Reauthorizations Cause Sponsor Angst For PREA, BPCA Studies, GAO Finds
The regular reauthorization of PREA and BPCA, when coupled with the long review horizon for pediatric studies at FDA, could be hindering sponsors’ willingness to conduct the trials, according to a Government Accountability Office Report.
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FDA Pediatric Incentives, Powers Would Become Permanent Under Draft Bill
In the absence of sunset provisions that necessitate periodic reauthorization of the pediatric laws, GAO would report to Congress on a five-year cycle about the accomplishments of the drug programs for children and make recommendations for amendments.
Pediatric Study Delays Could Draw Civil Penalties Under Proposal For PREA, BPCA Reauthorization
Civil penalties would be more flexible than FDA’s current authority to label a drug misbranded if sponsors fail to conduct pediatric studies, Commissioner Hamburg argues as the House Energy and Commerce Committee’s Health Subcommittee opens hearings on reauthorizing prescription drug user fees.
Drug Shortage Bills Likely Drivers Of PDUFA Add-ons
Rep. Burgess says there appears to be enough bipartisan support for dealing with the shortage problem that it almost certainly will be added to the reauthorizing legislation.