New authority leads to adverse impact

Share this article:
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.”

Share this article:

Email Newsletters

More in News

Gilead reaps huge HCV sales, payer fury

Gilead reaps huge HCV sales, payer fury

Sovaldi's debut has been marked by plenty of criticism from payers and lawmakers, but the hep. C drug's launch, now confirmed to be the fastest of all time, has also ...

Bayer drug gets orphan label

Bayer drug gets orphan label

The FDA designation is for an experimental, inhaled form of ciprofloxacin intended to treat a rare lung condition.

Lilly's cancer drug ramu granted gastric indication

Lilly's cancer drug ramu granted gastric indication

Ramucirumab received FDA approval today in advanced gastric cancer, a nod that could translate into $600 million in peak sales.