II

105TH CONGRESS

2D SESSION S. 2015

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

and Cosmetic Act to provide incentives for the development of drugs

for the treatment of addiction to illegal drugs, and for other purposes.

IN THE SENATE OF THE UNITED STATES

APRIL 30, 1998

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 Public Health Service Act and the Federal

Food, Drug, and Cosmetic Act to provide incentives for

the development of drugs for the treatment of 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 ‘‘New Medications to

5 Treat Addiction Act of 1998’’.
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1 TITLE I—PHARMACOTHERAPY

2 RESEARCH

3 SEC. 101. REAUTHORIZATION FOR MEDICATION DEVELOP4 MENT PROGRAM.

5 Section 464P(e) of the Public Health Service Act (42

6 U.S.C. 285o–4(e)) is amended to read as follows:

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

8 is authorized to be appropriated to carry out this section

9 such sums as may be necessary for each of the fiscal years

10 1999 through 2001 of which the following amount may

11 be appropriated from the Violent Crime Reduction Trust

12 Fund:

13 ‘‘(1) $100,000,000 for fiscal year 2000; and

14 ‘‘(2) $100,000,000 for fiscal year 2001.’’.

15 TITLE II—PATENT PROTECTIONS

16 FOR PHARMACOTHERAPIES

17 SEC. 201. RECOMMENDATION FOR INVESTIGATION OF

18 DRUGS.

19 Section 525(a) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 360aa(a)) is amended—

21 (1) in the first sentence, by striking ‘‘States’’

22 and inserting ‘‘States, or for treatment of an addic23 tion to illegal drugs,’’;
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1 (2) in the second sentence, by striking ‘‘States’’

2 and inserting ‘‘States, or for treatment of an addic3 tion to illegal drugs’’; and

4 (3) by striking ‘‘such disease or condition’’ each

5 place it appears and inserting ‘‘such disease or con6 dition, or treatment of such addiction,’’.

7 SEC. 202. DESIGNATION OF DRUGS.

8 Section 526(a) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 360bb(a)) is amended—

10 (1) in paragraph (1)—

11 (A) by inserting before the period in the

12 first sentence the following: ‘‘, or for treatment

13 of an addiction to illegal drugs’’;

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

15 disease or condition’’ and inserting ‘‘rare dis16 ease or condition, or for treatment of an addic17 tion to illegal drugs,’’;

18 (C) by striking ‘‘such disease or condi19 tion,’’ and inserting ‘‘such disease or condition,

20 or treatment of such addiction,’’; and

21 (D) by striking ‘‘such disease or condi22 tion.’’ and inserting ‘‘such disease or condition,

23 or treatment of such addiction.’’; and

24 (2) in paragraph (2)—
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1 (A) by striking ‘‘(2) For’’ and inserting

2 ‘‘(2)(A) For’’;

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

4 ‘‘(i) affects’’;

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

6 ‘‘(ii) affects’’; and

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

8 ‘‘(B) For purposes of this subchapter, the term

9 ‘treatment of an addiction to illegal drugs’ means treat10 ment by any pharmacological agent or medication that—

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

12 an individual who—

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

14 manner that endangers the public health, safe15 ty, or welfare; or

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

17 drug that the individual is not able to control

18 the addiction through the exercise of self-con19 trol;

20 ‘‘(ii) blocks the behavioral and physiological ef21 fects of an illegal drug for an individual described in

22 clause (i);

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

24 the treatment of abuse of an illegal drug for an indi25 vidual described in clause (i);
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1 ‘‘(iv) moderates or eliminates the process of

2 withdrawal from an illegal drug for an individual de3 scribed in clause (i);

4 ‘‘(v) blocks or reverses the toxic effect of an il5 legal drug on an individual described in clause (i);

6 or

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

8 abuse of an illegal drug in individuals at high risk.

9 ‘‘(C) The term ‘illegal drug’ means a controlled sub10 stance identified under schedules I, II, III, IV, and V in

11 section 202(c) of the Controlled Substances Act (21

12 U.S.C. 812(c)).’’.

13 SEC. 203. PROTECTION FOR DRUGS.

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

15 Act (21 U.S.C. 360cc) is amended—

16 (1) in subsection (a), by striking ‘‘rare disease

17 or condition,’’ and inserting ‘‘rare disease or condi18 tion, or for treatment of an addiction to illegal

19 drugs,’’;

20 (2) in subsection (b), by striking ‘‘rare disease

21 or condition’’ and inserting ‘‘rare disease or condi22 tion, or for treatment of an addiction to illegal

23 drugs,’’;
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1 (3) by striking ‘‘such disease or condition’’ each

2 place it appears and inserting ‘‘such disease or con3 dition, or treatment of such addiction,’’; and

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

7 SEC. 204. 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’’.

17 SEC. 205. CONFORMING AMENDMENTS.

18 (a) SUBCHAPTER HEADING.—The subchapter head19 ing of subchapter B of chapter V of the Federal Food,

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

21 amended by striking ‘‘CONDITIONS’’ and inserting ‘‘CON22 DITIONS, OR FOR TREATMENT OF AN ADDICTION’’.

