The ACCESS Through OTC Innovation Act directs the FDA to use the least burdensome approach when reviewing requests to approve over-the-counter monograph drugs—medications that don't require individual drug applications because their ingredients and uses are already recognized as safe and effective. The bill requires the FDA to meet with requestors if published research alone isn't sufficient, and to provide clear recommendations on what types of evidence, including study designs and sizes, would be needed to demonstrate safety and effectiveness. The FDA must also document these meetings and any guidance in writing for the administrative record. The legislation affects drugmakers and companies seeking to market OTC drugs under the monograph system, aiming to streamline the approval process while maintaining safety standards. No specific funding or timeline is allocated in the bill.
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