Drugmakers Hope to Avoid Premarket Drug Safety Reforms, FDA Official Says

As lawmakers and the FDA mull over proposals to address recent drug safety concerns, pharmaceutical firms are hoping that any potential fix will not focus on the premarket side of the equation, according to a top FDA official.

Potential changes to the premarket workup and approval standard for pharmaceutical products is the greatest concern to industry, said Janet Woodcock, the FDA's acting deputy commissioner for operations. "They think it could result in prolonging drug development ... and even affect the probability of success," she said at the World Health Care Congress in Washington, D.C.

Woodcock warned that there is a trade-off between developing greater certainty during the premarket phase and approving drugs in a timely fashion, she said.

Still, Congress or the FDA may be spurred to take some action in light of recent drug safety issues, Woodcock said, including the links between antidepressant use in children and suicidal behavior, and increases in cardiovascular events among patients taking Cox-2 inhibitors. The furor over these events has undermined public confidence in the FDA's regulatory process and has raised concerns about the structure and integrity of the drug review process, Woodcock said. "Periods of perception of crisis in drug regulation frequently lead to changes," she added.

But Woodcock also noted that any potential premarket modifications are unlikely to affect some products, including short-term treatments such as antibiotics, as well as drugs that treat life-threatening illnesses. It is the long-term treatments for non-life-threatening symptoms that raise the biggest questions about the kind of evaluation that is needed, she said, including what kind of clinical trials to conduct and the number of trials that should be required.