ACCESS Through OTC Innovation Act
Sponsored By: Representative Rep. Landsman, Greg [D-OH-1]
Introduced
Summary
Least burdensome evidence standard for OTC monograph requests. This bill would require the Secretary of Health and Human Services to use the least burdensome appropriate means when evaluating certain requests for administrative orders about over-the-counter monograph drugs, and to create a formal meeting and documentation process to advise requestors on needed evidence.
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- Drug requestors would be able to ask for a meeting when published reports are not enough. The Secretary must provide recommendations on the types of evidence needed, including possible study design and size.
- The Secretary must prepare and make meeting minutes available and put any recommendations and a summary of the discussion into the administrative record.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Easier FDA meetings for over-the-counter drug makers
This bill would require HHS to use the least burdensome way to review requests under subsection (b)(5) that ask whether an over-the-counter drug is generally recognized as safe and effective. If published reports are not enough and the requester submits a reasonable written request, the agency would have to meet with the requester and recommend what evidence or studies (including possible study design and size) would help. The agency would have to prepare and make meeting minutes available and put any study-parameter recommendations and a meeting summary into the administrative record. These steps would not change the rules for whether a request is complete or whether a drug meets the safety-and-effectiveness standard.
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Sponsors & CoSponsors
Sponsor
Rep. Landsman, Greg [D-OH-1]
OH • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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