FDA Chief Counsel Daniel Troy's intervention in civil suits on behalf of device maker Pacesetter and several drug firms has drawn a rebuke from House legislators in the form of funding cuts.

An amendment to the FDA appropriations bill, introduced by Rep. Maurice Hinchey (D-N.Y.) July 13 and accepted without opposition, pulls $500,000 from the budget of the Office of the Commissioner, with the intent that the money be deducted from the office of the General Counsel.

In the final House Agriculture appropriations bill, passed that day, the reallocated funds are earmarked for the Center for Drug Evaluation & Research for use by the center's Division of Drug Marketing, Advertising & Communications.

Hinchey introduced his amendment on the floor with a speech accusing the chief counsel of taking "the agency in a radical new direction," alleging the FDA official "has wasted taxpayer money on pursuits that are undermining FDA's basic mission."

Troy is "actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers" when they are being sued by individuals harmed by their products, Hinchey said. These actions undermine FDA's mission by "shutting down avenues used to expose fraud," the congressman asserted.

The cases in which FDA intervened are private civil suits filed in state courts, and the judge did not solicit FDA's opinion, Hinchey said. He maintained the agency has devoted 622 hours to working on the cases.

In the Pacesetter case (Murphree v. Pacesetter), the plaintiff's argument centered on FDA approval details for a steroid-eluting pacing lead produced by the St. Jude Medical subsidiary (¹ Also see "FDA Defends Its Turf, Argues Preemption In Tenn. Pacesetter Case" - Medtech Insight, 3 May, 2004., p. 8).

Troy filed a brief arguing that a jury should not be able to determine whether a device is fully PMA-approved, and therefore exempt from tort litigation. At the Food & Drug Law Institute's 2004 annual meeting, Troy referred to jury consideration of a device's approval status as a "frontal assault on [FDA's] congressionally-prescribed role."

Hinchey observes that Troy was in contact with Pacesetter counsel before filing an amicus brief on its behalf. The New York Democrat cited ² November 2003 correspondence between firm attorneys and Troy's office "directing FDA on how the agency should assist" in the case. Three weeks later, through the Department of Justice, FDA filed a statement of interest in support of Pacesetter's position.

In addition to the Pacesetter case, Hinchey highlighted two California drug cases where FDA intervened and sided with industry: one involving Pfizer (Motus v. Pfizer) and one with GlaxoSmithKline (Dowhal v. SmithKline Beecham Consumer Care).

Troy has justified FDA's actions by arguing the inventions are intended to preserve the agency's control over approval and regulation of drugs and devices.

Hinchey also voiced concern about a potential financial conflict of interest, noting that one of Troy's clients when he was the law firm Wiley, Rein & Fielding was Pfizer, "which paid that firm $415,000 for services provided directly by Mr. Troy."

At a July 13 press conference, Hinchey claimed Pfizer paid $360,000 for Troy's legal services in 2001, the year he took the chief counsel position at FDA. Pfizer counsel then contacted Troy less than a year after he had left private practice to join FDA, according to Hinchey.

The congressman had questioned FDA Acting Commissioner Lester Crawford, PhD/DVM, about Troy's alleged conflict of interest at the House Appropriations Committee's March 11 hearing for the funding bill. However, Crawford's answer failed to mention Pfizer's payments to Wiley, Rein & Fielding for services "provided directly" by Troy, Hinchey said.

The committee expressed concern with Crawford's "misleading" answer in its ³ appropriations bill report when it approved the legislation June 23.

"Information before the committee raises concerns about a response provided by FDA for the record to a question from a member of the committee relating to an FDA official's employment before coming to the agency and current activities by that official," the committee's report states.

"The question was posed due to concerns about a conflict of interest. The committee is concerned about whether the response was fully forthcoming and whether it may have had the effect of misleading the committee."

"The committee intends to look into this matter further and expects FDA to cooperate fully in this effort," the report concludes.

Crawford issued a statement July 13 declaring that Troy "fully complied with the ethical requirement to recuse himself from any matter involving a past client for a year after beginning work in the public sector."

"FDA has accurately reported the scope and nature of Dan's private sector work. Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false," the FDA chief maintains.

Hinchey's floor speech also highlighted FDA's reduced regulation of product advertising under Troy. "He is making it easier for drug companies to produce misleading advertisements," Hinchey contended.

The congressman noted that Troy published a Federal Register notice "questioning whether FDA's own regulations complied with the First Amendment. This notice is troubling because it would surely be used against FDA in lawsuits," Hinchey remarked. FDA issued the notice in May 2002 (⁴ Also see "FDA Opens Floor For Debate Of Off-Label Claims, First Amendment Issues" - Medtech Insight, 20 May, 2002., p. 15).

Hinchey added that after "wasting taxpayer money" by working 600 hours on the issue, FDA dropped it. Troy said in 2003 that rather than issue a single "omnibus" policy on regulating commercial speech, FDA would issue a series of guidances and rules (⁵ Also see "FDA First Amendment Plan: Series Of Guidances Rather Than Omnibus Rule" - Medtech Insight, 17 March, 2003., p. 29).

CDRH's regulation of promotional materials has been limited since Troy's 2001 appointment. The Promotions & Advertising Policy Staff dwindled to two people before it was folded into the Office of Compliance. Warning letters became infrequent with Troy's office vetting all such correspondence (⁶ Also see "CDRH Promotion/Advertising Merging With OC Under Reorganization Plan" - Medtech Insight, 3 February, 2003., p. 17).

Meanwhile, CDER's DDMAC currently has only seven reviewers, Hinchey noted. Despite a 6% increase in ads reviewed last year, enforcement letters dropped 75%, he claimed. The decrease in action results from "a conscious effort on the part of the FDA to weaken advertising regulations," the congressman contends.

FDA Approps Amendment Targets Chief Counsel Troy

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