Advancing Consumer Choice, Equity, Safety, and Self-Care Through OTC Innovation Act; ACCESS Through OTC Innovation Act
Summary
H.R. 6868, also known as the "Advancing Consumer Choice, Equity, Safety, and Self-Care Through OTC Innovation Act" or the "ACCESS Through OTC Innovation Act," aims to amend the Federal Food, Drug, and Cosmetic Act. The bill directs the Secretary of Health and Human Services to use the least burdensome means when evaluating administrative order requests for over-the-counter (OTC) monograph drugs. This includes meeting with requestors to provide recommendations on necessary evidence and study designs.
Expected Effects
The bill is likely to streamline the process for OTC drug approvals by reducing the evidentiary burden on manufacturers. This could lead to faster availability of new OTC drugs and potentially lower costs for consumers. However, it also raises concerns about whether reduced burdens might compromise safety evaluations.
Potential Benefits
- Faster approval process for OTC drugs.
- Increased innovation in the OTC drug market.
- Potential for lower drug costs for consumers.
- More consumer choice in OTC medications.
- Encourages self-care through increased access to OTC options.
Potential Disadvantages
- Potential compromise of safety evaluations due to reduced evidentiary burden.
- Risk of less rigorous review processes.
- Possible increase in unsafe or ineffective OTC drugs on the market.
- May disproportionately benefit large pharmaceutical companies.
- Could lead to inadequate information for consumers about potential risks.
Constitutional Alignment
The bill appears to align with the Constitution's Commerce Clause (Article I, Section 8), which grants Congress the power to regulate interstate commerce, including the regulation of drugs. The emphasis on consumer choice and self-care could be argued to promote the general welfare, as mentioned in the Preamble. However, the balance between promoting access and ensuring safety is a key consideration.
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).