‘(b)’’, by redesignating clauses (1) and (2) as

24 clauses (A) and (B), respectively, and by adding at

25 the end the following:
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1 ‘‘(2) The Secretary shall provide, at least 10 days

2 from the date of presentation of the report of conditions

3 or practices identified in paragraph (1), for the person re4 ceiving such report to respond. The Secretary shall take

5 no regulatory action against a person or article identified

6 in such a report until completing a review of such response

7 which is timely submitted to the Secretary, except the Sec8 retary may take immediate action when the Secretary

9 finds that there is a reasonable probability that a drug

10 intended for human use would cause serious, adverse

11 health consequences or death or that any regulated article

12 could present an unreasonable and substantial risk of in13 jury or illness to the public health. The Secretary shall

14 provide to the regulated person, within 30 days of receiv15 ing a response to the report identified in paragraph (1),

16 a written detailed assessment of the response.

17 ‘‘(3) At the time an accredited person completes an

18 inspection under the authority of this section and section

19 712, such person shall identify in writing to the person

20 subject to the inspection each condition or practice ob21 served during such inspection which suggests a deviation

22 from requirements of this Act. However, such accredited

23 person shall immediately submit to the Secretary the find24 ings of the inspection when the drug to which such find25 ings relate is intended for human use and presents a rea-
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1 sonable probability that such drug would cause serious,

2 adverse health consequences or death or that such drug

3 could present an unreasonable and substantial risk of in4 jury or illness to the public unless the person subject to

5 the inspection—

6 ‘‘(A) immediately ceases distribution of the

7 drug;

8 ‘‘(B) immediately notifies health professionals

9 and drug user facilities to instruct such professionals

10 and facilities to cease use of the drug; and

11 ‘‘(C) immediately undertakes all corrections

12 identified by the accredited person.

13 When such compliance is complete, the accredited person

14 shall provide the inspected person a certification of compli15 ance which includes the dates of inspections, a statement

16 that the inspected facility is in compliance with the re17 quirements of section 520(f), the date the compliance was

18 achieved at the facility, and the signature of the accredited

19 person attesting to the finding that the inspected facility

20 is in good manufacturing practices compliance as defined

21 by such section. When an accredited person has certified

22 compliance with good manufacturing practices require23 ments and provided the Secretary with a copy of the cer24 tification within 10 days of its being made, the Secretary

25 may not perform a good manufacturing practices inspec-
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1 tion of the person subject to an inspection for a period

2 of 2 years after the date of the certification unless justified

3 by good cause.’’; and

4 (5) in subsection (c), by striking ‘‘or employee’’

5 and inserting ‘‘, employee, or accredited person’’;

6 (6) in subsection (e), by striking ‘‘or employee’’

7 each place it occurs and inserting ‘‘, employee, or ac8 credited person’’; and

9 (7) by adding at the end the following:

10 ‘‘(f) Persons duly designated by the Secretary to con11 duct inspections under this section shall not request any

12 information not permitted under subsections (a) and (e)

13 unless such person states with specificity and in writing

14 the identification of the information subject to the request,

15 the reason for the request, and that the written request

16 seeks to obtain information not required to be produced

17 under this section. Such request shall not include informa18 tion related to sales (other than distribution), personnel,

19 or pricing data.’’.

20 SEC. 11. GOOD MANUFACTURING PRACTICES.

21 (a) AMENDMENT.—Section 501(a) (21 U.S.C.

22 351(a)) is amended—

23 (1) by striking ‘‘(a)(1)’’ and inserting

24 ‘‘(a)(1)(A)’’;
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1 (2) by redesignating subclauses (A) and (B) in

2 clauses (2) and (4) as subclauses (i) and (ii), respec3 tively; and

4 (3) by redesignating clauses (2) through (6) as

5 clauses (B) through (F), respectively;

6 (4) by adding at the end the following:

7 ‘‘(2) All chemistry, manufacturing, and controls

8 which comply with an approved new drug application

9 under section 505 or an approved drug application under

10 section 506 or with the opinion of an appropriate official

11 in the component of the Food and Drug Administration

12 responsible for the review of such chemistry, manufactur13 ing, or controls and which is reduced to writing and made

14 part of the administrative record shall be deemed to com15 ply with current good manufacturing practice. The Sec16 retary shall not take action to delay or prevent the manu17 facture or marketing of a drug under section 505 or 506

18 for failure to conform to current good manufacturing

19 practice unless there is reasonable probability of actual

20 harm to the public health or the Secretary determines in

21 writing, after an informal hearing, that the drug is—

22 ‘‘(A) not bioequivalent,

23 ‘‘(B) deviates from the specifications for the

24 drug established in the approved new drug applica-
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1 tion from the specifications for the drug established

2 by the manufacturer,

3 ‘‘(C) lacks adequate assurance that it will meet

4 the represented sterility, or

5 ‘‘(D) has been rendered unsafe or ineffective.’’.

6 (b) CONFORMING AMENDMENTS.—

7 (1) SECTION 303.—Section 303(g)(1)(B)(iii)

8 (21 U.S.C. 333(g)(1)(B)(iii)) is amended by striking

9 ‘‘501(a)(2)(A)’’ and inserting ‘‘501(a)(1)(B)(i)’’.

10 (2) SECTION 304.—Section 304(d)(1) (21

11 U.S.C. 334(d)(1)) is amended by striking

12 ‘‘501(a)(3)’’ and inserting ‘‘501(a)(1)(C)’’.

13 (3) SECTION 512.—Section 512(a)(1) (21

14 U.S.C. 360c(a)(1)) is amended by striking

15 ‘‘501(a)(5)’’ and inserting ‘‘501(a)(1)(E)’’, section

16 512(a)(2) (21 U.S.C. 360c(a)(2)) is amended by

17 striking ‘‘501(a)(6)’’ and inserting ‘‘501(a)(1)(F)’’,

18 and section 512(a)(3) (21 U.S.C. 360c(a)(3)) is

19 amended by striking ‘‘501(a)(5) or (6)’’ and insert20 ing ‘‘501(a)(1)(E) or 501(a)(1)(F)’’.

21 (4) SECTION 721.—Section 721(a) (21 U.S.C

22 379e(a)) is amended by striking ‘‘501(a)(4)’’ and in23 serting ‘‘501(a)(1)(D)’’.

24 (5) SECTION 802.—Sections 802(b)(1)(D) and

25 802(f)(1)(B) (21 U.S.C.382(b)(1)(D),382(f)(1)(B))
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1 are each amended by striking ‘‘(a)(1), (a)(2)(A),

2 (a)(3)’’ and inserting ‘‘(a)(1)(A), (a)(1)(B)(i),

3 (a)(1)(C)’’ .

4 SEC. 12. PILOT AND SMALL SCALE MANUFACTURE.

5 Section 505(c) (21 U.S.C. 355(c)) is amended by

6 adding at the end thereof the following:

7 ‘‘(4) A new drug manufactured in a pilot or other

8 small facility may be used to demonstrate the safety and

9 effectiveness of the drug and to obtain approval prior to

10 scaling up to a larger facility, unless the Secretary dem11 onstrates in writing and specifying in detail the reasons,

12 after an informal hearing, that a full scale production fa13 cility is necessary to ensure the safety or effectiveness of

14 the drug.’’.

15 SEC. 13. MANUFACTURING CHANGES.

16 Chapter VII (21 U.S.C. 371 et seq.) is amended by

17 adding at the end thereof the following:

18 ‘‘SUBCHAPTER D—MANUFACTURING CHANGES

19 ‘‘SEC. 740. MANUFACTURING CHANGES.

20 ‘‘(a) IN GENERAL.—A change in the manufacture of

21 a new drug, biological product, new animal drug, blood,

22 or blood component shall be made in accordance with this

23 section.

24 ‘‘(b) DRUG AND BIOLOGICAL PRODUCT.—A change

25 in the manufacture of a new drug or a biological product
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1 that is the subject of a monograph in an official compen2 dium, a biological product that can be adequately charac3 terized by chemical, physical, or biological means, or a new

4 animal drug, blood, or blood component shall require—

5 ‘‘(1) validation; and

6 ‘‘(2)(A) if there is no change in the approved

7 qualitative and quantitative formulation or in the

8 approved release specifications, or if there is a

9 change in the approved qualitative or quantitative

10 formula or in the approved release specifications of

11 a type permitted by the Secretary by regulation, may

12 be made at any time and shall be reported annually

13 to the Secretary; and

14 ‘‘(B) for any other change, shall require com15 pletion of an appropriate study demonstrating

16 equivalence according to criteria established by the

17 Secretary (unless such requirement is waived by the

18 Secretary), may be made at any time, and shall be

19 reported to the Secretary through a supplement or

20 amendment submitted at the time the change is

21 made.

22 ‘‘(c) BIOLOGICAL PRODUCT NOT SUBJECT TO A

23 MONOGRAPH.—A change in the manufacture of a biologi24 cal product that is not the subject of a monograph in an

25 official compendium and cannot be adequately character-
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1 ized by chemical, physical, or biological means shall re2 quire validation and—

3 ‘‘(1) if the change relates solely to a modifica4 tion of the manufacturing facility or change in per5 sonnel, with no change in the approved manufactur6 ing process or release specifications, may be made at

7 any time and shall be reported annually to the Sec8 retary; and

9 ‘‘(2) for any other change, shall require comple10 tion of a bioassay or other appropriate study dem11 onstrating equivalence according to criteria estab12 lished by the Secretary (unless such requirement is

13 waived by the Secretary), may be made at any time,

14 and shall be reported to the Secretary through an

15 amendment submitted at the time the change is

16 made.

17 ‘‘(d) SPECIAL DETERMINATION FOR A BIOLOGICAL

18 PRODUCT.—A determination shall be made prior to ap19 proval of a biological product under section 506 whether

20 the product can be adequately characterized for purposes

21 of this subsection. With respect to biological products ap22 proved prior to the date of enactment of the Drug and

23 Biological Products Reform Act of 1996, the determina24 tion shall be made within 90 days after the date of enact25 ment of such Act. Any determination under this sub-
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1 section is subject to change based upon new scientific in2 formation.’’.

3 SEC. 14. INSULIN AND ANTIBIOTICS.

4 (a) CERTIFICATION OF DRUGS CONTAINING INSU5 LIN.—

6 (1) AMENDMENT.—Section 506 (21 U.S.C.

7 356) is repealed.

8 (2) CONFORMING AMENDMENTS.—

9 (A) Sections 301(i)(1) and 301(j)(1) (21

10 U.S.C. 321(i)(1), 321(j)(1)) are each amended

11 by striking ‘‘506, 507,’’.

12 (B) Section 501(k) (21 U.S.C. 351(k)) is

13 repealed

14 (C) Section 502(k) (21 U.S.C. 352(k) is

15 repealed.

16 (D) Sections 510(j)(1)(A) and

17 510(j)(1)(D) (21 U.S.C. 360(j)(1)(A),

18 360(j)(1)(D)) are each amended by striking

19 ‘‘506, 507,’’.

