Legis Daily

Protecting Access to Safe and Effective Medicines Act of 2021

USA117th CongressHR-1857| House 
| Updated: 3/12/2021
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Cosponsors (1)
Brett Guthrie (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Protecting Access to Safe and Effective Medicines Act of 2021 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

Bill from Previous Congress

HR 116-4955
Protecting Access to Safe and Effective Medicines Act of 2019
Mar 11, 2021
Introduced in House
Mar 11, 2021
Referred to the House Committee on Energy and Commerce.
Mar 12, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4955
    Protecting Access to Safe and Effective Medicines Act of 2019


  • March 11, 2021
    Introduced in House


  • March 11, 2021
    Referred to the House Committee on Energy and Commerce.


  • March 12, 2021
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 117-19: Lower Costs, More Cures Act of 2021
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 2021

USA117th CongressHR-1857| House 
| Updated: 3/12/2021
Protecting Access to Safe and Effective Medicines Act of 2021 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

Bill from Previous Congress

HR 116-4955
Protecting Access to Safe and Effective Medicines Act of 2019
Mar 11, 2021
Introduced in House
Mar 11, 2021
Referred to the House Committee on Energy and Commerce.
Mar 12, 2021
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 116-4955
    Protecting Access to Safe and Effective Medicines Act of 2019


  • March 11, 2021
    Introduced in House


  • March 11, 2021
    Referred to the House Committee on Energy and Commerce.


  • March 12, 2021
    Referred to the Subcommittee on Health.
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Cosponsors (1)
Brett Guthrie (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 117-19: Lower Costs, More Cures Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresChemistryDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation