II 

109TH CONGRESS 

1ST SESSION S. 1956 

To amend the Federal Food, Drug, and Cosmetic Act to create a new 

three-tiered approval system for drugs, biological products, and devices 

that is responsive to the needs of seriously ill patients, and for other 

purposes. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 3, 2005 

Mr. BROWNBACK (for himself and Mr. INHOFE) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

create a new three-tiered approval system for drugs, 

biological products, and devices that is responsive to 

the needs of seriously ill patients, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access, Compassion, 

5 Care, and Ethics for Seriously Ill Patients Act’’ or the 

6 ‘‘ACCESS Act’’. 
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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) The necessity of placebo controlled studies 

4 has been questioned on both scientific and ethical 

5 grounds for seriously ill patients. 

6 (2) The current standards of the Food and 

7 Drug Administration for approval of drugs, biologi8 cal products, and devices deny the benefits of med9 ical progress to seriously ill patients who face mor10 bidity or death from their disease. 

11 (3) Promising therapies intended to treat seri12 ous or life threatening conditions or diseases and 

13 which address unmet medical needs have received 

14 unjustified delays and denials of approval. 

15 (4) Seriously ill patients have a right to access 

16 available investigational drugs, biological products, 

17 and devices. 

18 (5) The current Food and Drug Administration 

19 and National Cancer Institute case-by-case exception 

20 for compassionate access must be required to permit 

21 all seriously ill patients access to available experi22 mental therapies as a treatment option. 

23 (6) The current emphasis on statistical analysis 

24 of clinical information needs to be balanced by a 

25 greater reliance on clinical evaluation of this infor26 mation. 
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1 (7) Food and Drug Administration advisory 

2 committees should have greater representation of 

3 medical clinicians who represent the interests of seri4 ously ill patients in early access to promising inves5 tigational therapies. 

6 (8) The use of available investigational products 

7 for treatment is the responsibility of the physician 

8 and the patient. 

9 (9) The use of combinations of available inves10 tigational and approved products for treatment is 

11 the responsibility of the physician and the patient. 

12 (10) The development and approval of drugs, 

13 biological products, and devices intended to address 

14 serious or life-threatening conditions or diseases is 

15 often delayed by the inability of sponsors to obtain 

16 prompt meetings with the Food and Drug Adminis17 tration and to obtain prompt resolution of scientific 

18 and regulatory issues related to the investigation 

19 and review of new technologies. 

20 SEC. 3. TIERED APPROVAL SYSTEM FOR DRUGS, BIOLOGI21 CAL PRODUCTS, AND DEVICES. 

22 Section 506 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 356) is amended to read as follows: 
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1 ‘‘SEC. 506. TIERED APPROVAL SYSTEM. 

2 ‘‘(a) IN GENERAL.—Notwithstanding any other pro3 vision of law, the sponsor of an investigational drug, bio4 logical product, or device may submit an application to 

5 the Secretary for Tier I or Tier II approval in accordance 

6 with this section. 

7 ‘‘(b) TIER I APPROVAL.— 

8 ‘‘(1) IN GENERAL.— 

9 ‘‘(A) APPLICATION CONTENT.—A sponsor 

10 of an investigational drug, biological product, or 

11 device applying for Tier I approval of the prod12 uct shall submit to the Secretary an application 

13 as described under section 505(b)(1) or 

14 505(b)(2), section 351(a) of the Public Health 

15 Service Act, or section 510(k) or 515(c)(1), as 

16 applicable, which shall contain— 

17 ‘‘(i) data and information from com18 pleted Phase I clinical investigations and 

19 any other nonclinical or clinical investiga20 tions; 

21 ‘‘(ii) preliminary evidence that the 

22 product may be effective against a serious 

23 or life-threatening condition or disease, 

24 which evidence may be based on uncon25 trolled data such as case histories, infor26 mation about the pharmacological mecha-
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1 nism of action, data from animal and com2 puter models, comparison with historical 

3 data, or other preliminary information, and 

4 may be based on a small number of pa5 tients; and 

6 ‘‘(iii) an assurance that the sponsor 

7 will continue clinical investigation to obtain 

8 Tier III approval. 

9 ‘‘(B) LIMITATION.—Tier I approval shall 

10 be primarily based upon clinical evaluation, not 

11 statistical analysis. 