20 (E) Section 8126(h)(2) of title 38, United

21 States Code, is amended by inserting ‘‘or’’ at

22 the end of subparagraph (B), by striking ‘‘; or’’

23 at the end of subparagraph (C) and inserting a

24 period, and by striking subparagraph (D).
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1 (F) Section 1927(k)(2) of the Social Secu2 rity Act (42 U.S.C. 1396r–8(k)(2)) is amended

3 by striking ‘‘; and’’ at the end of subparagraph

4 (B) and inserting a period and by striking sub5 paragraph (C).

6 (b) CERTIFICATION OF ANTIBIOTICS.—

7 (1) AMENDMENT.—Section 507 (21 U.S.C.

8 357), as in effect on the date of the enactment of

9 this Act, is repealed.

10 (2) CONFORMING AMENDMENTS.—

11 (A) Section 201(aa) (21 U.S.C. 321(aa)) is

12 amended by striking out ‘‘or 507’’, section

13 201(dd) (21 U.S.C. 321(dd)) is amended by

14 striking ‘‘507,’’, and sections 201(ff)(2)(B) and

15 201(ff)(3) (21 U.S.C. 321(ff)(2)(B), 321(ff)(3))

16 are each amended by striking ‘‘, certified as an

17 antibiotic under section 507,’’.

18 (B) Section 301(e) (21 U.S.C. 331(e)) is

19 amended by striking ‘‘507(d) or (g),’’.

20 (C) Sections 301(i)(1) and 301(j) (21

21 U.S.C. 321(i)(1), 321(j)) are each amended by

22 striking ‘‘507,’’.

23 (D) Section 306(d)(4)(B)(ii) (21 U.S.C.

24 335a(d)(4)(B)(ii)) is amended by striking ‘‘or

25 507’’.
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1 (E) Section 502 (21 U.S.C. 352) is

2 amended by striking subsection (l).

3 (F) Section 510(j)(1)(D) (21 U.S.C.

4 360(j)(1)(D)) is amended by striking ‘‘507,’’.

5 (G) Section 520(l) is amended by striking

6 paragraph (4) and by striking ‘‘or Antibiotic

7 Drugs’’ in the subsection heading.

8 (H) Section 525(a) (21 U.S.C. 360aa(a))

9 is amended by inserting ‘‘or’’ at the end of

10 paragraph (1), by striking paragraph (2), and

11 by redesignating paragraph (3) as paragraph

12 (2).

13 (I) Section 525(a) (21 U.S.C. 360aa(a)) is

14 amended by striking ‘‘, certification of such

15 drug for such disease or condition under section

16 507,’’.

17 (J) Section 526(a)(1) (21 U.S.C. 360bb) is

18 amended by striking ‘‘the submission of an ap19 plication for certification of the drug under sec20 tion 507,’’, by inserting ‘‘or’’ at the end of sub21 paragraph (A), by striking subparagraph (B),

22 and by redesignating subparagraph (C) as sub23 paragraph (B).

24 (K) Section 526(b) (21 U.S.C. 360bb(b))

25 is amended by striking ‘‘, a certificate was is-
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1 sued for the drug under section 507,’’ each time

2 it appears and by striking ‘‘, approval of an ap3 plication for certification under section 507,’’.

4 (L) Section 527(a) (21 U.S.C. 360cc(a)) is

5 amended by inserting ‘‘or’’ at the end of para6 graph (1), by striking paragraph (2), by redes7 ignating paragraph (3) as paragraph (2), and

8 by striking ‘‘, issue another certificate under

9 section 507,’’.

10 (M) Section 527(b) (21 U.S.C. 360cc(b))

11 is amended by striking ‘‘, if a certification is is12 sued under section 507 for such a drug,’’, and

13 ‘‘, of the issuance of the certification under sec14 tion 507,’’.

15 (N) Section 704(a)(1) (21 U.S.C. 374) is

16 amended by striking ‘‘, section 507 (d) or (g)’’.

17 (O) Section 735(1) (21 U.S.C. 379g(1)(C))

18 is amended by inserting ‘‘or’’ at the end of sub19 paragraph (B), by striking subparagraph (C),

20 and by redesignating subparagraph (D) as sub21 paragraph (C).

22 (P) Sections 5(b)(1)(A) and 5(b)(1)(B) of

23 the Orphan Drug Act (21 U.S.C.

24 360ee(b)(1)(A), 360ee(b)(1)(B)) are each

25 amended by striking ‘‘or 507’’.
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1 (Q) Section 28(b)(2)(A)(ii)(II) of the In2 ternal Revenue Code of 1986 is amended by

3 striking ‘‘or 507’’.

4 (R) Section 156(f)(4)(B) of title 35,

5 United States Code, is amended by striking

6 ‘‘507,’’ each place it occurs.

7 (S) Section 1927(k)(2)(A)(i) of the Social

8 Security Act (42 U.S.C. 1396r–

9 8(k)(2)(A)(ii)(II)) is amended by striking ‘‘or

10 507’’.

11 (c) EXPORTATION.—Section 802 (21 U.S.C. 382) is

12 amended by adding at the end thereof the following:

13 ‘‘(h) EXPORTATION OF INSULIN AND ANTIBIOTICS.—

14 Insulin and antibiotics may be exported without regard to

15 the requirements in this section if the insulin and anti16 biotics meet the requirements in section 801(e)(1).’’.

17 SEC. 15. NONPRESCRIPTION DRUGS.

18 Chapter V is amended by adding after section 510

19 (21 U.S.C. 360) the following:

20 ‘‘NONPRESCRIPTION DRUGS

21 ‘‘SEC. 511. All applications or petitions requesting

22 that a drug be switched from prescription to

23 nonprescription status and all other matters relating to

24 nonprescription drugs shall be reviewed and acted upon

25 solely by a single office in the Center for Drug Evaluation

26 and Research or a successor entity, and that office shall
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1 report directly to the Director of the Center. A single sci2 entific advisory panel may provide conclusions and rec3 ommendations regarding any such matter.’’.

