I

104TH CONGRESS

1ST SESSION H. R. 1995

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

in the regulation of drugs.

IN THE HOUSE OF REPRESENTATIVES

JUNE 30, 1995

Mr. FOX of Pennsylvania (for himself, Mr. CLINGER, Mr. MCINTOSH, Mr.

OXLEY, Mr. MILLER of Florida, Mr. BILBRAY, Mr. BLUTE, Mr.

LATOURETTE, Mr. PETERSON of Minnesota, Mr. WELDON of Florida,

Mr. FRISA, Mr. COX of California, and Mr. COOLEY) introduced the following bill; which was referred to the Committee on Commerce

A BILL

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

make improvements in the regulation of drugs.

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 AND REFERENCE.

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

5 ‘‘Life Extending and Life Saving Drug Act’’.

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment

8 to, or repeal of, a section or other provision, the reference
2

•HR 1995 IH

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

3 SEC. 2. MISSION OF THE FOOD AND DRUG ADMINISTRA4 TION.

5 Section 903 (21 U.S.C. 393) is amended by adding

6 at the end the following:

7 ‘‘(d) The mission of the Food and Drug Administra8 tion (with respect to drugs, biological products, and de9 vices) is to promote and protect the health of the American

10 people. This mission should be achieved by—

11 ‘‘(1) facilitating the timely availability of safe

12 and effective products that benefit the American

13 public,

14 ‘‘(2) encouraging the efficient development of

15 new products in the United States,

16 ‘‘(3) taking prompt and appropriate action

17 where postmarketing surveillance demonstrates that

18 products present a health risk to the American pub19 lic,

20 ‘‘(4) ensuring that human drugs and biological

21 products are tested and manufactured consistent

22 with the goal of harmonization of international

23 standards,
3

•HR 1995 IH

1 ‘‘(5) facilitating the flow of information to edu2 cate health professionals and the American public,

3 and

4 ‘‘(6) enforcing the applicable statutes and regu5 lations in a timely, fair, and decisive manner.

6 SEC. 3. LIMITING THE REQUIREMENT FOR INVESTIGA7 TIONS USING PRODUCTS MANUFACTURED AT

8 A FULL-SCALE TESTING FACILITY; GUIDE9 LINES; HARMONIZATION.

10 (a) FACILITIES.—Section 505 (21 U.S.C. 355) is

11 amended—

12 (1) in subsection (b)(1), by inserting after the

13 second sentence the following: ‘‘The investigations

14 referred to in clause (A) shall be required to be per15 formed using products manufactured at a full-scale

16 commercial facility only if the Secretary finds, after

17 providing opportunity for an informal hearing, that

18 investigations using products manufactured at such

19 a facility are necessary to assure the safety and effi20 cacy of the drug being investigated or, in the case

21 of a biological product subject to section 351 of the

22 Public Health Service Act, to assure that the re23 quirements applicable under such section are met.’’;

24 and
4

•HR 1995 IH

1 (2) in clause (1) of subsection (d), by inserting

2 after ‘‘to subsection (b),’’ the following: ‘‘were not

3 performed at a full-scale commercial facility as re4 quired under subsection (b)(1) or’’.

5 (b) GUIDELINES.—The Secretary, acting through the

6 Commissioner of Food and Drugs and after consultation

7 with the Institute of Medicine, shall develop guidelines for

8 the clinical testing required by subsections (b) and (i) of

9 section 505 of the Federal Food, Drug, and Cosmetic Act

10 (21 U.S.C. 355).

11 (c) HARMONIZATION.—The Secretary shall take such

12 action as may be appropriate to harmonize the require13 ments of the Federal Food, Drug, and Cosmetic Act for

14 pre-clinical and clinical investigations with the require15 ments of similar laws in foreign countries through the

16 International Conference on Harmonization.

17 SEC. 4. REGULATION OF BIOLOGICAL PRODUCTS.

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

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

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

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

22 biological product to which this section applies unless—

23 ‘‘(i) such biological product has been propa24 gated, manufactured, or prepared in accordance with

25 good manufacturing practices;
5

•HR 1995 IH

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

2 approved product license or complies with a stand3 ard established by the Secretary; and

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

5 plainly marked with the proper name of the biologi6 cal product contained therein, the name, address,

7 and establishment number of the manufacturer, and

8 the date beyond which the contents cannot be ex9 pected to yield their specific results.