12 ‘‘(2) DETERMINATION BY SECRETARY.— 

13 ‘‘(A) IN GENERAL.—Not later than 30 

14 days after the receipt of an application for Tier 

15 I approval, the Secretary shall either— 

16 ‘‘(i) approve the application; or 

17 ‘‘(ii) refer the application to the Accel18 erated Approval Advisory Committee. 

19 ‘‘(B) RECOMMENDATION.—Within 90 days 

20 after receipt of an application for approval, the 

21 Accelerated Approval Advisory Committee shall 

22 issue a recommendation to the Secretary on 

23 whether the Secretary should approve the appli24 cation. 
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1 ‘‘(C) FINAL DECISION.—Within 30 days 

2 after receipt of the recommendation from the 

3 Accelerated Approval Advisory Committee, the 

4 Secretary shall either approve the application or 

5 shall issue an order setting forth a detailed ex6 planation of the reasons why the application 

7 was not approved and the specific data that the 

8 sponsor must provide so that the application 

9 may be approved. 

10 ‘‘(3) APPEAL.—If the Secretary does not ap11 prove an application for which the Accelerated Ap12 proval Advisory Committee recommended approval, 

13 the sponsor of the application shall have the right to 

14 appeal the decision to the Commissioner of Food 

15 and Drugs. The Commissioner shall provide the 

16 sponsor with a hearing within 30 days following the 

17 nonapproval of the application and shall issue an 

18 order within 30 days following the hearing either 

19 concurring in the nonapproval or approving the ap20 plication. The Commissioner shall not delegate the 

21 responsibility described in this paragraph to any 

22 other person. 

23 ‘‘(4) CRITERIA.—In making a determination 

24 under paragraph (2), the Secretary shall consider 

25 whether the totality of the information available to 
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1 the Secretary regarding the safety and effectiveness 

2 of an investigational drug, biological product, or de3 vice, as compared to the risk of morbidity or death 

4 from a condition or disease, indicates that a patient 

5 (who may be representative of a small patient sub6 population) may obtain more benefit than risk if 

7 treated with the drug, biological product, or device. 

8 If the potential risk to a patient of the condition or 

9 disease outweighs the potential risk of the product, 

10 and the product may possibly provide benefit to the 

11 patient, the Secretary shall approve the application. 

12 ‘‘(5) PRODUCT LABELING.—The labeling ap13 proved by the Secretary for the drug, biological 

14 product, or device— 

15 ‘‘(A) shall state that the product is in16 tended for use by a patient whose physician has 

17 documented in writing that the patient has— 

18 ‘‘(i) exhausted all treatment options 

19 approved by Secretary for the condition or 

20 disease for which the patient is a reason21 able candidate; and 

22 ‘‘(ii) unsuccessfully sought treatment, 

23 or obtained treatment that was not effec24 tive, with an investigational drug, biologi25 cal product, or device for which such indi-
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1 vidual is a reasonable candidate (which 

2 may include consideration of the lack of a 

3 source of supply or geographic factors); 

4 and 

5 ‘‘(B) shall state that every patient to 

6 whom the product is administered shall, as a 

7 mandatory condition of receiving the product, 

8 provide— 

9 ‘‘(i) written informed consent, as de10 scribed under part 50 of title 21, Code of 

11 Federal Regulations; 

12 ‘‘(ii) a written waiver of the right to 

13 sue the manufacturer or sponsor of the 

14 drug, biological product, or device, or the 

15 physicians who prescribed the product or 

16 the institution where it was administered, 

17 for an adverse event caused by the prod18 uct, which shall be binding in every State 

19 and Federal court; and 

20 ‘‘(iii) consent for the manufacturer of 

21 the product to obtain data and information 

22 about the patient and the patient’s use of 

23 the product that may be used to support 

24 an application for Tier II or Tier III ap25 proval. 
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1 ‘‘(6) LIMITATION ON CONDITIONS.—Tier I ap2 proval may be subject to the requirement that the 

3 sponsor conduct appropriate post-approval studies. 

4 ‘‘(c) TIER II APPROVAL.— 

5 ‘‘(1) IN GENERAL.—A sponsor of an investiga6 tional drug, biological product, or device applying for 

7 Tier II approval shall submit to the Secretary an ap8 plication as described under section 505(b)(1) or 

9 505(b)(2), section 351(a) of the Public Health Serv10 ice Act, or section 510(k) or 515(c)(1), as applica11 ble, which shall contain— 

12 ‘‘(A) data and information that the drug, 

13 biological product, or device has an effect on a 

14 clinical endpoint or on a surrogate endpoint or 

15 biomarker that is reasonably likely to predict 

16 clinical benefit to a patient (who may be rep17 resentative of a small patient subpopulation) 

18 suffering from a serious or life-threatening con19 dition or disease; and 

20 ‘‘(B) an assurance that the sponsor will 

21 continue clinical investigation to obtain Tier III 

22 approval. 