4 SEC. 16. INFORMATION SYSTEM.

5 Chapter IX, as amended by section 9, is amended by

6 adding at the end the following:

7 ‘‘SEC. 907. INFORMATION SYSTEM.

8 ‘‘The Secretary shall establish and maintain an infor9 mation system to track the status and progress of each

10 application or submission (including a petition, notifica11 tion, or other similar form of request) submitted to the

12 Food and Drug Administration requesting agency action.

13 The system shall permit access by the applicant.’’.

14 SEC. 17. ENVIRONMENTAL IMPACT REVIEW.

15 Chapter VII, as amended by section 13, is amended

16 by adding at the end the following:

17 ‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW

18 ‘‘SEC. 745. ENVIRONMENTAL IMPACT REVIEW.

19 ‘‘No action by the Secretary pursuant to this Act

20 shall require, with respect to an action to be taken by the

21 Secretary, the preparation of an environmental impact

22 statement under the National Environmental Policy Act

23 of 1969 or an environmental assessment unless the Sec24 retary demonstrates that—
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1 ‘‘(1) because of extraordinary circumstances the

2 action will have a significant effect on the human

3 environment; and

4 ‘‘(2) the consideration of such significant effect

5 on the human environment will directly affect the

6 Secretary’s decision on the action.’’.

7 SEC. 18. APPLICATION OF FEDERAL LAW TO THE PRACTICE

8 OF PHARMACY COMPOUNDING.

9 Section 503 (21 U.S.C. 353) is amended by adding

10 at the end the following:

11 ‘‘(h)(1) Sections 501(a)(1)(B)(ii), 501(f), 501(h),

12 502(f)(1), 502(l), 502(o), 502(s), 502(t), 505, 506, and

13 510 and sections 510 through 520 shall not apply to a

14 drug that is compounded by a licensed pharmacist on the

15 order of a licensed physician.

16 ‘‘(2) No provision of this Act shall apply to a bulk

17 drug product or other drug, including an imported product

18 drug, that is intended for use by a licensed pharmacist

19 in compounding a drug or device on the order of a licensed

20 physician, except to the extent that the provision relates

21 directly to the quality, purity, or identity of such drug.’’.

22 SEC. 19. HARMONIZATION.

23 Section 803 (21 U.S.C. 383) is amended by adding

24 at the end the following:
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1 ‘‘(c)(1) The Secretary shall regularly and continu2 ously participate in meetings with other countries to dis3 cuss methods and approaches to reduce the burden of reg4 ulation, harmonize regulatory requirements, and seek ap5 propriate reciprocal arrangements. The Secretary shall,

6 within 180 days of the date of enactment of this sub7 section, make public a plan that establishes a framework

8 for achieving mutual recognition of good manufacturing

9 practices.

10 ‘‘(2) The Secretary shall report to the Committee on

11 Commerce of the House of Representatives and the Com12 mittee on Labor and Human Resources of the Senate at

13 least 60 days before executing any bilateral or multilateral

14 agreement under paragraph (1).’’.

15 SEC. 20. USE OF SCIENTIFIC AND MEDICAL INFORMATION.

16 Section 502(f) (21 U.S.C. 352(f)) is amended by add17 ing at the end the following: ‘‘The dissemination of medi18 cal texts, articles from peer-reviewed scientific publica19 tions, information from Federal Government agencies, and

20 presentations at medical and scientific meetings shall not

21 form a basis to require adequate directions for use under

22 clause (1) or information for use (or the equivalent there23 of) under any exemption to clause (1) and shall not form

24 a basis to require the filing of a report required under

25 section 510(k) or the filing of an application under section
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1 505 or 515 unless such person, in addition to disseminat2 ing the above-referenced information, encourages the un3 approved use of a legally marketed drug or device through

4 labeling, advertising, or other means of promotion. Mere

5 knowledge that a legally available drug or device is used

6 by licensed practitioners for the treatment or diagnosis of

7 diseases or conditions in individual patients shall not form

8 a basis to require adequate directions for use under clause

9 (1), or information for use (or the equivalent thereof)

10 under any exemption to clause (1), and shall not form a

11 basis to require either the filing of a notification required

12 under section 510(k) or an application under section 505

13 or 515. The Secretary shall not consider the dissemination

14 of medical texts, articles from peer review scientific publi15 cations, information from Federal Government agencies,

16 presentations at medical and scientific meetings, and dis17 plays at trade shows relating to a drug or device which

18 is not approved for marketing or investigational use within

19 the meaning of section 505(i) or 520(g) to be activities

20 prohibited under published regulations of the Secretary

21 unless the sponsor of an investigation for the drug or de22 vice, or an agent of such sponsor, in addition to the afore23 mentioned activities encourages the use of a drug or de24 vice.’’.
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1 SEC. 21. INFORMAL AGENCY STATEMENTS.

2 Section 701 (21 U.S.C. 371) is amended by adding

3 at the end the following:

4 ‘‘(h)(1) The Secretary shall not rely upon informal

5 agency statements, including guidance documents, policy

6 statements, points to consider documents, or any other

7 statements that have not been promulgated in accordance

8 with the rulemaking requirements of chapter V of title 5,

9 United States Code, to require any action be taken to sat10 isfy a requirement of this Act.

11 ‘‘(2) The Secretary shall publish notice in the Federal

12 Register of the availability to the public of each type of

13 statement identified in paragraph (1). Additionally, the

14 Secretary shall undertake to make available all such state15 ments by electronic or other similar means.’’.

16 SEC. 22. EDUCATION AND RESEARCH; PRACTICE OF MEDI17 CINE.

18 Chapter IX, as amended by section 16, is amended

19 by adding at the end the following:

20 ‘‘SEC. 908. EDUCATION AND RESEARCH.

