November 16

FDA Chief Counsel, Daniel Troy, Resigned

FDA Chief Counsel, Daniel Troy, Resigned

Wed, 17 Nov 2004

FDA’s chief counsel, Daniel Troy, has resigned!
This is good news for consumers.

Troy was the symbol of what is rotten at the FDA: the pharmaceutical industry’s influence has ensured that business interests take precedence over public safety.

Industry-influenced advisory committees have led to the approval of lethal drugs that were widely marketed until the death toll became publicly known. Troy actively intervened on behalf of pharmaceutical companies in civil cases brought by individuals who sought justice in the court. Let us hope that other senior FDA officials who have similarly disregarded their role as public servants and have shielded drug manufacturers who concealed the hazardous effects of their products, resulting in preventable deaths, will resign as well.

The FDA has been derailed from its mission, which is to ensure that the public is protected from unsafe and ineffective drugs, and that physicians and the public rare provided scientifically accurate information.

Whereas Troy intervened on behalf of pharmaceutical companies claiming that the FDA’s authority pre-empted all others in matters of drug safety–even when they concealed lethal drug effects–New York State Attorney General, Eliot Spitzer, brought action against GlaxoSmithKline, charging the company with fraudulent marketing of Paxil (seroxat). That action undermined Troy’s pre-emption authority argument–and ultimately undermined his standing.

In light of the skyrocketing expenditures for prescription drugs–US consumers spent $216 billion on prescription drugs last year, up 11.5% in a year (according to IMS Health)–Dr. Lester Crawford’s claim that Daniel Troy’s “reforms” saved consumers $35 billion, is not credible.

Contact: Vera Hassner Sharav


To: FDA All-Hands
From: Acting Commissioner of Food and Drugs
Date: November 16, 2004
Subject: Departure

It is with mixed emotions that I announce today the resignation of Daniel E. Troy, Chief Counsel of the Food and Drug Administration and of the Food & Drug Division of the Department’s Office of the General Counsel.

Since August 2001, Dan has served the Agency with tireless dedication. Shortly after Dan’s arrival, he faced his first major challenge, assisting the Agency in addressing the myriad public health dimensions of the terrorist attacks of September 11, 2001. Thereafter, he provided excellent legal support to the Agency as we responded to the anthrax attacks and reoriented the Agency to its new counterterrorism responsibilities.

Dan’s legal acumen has equally benefited FDA’s programs aimed at carrying out the Agency’s traditional public health mission. Among his many notable accomplishments are a major package of reforms to the Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act, which are estimated to save drug consumers $35 billion over ten years. Dan has also put his personal reputation on the line defending the Agency’s prerogatives from intrusion by courts applying state law in product liability actions. I endorse this practice, and believe the policy is the correct one for the public health.

In my estimation, Dan’s principal legacy is having instilled in the Agency a deep and abiding respect for the rule of law, and for the limitations imposed on FDA by the Constitution, especially the First Amendment, and by our own enabling statutes. Dan embraced the responsibility, as befits an agency’s top lawyer, of helping FDA achieve our public health mission with respect for the powers Congress has — and has not — given us.

Throughout Dan’s tenure, he has given of himself and his time with utmost generosity and good humor. I am deeply sorry to lose his wise counsel and steadfast support. I am also sorry that he will be joined in his departure by his Special Assistant, Coleen Klasmeier. My regret at losing these two unparalleled talents is equaled only by the certainty that, wherever they land, they will continue to distinguish themselves as principled, hard-working, and brilliant attorneys.

Please join me in thanking Dan and Coleen for all their hard work and in wishing them, and their families, all the best.

Lester M. Crawford, DVM, PhD

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