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

11 biological products shall be required to have a product li12 cense or shall be subject to standards established under

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

14 components and derivatives (other than blood test kits)

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

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

17 requirements for product license applications. The Sec18 retary shall approve a product license application upon a

19 demonstration that there exists reasonable assurance that

20 the biological product which is the subject of the applica21 tion is safe and effective.

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

23 standards for biological products subject to such stand24 ards under paragraph (1)(B), except that tissue, blood,

25 and blood components or derivatives (other than blood test
6

•HR 1995 IH

1 kits) shall be subject to standards established under para2 graph (4). Standards shall, as appropriate, reasonably as3 sure the safety, purity, and potency of the biological prod4 uct or class of biological products subject to such stand5 ard.

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

7 under paragraph (2)(A) and regulations established by the

8 Secretary under paragraph (2)(B) may require that lots

9 or batches of a biological product be released only after

10 certification that such lots or batches have the characteris11 tics of safety, purity, and potency which the biological

12 product purports or is represented to possess.

13 ‘‘(B)(i) A product license shall specify whether certifi14 cation under subparagraph (A) will be by the manufac15 turer of the biological product, by the Secretary, or by a

16 certified individual or independent laboratory under sec17 tion 906 of the Federal Food, Drug, and Cosmetic Act.

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

19 or independent laboratory shall be required only for a pe20 riod of not more than 6 months, which period will not be

21 extended unless the Secretary determines in writing that

22 continuing such certification is required to assure the safe23 ty and efficacy of the biological product.’’.
7

•HR 1995 IH

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

2 by the manufacturer or upon the Secretary’s own initia3 tive, terminate any requirement for certification.

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

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

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

7 shall assure the safety and integrity of the tissue, blood,

8 and blood components or derivatives (other than blood test

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

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

11 blood components or derivatives (other than blood test

12 kits) and approved by the Secretary as appropriate for

13 purposes of this section, from professional and scientific

14 organizations. The Secretary shall publish such standards

15 as a notice of proposed rulemaking in accordance with

16 paragraph (2)(B)(ii).

17 ‘‘(B) The Secretary shall use professional and sci18 entific organizations and accrediting bodies used to assure

19 compliance with the standards of such organizations to as20 sist in the implementation of subparagraph (A) and to as21 sure that tissue, blood, and blood components or deriva22 tives (other than blood test kits) are processed in accord23 ance with good manufacturing practices established by the

24 Secretary under paragraph (6).
8

•HR 1995 IH

1 ‘‘(5) For purposes of this subsection, the term ‘tissue’

2 means a collection of human cells which are similar or the

3 intercellular substances surrounding them, or both,

4 which—

5 ‘‘(A) are intended for administration to a

6 human being for the diagnosis, cure, mitigation,

7 treatment, or prevention of any disease or condition;

8 ‘‘(B) are procured, processed, stored, or distrib9 uted by methods to prevent the transmission of in10 fectious disease and to preserve or enhance clinical

11 usefulness;

12 ‘‘(C) may be processed to remove some of its

13 constituents but have not been modified chemically;

14 ‘‘(D) may be combined with substances such as

15 excipients, fillers, or carriers that are not devices or

16 pharmacologically active;

17 ‘‘(E) if subjected to expansion, manipulation, or

18 other processing (which may include modification of

19 physical form or structure) before being trans20 planted or implanted, are not thereby substantially

21 altered in their inherent structural or functional

22 characteristics; and

23 ‘‘(F) achieve their principal intended purposes

24 through structural or functional support and not

25 systematic action;
9

•HR 1995 IH

1 but such term does not include vascularized human or2 gans.’’.

