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Bill116th CongressFiled Oct 30, 2019Health
S. 2740

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

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What it doesSummary passed senate (Dec 10, 2019)

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

What just happenedDec 14, 2019

Referred to the Subcommittee on Health.

Who’s behind it

Sen. Isakson, Johnny [R-GA](R-GA)Sponsor
5 cosponsors3 D2 R
Read on Congress.gov
5cosponsors2committees12actions4related bills13subjects
  1. Dec 14, 2019Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  2. Dec 11, 2019IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  3. Dec 11, 2019FloorH14000

    Received in the House.

  4. Dec 11, 2019Floor

    Message on Senate action sent to the House.

  5. Dec 10, 2019Floor

    Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)

  6. Dec 10, 2019Floor17000

    Passed/agreed to in Senate: Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389.(consideration: CR S6921-6930; text: CR S6921-6930)

  7. Nov 5, 2019Calendars

    Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.

  8. Nov 5, 2019Committee

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.

    Health, Education, Labor, and Pensions Committee
  9. Nov 5, 2019Committee14000

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.

    Health, Education, Labor, and Pensions Committee
  10. Oct 31, 2019Committee

    Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.

    Health, Education, Labor, and Pensions Committee
  11. Oct 30, 2019IntroReferral

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

    Health, Education, Labor, and Pensions Committee
  12. Oct 30, 2019IntroReferral10000

    Introduced in Senate

Passed SenateDec 10, 201955

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

Reported to SenateNov 5, 201925

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

Introduced in SenateOct 30, 2019

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 — Informed