21 ‘‘(a) EDUCATION.—The Secretary shall conduct

22 training and education programs for the employees of the

23 Food and Drug Administration relating to the regulatory

24 responsibilities and policies established by this Act, includ25 ing programs for scientific training, administrative process

26 and procedure, and integrity issues.
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1 ‘‘(b) RESEARCH.—The Secretary, acting through the

2 Food and Drug Administration, may conduct or contract

3 for scientific research only if it is directly related to the

4 implementation of this Act.

5 ‘‘SEC. 909. PRACTICE OF MEDICINE.

6 ‘‘Nothing in this Act shall be construed to limit or

7 interfere with the authority of a health care practitioner,

8 licensed by law to administer drugs and devices, to pre9 scribe or administer any legally marketed drug or device

10 to a patient for any condition or disease within a legiti11 mate health care practitioner-patient relationship.’’.

12 SEC. 23. DELEGATION OF AUTHORITY.

13 Section 903 (21 U.S.C. 393), as amended by section

14 2(b), is amended by adding at the end the following:

15 ‘‘(f) DELEGATION OF AUTHORITY.—The reference in

16 sections 505(b)(4)(A), 505(b)(4)(C), 505(i)(2)(B), and

17 505(n)(1) to the authority of a specific official or position

18 in the Food and Drug Administration to perform a par19 ticular function is an authority which shall be only exer20 cised by such official or individual in such position and

21 the authority to exercise such authority may not be dele22 gated.’’.

23 SEC. 24. JUDICIAL REVIEW.

24 Section 505(h) (21 U.S.C. 355(h)) is amended to

25 read as follows:
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1 ‘‘(h)(1) Not later than 30 days after—

2 ‘‘(A) any written decision respecting any aspect

3 of an investigational new drug; or

4 ‘‘(B) any written decision respecting any aspect

5 of an application, petition, or notification for mar6 keting review or approval for a drug under this sec7 tion;

8 any person adversely affected by such decision, notice, or

9 warning may file a petition with the United States Court

10 of Appeals for the District of Columbia or for the circuit

11 wherein such person resides or such person has a principal

12 place of business for judicial review of such decision, no13 tice, or warning. A copy of the petition shall be transmit14 ted by the clerk of the court to the Secretary or other

15 officer designated by the Secretary for that purpose. The

16 Secretary shall file in the court the record of the proceed17 ings on which the Secretary based the Secretary’s decision,

18 notice, or warning as provided in section 2112 of title 28,

19 United States Code. For purposes of this subsection, the

20 term ‘‘record’’ means all notices and other matter pub21 lished in the Federal Register with respect to the decision,

22 notice, or warning reviewed, all information submitted to

23 the Secretary with respect to such decision, notice, or

24 warning, proceedings of any scientific advisory panel with

25 respect to such decision, notice, or warning, any hearing
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1 held with respect to such decision, notice, or warning, and

2 any other information identified by the Secretary, in the

3 administrative proceeding held with respect to such deci4 sion, notice, or warning as being relevant to such regula5 tion or order.

6 ‘‘(2) If the petitioner applies to the court for leave

7 to adduce additional data, views, or arguments respecting

8 the decision, notice, or warning being reviewed and shows

9 to the satisfaction of the court that such additional data,

10 views, or arguments are material and that there were rea11 sonable grounds for the petitioner’s failure to adduce such

12 data, views, or arguments in the proceedings before the

13 Secretary, the court may order the Secretary to provide

14 additional opportunity for the oral presentation of data,

15 views, or arguments and for written submissions. The Sec16 retary may modify the Secretary’s findings, or make new

17 findings by reason of the additional data, views, or argu18 ments so taken and shall file with the court such modified

19 or new findings, and the Secretary’s recommendation, if

20 any, for the modification or setting aside of the decision,

21 notice, or warning being reviewed, with the return of such

22 additional data, views, or arguments.

23 ‘‘(3) Upon the filing of the petition under paragraph

24 (1) for judicial review of a decision, notice, or warning,

25 the court shall have jurisdiction to review the decision, no-
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1 tice, or warning in accordance with chapter 7 of title 5,

2 United States Code, and to grant appropriate relief, in3 cluding interim relief, as provided in such chapter.

4 ‘‘(4) The judgment of the court affirming or setting

5 aside, in whole or in part, any decision, notice, or warning

6 shall be final, subject to review by the Supreme Court of

7 the United States upon certiorari or certification, as pro8 vided in section 1254 of title 28 of the United States Code.

9 ‘‘(5) The remedies provided for in this subsection

10 shall be in addition to and not in lieu of any other rem11 edies provided by law.

12 ‘‘(6) To facilitate judicial review under this sub13 section or under any other provision of law of a decision,

14 notice, or warning issued under this section, each such de15 cision, notice, or warning shall contain a statement of the

16 reasons for its issuance and the basis, in the record of

17 the proceedings held in connection with its issuance, for

18 its issuance.’’.

19 SEC. 25. PUBLICATION OF NOTICE OF DEVIATION.

20 Section 705 (21 U.S.C 375) is amended by adding

21 at the end the following:

22 ‘‘(c) The Secretary may make public or communicate

23 to any person outside the Food and Drug Administration

24 any information regarding a notice which informs a regu25 lated person of a purported deviation from a requirement
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1 of this Act only after the Secretary has completed the in2 vestigation of such deviation.’’.