3 SEC. 5. GOOD MANUFACTURING PRACTICES.

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

5 (1) by inserting ‘‘(A)’’ after ‘‘(a)(1)’’ and redes6 ignating ‘‘(2)(A)’’ as ‘‘(B)(i)’’, ‘‘(B)’’ as ‘‘(ii)’’ both

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

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

9 the second time it appears; and

10 (2) by inserting the following at the end of sub11 section (a):

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

13 manufacturing practices applicable to drugs subject to sec14 tion 505 of this Act and biological products (other than

15 blood) subject to section 351 of the Public Health Service

16 Act as follows:

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

18 drugs and biological products which cannot be char19 acterized adequately by physical or chemical meth20 ods.

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

22 only to drugs and biological products which can be

23 characterized adequately by physical or chemical

24 methods.
10

•HR 1995 IH

1 ‘‘(C) Regulations established under subparagraph

2 (B) shall establish requirements for submissions to the

3 Secretary of changes in manufacturing practices by the

4 applicant or holder. Such regulations shall provide as fol5 lows:

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

7 which can adequately be characterized by physical or

8 chemical methods, approval of manufacturing

9 changes shall be required prior to implementation of

10 such changes only if such manufacturing changes

11 are specified in regulations as substantially affecting

12 the safety or efficacy of such drugs and biological

13 products.

14 ‘‘(ii) In the case of drugs and biological prod15 ucts which cannot be characterized adequately by

16 physical or chemical methods, approval of such man17 ufacturing changes before implementation shall be

18 required—

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

20 product which is required under section

21 351(a)(1)(B) of the Public Health Service Act

22 to have a product license, only if such manufac23 turing changes are specified in regulations as

24 substantially affecting the safety and efficacy of

25 such drug or biological product; or
11

•HR 1995 IH

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

2 which is subject to standards as determined

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

4 Health Service Act, only if such manufacturing

5 changes are specified in the regulations as sub6 stantially affecting the safety, purity, potency

7 (or, in the case of tissue, safety, and integrity)

8 of such biological products.

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

10 manufacturing changes that must be submitted in

11 writing to the Secretary (but not required to be ap12 proved prior to implementation). A request to make

13 such changes must be submitted by the applicant or

14 holder at least 30 days prior to implementation of

15 such changes. Such request shall be deemed ap16 proved on the 31st day after submission unless on

17 or before such day the Secretary disapproves such

18 request and notifies the applicant or holder in writ19 ing of such disapproval. Such notification shall in20 clude a complete statement of the reasons for dis21 approval and a statement of modifications to the re22 quest which, if made by the applicant or holder, will

23 allow approval of the request.

24 ‘‘(iv) A description of manufacturing changes

25 not covered by clauses (i) or (iii) shall be submitted
12

•HR 1995 IH

1 by the applicant or holder to the Secretary on an an2 nual basis.

3 ‘‘(D)(i) The Secretary shall, after notice and oppor4 tunity for public comment pursuant to section 553 of title

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

6 31, 1998, regulations to be used in determining whether

7 a drug or a biological product can adequately be character8 ized by physical or chemical methods.

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

10 by the Secretary that the drug or biological product which

11 is the subject of an application cannot be adequately char12 acterized by physical or chemical methods, such applicant

13 may contest such determination by requesting an informal

14 hearing.

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

16 (D)—

17 ‘‘(i) the term ‘changes in manufacturing prac18 tices’ means—

19 ‘‘(I) changes in manufacturing procedures

20 generally applicable throughout the facility,

21 such as changes in recordkeeping procedures,

22 validation processes, methods of training of per23 sonnel, and methods of qualification of equip24 ment;

25 ‘‘(II) changes in equipment; and
13

•HR 1995 IH

1 ‘‘(III) changes in manufacturing proce2 dures of specific applicability to a biological

3 product;

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

5 drug application submitted under section 505 or

6 product license application submitted under section

7 351 of the Public Health Service Act has been ap8 proved; and

9 ‘‘(iii) the term ‘applicant’ means a person

10 whose application described under clause (ii) has

11 been submitted to, but not approved by, the Sec12 retary.’’.

