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Public Law117th CongressHealth
S. 415Became Law

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.

This bill became law

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What it doesSummary public law (Apr 23, 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.

What just happenedApr 23, 2021

Became Public Law No: 117-9.

Who’s behind it

Sen. Cassidy, Bill [R-LA](R-LA)Sponsor
2 cosponsors1 D1 R
Read on Congress.gov
2cosponsors1committees21actions4subjects
  1. Apr 23, 2021President

    Became Public Law No: 117-9.

  2. Apr 23, 2021BecameLaw36000

    Became Public Law No: 117-9.

  3. Apr 23, 2021President

    Signed by President.

  4. Apr 23, 2021BecameLaw36000

    Signed by President.

  5. Apr 20, 2021Floor

    Presented to President.

  6. Apr 20, 2021President28000

    Presented to President.

  7. Apr 14, 2021FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  8. Apr 14, 2021FloorH37300

    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)

  9. Apr 14, 2021Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755)

  10. Apr 14, 2021FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on S. 415.

  11. Apr 14, 2021FloorH30000

    Considered under suspension of the rules. (consideration: CR H1755-1756)

  12. Apr 14, 2021FloorH30300

    Mr. Pallone moved to suspend the rules and pass the bill.

  13. Mar 12, 2021FloorH15000

    Held at the desk.

  14. Mar 12, 2021FloorH14000

    Received in the House.

  15. Mar 11, 2021Floor

    Message on Senate action sent to the House.

  16. Mar 10, 2021Floor

    Passed Senate without amendment by Unanimous Consent. (text: CR S1435)

  17. Mar 10, 2021Floor17000

    Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1435)

  18. Mar 10, 2021Discharge

    Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)

    Health, Education, Labor, and Pensions Committee
  19. Mar 10, 2021Committee14500

    Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1435)

    Health, Education, Labor, and Pensions Committee
  20. Feb 24, 2021IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  21. Feb 24, 2021IntroReferral10000

    Introduced in Senate

Public LawApr 23, 202149

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.

Passed HouseApr 14, 202153

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.

Passed SenateMar 10, 202155

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.

Introduced in SenateFeb 24, 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.

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new … — Informed