II

104TH CONGRESS

2D SESSION S. 2051

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

development of drugs to treat an addiction to illegal drugs, and for

other purposes.

IN THE SENATE OF THE UNITED STATES

SEPTEMBER 3, 1996

Mr. BIDEN introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

A BILL

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

provide for the development of drugs to treat an addiction to illegal drugs, and for other purposes.

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

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Pharmacotherapy De5 velopment Act of 1996’’.
2

•S 2051 IS

1 TITLE I—DEVELOPMENT OF

2 DRUGS FOR THE TREATMENT

3 OF ADDICTIONS TO ILLEGAL

4 DRUGS

5 SEC. 101. RECOMMENDATION FOR INVESTIGATION OF

6 DRUGS.

7 Section 525(a) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 360aa(a)) is amended—

9 (1) by striking ‘‘States’’ each place it appears

10 and inserting ‘‘States, or for treatment of an addic11 tion to illegal drugs’’; and

12 (2) by striking ‘‘such disease or condition’’ each

13 place it appears and inserting ‘‘such disease, condi14 tion, or treatment of such addiction’’.

15 SEC. 102. DESIGNATION OF DRUGS.

16 Section 526(a) of the Federal, Food, Drug, and Cos17 metic Act (21 U.S.C. 360bb(a)) is amended—

18 (1) in paragraph (1)—

19 (A) by inserting before the period in the

20 first sentence the following: ‘‘or for treatment

21 of an addiction to illegal drugs’’;

22 (B) in the third sentence, by striking ‘‘rare

23 disease or condition’’ and inserting ‘‘rare dis24 ease or condition, or for treatment of an addic25 tion to illegal drugs,’’; and
3

•S 2051 IS

1 (C) by striking ‘‘such disease or condition’’

2 each place it appears and inserting ‘‘such dis3 ease, condition, or treatment of such addic4 tion’’; and

5 (2) in paragraph (2)—

6 (A) by striking ‘‘(2) For’’ and inserting

7 ‘‘(2)(A) For’’;

8 (B) by striking ‘‘(A) affects’’ and inserting

9 ‘‘(i) affects’’;

10 (C) by striking ‘‘(B) affects’’ and inserting

11 ‘‘(ii) affects’’; and

12 (D) by adding at the end thereof the fol13 lowing new subparagraphs:

14 ‘‘(B) The term ‘treatment of an addiction to illegal

15 drugs’ means any pharmacological agent or medication

16 that—

17 ‘‘(i) reduces the craving for an illegal drug for

18 an individual who—

19 ‘‘(I) habitually uses the illegal drug in a

20 manner that endangers the public health, safe21 ty, or welfare; or

22 ‘‘(II) is so addicted to the use of the illegal

23 drug that the individual is not able to control

24 the addiction through the exercise of self-con25 trol;
4

•S 2051 IS

1 ‘‘(ii) blocks the behavioral and physiological ef2 fects of an illegal drug for an individual described in

3 clause (i);

4 ‘‘(iii) safely serves as a replacement therapy for

5 the treatment of drug abuse for an individual de6 scribed in clause (i);

7 ‘‘(iv) moderates or eliminates the process of

8 withdrawal for an individual described in clause (i);

9 ‘‘(v) blocks or reverses the toxic effect of an il10 legal drug on an individual described in clause (i);

11 or

12 ‘‘(vi) prevents, where possible, the initiation of

13 drug abuse in individuals at high risk.

14 ‘‘(C) The term ‘illegal drug’ means a controlled sub15 stance identified under schedules I, II, III, IV, and V in

16 section 202(c) of the Controlled Substance Act (21 U.S.C.

17 812(c)).’’.

18 SEC. 103. PROTECTION FOR DRUGS.

19 Section 527 of the Federal Food, Drug, and Cosmetic

20 Act (21 U.S.C. 360cc) is amended—

21 (1) by striking ‘‘rare disease or condition’’ each

22 place it appears and inserting ‘‘rare disease or con23 dition or for treatment of an addiction to illegal

24 drugs’’;
5

•S 2051 IS

1 (2) by striking ‘‘such disease or condition’’ each

2 place it appears and inserting ‘‘such disease, condi3 tion, or treatment of the addiction’’; and

4 (3) in subsection (b)(1), by striking ‘‘the dis5 ease or condition’’ and inserting ‘‘the disease, condi6 tion, or addiction’’.