13 SEC. 6. NEW DRUG APPROVAL STANDARD.

14 The last sentence of section 505(d) (21 U.S.C.

15 355(d)) is amended to read as follows: ‘‘As used in this

16 subsection and subsection (e), the term ‘substantial evi17 dence’ means evidence consisting of scientifically sound

18 data, including data from one well-controlled clinical inves19 tigation and confirmatory evidence (obtained either before

20 or after such investigation) on the basis of which experts

21 qualified by scientific training and experience to evaluate

22 the effectiveness of the drug involved could fairly and re23 sponsibly conclude, taking into account the entire knowl24 edge base on the drug’s effectiveness and safety, inter25 preted as a whole, that the drug will have the effect it
14

•HR 1995 IH

1 purports or is represented to have under the conditions

2 of use prescribed, recommended, or suggested in the label3 ing or proposed labeling of the drug.’’.

4 SEC. 7. EXPEDITED REVIEW OF NEW DRUGS.

5 Section 505 (21 U.S.C. 355), as amended by section

6 6, is amended by adding at the end the following:

7 ‘‘(o)(1) Any person who could submit or has submit8 ted an application for a new drug pursuant to subsection

9 (b)(1), other than an application described in subsection

10 (b)(2), may submit an application for approval pursuant

11 to this subsection.

12 ‘‘(2) Any person may submit to the Secretary an ap13 plication (including a supplemental application for a new

14 indication) for approval of a new drug, including approval

15 of a switch of a new drug from prescription to

16 nonprescription status, at any dose and for any indication

17 based upon an evaluation by a domestic nongovernmental

18 organization under clause (C) following licensing or ap19 proval of such new drug after the date of enactment of

20 the Life Extending and Life Saving Drug Act by any of

21 the following third party organizations:

22 ‘‘(A) The European Medicines Evaluation

23 Agency or any successor organization.

24 ‘‘(B) The United Kingdom Medicines Control

25 Agency or any successor organization.
15

•HR 1995 IH

1 ‘‘(C) Any competent governmental or non2 governmental organization established to evaluate

3 the safety and effectiveness of drugs which meets

4 any general criteria that the Secretary may by regu5 lation establish.

6 ‘‘(3) The application shall consist of the following ma7 terials:

8 ‘‘(A) The complete dossier or other submission

9 made to a third party organization described in

10 paragraph (2) (in this paragraph referred to as ‘the

11 third party organization’), including any amend12 ments or additions.

13 ‘‘(B) All correspondence, memoranda of meet14 ings and telephone discussions, and similar docu15 ments reflecting communications between the appli16 cant and the third party organization or persons

17 working with the third party organization prepared

18 or received by the applicant relating to the new

19 drug.

20 ‘‘(C) All analyses and other documents pre21 pared by or for the third party organization relating

22 to any aspect of the new drug that the third party

23 organization provides to the applicant upon request

24 and a letter authorizing the Secretary to obtain any

25 other such document directly from the third party.
16

•HR 1995 IH

1 ‘‘(D) A summary of adverse event information

2 obtained as the result of any marketing outside the

3 United States.

4 ‘‘(E) A copy of the labeling approved by the

5 third party organization and proposed United States

6 labeling that is consistent with the Secretary’s gen7 erally applicable labeling requirements.

8 ‘‘(F) An adequate summary of the documents

9 that constitute the application.

10 ‘‘(4) Within 7 days after receipt of the application,

11 the Secretary shall send the summary to each member of

12 a scientific review group established pursuant to section

13 904. Within 60 days after receipt of the application by

14 the Secretary, the scientific review group shall meet to

15 consider the application and to make its conclusions and

16 recommendations to the Secretary.