3 SEC. 26. BIOLOGICAL PRODUCTS.

4 (a) DEFINITIONS.—

5 (1) BIOLOGICAL PRODUCT AND TISSUE.—Sec6 tion 201 (21 U.S.C. 321) is amended by adding at

7 the end the following:

8 ‘‘(gg) The term ‘biological product’ means a virus,

9 therapeutic serum, toxin, antitoxin, vaccine, allergenic

10 product, derivative of blood and blood components, or

11 analogous product, or arsphenamine or its derivatives, in12 tended for use in the diagnosis, cure, mitigation, treat13 ment, or prevention of a disease or physiologic condition

14 in man, but does not include blood, blood components, or15 gans, eyes, milk, or human tissue. A biological product is

16 a drug within the meaning of paragraph (g) but is not

17 a new drug within the meaning of paragraph (p).

18 ‘‘(hh) The term ‘human tissue’ means a collection of

19 human cells which are intended for use in the diagnosis,

20 cure, mitigation, treatment, or prevention of a disease or

21 physiological condition in man or for the augmentation of

22 a natural bodily function. Human tissue may be combined

23 with biologically inactive substances and subjected to any

24 form of processing before use subject to operating stand25 ards established under section 506(a)(2)(A). Human tis-
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1 sue achieves its primary intended purposes through struc2 tural support or cellular function and not systemic action.

3 Human tissue is not a drug or device and does not include

4 blood, blood components, organs, or milk.’’.

5 (2) BLOOD, BLOOD COMPONENTS, ORGANS,

6 MILK, OR HUMAN TISSUE.—Section 201(g)(1) (21

7 U.S.C 321(g)(1)) is amended by adding at the end

8 the following: ‘‘Blood, a blood component, an organ,

9 milk, or human tissue is not a drug.’’.

10 (3) DEVICE.—Section 201(h) (21 U.S.C.

11 321(h)) is amended by adding at the end the follow12 ing: ‘‘Computer software developed by, modified by,

13 and used in a human tissue establishment shall not

14 be subject to any premarket clearance requirement

15 under this Act but such software shall be validated

16 to demonstrate that it achieves its intended purpose

17 before use and it shall be subject to the good manu18 facturing requirements of this Act.’’.

19 (b) REGULATION OF BIOLOGICAL PRODUCTS.—

20 Chapter V, as amended by section 14, is amended by add21 ing after section 505 the following:

22 ‘‘BIOLOGICAL PRODUCTS

23 ‘‘SEC. 506. (a) No person shall introduce or deliver

24 for introduction into interstate commerce a biological

25 product unless an approval of a product license application

26 filed pursuant to this section is effective with respect to
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1 such product and the biological product meets the good

2 manufacturing practice requirement of section

3 501(a)(1)(B)(ii).

4 ‘‘(b) A product license application for a biological

5 product shall—

6 ‘‘(1) contain the information that is required

7 for a new drug under the second sentence of section

8 505(b)(1);

9 ‘‘(2) be subject to the procedures and standards

10 established for a new drug in sections 505(c)(1),

11 505(d), 505(e), 505(f), 505(g), and 505(h) but not

12 the standards of sections 505(d)(6) and 505(e)(4);

13 ‘‘(3) be subject to the provisions for an inves14 tigational new drug in section 505(i);

15 ‘‘(4) be subject to the requirements for a new

16 drug established in section 505(k); and

17 ‘‘(5) in the case of a derivative of blood and

18 blood components, apply to all facilities of the appli19 cant that are licensed under subsection (c).

20 Within 2 years of the date of enactment of this section

21 the Secretary shall harmonize the regulations governing

22 product license applications with the regulations governing

23 new drug applications filed pursuant to section 505(b)(1)

24 and the regulations governing good manufacturing prac25 tices promulgated under section 501(a)(1)(B)(ii). If the
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1 Secretary fails to implement such harmonization within 2

2 years, the regulations governing product license applica3 tions shall be null and void and all biological products shall

4 be subject to the regulations governing new drug applica5 tions filed pursuant to section 505(b)(1). The amendments

6 made to section 505 by the Drug Price Competition and

7 Patent Term Restoration Act of 1984 shall not apply to

8 biological products.

9 ‘‘(c)(1) No person shall introduce or deliver for intro10 duction into interstate commerce blood or blood compo11 nents unless an approval of a product license application

12 filed pursuant to this section is effective with respect to

13 such product. Blood and blood components intended for

14 use in the diagnosis, cure, mitigation, treatment, or pre15 vention of a disease or physiologic condition in man shall

16 be subject to—

17 ‘‘(A) performance standards for safety, purity,

18 and where applicable, potency,

19 ‘‘(B) good manufacturing practices, and

20 ‘‘(C) labeling,

21 established by regulations promulgated by the Secretary,

22 and shall be obtained and processed only in facilities li23 censed by the Secretary.

24 ‘‘(2) Licensed establishments shall be subject to in25 spection under section 704. During such an inspection the
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•HR 3199 IH

1 Secretary shall have access to or copies of patient and

2 donor names and other donor identifying information

3 when such access is critical to public health. Such an in4 spection may be conducted by nonprofit membership orga5 nizations that meet requirements established by the Sec6 retary for individuals and organizations accredited by the

7 Secretary under section 712.

8 ‘‘(3)(A) The Secretary shall by regulation establish

9 the requirements that a facility or a group of facilities

10 within one corporate entity shall meet to be eligible to be

11 licensed under a single facility license to obtain and proc12 ess a specific set of blood and blood components.

