PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Subcommittee on Health.
Congressional Research Service
Version 55 · 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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Sen. Isakson, Johnny [R-GA] · R–GA
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Received in the House.
Message on Senate action sent to the House.
Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
Senate roll call 389 · Individual votesPassed/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)
Senate roll call 389 · Individual votesPlaced on Senate Legislative Calendar under General Orders. Calendar No. 290.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
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Source last updated: Jan 20, 2026. Consult Congress.gov for the current record.
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