17 ‘‘(5) Within 180 days after receipt of the submission

18 by the Secretary (or if an application under subsection

19 (b)(1) was submitted before the submission under this

20 subsection, then within 180 days of receipt of the applica21 tion under subsection (b)(1) or 90 days of the receipt of

22 the submission under this subsection, whichever is later),

23 the Secretary, taking into account any conclusions and

24 recommendations of the scientific review group, shall ei25 ther (A) approve the application, (B) disapprove the appli-
17

•HR 1995 IH

1 cation if the Secretary demonstrates, based on the infor2 mation in the submission (and, if an application has been

3 filed under subsection (b)(1), on the information in such

4 application) that the drug is unsafe or ineffective, and (C)

5 if the application is disapproved, publish a notice of the

6 decision in the Federal Register. If the Secretary does not

7 publish a notice of disapproval in the Federal Register

8 within such 180 days, the conclusions and recommenda9 tions of the scientific review group regarding the applica10 tion shall be deemed to be the decision of the Secretary

11 and the Secretary shall implement them immediately. If

12 the Secretary does not publish a notice of disapproval in

13 the Federal Register within 90 days and no scientific

14 group has made conclusions or recommendations within

15 that period regarding the application, the application shall

16 be deemed to be approved and the Secretary shall imme17 diately approve the application. The failure of the Sec18 retary to take any such action shall constitute final agency

19 action for purposes of judicial review. The Secretary may

20 at any time take action to revoke the approval of an appli21 cation approved pursuant to this paragraph on the ground

22 specified in clause (B) using the procedures established

23 in subsections (e) through (h) of this section.

24 ‘‘(6) The Secretary shall continue to pursue inter25 national harmonization of drug regulation among nations
18

•HR 1995 IH

1 both through (A) adoption of uniform technical require2 ments and a registration dossier and (B) mutual recogni3 tion of marketing approval.’’.

4 SEC. 8. CLINICAL RESEARCH.

5 Section 505(i) (21 U.S.C. 355(i)) is amended by add6 ing at the end the following: ‘‘A clinical study of a new

7 drug may begin after the Secretary has received from the

8 sponsor a notification containing information about the

9 drug and the clinical study. Such notification shall be re10 quired to contain only summaries of basic information,

11 certified by the applicant to be accurate, needed to assess

12 the safety of the clinical study and shall not be required

13 to contain detailed information on chemistry, manufactur14 ing, or controls or primary data tabulations or case report

15 forms or tabulations from animal or human studies. At

16 any time the director of the office within which the appli17 cation is being reviewed may issue to the sponsor in writ18 ing a clinical hold prohibiting the sponsor from conducting

19 the investigation and specifying the basis for the clinical

20 hold. The director of such office may issue a clinical hold

21 only upon a demonstration, based on specific information

22 available to the Secretary, that the drug represents an un23 reasonable risk to the safety of the persons who are the

24 subject of the clinical study, taking into account the condi25 tion for which the drug is to be investigated and the health
19

•HR 1995 IH

1 status of the subjects involved. Any response from the

2 sponsor to the director of such office requesting that the

3 clinical hold be removed shall receive a decision, in writing

4 and specifying the reasons therefor, within 15 days or the

5 clinical hold shall be deemed to be withdrawn. The director

6 may not delegate the authority to issue a clinical hold.

7 SEC. 9. CONTENT AND REVIEW OF NEW DRUG APPLICA8 TION.

9 (a) SUBSECTION (B)(1) APPLICATION.—Section

10 505(b) (21 U.S.C. 355) is amended by adding at the end

11 the following:

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

13 (1) shall include reports of studies on safety and effective14 ness certified by the applicant to be accurate summaries

15 which are supported by summary tables of the relevant

16 data. Such an application shall not be required to include

17 the primary data tabulations or case report forms or tab18 ulations. In extraordinary circumstances, the director of

19 the office of the Food and Drug Administration respon20 sible for review of the drug for which the application is

21 submitted may request, in writing and specifying the rea22 sons for the request, the submission of primary data tab23 ulations. The director may not delegate the authority to

24 make such a request.
20

•HR 1995 IH

1 ‘‘(B) In reviewing an application submitted under

2 paragraph (1), the Secretary, after obtaining agreement

3 of the applicant, shall contract with outside organizations

4 or individuals with expertise in relevant disciplines for the

5 review of all or parts of such application.

