I 

111TH CONGRESS 

2D SESSION H. R. 4816 

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

deposit in the general fund of the Treasury of fees that are collected 

from manufacturers of drugs and devices under chapter VII of such 

Act, to terminate the authority of the Food and Drug Administration 

to negotiate with the manufacturers on particular uses of the fees, 

to establish a Center for Postmarket Drug Safety and Effectiveness, 

to establish additional authorities to ensure the safe and effective use 

of drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 10, 2010 

Mr. HINCHEY introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

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

provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of 

drugs and devices under chapter VII of such Act, to 

terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular 

uses of the fees, to establish a Center for Postmarket 

Drug Safety and Effectiveness, to establish additional 

authorities to ensure the safe and effective use of drugs, 

and for other purposes. 


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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 ‘‘Food and Drug Ad5 ministration Improvement Act of 2010’’. 

6 SEC. 2. FEES PAID BY MANUFACTURERS TO FOOD AND 

7 DRUG ADMINISTRATION; DEPOSIT IN GEN8 ERAL FUND OF TREASURY; DIRECT SPEND9 ING. 

10 (a) IN GENERAL.—Subchapter C of chapter VII of 

11 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

12 379f et seq.) is amended by adding at the end the fol13 lowing part: 

14 ‘‘PART 6—MODIFICATIONS REGARDING USER-FEE 

15 PROGRAMS 

16 ‘‘SEC. 743. DEPOSIT OF FEES IN GENERAL FUND OF TREAS17 URY; DIRECT SPENDING. 

18 ‘‘(a) DEPOSIT IN GENERAL FUND.—Notwithstanding 

19 any other provision of this Act related to the collection 

20 of fees related to drugs, devices, animal drugs, or generic 

21 animal drugs, all such fees collected under this Act shall 

22 be deposited in the general fund of the Treasury. 

23 ‘‘(b) DIRECT SPENDING.— 

24 ‘‘(1) IN GENERAL.—Notwithstanding any other 

25 provision of this Act related to the collection of such 


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1 fees, amounts are available to the Secretary for obli2 gation in accordance with the following: 

3 ‘‘(A) The amount authorized to be appro4 priated under section 736 for fees related to 

5 drugs is, to the extent described in section 

6 736(g)(2)(A)(ii) (as in effect on September 30, 

7 2010), available to the Secretary for obligation 

8 solely for the process for the review of human 

9 drug applications (within the meaning given to 

10 such term in section 735, as in effect on Sep11 tember 30, 2010). 

12 ‘‘(B) The amount authorized to be appro13 priated under section 736A for fees relating to 

14 advisory review of prescription-drug television 

15 advertising is, to the extent described in section 

16 736A(g)(2)(A)(ii) (as in effect on September 

17 30, 2010), available to the Secretary for obliga18 tion solely for the process for the advisory re19 view of prescription drug advertising (within the 

20 meaning given to such terms in section 736A, 

21 as in effect on September 30, 2010). 

22 ‘‘(C) The amount authorized to be appro23 priated under section 736A–1 for fees relating 

24 to the regulation of advertisements for drugs 


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1 and devices is available to the Secretary for ob2 ligation solely for such regulation. 

3 ‘‘(D) The amount authorized to be appro4 priated under this Act for fees related to de5 vices is, to the extent described in section 

6 738(h)(2)(A)(ii) (as in effect on September 30, 

7 2010), available to the Secretary for obligation 

8 solely for the process for the review of device 

9 applications (within the meaning given to such 

10 terms in section 737, as in effect on September 

11 30, 2010). 

12 ‘‘(E) The amount authorized to be appro13 priated under this Act for fees related to animal 

14 drugs is, to the extent described in section 

15 740(g)(2)(A)(ii) (as in effect on September 30, 

16 2010), available to the Secretary for obligation 

17 solely for the process for the review of animal 

18 drug applications (within the meaning given to 

19 such terms in section 739, as in effect on Sep20 tember 30, 2010). 