23 ‘‘(2) DETERMINATION BY SECRETARY.— 
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1 ‘‘(A) IN GENERAL.—Not later than 30 

2 days after the receipt of an application for Tier 

3 II approval, the Secretary shall either— 

4 ‘‘(i) approve the application; or 

5 ‘‘(ii) refer the application to the Accel6 erated Approval Advisory Committee. 

7 ‘‘(B) RECOMMENDATION.—Within 90 days 

8 after receipt of an application for approval, the 

9 Accelerated Approval Advisory Committee shall 

10 issue a recommendation to the Secretary on 

11 whether the Secretary should approve the appli12 cation. 

13 ‘‘(C) FINAL DECISION.—Within 30 days 

14 after receipt of the recommendation from the 

15 Accelerated Approval Advisory Committee, the 

16 Secretary shall either approve the application or 

17 issue an order setting forth a detailed expla18 nation of the reasons why the application was 

19 not approved and the specific data that the 

20 sponsor must provide so that the application 

21 may be approved. 

22 ‘‘(3) APPEAL.—If the Secretary does not ap23 prove an application for which the Accelerated Ap24 proval Advisory Committee recommended approval, 

25 the sponsor of the application shall have the right to 
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1 appeal the decision to the Commissioner of Food 

2 and Drugs. The Commissioner shall provide the 

3 sponsor with a hearing within 30 days following the 

4 nonapproval of the application and shall issue an 

5 order within 30 days following the hearing either 

6 concurring in the nonapproval or approving the ap7 plication. The Commissioner shall not delegate the 

8 responsibility described in this paragraph to any 

9 other person. 

10 ‘‘(4) LIMITATION ON CONDITIONS.— 

11 ‘‘(A) POST-APPROVAL STUDIES.—Tier II 

12 approval may be subject to the requirement 

13 that the sponsor conduct appropriate post-ap14 proval studies to validate the surrogate end15 point or biomarker or otherwise confirm the ef16 fect on the clinical endpoint. 

17 ‘‘(B) RULE OF CONSTRUCTION.—Nothing 

18 in this subsection shall be construed to permit 

19 the Secretary to condition Tier II approval on 

20 compliance with any other standards, including 

21 any standard necessary to meet Tier III ap22 proval. 

23 ‘‘(d) TIER III APPROVAL.—For purposes of this Act, 

24 the term ‘Tier III approval’ means— 
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1 ‘‘(1) with respect to a new drug or new biologi2 cal product, approval of such drug or product under 

3 section 505(b)(1) or 505(b)(2) or section 351 of the 

4 Public Health Service Act, as the case may be; and 

5 ‘‘(2) with respect to a new device, clearance of 

6 such device under section 510(k) or approval of such 

7 device under section 515(c)(1). 

8 ‘‘(e) PROMOTIONAL MATERIALS.—Approval of a 

9 product under either Tier I or II may be subject to the 

10 requirements that— 

11 ‘‘(1) the sponsor submit copies of all advertising 

12 and promotional materials related to the product 

13 during the preapproval review period and, following 

14 approval and for such period thereafter as the Sec15 retary determines to be appropriate, and at least 30 

16 days prior to the dissemination of the materials; 

17 ‘‘(2) all advertising and promotional materials 

18 prominently disclose the limited approval for the 

19 product and data available supporting the safety and 

20 effectiveness of the product; and 

21 ‘‘(3) the sponsor shall not disseminate adver22 tising or promotional material prior to obtaining 

23 written notification from the Secretary that the ad24 vertising or promotional material complies with this 

25 subchapter. 
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1 ‘‘(f) EXPEDITED WITHDRAWAL OF APPROVAL.—The 

2 Secretary may withdraw Tier I or Tier II approval using 

3 expedited procedures (as prescribed by the Secretary in 

4 regulations which shall include an opportunity for a hear5 ing) if— 

6 ‘‘(1) the sponsor fails to conduct post-approval 

7 studies with due diligence, considering all of the cir8 cumstances involved; 

9 ‘‘(2) a post-approval study fails to verify clinical 

10 benefit of the product for even a small patient sub11 population; 

12 ‘‘(3) other evidence demonstrates that the prod13 uct is not safe or effective under the conditions of 

14 use for even a small patient subpopulation; or 

15 ‘‘(4) the sponsor disseminates false or mis16 leading promotional materials with respect to the 

17 product and fails to correct the material promptly 

18 after written notice from the Secretary. 

