“This package is critical to patients,” Rep. Joseph Pitts (R-Pa.) said in a statement in front of the subcommittee. “It will ensure that FDA has the resources and reforms needed to speed new drugs, devices and treatments to those who are ill.”
Specifically, the bill:
- Authorizes a new user fee program for generic drugs.
- Require drug makers to report to the FDA on discontinuations and interruptions in drug supplies.
- Expands the FDA’s reporting on drug shortages.
- Expedites applications to spur manufacturing of shortage drugs.
- Expedites Drug Enforcement Agency review of requests to increase controlled substance drug quotas.
The full House Energy and Commerce Committee will mark up the bill on Thursday. Both the Senate and House are expected to have a final version of the bill ready before the current law authorizing FDA user fees expires July 31.
More Articles Related to the FDA:
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FDA Announces Fewer Drug Shortages This Year Compared to Last
Bipartisan FDA Reauthorization Bill Passes Senate Committee
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