21 ‘‘(F) The amount authorized to be appro22 priated under this Act for fees related to ge23 neric new animal drugs is, to the extent de24 scribed in section 741(g)(2)(A)(ii) (as in effect 

25 on September 30, 2010), available to the SecVerDate Nov 24 2008 00:32 Mar 13, 2010 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4816.IH H4816

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1 retary for obligation solely for the process for 

2 the review of abbreviated applications for ge3 neric new animal drugs (within the meanings 

4 given to such terms in section 741, as in effect 

5 on September 30, 2010). 

6 ‘‘(2) LIST OF MANDATORY APPROPRIATIONS.— 

7 The program of spending established in paragraph 

8 (1) shall be considered entitlement authority within 

9 the meaning of section 250(c)(17) of the Balanced 

10 Budget and Emergency Deficit Control Act of 1985. 

11 ‘‘SEC. 744. TERMINATION OF AUTHORITY FOR NEGOTIA12 TIONS WITH MANUFACTURERS ON USE OF 

13 FEES. 

14 ‘‘(a) IN GENERAL.—With respect to persons from 

15 whom fees related to drugs, devices, animal drugs, or ge16 neric animal drugs are collected under this Act and not17 withstanding any other provision of this Act related to the 

18 collection of such fees: 

19 ‘‘(1) On and after the date of the enactment of 

20 the Food and Drug Administration Improvement 

21 Act of 2010: 

22 ‘‘(A) The Secretary may not enter into 

23 agreements with such persons on particular 

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1 ities, performance goals, or other commitments 

2 relating to— 

3 ‘‘(i) review times for human drug ap4 plications or supplements (within the 

5 meaning given to such terms in section 

6 735, as in effect on September 30, 2010); 

7 ‘‘(ii) review times for providing advi8 sory comments on direct-to-consumer tele9 vision advertisements (within the meaning 

10 given to such terms in section 736A, as in 

11 effect on September 30, 2010); 

12 ‘‘(iii) review times for premarket ap13 plications, premarket reports, premarket 

14 notification submissions, or supplements 

15 (within the meaning given to such terms in 

16 section 737, as in effect on September 30, 

17 2010); 

18 ‘‘(iv) review times for animal drug ap19 plications or supplements (within the 

20 meaning given to such terms in section 

21 739, as in effect on September 30, 2010); 

22 or 

23 ‘‘(v) review times for abbreviated ap24 plications for a generic new animal drug or 

25 supplements thereto (within the meaning 


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1 given to such terms in section 741, as in 

2 effect on September 30, 2010). 

3 ‘‘(B) The Secretary may not otherwise ne4 gotiate understandings with such persons on 

5 particular uses of the fees. 

6 ‘‘(2) On and after October 1, 2010: 

7 ‘‘(A) Any such agreement or under8 standing that was in effect on the day before 

9 the date of the Food and Drug Administration 

10 Improvement Act of 2010 is terminated, includ11 ing agreements or understandings pursuant to 

12 letters referred to in section 502(4) of Public 

13 Law 107–188 (116 Stat. 688), section 101(3) 

14 of Public Law 107–250 (116 Stat. 1589), sec15 tion 2(3) of Public Law 108–130 (117 Stat. 

16 1361), and section 101(c) of Public Law 110– 

17 85 (121 Stat. 823). 

18 ‘‘(B) The Secretary is relieved of responsi19 bility for meeting any particular goals con20 cerning such review times that were established 

21 in such letters. 

22 ‘‘(b) RULES OF CONSTRUCTION.—Subsection (a) 

23 may not be construed— 

24 ‘‘(1) as affecting the responsibility of the Sec25 retary to work toward the general goal of adminVerDate Nov 24 2008 00:32 Mar 13, 2010 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4816.IH H4816

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1 istering this Act efficiently, including the review of 

2 applications, reports, supplements and other submis3 sions referred to in subsection (a)(1)(A); or 

4 ‘‘(2) as terminating requirements for the collec5 tion of fees under any other provision of this Act.’’. 

