H.R. 4955 · 116th Congress
Protecting Access to Safe and Effective Medicines Act of 2019
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
EngelSponsor3 cosponsors · 1 D, 2 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Protecting Access to Safe and Effective Medicines Act of 2019
What it does: CRS summary · Introduced in House · Oct 31, 2019
Protecting Access to Safe and Effective Medicines Act of 2019
This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases.
Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.
The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Protecting Access to Safe and Effective Medicines Act of 2019
Latest action (Nov 1, 2019): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Oct 31, 2019
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.