23 (b) SECTION HEADINGS.—The section heading of

24 sections 525 through 528 of the Federal Food, Drug, and

25 Cosmetic Act (21 U.S.C. 360aa through 360dd) are
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1 amended by striking ‘‘CONDITIONS’’ and inserting ‘‘CONDI2 TIONS, OR FOR TREATMENT OF AN ADDICTION’’.

3 (c) FEES.—Section 736(a)(1)(E) of the Federal

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)(E))

5 is amended—

6 (1) in the subparagraph heading, by striking

7 ‘‘ORPHAN’’;

8 (2) by striking ‘‘for a rare disease or condition’’

9 each place it appears and inserting ‘‘for a rare dis10 ease or condition, or for treatment of an addiction

11 to illegal drugs,’’; and

12 (3) in the first sentence, by striking ‘‘rare dis13 ease or condition.’’ and inserting ‘‘rare disease or

14 condition, or other than for treatment of an addic15 tion to illegal drugs, respectively.’’.

16 TITLE III—ENCOURAGING PRI17 VATE SECTOR DEVELOPMENT

18 OF PHARMACOTHERAPIES

19 SEC. 301. DEVELOPMENT, MANUFACTURE, AND PROCURE20 MENT OF DRUGS FOR THE TREATMENT OF

21 ADDICTION TO ILLEGAL DRUGS.

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

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

24 end the following:
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1 ‘‘Subchapter F—Drugs for Cocaine and

2 Heroin Addictions

3 ‘‘SEC. 571. CRITERIA FOR AN ACCEPTABLE DRUG TREAT4 MENT FOR COCAINE AND HEROIN ADDIC5 TIONS.

6 ‘‘(a) IN GENERAL.—Subject to subsections (b) and

7 (c), the Secretary shall, in cooperation with the Institute

8 of Medicine of the National Academy of Sciences, establish

9 criteria for an acceptable drug for the treatment of an ad10 diction to cocaine and for an acceptable drug for the treat11 ment of an addiction to heroin. The criteria shall be used

12 by the Secretary in making a contract, or entering into

13 a licensing agreement, under section 572.

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

15 under subsection (a) for a drug shall include require16 ments—

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

18 treatment of addiction to cocaine or heroin was filed

19 and approved by the Secretary under this Act after

20 the date of enactment of this section;

21 ‘‘(2) that a performance based test on the

22 drug—

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

24 of a randomly selected test group that received

25 the drug as a treatment and a randomly se-
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1 lected control group that received a placebo;

2 and

3 ‘‘(B) has compared the long term dif4 ferences in the addiction levels of control group

5 participants and test group participants;

6 ‘‘(3) that the performance based test conducted

7 under paragraph (2) demonstrates that the drug is

8 effective through evidence that—

9 ‘‘(A) a significant number of the partici10 pants in the test who have an addiction to co11 caine or heroin are willing to take the drug for

12 the addiction;

13 ‘‘(B) a significant number of the partici14 pants in the test who have an addiction to co15 caine or heroin and who were provided the drug

16 for the addiction during the test are willing to

17 continue taking the drug as long as necessary

18 for the treatment of the addiction; and

19 ‘‘(C) a significant number of the partici20 pants in the test who were provided the drug

21 for the period of time required for the treat22 ment of the addiction refrained from the use of

23 cocaine or heroin, after the date of the initial

24 administration of the drug on the participants,

25 for a significantly longer period than the aver-
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1 age period of refraining from such use under

2 currently available treatments (as of the date of

3 the application described in paragraph (1)); and

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

5 of production.

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

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

8 publication and application of such criteria, be submitted

9 for review to the Committee on the Judiciary, and the

10 Committee on Education and the Workplace, of the House

11 of Representatives, and the Committee on the Judiciary,

12 and the Committee on Labor and Human Resources, of

13 the Senate. Not later than 90 days after notifying each

14 of the committees, the Secretary shall publish the criteria

15 in the Federal Register.

16 ‘‘SEC. 572. PURCHASE OF PATENT RIGHTS FOR DRUG DE17 VELOPMENT.

18 ‘‘(a) APPLICATION.—

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

20 to treat an addiction to cocaine or heroin, may sub21 mit an application to the Secretary—

22 ‘‘(A) to enter into a contract with the Sec23 retary to sell to the Secretary the patent rights

24 of the owner relating to the drug; or
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1 ‘‘(B) in the case in which the drug is ap2 proved under section 505 by the Secretary for

3 more than 1 indication, to enter into an exclu4 sive licensing agreement with the Secretary for

5 the manufacture and distribution of the drug to

6 treat an addiction to cocaine or heroin.