6 (b) APPLICABILITY.—Section 743 of the Federal 

7 Food, Drug, and Cosmetic Act, as added by subsection 

8 (a) of this section, applies with respect to fiscal year 2011 

9 and subsequent fiscal years. 

10 (c) MANAGEMENT STRATEGY TO ENSURE THE TIME11 LY REVIEW OF APPLICATIONS.— 

12 (1) IN GENERAL.—The Secretary of Health and 

13 Human Services (in this subsection referred to as 

14 the ‘‘Secretary’’) shall submit to the Committees on 

15 Appropriations and Energy and Commerce of the 

16 House of Representatives and the Committees on 

17 Appropriations and Health, Education, Labor, and 

18 Pensions of the Senate a comprehensive review of 

19 the drug and device application and amendment 

20 process to identify ways to increase efficiency, re21 duce paperwork, speed analysis, and promote the 

22 quickest possible decision process designed to ensure 

23 the entry of safe, effective drugs and devices into the 

24 marketplace. 


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1 (2) CONSIDERATIONS.—In carrying out the re2 view under paragraph (1), the Secretary shall con3 sider a time-and-motion study to identify best prac4 tices in processing applications and ensure the con5 sideration of safety issues. 

6 (3) STAFF-TO-APPLICATION RATIO.—In car7 rying out the review under paragraph (1), not later 

8 than 180 days after the date of enactment of this 

9 Act, the Secretary shall submit to the committees re10 ferred to in such paragraph recommendations on an 

11 ideal staff-to-application ratio to address safety 

12 issues without slowing the decision process. 

13 SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET 

14 DRUG, DEVICE, AND BIOLOGIC SAFETY AND 

15 EFFECTIVENESS. 

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

17 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

18 section 505D the following: 

19 ‘‘SEC. 505E. CENTER FOR POSTMARKET DRUG, DEVICE, AND 

20 BIOLOGIC SAFETY AND EFFECTIVENESS. 

21 ‘‘(a) ESTABLISHMENT.—Not later than 180 days 

22 after the date of the enactment of the Food and Drug 

23 Administration Improvement Act of 2010, the Secretary 

24 shall establish within the Food and Drug Administration 

25 a center to be known as the Center for Postmarket Drug, 


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1 Device, and Biologic Safety and Effectiveness (referred to 

2 in this section as the ‘Center’), which shall be headed by 

3 a director appointed by the Commissioner of Food and 

4 Drugs in consultation with the Secretary (without regard 

5 to the delegation to the Commissioner under section 

6 1003(d)(2)). The Center shall be established as a separate 

7 center at the organizational level immediately below the 

8 Office of the Commissioner. The Director of the Center 

9 shall report directly to the Commissioner. 

10 ‘‘(b) DUTIES.— 

11 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

12 the Director of the Center shall have the principal 

13 responsibility within the Food and Drug Administra14 tion, below the Office of the Commissioner of Food 

15 and Drugs, for assisting the Commissioner in regu16 lating approved drugs and devices. Such assistance 

17 includes the following: 

18 ‘‘(A) Monitoring approved drugs to deter19 mine whether there are any issues regarding 

20 safety or effectiveness. 

21 ‘‘(B) Administering section 502 (relating 

22 to misbranding). 

23 ‘‘(C) Establishing and administering re24 quirements for advertising under section 502(n) 

25 or 503(b). 


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1 ‘‘(D) Administering requirements for stud2 ies and clinical trials that were required as con3 ditions for the approval of applications under 

4 section 505. 

5 ‘‘(E) Withdrawing the approval of drugs 

6 under section 505(e). 

7 ‘‘(F) Administering section 505(l)(2) (re8 lating to action packages for approval). 

9 ‘‘(G) Establishing and administering re10 quirements for modifications in labeling under 

11 section 505(o)(4). 

12 ‘‘(H) Administering authorities under sec13 tions 505(p) and 505–1 (relating to risk evalua14 tion and mitigation strategies). 

15 ‘‘(I) Administering section 505(r) (relating 

16 to postmarket drug safety information for pa17 tients and providers). 

