Rep. Ed Markey’s report on accelerated approval delinquency
I found a copy of the Markey report on FDA’s accelerated approval program on the Huffington Post blog site. I made an independent check of some of the data, focusing on Markey’s allegations regarding the lack of public disclosure of accelerated approval study commitments by public companies. The three companies I looked into (Skyepharma, Mylan, and King) checked out–they hadn’t publicly disclosed accelerated approval study commitments in SEC filings as Markey alleged.
In addition to hammering public companies for non-disclosure of postmarketing study commitments, Rep. Markey cites data to support his conclusions that the accelerated approval system is in need of an overhaul. In particular: Half of the 91 study commitments (from 28 companies, representing 42 products) are not completed, and, of those not completed, half have not started an average of nearly two years after accelerated approval. Markey views this as non-enforcement by FDA of its rules. FDA doesn’t inform patients or their physicians about accelerated approval postmarketing study commitments. FDA provided different data to Markey and the public (via its website), suggesting improper monitoring and/or reporting of study commitments.
Assuming the evidence is correct, and not simply the result of sloppy record-keeping by the FDA, it’s hard to argue that Markey has no reason for concern. Even in those cases in which a postmarketing commitment has become irrelevant (for example, due to changing therapeutic strategies or supersession by non-required studies), FDA has an obligation to let the public know what it originally asked of the drug sponsor, and why their opinion might have changed. The information FDA provides should be consistent, regardless of who is asking for it. And companies have an obligation to shareholders, prescribers, and patients to make it known when drugs have been approved under an accelerated schedule. Such information should not be alarmist, but it should be readily available.
Finally, Markey’s call for financial penalties for non-compliance is overkill. FDA already has the authority to pull drugs off the market when their sponsors don’t comply with accelerated approval requirements. They just need to use the threat of this authority every so often to remind sponsors of their obligations.