6 ‘‘(C) The Secretary shall establish standards for the

7 review of applications submitted under paragraph (1) re8 lating to promptness, technical excellence, lack of bias and

9 conflict of interest, and a knowledge of regulatory and sci10 entific standards which apply equally to outside reviewers

11 and to employees of the Secretary who review such appli12 cations. The Secretary shall conduct and maintain records

13 of training programs for outside reviewers and employees

14 of the Secretary who review such applications to assure

15 their compliance with good review practices and good re16 view standards and shall monitor their compliance with

17 such practices and standards, the requirements of section

18 708, and the statutory time limits for action.

19 ‘‘(D) Advice provided to a sponsor or applicant at its

20 request by a responsible Food and Drug Administration

21 employee regarding appropriate testing of a new drug

22 shall not be changed after such testing begins except with

23 the written agreement of the sponsor or applicant or by

24 a decision in writing after an informal hearing by the di25 rector of the office in which the drug is reviewed. The di-
21

•HR 1995 IH

1 rector may not delegate the authority to require such a

2 change.

3 ‘‘(E) The written decisions of the center for drugs

4 and the center for biologics of the Food and Drug Admin5 istration on all aspects of matters relating to a new drug

6 or biologic shall be binding upon, and may not directly

7 or indirectly be changed by, the field personnel or the of8 fices of compliance in the centers.

9 ‘‘(F) No action by the center for drugs or the center

10 for biologics on any matter relating to a new drug or bio11 logic may at any time or under any circumstance be de12 layed because of the unavailability of information or action

13 by the field personnel or because of issues relating to the

14 integrity of data, except on the basis of evidence presented

15 to the applicant, followed by an informal hearing, that

16 data in that particular application are false.’’.

17 (b) SUMMARIES.—Section 505(b)(1)(A) (21 U.S.C.

18 355(b)(1)(A)) is amended by inserting ‘‘(including de19 tailed summaries)‘‘ after ‘‘full reports and investigations’’.

20 SEC. 10. REVIEW BY INDEPENDENT TESTING ORGANIZA21 TIONS.

22 (a) PRIVATIZATION.—Chapter IX is amended by add23 ing after section 905 (21 U.S.C. 395) the following:

24 ‘‘PRIVATIZATION OF APPROVAL FUNCTIONS

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

26 Commissioner of Food and Drugs, may establish and im-
22

•HR 1995 IH

1 plement a program under which the Commissioner will

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

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

4 under such conditions as the Secretary may specify to as5 sure unbiased scientifically valid results, the following ac6 tivities and responsibilities of the Food and Drug Adminis7 tration in connection with the approval of drugs and de8 vices under sections 505 and 515 and with reviewing noti9 fications required under section 510(k) and making writ10 ten recommendations of initial classification under section

11 513(f)(1) of devices:

12 ‘‘(1) Toxicology reviews to determine if applica13 ble requirements are being met.

14 ‘‘(2) Chemistry reviews to determine if applica15 ble requirements are being met.

16 ‘‘(3) Statistical analysis to determine if applica17 ble requirements are being met.

18 ‘‘(4) Preapproval manufacturing practice in19 spections to determine if applicable requirements are

20 being met.

21 ‘‘(5) Clinical reviews to determine if applicable

22 requirements are being met.

23 ‘‘(6) Any other function of the Food and Drug

24 Administration relating to the review and approval

25 of drugs or devices that the Secretary determines
23

•HR 1995 IH

1 can be adequately performed under contract with

2 qualified individuals and laboratories.

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

4 of Food and Drugs, shall certify individuals and labora5 tories as qualified to carry out the functions described in

6 paragraphs (1) through (6) of subsection (a) under a con7 tract with the Commissioner of Food and Drugs.