18 ‘‘(2) EXCLUSION.—The responsibility vested in 

19 the Director of the Center does not include review 

20 of any request for approval, licensure, or clearance 

21 of a new active ingredient, new indication, new dos22 age form, new dosing regimen, new route of adminis23 tration, or any other new characteristic with respect 

24 to a previously approved, licensed, or cleared drug, 

25 biological product, or device. 


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1 ‘‘(3) TRANSFERS.—Not later than 1 year after 

2 the date of the enactment of this section, the Sec3 retary shall transfer to the Center all responsibilities 

4 for the matters referred to in paragraph (1) that, on 

5 the day before the date of such transfer, were vested 

6 in the Center for Drug Evaluation and Research, the 

7 Center for Biologics Evaluation and Research, or the 

8 Center for Devices and Radiological Health Organi9 zation. 

10 ‘‘(c) INTERACTIONS WITH OTHER CENTERS.— 

11 ‘‘(1) CONSULTATION.—The Director of the 

12 Center shall carry out this section in consultation 

13 with the Directors of the Centers referred to in sub14 section (b)(3). 

15 ‘‘(2) ACCESS TO INFORMATION.—The Secretary 

16 shall ensure that the Director of the Center has full 

17 access to all information possessed by the Food and 

18 Drug Administration that relates to the safety and 

19 effectiveness of approved drugs and devices, includ20 ing information possessed by the Centers referred to 

21 in subsection (b)(3). 

22 ‘‘(d) DEFINITION.—For purposes of this section, the 

23 term ‘approved drugs and devices’ includes a drug for 

24 which an approved application under section 505 of this 

25 Act is in effect, a biological product for which a biologics 


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1 license under section 351 of the Public Health Service Act 

2 is in effect, or a device for which a clearance or approved 

3 application under section 510(k) or 515 of this Act is in 

4 effect. 

5 ‘‘(e) FUNDING.—For the purpose of carrying out this 

6 section, the Secretary shall make available for a fiscal 

7 year, from the amount appropriated for the Food and 

8 Drug Administration for such year, the following amount, 

9 as applicable to such year: 

10 ‘‘(1) For fiscal year 2011, $150,000,000. 

11 ‘‘(2) For fiscal year 2012, $175,000,000. 

12 ‘‘(3) For fiscal year 2013, $200,000,000. 

13 ‘‘(4) For fiscal year 2014, $225,000,000. 

14 ‘‘(5) For fiscal year 2015, $250,000,000.’’. 

15 SEC. 4. STATEMENT FOR INCLUSION IN DIRECT-TO-CON16 SUMER ADVERTISEMENTS OF DRUGS. 

17 (a) IN GENERAL.—Paragraph (3) of section 502(n) 

18 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 352(n)) is amended by striking ‘‘published direct-to-con20 sumer advertisements’’ and inserting ‘‘published or tele21 vised direct-to-consumer advertisements’’. 

22 (b) EFFECTIVE DATE.—The requirements of section 

23 502(n)(3) of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 352(n)(3)) applicable to televised direct-to-con25 sumer advertisements, as added by subsection (a), take 


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1 effect on the date that is 180 days after the date of the 

2 enactment of this Act. 

3 (c) REGULATIONS.—Not later than the date that is 

4 180 days after the date of the enactment of this Act, the 

5 Secretary of Health and Human Services shall promulgate 

6 final regulations to implement such requirements. 

7 SEC. 5. LIABILITY UNDER STATE AND LOCAL REQUIRE8 MENTS RESPECTING DEVICES. 

9 (a) AMENDMENT.—Section 521 of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by 

11 adding at the end the following: 

12 ‘‘(c) NO EFFECT ON LIABILITY UNDER STATE

13 LAW.—Nothing in this section shall be construed to mod14 ify or otherwise affect any action for damages or the liabil15 ity of any person under the law of any State.’’. 

16 (b) EFFECTIVE DATE; APPLICABILITY.—The amend17 ment made by subsection (a) shall— 

18 (1) take effect as if included in the enactment 

19 of the Medical Device Amendments of 1976 (Public 

20 Law 94–295); and 

21 (2) apply to any civil action pending or filed on 

22 or after the date of enactment of this Act. 

