II

105TH CONGRESS

2D SESSION S. 2026

To require the Commissioner of Food and Drugs to conduct assessments

and take other actions relating to the transition from use of

chlorofluorocarbons in metered-dose inhalers, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MAY 1, 1998

Mr. DEWINE (for himself and Mr. HUTCHINSON) introduced the following bill;

which was read twice and referred to the Committee on Labor and

Human Resources

A BILL

To require the Commissioner of Food and Drugs to conduct

assessments and take other actions relating to the transition from use of chlorofluorocarbons in metered-dose inhalers, 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 ‘‘Asthma Inhaler Pro5 tection Act’’.
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1 SEC. 2. ASSESSMENTS RELATED TO TRANSITION FROM USE

2 OF CHLOROFLUOROCARBONS IN METERED3 DOSE INHALERS.

4 (a) ASSESSMENTS.—Before beginning rulemaking to

5 issue a regulation described in section 3(a), the Commis6 sioner of Food and Drugs (referred to in this Act as the

7 ‘‘Commissioner’’) shall conduct the following assessments

8 concerning the transition from use of chlorofluorocarbons

9 in metered-dose inhalers:

10 (1) An assessment of the health risks and bene11 fits of the regulatory approach set forth in the ad12 vance notice of proposed rulemaking entitled

13 ‘‘Chlorofluorocarbon Propellants in Self-Pressurized

14 Containers; Determinations That Uses Are No

15 Longer Essential; Request for Comments’’, pub16 lished in the Federal Register on March 6, 1997, 62

17 Fed. Reg. 10242, and the health risks and benefits

18 of alternative policies for facilitating the transition

19 to non-chlorofluorocarbon treatments for asthma

20 and other respiratory diseases.

21 (2) An assessment of the environmental risks

22 and benefits of the regulatory approach set forth in

23 the notice described in paragraph (1), and the envi24 ronmental risks and benefits of alternative policies

25 for facilitating the transition to non-
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1 chlorofluorocarbon treatments for asthma and other

2 respiratory diseases.

3 (3) An assessment of whether measures and

4 recommendations adopted by the Tenth Meeting of

5 the Parties to the Montreal Protocol on Substances

6 That Deplete the Ozone Layer will, when imple7 mented in the United States, facilitate the transition

8 in the United States to non-chlorofluorocarbon treat9 ments for asthma and other respiratory diseases by

10 2005 without increasing the health risks to patients

11 of such diseases.

12 (b) BASIS FOR ASSESSMENTS.—

13 (1) HEALTH RISKS AND BENEFITS.—The Com14 missioner shall base the assessment described in

15 subsection (a)(1) on factors including extensive con16 sultations with patients, physicians, other health

17 care providers, manufacturers of metered-dose inhal18 ers, and other interested parties.

19 (2) ENVIRONMENTAL RISKS AND BENEFITS.—

20 The Commissioner shall conduct the assessment de21 scribed in subsection (a)(2) in a manner consistent

22 with section 102(2) of the National Environmental

23 Policy Act of 1969 (42 U.S.C. 4332(2)), and parts

24 10, 20, 25, 71 , 101, 170, 171, 312, 314, 511, 514,

25 570, 571, 601, 812, and 814 of title 21, Code of
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1 Federal Regulations. In conducting such assessment,

2 the Commissioner shall consult with the Adminis3 trator of the Environmental Protection Agency, the

4 Administrator of the National Oceanic and Atmos5 pheric Administration, and the Administrator of the

6 National Aeronautics and Space Administration, as

7 appropriate.

8 (c) REPORTS.—The Commissioner shall prepare and

9 submit to Congress a report for each assessment and shall

10 publish the reports in the Federal Register.

11 SEC. 3. RULEMAKING ON CHLOROFLUOROCARBONS IN ME12 TERED-DOSE INHALERS.

13 (a) REGULATION.—After completing the duties de14 scribed in section 2, the Commissioner shall issue a regula15 tion setting forth criteria for determining whether and in

16 what cases particular chlorofluorocarbon metered-dose in17 halers are necessary for purposes of eligibility for class

18 I allowances under section 604(d) of the Clean Air Act

19 (42 U.S.C. 7671c(d)) and, as a result, represent essential

20 uses of class I substances under title VI of the Clean Air

21 Act (42 U.S.C. 7671 et seq.).

22 (b) ALTERNATIVES.—The criteria described in sec23 tion 3(a) shall ensure that a range of non24 chlorofluorocarbon inhaler alternatives are available for

25 each active moiety, to the extent consistent with title 35,
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1 United States Code, and section 505 of the Federal Food,

2 Drug, and Cosmetic Act (21 U.S.C. 355), and that such

3 alternatives are, for all populations of users, comparable

4 to existing treatments (in existence on the date of issuance

5 of the regulation) in terms of safety and effectiveness, use

6 for therapeutic indications, dosage strength, delivery sys7 tem, and sufficient availability to meet consumer needs.

8 (c) LIMITATIONS.—The criteria described in section

9 3(a) shall not utilize a therapeutic class approach. If a

10 determination described in subsection (a) results in the

11 withdrawal of a class I allowance for use of a

12 chlorofluorocarbon in a type of inhaler, inhalers of the

13 type involved that were introduced into interstate com14 merce prior to the date of the determination shall not be

15 considered to be adulterated or misbranded under the

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321

17 et seq.) solely on the basis of the withdrawal.

18 SEC. 4. APPROVALS OF NEW MEDICAL PRODUCTS CON19 TAINING CHLOROFLUOROCARBONS.

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

21 Act is amended by inserting after section 505A (21 U.S.C.

22 355a) the following:
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1 ‘‘SEC. 505B. APPROVALS OF NEW DRUGS CONTAINING

2 CHLOROFLUOROCARBONS.

3 ‘‘(a) PRELIMINARY ASSESSMENTS AND TERMI4 NATIONS OF REVIEW.—Notwithstanding any other provi5 sion of this Act, with respect to any application submitted

6 to the Secretary under subsection (b) or (j) of section 505

7 (21 U.S.C. 355) after December 31, 1998, for any drug

8 containing chlorofluorocarbons, the Secretary shall con9 duct a preliminary assessment of such application to de10 termine if the drug represents a significant therapeutic ad11 vance over products previously approved under this chap12 ter. If the Secretary determines that the drug does not

13 represent a significant therapeutic advance over such ap14 proved products, the Secretary shall terminate review of

15 such application and not approve the application for the

16 drug.

17 ‘‘(b) LIMITATIONS.—Subsection (a) shall not apply to

18 a supplement to an application if the application was ap19 proved under subsection (c) or (j)(4) of section 505.

20 ‘‘(c) CONSTRUCTION.—Notwithstanding any other

21 provision of this chapter, use of a drug containing

22 chlorofluorocarbons in a chlorofluorocarbon metered-dose

23 inhaler shall be subject to the regulation referred to in

24 section 3(a) of the Asthma Inhaler Protection Act, regard25 less of whether an application or supplement for the drug
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1 is approved under section 505 in accordance with this sec2 tion.’’.

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