The Senate Committee on Health, Education, Labor and Pensions on May 11 advanced the Food and Drug Administration's proposed user fee reauthorization bill with a 21-2 vote, reports Regulatory Focus.
If passed, the bill would reauthorize the fee system drug and devicemakers must follow for the FDA to review their products.
Rachels Sachs, an associate professor of law at St. Louis-based Washington University, highlighted some of the bill's key provisions in a recent Health Affairs blog post.
These provisions include the following proposed requirements for the FDA:
- Prioritize review of generic drug applications when three or fewer approved generics copies exist on the market
- Examine barriers to clinical trial participation
- Place restrictions on importing certain drugs from outside of the U.S.
- Broaden the definition of patient experience data
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