19 ‘‘(g) ACCELERATED APPROVAL ADVISORY COM20 MITTEE.— 

21 ‘‘(1) IN GENERAL.—In order to facilitate the 

22 development and expedite the review of drugs, bio23 logical products, and devices intended to treat seri24 ous or life threatening conditions, the Secretary shall 
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1 establish the Accelerated Approval Advisory Com2 mittee. 

3 ‘‘(2) DELEGATION.—The Secretary may dele4 gate authority for the Accelerated Approval Advisory 

5 Committee to the Commissioner of Food and Drugs. 

6 The Accelerated Approval Advisory Committee shall 

7 be staffed and administered in the Office of the 

8 Commissioner. 

9 ‘‘(3) COMPOSITION.— 

10 ‘‘(A) IN GENERAL.—The Committee shall 

11 be composed of 11 voting members, including 1 

12 chairperson and 5 permanent members each of 

13 whom shall serve a term of 3 years and may be 

14 reappointed for a second 3-year term, and 5 

15 nonpermanent members who shall be appointed 

16 to the Committee for a specific meeting, or part 

17 of a meeting, in order to provide adequate ex18 pertise in the subject being reviewed. The Com19 mittee shall include as voting members no less 

20 than 2 representatives of patient interests, of 

21 which 1 shall be a permanent member of the 

22 Committee. The Committee shall include as 

23 nonvoting members a representative of interests 

24 of the drug, biological product, and device in25 dustry. 
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1 ‘‘(B) APPOINTMENTS.—The Secretary 

2 shall appoint to the Committee persons who are 

3 qualified by training and experience to evaluate 

4 the safety and effectiveness of the types of 

5 products to be referred to the Committee and 

6 who, to the extent feasible, possess skill in the 

7 use of, or experience in the development, manu8 facture, or utilization of, such products. The 

9 Secretary shall make appointments to the Com10 mittee so that the Committee shall consist of 

11 members with adequately diversified expertise 

12 and practical experience in such fields as clin13 ical medicine, biological and physical sciences, 

14 and other related professions. Scientific, indus15 try, and consumer organizations and members 

16 of the public shall be afforded an opportunity to 

17 nominate individuals for appointment to the 

18 Committee. No individual who is in the regular 

19 full-time employ of the United States and en20 gaged in the administration of this chapter may 

21 be a member of the Committee. 

22 ‘‘(4) COMPENSATION.—Committee members, 

23 while attending meetings or conferences of the Com24 mittee or otherwise engaged in its business, shall be 

25 entitled to receive compensation at rates to be fixed 
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1 by the Secretary, but not at rates exceeding the 

2 daily equivalent of the rate in effect for grade GS– 

3 18 of the General Schedule, for each day so en4 gaged, including traveltime, and while so serving 

5 away from their homes or regular places of business 

6 each member may be allowed travel expenses (in7 cluding per diem in lieu of subsistence) as author8 ized by section 5703 of title 5, for persons in the 

9 Government service employed intermittently. 

10 ‘‘(5) ASSISTANCE.—The Secretary shall furnish 

11 the Committee with adequate clerical and other nec12 essary assistance. 

13 ‘‘(6) ANNUAL TRAINING.—The Secretary shall 

14 employ nongovernmental experts to provide annual 

15 training to the Committee on the statutory and reg16 ulatory standards for product approval. 

17 ‘‘(7) TIMELINE.—The Committee shall be 

18 scheduled to meet at such times as may be appro19 priate for the Secretary to meet applicable statutory 

20 deadlines. 

21 ‘‘(8) MEETINGS.— 

22 ‘‘(A) OPPORTUNITIES FOR INTERESTED

23 PERSONS.—Any person whose product is spe24 cifically the subject of review by the Committee 

25 shall have— 
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1 ‘‘(i) the same access to data and in2 formation submitted to the Committee as 

3 the Secretary; 

4 ‘‘(ii) the opportunity to submit, for re5 view by the Committee, data or informa6 tion, which shall be submitted to the Sec7 retary for prompt transmittal to the Com8 mittee; and 

9 ‘‘(iii) the same opportunity as the 

10 Secretary to participate in meetings of the 

11 Committee. 

12 ‘‘(B) ADEQUATE TIME; FREE AND OPEN

13 PARTICIPATION.—Any meetings of the Com14 mittee shall provide adequate time for initial 

15 presentations and for response to any differing 

16 views by persons whose products are specifically 

17 the subject of the Committee review, and shall 

18 encourage free and open participation by all in19 terested persons. 