7 ‘‘(2) REQUIREMENTS.—An application de8 scribed in paragraph (1) shall be submitted at such

9 time and in such manner, and accompanied by such

10 information, as the Secretary may require.

11 ‘‘(b) CONTRACT AND LICENSING AGREEMENTS.—

12 ‘‘(1) REQUIREMENTS.—The Secretary may

13 enter into a contract or a licensing agreement de14 scribed in subsection (a) with a patent owner who

15 has submitted an application in accordance with

16 subsection (a) if the drug covered under the contract

17 or licensing agreement meets the criteria established

18 by the Secretary under section 551(a).

19 ‘‘(2) SPECIAL RULE.—The Secretary may,

20 under paragraph (1), enter into—

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

22 licensing agreement relating to a drug for the

23 treatment of an addiction to cocaine; and
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1 ‘‘(B) not more than 1 contract or licensing

2 agreement relating to a drug for the treatment

3 of an addiction to heroin.

4 ‘‘(3) COVERAGE.—A contract or licensing

5 agreement described in subparagraph (A) or (B) of

6 paragraph (2) shall cover not more than 1 drug.

7 ‘‘(4) PURCHASE AMOUNT.—Subject to amounts

8 provided in advance in appropriations Acts—

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

10 owner who has entered into a contract or licens11 ing agreement under this subsection relating to

12 a drug to treat an addiction to cocaine shall not

13 exceed $100,000,000; and

14 ‘‘(B) 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 heroin shall not

18 exceed $50,000,000.

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

20 LICENSING AGREEMENT.—

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

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

23 drug to treat cocaine or heroin addiction shall trans24 fer to the Secretary—
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1 ‘‘(A) the exclusive right to make, use, or

2 sell the patented drug within the United States

3 for the term of the patent;

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

5 patent owner with respect to the drug;

6 ‘‘(C) any patent rights relating to the proc7 ess of manufacturing the drug; and

8 ‘‘(D) any trade secret or confidential busi9 ness information relating to the development of

10 the drug, process for manufacturing the drug,

11 and therapeutic effects of the drug.

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

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

14 exclusive license relating to manufacture and dis15 tribution of a drug to treat an addiction to cocaine

16 or heroin shall transfer to the Secretary—

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

18 sell the patented drug for the purpose of treat19 ing an addiction to cocaine or heroin within the

20 United States for the term of the patent;

21 ‘‘(B) the right to use any patented proc22 esses relating to manufacturing the drug; and

23 ‘‘(C) any trade secret or confidential busi24 ness information relating to the development of

25 the drug, process for manufacturing the drug,
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1 and therapeutic effects of the drug relating to

2 use of the drug to treat an addiction to cocaine

3 or heroin.

4 ‘‘SEC. 573. PLAN FOR MANUFACTURE AND DEVELOPMENT.

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

6 date on which the Secretary purchases the patent rights

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

8 with a patent owner, under section 572, relating to a drug

9 under section 571, the Secretary shall develop a plan for

10 the manufacture and distribution of the drug.

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

12 forth—

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

14 licensing agreements with private entities for the

15 manufacture and the distribution of the drug;

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

17 to nonprofit entities and private entities to use in

18 the treatment of a cocaine or heroin addiction;

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

20 drug; and

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

22 use of Federal funds by State and local governments

23 or nonprofit entities to purchase the drug from the

24 Secretary.
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1 ‘‘(c) APPLICABILITY OF PROCUREMENT AND LICENS2 ING LAWS.—Federal law relating to procurements and li3 censing agreements by the Federal Government shall be

4 applicable to procurements and licenses covered under the

5 plan described in subsection (a).

6 ‘‘(d) REVIEW OF PLAN.—

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

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

9 the Committee on the Judiciary, and the Committee

10 on Education and the Workplace, of the House of

11 Representatives, and the Committee on the Judici12 ary, and the Committee on Labor and Human Re13 sources, of the Senate, of the development of the

14 plan and publish the plan in the Federal Register.

15 The Secretary shall provide an opportunity for pub16 lic comment on the plan for a period of not more

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

18 plan in the Federal Register.

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

20 after the date of the expiration of the comment pe21 riod described in paragraph (1), the Secretary shall

22 publish in the Federal Register a final plan de23 scribed in subsection (a). The implementation of the

24 plan shall begin on the date of the publication of the

25 final plan.
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1 ‘‘(e) CONSTRUCTION.—The development, publication,

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

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

4 action subject to judicial review. No official or court of

5 the United States shall have power or jurisdiction to re6 view the decision of the Secretary on any question of law

7 or fact relating to any agency action with respect to the

8 plan.

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

10 regulations to carry out this section.

11 ‘‘SEC. 574. AUTHORIZATION OF APPROPRIATIONS.

12 ‘‘There is authorized to be appropriated to carry out

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

14 of the fiscal years 1999 through 2001.’’.

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