7 SEC. 104. OPEN PROTOCOLS FOR INVESTIGATIONS OF

8 DRUGS.

9 Section 528 of the Federal Food, Drug, and Cosmetic

10 Act (21 U.S.C. 360dd) is amended—

11 (1) by striking ‘‘rare disease or condition’’ and

12 inserting ‘‘rare disease or condition or for treatment

13 of an addiction to illegal drugs’’; and

14 (2) by striking ‘‘the disease or condition’’ each

15 place it appears and inserting ‘‘the disease, condi16 tion, or addiction’’.
6

•S 2051 IS

1 TITLE II—DEVELOPMENT, MANU2 FACTURE, AND PROCURE3 MENT OF DRUGS FOR THE

4 ADDICTION OF COCAINE AND

5 HEROIN ADDICTIONS

6 SEC. 201. DEVELOPMENT, MANUFACTURE, AND PROCURE7 MENT OF DRUGS FOR THE TREATMENT OF

8 ADDICTIONS TO ILLEGAL DRUGS.

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

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

11 end thereof the following new subchapter:

12 ‘‘Subchapter D—Drugs for Cocaine and

13 Heroin Addictions

14 ‘‘SEC. 551. CRITERIA FOR AN ACCEPTABLE DRUG TREAT15 MENT FOR COCAINE AND HEROIN ADDIC16 TIONS.

17 ‘‘(a) IN GENERAL.—Subject to the provisions of sub18 sections (b) and (c), the Secretary shall, through the Insti19 tute of Medicine of the National Academy of Sciences, es20 tablish criteria for an acceptable drug for the treatment

21 of an addiction to cocaine and for an acceptable drug for

22 the treatment of an addiction to heroin. The criteria shall

23 be used by the Secretary in making a contract, or entering

24 to a licensing agreement, under section 552.
7

•S 2051 IS

1 ‘‘(b) REQUIREMENTS.—The criteria established

2 under subsection (a) for a drug shall include require3 ments—

4 ‘‘(1) that the application to use the drug for the

5 treatment of addiction to cocaine or heroin was filed

6 and approved by the Secretary under this Act after

7 the date of enactment of this section;

8 ‘‘(2) that a performance-based test on the

9 drug—

10 ‘‘(A) has been conducted through the use

11 of a randomly selected test group that received

12 the drug as a treatment and a randomly se13 lected control group that received a placebo;

14 and

15 ‘‘(B) has compared the long-term dif16 ferences in the addiction levels of control group

17 participants and test group participants;

18 ‘‘(3) that the performance-based test conducted

19 under paragraph (2) demonstrates that the drug is

20 effective through evidence that—

21 ‘‘(A) a significant number of the partici22 pants in the test who have an addiction to co23 caine or heroin are willing to take the drug for

24 the addiction;
8

•S 2051 IS

1 ‘‘(B) a significant number of the partici2 pants in the test who have an addiction to co3 caine or heroin and who were provided the drug

4 for the addiction during the test are willing to

5 continue taking the drug as long as necessary

6 for the treatment of the addiction; and

7 ‘‘(C) a significant number of the partici8 pants in the test who were provided the drug

9 for the period of time required for the treat10 ment of the addiction refrained from the use of

11 cocaine or heroin for a period of 3 years after

12 the date of the initial administration of the

13 drug on the participants; and

14 ‘‘(4) that the drug shall have a reasonable cost

15 of production.

16 ‘‘(c) REVIEW AND PUBLICATION OF CRITERIA.—The

17 criteria established under subsection (a) shall, prior to the

18 publication and application of such criteria, be submitted

19 for review to the Committee on the Judiciary and the

20 Committee on Economic and Educational Opportunities of

21 the House of Representatives, and the Committee on the

22 Judiciary and the Committee on Labor and Human Re23 sources of the Senate. Not later than 90 days after notify24 ing each of the committees, the Secretary shall publish the

25 criteria in the Federal Register.
9

•S 2051 IS

1 ‘‘SEC. 552. PURCHASE OF PATENT RIGHTS FOR DRUG DE2 VELOPMENT.

3 ‘‘(a) APPLICATION.—

4 ‘‘(1) IN GENERAL.—The patent owner of a drug

5 to treat an addiction to cocaine or heroin, may sub6 mit an application to the Secretary—

7 ‘‘(A) to enter into a contract with the Sec8 retary to sell to the Secretary the patent rights

9 of the owner relating to the drug; or

10 ‘‘(B) in the case in which the drug is ap11 proved by the Secretary for more than 1 indica12 tion, to enter into an exclusive licensing agree13 ment with the Secretary for the manufacture

14 and distribution of the drug to treat an addic15 tion to cocaine or heroin.

16 ‘‘(2) REQUIREMENTS.—An application de17 scribed in paragraph (1) shall be submitted at such

18 time and in such manner, and accompanied by such

19 information, as the Secretary may require.

20 ‘‘(b) CONTRACT AND LICENSING AGREEMENT.—

21 ‘‘(1) REQUIREMENTS.—The Secretary shall

22 enter into a contract or a licensing agreement with

23 a patent owner who has submitted an application in

24 accordance with (a) if the drug covered under the

25 contract or licensing agreement meets the criteria

26 established by the Secretary under section 551(a).
10

•S 2051 IS

1 ‘‘(2) SPECIAL RULE.—The Secretary shall enter

2 into—

3 ‘‘(A) not more than 1 contract or exclusive

4 licensing agreement relating to a drug for the

5 treatment of an addiction to cocaine; and

6 ‘‘(B) not more than 1 contract or licensing

7 agreement relating to a drug for the treatment

8 of an addiction to heroin.