8 ‘‘(c) The Secretary shall provide that drugs and de9 vices which are subject to review under subsection (a) shall

10 be approved under sections 505 and 515 if the review de11 termines that the drugs and devices meet all applicable

12 approval requirements.

13 ‘‘(d)(1) Information otherwise protected from disclo14 sure to the public under section 301(j) or 520(c) may be

15 disclosed to—

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

17 and

18 ‘‘(B) employees of such contractors,

19 if, in the opinion of the Secretary, such disclosure is nec20 essary for the satisfactory performance by the contractor

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

22 ‘‘(2) The Secretary shall, in writing, require as a con23 dition to the disclosure of information under paragraph

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

25 security precautions respecting the information as the Sec-
24

•HR 1995 IH

1 retary shall by regulation prescribe. Disclosure by such

2 person of such information to a person not authorized to

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

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

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

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

7 under section 351 of the Public Health Service Act shall

8 not include the review of the environmental impact of such

9 drug, device, or biological product under the Environ10 mental Quality Improvement Act of 1970 (42 U.S.C. 4371

11 et seq.).’’.

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

13 year from the date of the enactment of this Act, the Sec14 retary of Health and Human Services shall report to the

15 Congress on—

16 (1) the use the Secretary has made under sec17 tion 906 of the Federal Food, Drug, and Cosmetic

18 Act of the authority to contract for individuals and

19 laboratories to perform duties of the Food and Drug

20 Administration, and

21 (2) any difficulties encountered in contracting

22 under such section 906.

23 SEC. 11. RESEARCH ACTIVITIES.

24 (a) ACTIVITIES.—Chapter IX, as amended by section

25 10, is amended by adding after section 906 the following:
25

•HR 1995 IH

1 ‘‘RESEARCH ACTIVITIES

2 ‘‘SEC. 907. Research activities of the Food and Drug

3 Administration relating to drugs, devices, and biological

4 products, which are authorized under section

5 903(b)(2)(D) and section 352 of the Public Health Service

6 Act, shall directly relate to the review and approval of

7 drugs, devices, and biological products. In conducting such

8 research activities, the Food and Drug Administration

9 may collaborate with the National Institutes of Health,

10 academic health centers, and other scientific institutions

11 and the drug and device industry.’’.

12 (b) PURPOSE.—Section 903 (21 U.S.C. 393), as

13 amended by section 2, is amended by adding at the end

14 the following:

15 ‘‘(e) Any research conducted by or for the Food and

16 Drug Administration shall be solely related directly to (1)

17 the regulatory mission or (2) professional staff develop18 ment related to that mission and shall be limited to the

19 minimum necessary to achieve such purposes.’’.

20 SEC. 12. POLICY AND PERFORMANCE REVIEW.

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

22 11(b), is amended by adding at the end the following:

23 ‘‘(f)(1) The Secretary shall establish, in the office of

24 the Assistant Secretary for Health, a permanent commis25 sion responsible for broad oversight of the policy and per-
26

•HR 1995 IH

1 formance of the Food and Drug Administration. The com2 mission, which shall be subject to the provisions of sub3 section (c) of this section, shall review the performance

4 of individuals and groups in meeting the mission of the

5 Food and Drug Administration and the development of

6 appropriate agency policy to implement that mission and

7 shall include outcomes measurements and performance as8 sessments in evaluating agency activities. Such review

9 shall also include a comparison of the performance of the

10 Food and Drug Administration with that of agencies per11 forming similar functions for other countries and an eval12 uation of the effect of the Food and Drug Administra13 tion’s performance on the competitiveness of the regulated

14 American industries.

15 ‘‘(2)(A) The members of the commission shall include

16 the nation’s leading medical experts, medical society rep17 resentatives, scientific and health policy authorities, and

18 representatives from the trade associations for the regu19 lated industries and from voluntary health associations.

20 ‘‘(B) Members of the commission shall serve at the

21 discretion of the Secretary from year to year with no fixed

22 term.

