To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
Latest action · Jul 24, 2019 Sponsor introductory remarks on measure. (CR E971)
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJun 24, 2019
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 3
Members who signed on, in the order they did. All signed on Jun 24, 2019.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-KY | Brett Guthrie | Original | Jun 24, 2019 |
| D-MI | Debbie Dingell | Original | Jun 24, 2019 |
| R-OH | Robert E. Latta | Original | Jun 24, 2019 |
Actions 4
Everything that happened, newest first.
- Jul 24, 2019Sponsor introductory remarks on measure. (CR E971)
- Jun 25, 2019Referred to the Subcommittee on Health.
- Jun 24, 2019Introduced in House
- Jun 24, 2019Referred to the House Committee on Energy and Commerce.
Related bills 4
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 19 | Lower Costs, More Cures Act of 2019 | Related bill | Dec 19, 2019 |
| HR 269 | Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 | Related bill | Jan 10, 2019 |
| HR 748 | CARES Act | Related bill | Jul 23, 2020 |
| S 2740 | Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 | Related bill | Dec 14, 2019 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Administrative remedies
- Child health
- Congressional oversight
- Cosmetics and personal care
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Government information and archives
- Government studies and investigations
- Health
- Inflation and prices
- Judicial review and appeals
- Marketing and advertising
- User charges and fees
Text 1
Each version as it was printed, newest first.
- Jun 24, 2019Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.