9 A contract or licensing agreement described in sub10 paragraph (A) or (B) shall cover not more than 1

11 drug.

12 ‘‘(3) PURCHASE AMOUNT.—Subject to appro13 priations—

14 ‘‘(A) the amount to be paid to a patent

15 owner who has entered into a contract or licens16 ing agreement under this subsection relating to

17 a drug to treat an addiction to cocaine shall be

18 $100,000,000; and

19 ‘‘(B) the amount to be paid to a patent

20 owner who has entered into a contract or licens21 ing agreement under this subsection relating to

22 a drug to treat an addiction to heroin shall be

23 $50,000,000.

24 ‘‘(c) TRANSFER OF RIGHTS UNDER CONTRACTS AND

25 LICENSING AGREEMENT.—
11

•S 2051 IS

1 ‘‘(1) CONTRACTS.—A contract under subsection

2 (b)(1) to purchase the patent rights relating to a

3 drug to treat cocaine or heroin addiction shall trans4 fer to the Secretary—

5 ‘‘(A) the exclusive right to make, use, or

6 sell the patented drug within the United States

7 for the term of the patent;

8 ‘‘(B) any foreign patent rights held by the

9 patent owner;

10 ‘‘(C) any patent rights relating to the proc11 ess of manufacturing the drug; and

12 ‘‘(D) any trade secret or confidential busi13 ness information relating to the development of

14 the drug, process for manufacturing the drug,

15 and therapeutic effects of the drug.

16 ‘‘(2) LICENSING AGREEMENTS.—A licensing

17 agreement under subsection (b)(1) to purchase an

18 exclusive license relating to manufacture and dis19 tribution of a drug to treat an addiction to cocaine

20 or heroin shall transfer to the Secretary—

21 ‘‘(A) the exclusive right to make, use, or

22 sell the patented drug for the purpose of treat23 ing an addiction to cocaine or heroin within the

24 United States for the term of the patent;
12

•S 2051 IS

1 ‘‘(B) the right to use any patented proc2 esses relating to manufacturing the drug; and

3 ‘‘(C) any trade secret or confidential busi4 ness information relating to the development of

5 the drug, process for manufacturing the drug,

6 and therapeutic effects of the drug relating to

7 use of the drug to treat an addiction to cocaine

8 or heroin.

9 ‘‘SEC. 553. PLAN FOR MANUFACTURE AND DEVELOPMENT.

10 ‘‘(a) IN GENERAL.—Not later than 90 days after the

11 date on which the Secretary purchases the patent rights

12 of a patent owner, or enters into a licensing agreement

13 with a patent owner, relating to a drug under section 551,

14 the Secretary shall develop a plan for the manufacture and

15 distribution of the drug.

16 ‘‘(b) PLAN REQUIREMENTS.—The plan shall set

17 forth—

18 ‘‘(1) procedures for the Secretary to enter into

19 licensing agreements with private entities for the

20 manufacture and the distribution of the drug;

21 ‘‘(2) procedures for making the drug available

22 to nonprofit entities and private entities to use in

23 the treatment of a cocaine or heroin addiction;

24 ‘‘(3) a system to establish the sale price for the

25 drug; and
13

•S 2051 IS

1 ‘‘(4) policies and procedures with respect to the

2 use of Federal funds by State and local governments

3 or nonprofit entities to purchase the drug from the

4 Secretary.

5 ‘‘(c) APPLICABILITY OF PROCUREMENT AND LICENS6 ING LAWS.—The procurement and licensing laws of the

7 United States shall be applicable to procurements and li8 censes covered under the plan described in subsection (a).

9 ‘‘(d) REVIEW OF PLAN.—

10 ‘‘(1) IN GENERAL.—Upon completion of the

11 plan under subsection (a), the Secretary shall notify

12 the Committee on the Judiciary and the Committee

13 on Economic and Educational Opportunities of the

14 House of Representatives, and the Committee on the

15 Judiciary and the Committee on Labor and Human

16 Resources of the Senate, of the development of the

17 plan and publish the plan in the Federal Register.

18 The Secretary shall provide an opportunity for pub19 lic comment on the plan for a period of not more

20 than 30 days after the date of the publication of the

21 plan in the Federal Register.

22 ‘‘(2) FINAL PLAN.—Not later than 60 days

23 after the date of the expiration of the comment pe24 riod described in paragraph (1), the Secretary shall

25 publish in the Federal Register a final plan. The im-
14

•S 2051 IS

1 plementation of the plan shall begin on the date of

2 the final publication of the plan.

3 ‘‘(e) CONSTRUCTION.—The development, publication,

4 or implementation of the plan, or any other agency action

5 with respect to the plan, shall not be considered agency

6 action subject to judicial review.

7 ‘‘(f) REGULATIONS.—The Secretary may promulgate

8 regulations to carry out this section.

9 ‘‘SEC. 554. AUTHORIZATION OF APPROPRIATIONS.

10 ‘‘There are authorized to be appropriated to carry out

11 this subchapter, such sums as may be necessary in each

12 of the fiscal years 1997 through 1999.’’.

Æ