Pediatric Study Delays Could Draw Civil Penalties Under Proposal For PREA, BPCA Reauthorization
This article was originally published in The Pink Sheet Daily
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.
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Rather than assessing monetary penalties for violating study deadlines, H.R. 4274 directs FDA to issue warning letters and publish them on its website.
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.
Duke University economics professor Henry Grabowski and his colleagues suggest the Hatch-Waxman statute be revised to mirror biosimilars legislation and provide 12 years of market exclusivity.