New authority leads to adverse impact

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The FDA needs more resources and not more authority to help it manage drug safety, and if it gets the new authority that some legislative proposals are calling for, there could be “adverse impacts,” according to former FDA chief counsel Dan Troy, now a partner at Sidley Austin.

Speaking at the Food and Drug Law Institute’s 50th Annual Conference, Troy warned that if new drug safety authorities get passed, then those will be the new baseline, and “whatever authorities the agency has been given it will exercise plus more.” He was joined in some of his concerns by former deputy commissioner Mary Pendergast.

The pendulum has swung back to FDA slowness, Troy told the FDLI audience, because of recent drug safety controversies.

“But the really big issue, I think, is that there has developed in the agency a whistleblower culture, which it never had before,” he said. “The agency, I think, was very good at collaborative decision-making and now I think people are afraid to air things out the way they once did.”

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