Asthma Inhaler Protection Act

Summary: Asthma Inhaler Protection Act - Requires the Commissioner of Food and Drugs, before beginning the rulemaking mandated below, to conduct specified assessments regarding:  (1) health and environmental risks and benefits; and (2) whether measures and recommendations adopted by the Tenth Meeting of the Parties to the Montreal Protocol on Substances That Deplete the Ozone Layer will facilitate the U.S. transition to non-chlorofluorocarbon (non-CFC) respiratory disease treatments without increasing health risks. 
Mandates, after the assessments above, a regulation regarding whether and in what cases particular CFC metered-dose inhalers are necessary for purposes of eligibility for class I allowances and represent essential uses of class I substances under specified provisions of the Clean Air Act. 
Amends the Federal Food, Drug, and Cosmetic Act to require, regarding any new drug or abbreviated new drug application for any drug containing CFCs, a preliminary assessment of whether the drug represents a significant therapeutic advance over previously-approved products and, if not, requires application disapproval.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Asthma Inhaler Protection Act''.

SEC. 2. ASSESSMENTS RELATED TO TRANSITION FROM USE OF 
              CHLOROFLUOROCARBONS IN METERED-DOSE INHALERS.

    (a) Assessments.--Before beginning rulemaking to issue a regulation 
described in section 3(a), the Commissioner of Food and Drugs (referred 
to in this Act as the ``Commissioner'') shall conduct the following 
assessments concerning the transition from use of chlorofluorocarbons 
in metered-dose inhalers:
            (1) An assessment of the health risks and benefits of the 
        regulatory approach set forth in the advance notice of proposed 
        rulemaking entitled ``Chlorofluorocarbon Propellants in Self-
        Pressurized Containers; Determinations That Uses Are No Longer 
        Essential; Request for Comments'', published in the Federal 
        Register on March 6, 1997, 62 Fed. Reg. 10242, and the health 
        risks and benefits of alternative policies for facilitating the 
        transition to non-chlorofluorocarbon treatments for asthma and 
        other respiratory diseases.
            (2) An assessment of the environmental risks and benefits 
        of the regulatory approach set forth in the notice described in 
        paragraph (1), and the environmental risks and benefits of 
        alternative policies for facilitating the transition to non-
        chlorofluorocarbon treatments for asthma and other respiratory 
        diseases.
            (3) An assessment of whether measures and recommendations 
        adopted by the Tenth Meeting of the Parties to the Montreal 
        Protocol on Substances That Deplete the Ozone Layer will, when 
        implemented in the United States, facilitate the transition in 
        the United States to non-chlorofluorocarbon treatments for 
        asthma and other respiratory diseases by 2005 without 
        increasing the health risks to patients of such diseases.
    (b) Basis for Assessments.--
            (1) Health risks and benefits.--The Commissioner shall base 
        the assessment described in subsection (a)(1) on factors 
        including extensive consultations with patients, physicians, 
        other health care providers, manufacturers of metered-dose 
        inhalers, and other interested parties.
            (2) Environmental risks and benefits.--The Commissioner 
        shall conduct the assessment described in subsection (a)(2) in 
        a manner consistent with section 102(2) of the National 
        Environmental Policy Act of 1969 (42 U.S.C. 4332(2)), and parts 
        10, 20, 25, 71 , 101, 170, 171, 312, 314, 511, 514, 570, 571, 
        601, 812, and 814 of title 21, Code of Federal Regulations. In 
conducting such assessment, the Commissioner shall consult with the 
Administrator of the Environmental Protection Agency, the Administrator 
of the National Oceanic and Atmospheric Administration, and the 
Administrator of the National Aeronautics and Space Administration, as 
appropriate.
    (c) Reports.--The Commissioner shall prepare and submit to Congress 
a report for each assessment and shall publish the reports in the 
Federal Register.

SEC. 3. RULEMAKING ON CHLOROFLUOROCARBONS IN METERED-DOSE INHALERS.

    (a) Regulation.--After completing the duties described in section 
2, the Commissioner shall issue a regulation setting forth criteria for 
determining whether and in what cases particular chlorofluorocarbon 
metered-dose inhalers are necessary for purposes of eligibility for 
class I allowances under section 604(d) of the Clean Air Act (42 U.S.C. 
7671c(d)) and, as a result, represent essential uses of class I 
substances under title VI of the Clean Air Act (42 U.S.C. 7671 et 
seq.).
    (b) Alternatives.--The criteria described in section 3(a) shall 
ensure that a range of non-chlorofluorocarbon inhaler alternatives are 
available for each active moiety, to the extent consistent with title 
35, United States Code, and section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), and that such alternatives are, for all 
populations of users, comparable to existing treatments (in existence 
on the date of issuance of the regulation) in terms of safety and 
effectiveness, use for therapeutic indications, dosage strength, 
delivery system, and sufficient availability to meet consumer needs.
    (c) Limitations.--The criteria described in section 3(a) shall not 
utilize a therapeutic class approach. If a determination described in 
subsection (a) results in the withdrawal of a class I allowance for use 
of a chlorofluorocarbon in a type of inhaler, inhalers of the type 
involved that were introduced into interstate commerce prior to the 
date of the determination shall not be considered to be adulterated or 
misbranded under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321 et seq.) solely on the basis of the withdrawal.

SEC. 4. APPROVALS OF NEW MEDICAL PRODUCTS CONTAINING 
              CHLOROFLUOROCARBONS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 505A (21 U.S.C. 355a) the following:

``SEC. 505B. APPROVALS OF NEW DRUGS CONTAINING CHLOROFLUOROCARBONS.

    ``(a) Preliminary Assessments and Terminations of Review.--
Notwithstanding any other provision of this Act, with respect to any 
application submitted to the Secretary under subsection (b) or (j) of 
section 505 (21 U.S.C. 355) after December 31, 1998, for any drug 
containing chlorofluorocarbons, the Secretary shall conduct a 
preliminary assessment of such application to determine if the drug 
represents a significant therapeutic advance over products previously 
approved under this chapter. If the Secretary determines that the drug 
does not represent a significant therapeutic advance over such approved 
products, the Secretary shall terminate review of such application and 
not approve the application for the drug.
    ``(b) Limitations.--Subsection (a) shall not apply to a supplement 
to an application if the application was approved under subsection (c) 
or (j)(4) of section 505.
    ``(c) Construction.--Notwithstanding any other provision of this 
chapter, use of a drug containing chlorofluorocarbons in a 
chlorofluorocarbon metered-dose inhaler shall be subject to the 
regulation referred to in section 3(a) of the Asthma Inhaler Protection 
Act, regardless of whether an application or supplement for the drug is 
approved under section 505 in accordance with this section.''.