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Protecting Access to Safe and Effective Medicines Act of 2019

USA116th CongressHR-4955| House 
| Updated: 11/1/2019
Eliot L. Engel

Eliot L. Engel

Democratic Representative

New York

Cosponsors (3)
Brett Guthrie (Republican)Kurt Schrader (Democratic)Richard Hudson (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Oct 31, 2019
Introduced in House
Oct 31, 2019
Referred to the House Committee on Energy and Commerce.
Nov 1, 2019
Referred to the Subcommittee on Health.
  • October 31, 2019
    Introduced in House


  • October 31, 2019
    Referred to the House Committee on Energy and Commerce.


  • November 1, 2019
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 116-1895: Lower Health Care Costs Act
  • S 116-1636: Ensuring Innovation Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
Administrative law and regulatory proceduresChemistryDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation

Protecting Access to Safe and Effective Medicines Act of 2019

USA116th CongressHR-4955| House 
| Updated: 11/1/2019
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Oct 31, 2019
Introduced in House
Oct 31, 2019
Referred to the House Committee on Energy and Commerce.
Nov 1, 2019
Referred to the Subcommittee on Health.
  • October 31, 2019
    Introduced in House


  • October 31, 2019
    Referred to the House Committee on Energy and Commerce.


  • November 1, 2019
    Referred to the Subcommittee on Health.
Eliot L. Engel

Eliot L. Engel

Democratic Representative

New York

Cosponsors (3)
Brett Guthrie (Republican)Kurt Schrader (Democratic)Richard Hudson (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 116-1895: Lower Health Care Costs Act
  • S 116-1636: Ensuring Innovation Act
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresChemistryDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation