Expect an increase in warning letters from the FDA now that it has unshackled itself from legal reviews prior to issuing the letters. Drugmakers should expect "far more, and more legally dubious," warnings, writes Henry Miller, a fellow at Stanford University's Hoover Institution and founding director of the FDA's Office of Biotechnology, in Forbes.
Stringent regulation is not synonymous with greater health and safety, he adds. In fact, patients may suffer because overly cautious regulators sometimes attempt to steer clear of new products or technologies that they don't understand. The FDA works hard to prevent the high-visibility error of approving harmful products. But by doing so it can inadvertently prevent good cures from coming to market. For the former it is subject to public lashings; for the latter, there are virtually no consequences.
The FDA needs a new ethic, "one that better balances the risks of risk-aversion against those of timely approvals. And for that, there will need to be new, more courageous and intelligent leadership, and more enlightened congressional oversight."
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