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9/22/2004

Angry parents want Congress to sack the FDA's top lawyer

http://www.nj.com/business/ledger/index.ssf?/base/business-0/1095831070262870.xml

Ed Silverman

A group of angry parents is urging Congress to oust the top lawyer at the Food and Drug Administration.

In a three-page letter to be delivered tomorrow to the House Subcommittee on Oversight and Investigations, which is probing the FDA, the parents argue Daniel Troy has unfairly sided with drug makers in lawsuits involving side effects and injuries.

As the agency's chief counsel, Troy has argued it is the purview of the FDA -- not state courts -- to determine whether a product is safe. Moreover, FDA legal briefs maintain agency authority pre- empts lawsuits seeking damages.

"Since Mr. Troy took office, he has initiated an unprecedented number of FDA interventions in civil lawsuits," the letter states. "He has done so in an effort to derail the efforts of consumers to obtain justice and expose the true dangers of drugs through litigation."

The letter also notes Troy once represented Pfizer while in private practice and he also filed lawsuits challenging the FDA's power to test drugs for pediatric use.

The missive is an outgrowth of the controversy over the safety of antidepressant pills. The subcommittee tomorrow will hold a hearing about the FDA's handling of clinical-trial data, including the alleged muzzling of an agency medical reviewer earlier this year.

Last week, an FDA advisory panel voted in favor of placing severe warnings on the drugs after reviewing trial data showing antidepressants are ineffective in youngsters and were linked to suicidal behavior.