20 ‘‘(C) SUMMARIES.—At all meetings of the 

21 Committee, the Secretary shall provide a sum22 mary to the Committee of all Tier I and Tier 

23 II applications that the Committee did not con24 sider that were approved by the Secretary since 

25 the last meeting of the Committee. 
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1 ‘‘(h) COMMENCEMENT OF REVIEW.—If the Secretary 

2 determines, after preliminary evaluation of the data and 

3 information submitted by the sponsor, that the product 

4 may be effective, the Secretary shall evaluate for filing, 

5 and may commence review of portions of, an application 

6 for Tier I or Tier II approval before the sponsor submits 

7 a complete application. The Secretary shall commence 

8 such review only if the applicant provides a schedule for 

9 submission of information necessary to make the applica10 tion complete. 

11 ‘‘(i) INAPPLICABILITY OF PROVISIONS.—The fol12 lowing provisions shall not apply to Tier I or Tier II appli13 cations and approvals: 

14 ‘‘(1) Chapter VII, subchapter C, parts 2 and 3 

15 relating to fees for drugs, biological products, and 

16 devices. 

17 ‘‘(2) The provisions of the Drug Price Competi18 tion and Patent Term Restoration Act of 1984 that 

19 authorize approval of abbreviated new drug applica20 tions and applications submitted under section 

21 505(b)(2). Market exclusivity and patent term res22 toration of Tier I and Tier II approved drugs, bio23 logical products, and devices shall be determined 

24 solely at the time of Tier III approval without re25 gard to prior Tier I or Tier II approval. Prior to 
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1 Tier III approval, the Secretary shall not approve 

2 any application submitted under section 505(b)(2) 

3 or section 505(j) that references a drug approved 

4 under subsections (b) or (c) of this section.’’. 

5 SEC. 4. ETHICS IN HUMAN TESTING. 

6 Chapter V of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 351 et seq.) is amended by adding at the 

8 end of section 505(i) the following: 

9 ‘‘(5) Notwithstanding any other provision of 

10 law, the Secretary shall prohibit placebo-only or no11 treatment-only concurrent controls in any clinical in12 vestigation conducted under this chapter or, in the 

13 use of the last-observation-carried-forward conven14 tion, in any clinical investigation conducted under 

15 this chapter or section 351 of the Public Health 

16 Service Act with respect to any life-threatening con17 dition or disease where reasonably effective approved 

18 alternative therapies exist for the specific indica19 tion.’’. 

20 SEC. 5. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS 

21 AND DEVICES. 

22 (a) IN GENERAL.—Chapter V of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend24 ed by adding at the end of section 561 the following: 
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1 ‘‘(f) EXPANDED ACCESS PROGRAM.—The Food and 

2 Drug Administration shall establish a new program to ex3 pand access to investigational treatments for individuals 

4 with serious or life threatening conditions and diseases. 

5 In carrying out this expanded access program, the Sec6 retary shall publish and broadly disseminate written guid7 ance that— 

8 ‘‘(1) describes such expanded access programs 

9 for investigational drugs, biological products, and de10 vices intended to treat serious or life-threatening 

11 conditions or diseases; 

12 ‘‘(2) encourages and facilitates submission of 

13 Tier I and Tier II applications and approvals; and 

14 ‘‘(3) facilitates the provision of investigational 

15 drugs and devices to seriously ill individuals without 

16 unreasonable delay by recognizing that the use of 

17 available investigational products for treatment is 

18 the responsibility of the physician and the patient. 

19 ‘‘(g) IMPLEMENTATION OF EXPANDED ACCESS PRO20 GRAMS.— 

21 ‘‘(1) TRAINING OF PERSONNEL.—Not later 

22 than 90 days after the date of enactment of this 

23 subsection, the Secretary shall implement training 

24 programs at the Food and Drug Administration with 
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1 respect to the expanded access programs established 

2 under this section. 

3 ‘‘(2) POLICIES, REGULATIONS, AND GUID4 ANCE.—The Secretary shall establish policies, regu5 lations, and guidance designed to most directly ben6 efit seriously ill patients. 

