To increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
Summary
This bill, S. 2529, aims to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches. It amends Section 505(b) of the Federal Food, Drug, and Cosmetic Act, mandating the Secretary to issue guidance and engage with stakeholders. The bill also requires a GAO report evaluating the number of Rx-to-nonprescription switch applications approved.
Expected Effects
The bill will likely result in clearer guidelines and a more predictable process for drug manufacturers seeking to switch prescription drugs to over-the-counter status. This could lead to more drugs becoming available without a prescription. It also mandates a GAO report to assess the effectiveness of the switch process and identify potential barriers.
Potential Benefits
- Increased access to medications for consumers.
- Reduced healthcare costs due to fewer doctor visits for prescriptions.
- More efficient drug approval process.
- Greater transparency and predictability for drug manufacturers.
- Potential for innovation in drug delivery and consumer information through mobile apps and decision aids.
Potential Disadvantages
- Potential risks to public health if consumers inappropriately self-select or use drugs.
- Increased burden on the FDA to develop guidance and engage with stakeholders.
- Possible delays in drug approvals due to the new requirements.
- Concerns about the accuracy and completeness of information provided by mobile applications or decision aids.
- Potential for misuse or abuse of drugs that are more easily accessible.
Constitutional Alignment
The bill aligns with the Constitution's goal of promoting the general welfare (Preamble). Congress has the power to regulate interstate commerce, which includes the regulation of drugs (Article I, Section 8, Clause 3). The bill does not appear to infringe on any individual liberties or rights protected by the Bill of 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).