13 ‘‘(B) Within 90 days after the Secretary receives an

14 application for a license under this subsection from a facil15 ity, the Secretary shall review the application and may in16 spect the facility to determine compliance with the require17 ments established under this subsection. Such inspection

18 may be conducted by non-profit organizations that meet

19 requirements established by the Secretary or by persons

20 accredited by the Secretary under section 712. Within

21 such 90 days, the Secretary shall grant a license or shall

22 deny a license and specify in writing the reasons for the

23 denial and the requirements that must be met to obtain

24 a license.
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1 ‘‘(C) The Secretary may at any time revoke or sus2 pend a license in accordance with this paragraph for fail3 ure to comply with the requirements established under this

4 subsection as follows:

5 ‘‘(i) The license may be immediately suspended

6 with an informal hearing to follow if the Secretary

7 demonstrates that the deficiencies identified con8 stitute an immediate danger of serious adverse

9 health consequences or death.

10 ‘‘(ii) Before revoking a license, the Secretary

11 shall provide the facility in writing a list of specific

12 deficiencies that must be corrected in order to retain

13 the license and shall provide 30 days for a written

14 response and for correction of the deficiencies. If the

15 facility fails to provide an adequate response or to

16 make a correction, the Secretary shall provide the

17 opportunity for an informal hearing. Such hearing

18 shall be held within 30 days of the receipt of the

19 written response.

20 ‘‘(iii) The revocation or suspension of any li21 cense shall not prevent the continued use of any

22 blood or blood component which has left the control

23 of the licensee unless the Secretary determines, as

24 part of the revocation or suspension order, that such

25 use represents an actual harm to the public health.
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1 ‘‘(4) Blood and blood components are not biological

2 products, drugs, devices, or human tissue. Computer soft3 ware developed by, modified by, and used in a blood or

4 blood component establishment shall not be subject to any

5 premarket clearance requirement under this Act but such

6 software shall be validated to demonstrate that it achieves

7 its intended purpose before use and it shall be subject to

8 the good manufacturing requirements of this Act.

9 ‘‘(5) Blood components and derivatives of blood and

10 blood components intended for use as a blood test or in

11 the diagnosis of disease are devices and are not drugs, bio12 logical products, or human tissue.

13 ‘‘(d)(1) Human tissue shall be subject to regulation

14 under this subsection only if the Secretary demonstrates,

15 in writing published in the Federal Register and after a

16 hearing before the Commissioner, that voluntary regula17 tion under generally accepted scientific standards is inad18 equate to protect the public health with respect to any par19 ticular type of human tissue or human tissue generally.

20 ‘‘(2)(A) Based upon such a demonstration, the Sec21 retary may establish by regulation operating standards for

22 the safety of human tissue and may require human tissue

23 to be processed only in an establishment registered in ac24 cordance with the procedures established for drugs under

25 section 510.
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•HR 3199 IH

1 ‘‘(B) The operating standards authorized under this

2 paragraph shall be limited to the following general require3 ments for the recovery, processing, storage, and shipment

4 of human tissue:

5 ‘‘(i) Requirements for universal infection con6 trol designs to prevent transmission of disease.

7 ‘‘(ii) Good processing practices that assure the

8 safety, maintenance of structure, and preservation of

9 original cellular function of tissue.

10 ‘‘(iii) Labeling requirements for the identifica11 tion of the type of tissue, the addition of any foreign

12 substance, and information needed to permit tracing.

13 ‘‘(C) Registered establishments shall be subject to in14 spection under section 704. During such an inspection the

15 Secretary shall have access to or copies of patient and

16 donor names and other donor identifying information

17 when such access is critical to public health as defined in

18 regulations to be promulgated by the Secretary for par19 ticular types of tissue. Such inspection may be conducted

20 by nonprofit membership organizations that meet require21 ments established by the Secretary for individuals and or22 ganizations accredited by the Secretary under section 712.

23 ‘‘(3) The requirements established under paragraph

24 (2) shall not apply to human tissue not stored for a signifi25 cant period or not significantly processed.
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1 ‘‘(e) The Secretary may take action to enforce the

2 requirements of good manufacturing practice for blood,

3 blood components, and good operating standards for

4 human tissue in the same manner as is done for drugs.’’.

5 (c) TRANSITION.—The requirements of the interim

6 regulation promulgated by the Secretary of Health and

7 Human Services on December 1993, shall remain in effect

8 for a period of 18 months after the date of the enactment

9 of this section so that the Secretary may have an oppor10 tunity to establish general controls for tissue pursuant to

11 section 506(d)(1)(A) of the Federal Food, Drug, and Cos12 metic Act. The Secretary shall not regulate eyes until such

13 time that the Secretary makes a finding under section

14 506(d)(1)(A) of such Act that voluntary regulation under

15 generally accepted standards is inadequate to protect the

16 public health.

17 (d) CONFORMING AMENDMENTS.—

18 (1) SECTION 301(d).—Section 301(d) (21

19 U.S.C. 331(d)) is amended by striking ‘‘or 505’’ and

20 inserting ‘‘, 505, or 506’’.

21 (2) SECTION 301(e).—Section 301(e) (21

22 U.S.C. 331(e)) is amended by inserting after ‘‘(k),’’

23 the following: ‘‘506(b),’’.
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1 (3) SECTION 301.—Section 301 (21 U.S.C.

2 331), as amended by section 8(b), is amended by

3 adding after paragraph (w) the following:

4 ‘‘(x) The failure of blood, blood component, or human

5 tissue to comply with any applicable requirement estab6 lished under section 506.’’.

7 (4) SECTION 501.—Section 501 (21 U.S.C. 351)

8 is amended by adding at the end the following:

9 ‘‘(j) If it is a biological product, blood, blood compo10 nent, or human tissue and it does not comply with any

11 applicable requirement established under section 506.’’.

