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All recent votes116th CongressSenate
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.
Written by the nonpartisan Congressional Research Service, describing S. 2740 as passed Senate on Dec 10, 2019. It is not the text of the measure; a later amendment may have changed what it does.
Senate Dec 10, 2019
S. 2740
Bill Passed
91 Yea 2 Nay 7 not voting
Crossed both parties 2 of 93 voting members broke with their own party: 2 Republicans.
DemocratsIndependentsRepublicansFilled: YeaRing: NayGrey: not voting or present
100 members on this roll call, from the official Senate record. Party majorities need at least five voting members, so an independent never counts as breaking with a party.
Signing on is not a vote: a member can cosponsor S. 2740 and vote against it. 1 signed when it was filed.
Organizations that named S. 2740 in a lobbying disclosure. Only those that cited the bill by number appear, so this is a floor, not a full list.
34 disclosures name this measure. Retrieved from LDA.gov on 2026-10-05. Senate Office of Public Records cannot vouch for the data or analyses derived from these data after the data have been retrieved from LDA.gov.