7 ‘‘(h) DEVELOPMENT OF SURROGATE ENDPOINTS

8 AND BIOMARKERS.—The Secretary shall— 

9 ‘‘(1) establish a program to encourage the de10 velopment of surrogate endpoints and biomarkers 

11 that are reasonably likely to predict clinical benefit 

12 for serious or life-threatening conditions for which 

13 there exist significant unmet medical needs; 

14 ‘‘(2) request the Institute of Medicine to under15 take a study to identify validated surrogate 

16 endpoints and biomarkers, and recommend research 

17 to validate surrogate endpoints and biomarkers, that 

18 may support approvals for products intended for the 

19 treatment of serious or life-threatening conditions or 

20 diseases; and 

21 ‘‘(3) make widely available to the public a list 

22 of drugs, biological products, and devices that are 

23 being investigated for serious or life-threatening con24 ditions or diseases and that have not yet received 

25 Tier I or Tier II approval for marketing.’’. 
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1 (b) CONFORMING AMENDMENT.—Section 561(c) of 

2 the Federal Food, Drug, and Cosmetic Act is amended 

3 by striking the heading and inserting ‘‘EXPANDED ACCESS

4 TO INVESTIGATIONAL DRUGS AND DEVICES FOR SERI5 OUSLY ILL PATIENTS’’. 

6 SEC. 6. MODERNIZATION OF THE FOOD AND DRUG ADMIN7 ISTRATION. 

8 Subchapter E of chapter V of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

10 amended by adding at the end the following: 

11 ‘‘SEC. 565. POLICIES RELATED TO STUDY EVALUATION IN12 FORMATION. 

13 ‘‘(a) IN GENERAL.— 

14 ‘‘(1) NONSTATISTICAL MEASURES.—The Sec15 retary shall give equal weight to clinical judgment 

16 and statistical analysis in the evaluation of the safe17 ty and effectiveness of drugs, biological products, 

18 and devices, and shall not disapprove a product ap19 plication solely on the basis of a statistical analysis 

20 or the rigid use of the 95 percent confidence level 

21 convention. This policy shall apply— 

22 ‘‘(A) in evaluating clinical study designs 

23 and endpoints; and 

24 ‘‘(B) in making decisions with respect to 

25 product applications. 
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1 ‘‘(2) TYPES OF NONSTATISTICAL MEASURES.— 

2 The policy established under paragraph (1), for the 

3 purposes described in such paragraph— 

4 ‘‘(A) shall include but not be limited to 

5 such nonstatistical information as— 

6 ‘‘(i) clinical evaluation information, 

7 such as case history reports; 

8 ‘‘(ii) scientific and clinical studies de9 signed to measure or define mechanisms of 

10 action or molecular targeting; 

11 ‘‘(iii) data from animal and computer 

12 models; and 

13 ‘‘(iv) comparison with historical data; 

14 and 

15 ‘‘(B) shall incorporate the use of— 

16 ‘‘(i) evaluations of the adverse effect 

17 of delaying the availability of an investiga18 tional drug to even a small subpopulation 

19 of seriously ill patients; and 

20 ‘‘(ii) scientific, observational, or clin21 ical studies designed and conducted to col22 lect well-documented information. 

23 ‘‘(b) MEETINGS.—A meeting to address any pending 

24 scientific, medical, regulatory, or other issue relating to 

25 the development, investigation, review, or other aspect of 
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1 a drug, biological product, or device shall ordinarily be 

2 held within 15 days of the receipt of a written request 

3 for the meeting by the sponsor of the product, which may 

4 be extended to 30 days for good cause. Such meetings 

5 shall ordinarily be conducted in person, but may be con6 ducted by telephone or other form of communication if 

7 both parties agree. In order to reduce the burden of meet8 ings, only those Food and Drug Administration employees 

9 who are intended to actively participate in the discussion 

10 shall attend a meeting. Minutes of a meeting shall be 

11 promptly prepared and exchanged by both parties imme12 diately following the meeting and shall accurately summa13 rize what occurred at the meeting 

14 ‘‘(c) RULE OF CONSTRUCTION.—The provisions of 

15 chapter V and section 351 of the Public Health Service 

16 Act shall be construed to incorporate the policy established 

17 in this section.’’. 

18 SEC. 7. MEMBERSHIP OF ONCOLOGY DRUGS ADVISORY 

19 COMMITTEE. 

20 Membership of the Oncology Drugs Advisory Com21 mittee of the Food and Drug Administration shall consist 

22 of no less than 2 patient representatives who are voting 

23 members of the committee. 

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