OTC Monograph Drug User Fee Transparency Act
Summary
The "OTC Monograph Drug User Fee Transparency Act" aims to amend the Federal Food, Drug, and Cosmetic Act to enhance transparency and reporting related to over-the-counter (OTC) drug monograph activities. It mandates more detailed performance reports from the FDA regarding OTC monograph order requests and postmarket safety activities. Additionally, it requires the public availability of minutes from negotiation meetings between the FDA and the regulated industry.
Expected Effects
This act will likely increase transparency in the OTC drug approval process. It will also provide more information to the public regarding the safety and supply chain of OTC drugs. The required GAO report will offer an independent assessment of the OTC drug supply chain.
Potential Benefits
- Increased transparency in the FDA's OTC drug monograph process.
- Improved public access to information regarding OTC drug safety.
- Enhanced oversight of OTC drug facility registration and fee payment.
- Independent assessment of the OTC drug supply chain by the GAO.
- Greater accountability of the FDA in meeting its goals for OTC drug regulation.
Most Benefited Areas:
Potential Disadvantages
- Potential increase in administrative burden for the FDA.
- Possible delays in the OTC drug approval process due to increased reporting requirements.
- Risk of misinterpretation of publicly available negotiation meeting minutes.
- Potential for increased costs to the regulated industry due to enhanced reporting.
- No direct disadvantages to the American people.
Constitutional Alignment
The act aligns with the Constitution by promoting the general welfare (Preamble) through ensuring the safety and efficacy of OTC drugs. Congress's authority to regulate interstate commerce (Article I, Section 8, Clause 3) provides the basis for regulating drug manufacturing and distribution. The reporting requirements do not infringe on individual liberties or rights.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).