12 (5) SECTION 351.—Section 351 of the Public

13 Health Service Act (42 U.S.C. 262) is amended by

14 striking the section heading and ‘‘SEC. 351.’’ and

15 subsections (a) through (d)(1) and (e) through (g)

16 of such section 351 are repealed.

17 (6) SECTION 351.—Subsection (d)(2) of such

18 section 351 is redesignated as subsection (g) of sec19 tion 511.

20 (7) MULTIPLE SECTIONS.—Sections 525(a),

21 526(a)(1), 526(a)(1)(C), 526(b)(1), 526(b)(2),

22 527(a), 527(b), 735(1)(D), 735(3), 735(6)(D),

23 802(a)(1)(B), 802(b)(1)(A)(ii)(II), 802(b)(1)(C),

24 802(c)(1)(C), 802(d)(3), 802(d)(4), and 902(c) (21

25 U.S.C. 360aa(a), 360bb(a)(1), (a)(1)(C), (b)(1),
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1 (b)(2), 360cc(a), (b), 379g(1)(D), (3), (6)(D),

2 382(a)(1)(B), (b)(1)(A)(ii)(II), (b)(1)(C), (c)(1)(C),

3 (d)(3), (d)(4), 392(c)) are each amended by striking

4 ‘‘section 351 of the Public Health Service Act’’

5 wherever it appears and inserting ‘‘section 506’’.

6 (8) SECTION 201.—Section 201(ff)(3)(A) (21

7 U.S.C 321(ff)(3)(A)) is amended by striking ‘‘under

8 section 351 of the Public Health Service Act (42

9 U.S.C.262)’’ and inserting ‘‘section 506’’.

10 (9) SECTION 503.—Section 503(g)(4)(A) (21

11 U.S.C 353(g)(4)(A)) is amended by striking ‘‘in sec12 tion 351(a) of the Public Health Service Act (42

13 U.S.C. 262(a))’’ and inserting ‘‘in section 506’’.

14 (10) SECTION 503.—Section 503(g)(4)(B) (21

15 U.S.C. 353(g)(4)(B)) is amended to read as follows:

16 ‘‘(B) As used in this subsection, the term ‘mar17 ket clearance’ includes—

18 ‘‘(i) approval of an application under sec19 tion 505, 507, 511, 515, or 520(g) and

20 ‘‘(ii) a finding of substantial equivalence

21 under this subchapter.’’.

22 (11) PUBLIC HEALTH SERVICE ACT.—The fol23 lowing sections of the Public Health Service Act are

24 amended as follows:
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1 (A) Section 227(c)(5) (42 U.S.C.

2 236(c)(5)) is amended by striking ‘‘under sec3 tion 351 of this Act’’ and inserting ‘‘under sec4 tion 506 of such Act’’.

5 (B) Sections 352(a) and 352(b) (42 U.S.C.

6 263(a), 263(b)) are each amended by striking

7 ‘‘in section 351’’ and inserting ‘‘in section 506

8 of the Federal Food, Drug, and Cosmetic Act’’.

9 (C) Section 2122(b)(2) (42 U.S.C. 360aa–

10 22(b)(2)) is amended by striking ‘‘section 351

11 of the Public Health Service Act’’ and inserting

12 ‘‘section 506 of the Federal Food, Drug, and

13 Cosmetic Act’’.

14 (D) Section 2123(d)(2)(A) (42 U.S.C

15 360aa–23(d)(2)(A)) is amended by striking

16 ‘‘under section 351’’ and inserting ‘‘under sec17 tion 506 of the Federal Food, Drug, and Cos18 metic Act’’.

19 (12) SECTION 1927.—Section 1927(k)(2)(B) of

20 the Social Security Act (42 U.S.C. 1396r–

21 8(k)(2)(B)) is amended by striking ‘‘under section

22 351 of the Public Health Service Act’’ and inserting

23 ‘‘under section 506 of the Federal Food, Drug, and

24 Cosmetic Act’’.
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1 (13) ORPHAN DRUG ACT.—Sections 5(b)(1)(A)

2 and 5(b)(1)(B) of the Orphan Drug Act (21 U.S.C.

3 360ee(b)(1)(A), 360ee(b)(1)(B)) are each amended

4 by striking ‘‘section 351 of the Public Health Serv5 ice Act’’ and inserting ‘‘section 506 of the Federal

6 Food, Drug, and Cosmetic Act’’.

7 (14) PATENTS.—Section 156 of title 35, United

8 States Code, is amended—

9 (A) in subsection (f)(2)(A), by striking

10 ‘‘and the Public Health Service Act’’;

11 (B) in subsection (f)(4)—

12 (i) by striking subparagraph (A) and

13 redesignating subparagraphs (B) and (C)

14 as subparagraphs (A) and (B), respec15 tively; and

16 (ii) by inserting ‘‘506,’’ after ‘‘505,’’

17 each place it appears in subparagraph (A)

18 (as so redesignated); and

19 (C) in subsection (g)(1)(B)(ii), by striking

20 ‘‘under section 351, subsection (b) of section

21 505’’ and inserting ‘‘under subsection (b) of

22 section 505, 506’’.

23 (15) INTERNAL REVENUE CODE OF 1986.—Sec24 tion 28(b)(2)(A)(ii)(II) of the Internal Revenue Code

25 of 1986 is amended by striking ‘‘under section 351
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1 of the Public Health Service Act’’ and inserting

2 ‘‘under section 506 of such Act’’.

3 (d) LICENSES.—All licenses effective under section

4 351 of the Public Health Service Act as of the date of

5 enactment of the Drug and Biological Products Reform

6 Act of 1996 shall be deemed to have been granted under

7 the applicable provisions of this Act as of such date and

8 shall be subject to the provisions of this Act as of such

9 date.

Æ