23 SEC. 6. CLARITY IN DRUG LABELING. 

24 (a) IN GENERAL.—Not later than 1 year after the 

25 date of the enactment of this Act, the Secretary of Health 


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1 and Human Services (in this section referred to as the 

2 ‘‘Secretary’’), acting through the Commissioner of Food 

3 and Drugs, shall— 

4 (1) complete a review of the Food and Drug 

5 Administration’s regulations and guidance per6 taining to the labeling of drugs and biological prod7 ucts; and 

8 (2) revise such regulations and guidance as ap9 propriate to improve the clarity and readability of 

10 such labeling. 

11 (b) APPLICABILITY.— 

12 (1) NEW PRODUCTS.—With respect to the label13 ing of any drug or biological product that is ap14 proved or licensed under section 505 of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 

16 section 351 of the Public Health Service Act (42 

17 U.S.C. 262) on or after the day that is 1 year after 

18 the date of the enactment of this Act, the revised 

19 regulations and guidance under subsection (a)(2) 

20 shall apply as of the date of such approval or licen21 sure. 

22 (2) EXISTING PRODUCTS.—With respect to any 

23 drug or biological product that was so approved or 

24 licensed before such day, the revised regulations and 


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1 guidance under subsection (a)(2) shall apply as soon 

2 as the Secretary determines practicable. 

3 SEC. 7. DISCLOSURE OF CLINICAL TRIAL ADVERSE EVENTS 

4 ON FDA WEB SITE. 

5 (a) IN GENERAL.—The Secretary of Health and 

6 Human Services, acting through the Commissioner of 

7 Food and Drugs, shall make all clinical trial adverse 

8 events included in the registry and results data bank of 

9 the National Institutes of Health publicly available on the 

10 Web site of the Food and Drug Administration. 

11 (b) DEFINITION.—In this section, the term ‘‘registry 

12 and results data bank’’ has the meaning given to such 

13 term in section 402(j)(3)(B)(i) of the Public Health Serv14 ice Act (42 U.S.C. 282(j)(3)(B)(i)). 

15 SEC. 8. PROHIBITION AGAINST PARTICIPATION BY ADVI16 SORY COMMITTEE MEMBERS WITH CON17 FLICTS OF INTEREST. 

18 Section 712 of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 379d–1) is amended— 

20 (1) in paragraph (2) of subsection (b), by strik21 ing ‘‘, so as to reduce’’ and all that follows through 

22 the end of the paragraph and inserting a period; 

23 (2) in subsection (c)— 


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1 (A) by amending the subsection heading to 

2 read as follows: ‘‘PROHIBITION; INAPPLICA3 BILITY OF WAIVERS’’; 

4 (B) in subparagraph (A) of paragraph (2), 

5 by striking ‘‘Except as provided under subpara6 graph (B), a member’’ and inserting ‘‘A mem7 ber’’; 

8 (C) by striking subparagraphs (B) and (C) 

9 of paragraph (2) and inserting the following: 

10 ‘‘(B) INAPPLICABILITY OF WAIVERS.—A 

11 member of an advisory committee under this 

12 Act may not, with respect to service on such 

13 committee, be granted a written determination 

14 as referred to in section 208(b)(1) of title 18, 

15 United States Code, or a written certification as 

16 referred to in section 208(b)(3) of title 18, 

17 United States Code.’’; and 

18 (D) by striking paragraph (3); 

19 (3) in subsection (e)— 

20 (A) in paragraph (1), by inserting ‘‘and’’ 

21 at the end; 

22 (B) by striking paragraphs (2) and (3); 

23 and 

24 (C) by redesignating paragraph (4) as 

25 paragraph (2); and 


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1 (4) by striking subsection (f). 

