Conflict Of Interest Rules Get Clean Sweep In House Draft User Fee Bill
Reforms merit one sentence, which would end waiver caps for conflicts of interest, but it is unclear whether it will solve the problems patient groups and others have with the advisory committee selection process.
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FDA user fee reauthorization eliminates limits on waivers, which may ease the burden on FDA to fill open seats on its advisory committees. Vacancy rates have been as high as 24% in FY 2012.
Profound reforms to FDA’s mission were set aside, but industry seems poised for several big wins, including (probably) additional antibiotic exclusivity and even a national track and trace standard.
Manager’s amendment released in lead-up to committee mark-up still does not include drug tracking provisions, but will expand advisory committee recruiting and eliminate conflict of interest waivers using language in Rep. Burgess’ bill.