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.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 1 May 1998

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 1 May 1998

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• Introduced in Senate

  summary · EN · 1 May 1998

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