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Reports of concussions from youth sports rise along with awareness of the problem.

passage of the Food and Drug Administration Amendments Act of 2007 should have given the agency more regulatory ammunition to push companies to comply with conducting postmarketing studies. “The problem prior to the act’s passage was that some of the commitments to complete postmarketing studies had no deadlines, so it was hard to claim they were delinquent. And clearly there have been no consequences and no one at the FDA paid attention to this problem,” Furberg said. “The changes in the regulations should help, but when I look at the list of studies on the accelerated approval list, some have been conducted and some are pending, and to me it is hard to say the situation has improved.” Nissen remains frustrated with the inaction by FDA leadership to improve the accelerated approval process. “The people at the FDA approving drugs are very pharma friendly; they view pharmaceutical manufacturers as their principal clients. So we see this lack of enforcement over and over,” Nissen said. “I do not think we need tough laws; we need tougher regulators.”