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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