23 ‘‘(C) The Secretary shall pay members of the com24 mission at an appropriate level commensurate with the

25 services they provide.
27

•HR 1995 IH

1 ‘‘(3)(A) The commission shall issue a report to the

2 Secretary and the Congress annually on the performance

3 of the Food and Drug Administration. The Food and

4 Drug Administration shall be given an opportunity to re5 view and respond to the report before it is submitted to

6 the Secretary and the Congress.

7 ‘‘(B) As part of its annual report under subparagraph

8 (A), the commission shall recommend personnel and policy

9 changes to improve the performance of the Food and Drug

10 Administration in order to meet its mission as set forth

11 in subsection (d).’’.

12 SEC. 13. APPEALS.

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

14 12, is amended by adding the following new subsection

15 at the end thereof:

16 ‘‘(g)(1) The Secretary shall establish within the Food

17 and Drug Administration a drug and biologics policy ap18 peals committee consisting of the director and deputy di19 rector of the center for drugs and the director and deputy

20 director of the center for biologics. The appeals committee

21 shall meet to hear and consider any dispute raised by an

22 individual who wishes to contest a policy matter relating

23 to drugs or biologics. The appeals committee shall meet

24 to hear the individual within 15 days of receiving the re-
28

•HR 1995 IH

1 quest from the individual and shall decide the matter with2 in 10 days after the hearing.

3 ‘‘(2) The Secretary shall establish standing panels of

4 qualified experts who are not employees of the United

5 States Government or of any State or local government

6 for the purpose of hearing appeals by individuals who have

7 exhausted their informal appeals within the Food and

8 Drug Administration and who wish to contest the action

9 or failure to act by the Food and Drug Administration

10 in a particular matter. The Secretary shall establish an

11 appeal procedure that assures immediate access to such

12 a panel and prompt conclusions and recommendations by

13 the panel. Following the conclusions and recommendations

14 of the panel, the official of the Food and Drug Adminis15 tration who reports to the Commissioner of Food and

16 Drugs and is the director of the component responsible

17 for regulation of the matter shall personally review the

18 matter, in light of such conclusions and recommendations,

19 and shall make a final decision within 15 days after receiv20 ing the conclusions and recommendations. Such official

21 may not delegate the requirement to review and make a

22 final decision. The decision of that official shall imme23 diately be implemented. If that official fails to make a de24 cision within 15 days, or if the decision is not immediately

25 implemented, the conclusions and recommendations of the
29

•HR 1995 IH

1 panel shall be deemed to be the decision of the Food and

2 Drug Administration and shall be implemented imme3 diately. The failure of the Secretary to take action to im4 plement that decision immediately shall constitute final

5 agency action for purposes of judicial review.’’.

6 SEC. 14. EXPORT OF NEW DRUGS.

7 Section 801(e) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 381(e) is amended—

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

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

11 505 or section 351 of the Public Health Service

12 Act’’,

13 (2) in paragraph (1), by striking the last sen14 tence, and

15 (3) by amending paragraph (2) to read as fol16 lows:

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

18 ‘‘(A) any device—

19 ‘‘(i) which does not comply with an appli20 cable requirement under section 514 or 515,

21 ‘‘(ii) which under section 520(g) is exempt

22 from either such section, or

23 ‘‘(iii) which is a banned device under sec24 tion 516, or
30

•HR 1995 IH

1 ‘‘(B) any drug (including a biological product)

2 which does not comply with an applicable require3 ment under section 505 or 512 or section 351 of the

4 Public Health Service Act,

5 unless the device or drug is in compliance with the require6 ments of paragraph (1). In the case of a device or drug

7 for which an export notice is required under this para8 graph, the Secretary may prohibit the export of such de9 vice or drug if the Secretary determines that the possibil10 ity of the reimportation of the device or drug into the

11 United States presents an imminent hazard to the public

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

13 of limiting the hazard is to prohibit the export of the de14 vice or drug.’’.

15 SEC. 15. EXPORT OF CERTAIN UNAPPROVED PRODUCTS.

16 Section 802 (21 U.S.C. 382) is repealed.

Æ

HR 1995 IH——2

HR 1995 IH——3