FDA: Drug Companies Drop Ball on Studies
Exactly when is PhRMA going to realize that it undermines its mission when it lays a steaming pile of horseshit on the American public’s lap, like Alan Goldhammer did in this AP story on delayed Phase 4 commitments? An excerpt:
Alan Goldhammer, of the Pharmaceutical Research and Manufacturers of America, an industry group, said the figures should not be “distorted.” “To be clear, pending does not mean delayed. It does mean, however, that the immense and vitally important tasks of developing research protocols, finding investigators and researchers and even recruiting patients to participate in the study is in process,” Goldhammer said.
On the other hand, Goldhammer is literally correct. According to the report , just 2% of the outstanding NDA commitments are delayed, with 17% of BLAs delayed. The majority of postmarketing study commitments are pending (that is, not started, but not delayed past the agreed-to start date). Critics are lambasting FDA for not taking action, but, of course, there’s no action they can take short of pulling a drug from the market, which, with very few exceptions, is an empty threat. And besides, what would they take action on exactly? If the studies are begun according to the timetable laid out in the postmarketing commitment agreement, there’s no basis for action. So, except for these small number of delayed studies, there’s nothing FDA could do, even if it had legal authority to fine companies for delayed commitments. The only question for Congress is whether providing FDA with authority to fine to enforce its postmarketing commitments would have an overall beneficial effect on patient safety. For reasons I’ll discuss in a future post, it almost certainly would not, at least not without concomitant changes to review-time goals under PDUFA/MDUFA.