2 SEC. 9. FEES RELATING TO ADVERTISEMENTS FOR DRUGS 

3 AND DEVICES. 

4 Part 2 of subchapter C of chapter VII (21 U.S.C. 

5 379g et seq.) is amended by inserting after section 736A 

6 the following: 

7 ‘‘SEC. 736A–1. FEES RELATING TO ADVERTISEMENTS FOR 

8 DRUGS AND DEVICES. 

9 ‘‘(a) IN GENERAL.—Beginning with respect to fiscal 

10 year 2011, each person intending to publish or dissemi11 nate an advertisement for a drug or device during a fiscal 

12 year shall, prior to the advertisement’s initial publication 

13 or dissemination during such fiscal year, pay a fee to the 

14 Secretary in the amount established under subsection (b). 

15 ‘‘(b) FEE AMOUNTS.— 

16 ‘‘(1) TOTAL REVENUE AMOUNTS.—For each of 

17 fiscal years 2011 through 2015, the Secretary shall 

18 establish fees under subsection (a) to generate a 

19 total revenue amount equal to $4,000,000, except 

20 that such amount shall be adjusted for each of fiscal 

21 years 2012 through 2015 to reflect inflation. 

22 ‘‘(2) FEE SETTING.—The Secretary shall— 

23 ‘‘(A) set the amount of fees to be assessed 

24 and collected under this section before the start 

25 of the relevant fiscal year; 


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1 ‘‘(B) make such fees payable with respect 

2 to each distinct advertisement for a drug or de3 vice to be published or disseminated during the 

4 fiscal year; and 

5 ‘‘(C) set the amount of such fees without 

6 regard to the number of times on which the ad7 vertisement is so published or disseminated. 

8 ‘‘(3) LIMIT.—Notwithstanding paragraph (1), 

9 the fees under this section shall be retained in each 

10 fiscal year in an amount not to exceed the total costs 

11 for such fiscal year for the regulation of advertise12 ments for drugs and devices. 

13 ‘‘(c) DEFINITION.—In this section: 

14 ‘‘(1) The term ‘advertisement’ shall be defined 

15 by the Secretary. 

16 ‘‘(2) The term ‘regulation of advertisements for 

17 drugs and devices’— 

18 ‘‘(A) means any regulation of advertise19 ments for drugs and devices by the Food and 

20 Drug Administration under this Act; and 

21 ‘‘(B) notwithstanding subparagraph (A), 

22 excludes activities for which fees are assessed 

23 and collected under section 736A (relating to 

24 the process for the advisory review of prescrip25 tion drug advertising). 


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1 ‘‘(d) COLLECTIONS AND APPROPRIATION ACTS.— 

2 ‘‘(1) IN GENERAL.—The fees authorized by this 

3 section— 

4 ‘‘(A) notwithstanding subsection (b)(1), 

5 shall be retained in each fiscal year in an 

6 amount not to exceed the amount specified in 

7 appropriation Acts, or otherwise made available 

8 for obligation, for such fiscal year; and 

9 ‘‘(B) shall only be collected and available 

10 to defray the costs for such fiscal year for the 

11 regulation of advertisements of drugs and de12 vices. 

13 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

14 For each of fiscal years 2011 through 2015, there 

15 is authorized to be appropriated for the assessment, 

16 collection, and use of fees under this section an 

17 amount equal to the total revenue amount deter18 mined under subsection (b) for the fiscal year.’’. 

19 SEC. 10. CERTAIN USES OF APPROVED DRUGS. 

20 Chapter X of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

22 end the following: 


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1 ‘‘SEC. 1011. REQUIREMENT REGARDING INFORMED CON2 SENT FOR CERTAIN TREATMENTS. 

3 ‘‘With respect to the prescribing of a drug for a use 

4 not included in the approved labeling for the drug under 

5 section 505 or under section 351 of the Public Health 

6 Service Act, the Secretary shall promulgate regulations re7 quiring that, before prescribing the drug— 

8 ‘‘(1) the physician inform the patient that the 

9 use for which the physician intends to prescribe the 

10 drug has not been approved by the Food and Drug 

11 Administration; and 

12 ‘‘(2) the physician obtain from the patient an 

13 acknowledgment of such fact and the consent of the 

14 patient to use the drug for such use notwithstanding 

15 such fact.’’. 

Æ 


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