Lawsuits are no substitute for agency's judgment

CONTRARY TO the conclusions of your Sept. 27 editorial "No haven for dangerous drugs," there is a sure-fire way to bolster drug safety and better serve patients: a strong, well-funded Food and Drug Administration.

Mass tort suits that challenge the adequacy of a medicine's labeling are no substitute for the FDA's expert scientific judgment.

Importantly, in the Wyeth v. Levine case before the Supreme Court, the FDA's actions led to appropriate warnings on the drug's label.

This is in keeping with the FDA's mandate for the past 70 years. Congress has charged the agency with ensuring that medicine labeling adequately warns about potential side effects following the FDA's review of complex scientific data.

The agency has new authority - and has used it - to compel companies to update labeling as new post-marketing information becomes available.

Finally, we must correct the record: Earning FDA approval does not immunize a pharmaceutical company from any and all future lawsuits.

However, if the plaintiff's bar has its way, even if patients are informed of rare risks, companies could be saddled with crippling lawsuits. Companies may struggle to develop therapeutic products with rare but serious side effects in that environment.

The clear losers would be patients and public health.

DIANE BIERI
Executive vice president and general counsel
Pharmaceutical Research and Manufacturers of America
Washington