FDA Runs Protection Racket For Big Pharma

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By Evelyn Pringle (about the author) Page 3 of 10 page(s)

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One of the main authors of the new labeling rules was the FDA's Chief Counsel at the time, Daniel Troy, who in previous employment fought the FDA in court to allow drug companies to promote drugs to doctors for "off label" use.

Its now obvious when looking back, that Mr. Troy was appointed by the Bush administration to implement tort reform under the guise of preemption, and under the cover of the Office of Chief Counsel at the FDA.

In the midst of the Vioxx and SSRI antidepressant disasters, instead of going after the drug makers for knowingly injuring hundreds of thousands of consumers with dangerous products, Mr. Troy devoted the majority of his time on the clock to filing five amicus briefs on behalf of Big Pharma to be used against the very citizens who were paying his salary.

In his briefs, Mr. Troy focused his main attention on protecting the profits of the makers of SSRIs, drugs second only to Vioxx when it comes to the concealment of studies and information about harm that if revealed, could have prevented tens of thousands of deaths and injuries over the past 20 years.

And even though there has been an infinite number of reports over the past decade regarding an increased risk of suicide with SSRIs, instead of withdrawing the approval of the drugs, requiring more studies, or demanding a warning be added to their label, Mr. Troy did nothing to protect potential SSRI victims as Chief Counsel of the FDA.

In late 2004, Mr. Troy quit the FDA to go back into private practice to once again represent pharmaceutical companies openly against private citizens, only with the added benefit of using the preemption defense he put in place.

On October 9, 2006, Mr. Troy published an article in the Legal Times, that said, "I was also at the FDA while January's Physician Labeling Rule, which contains a statement in its preamble about the FDA's pre-emption authority, was written."

"And I now," he states in an obvious ad for new clients, "advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements."

In the Times article, Mr. Troy points out the importance of drug companies staying cozy with the FDA to ensure success in future litigation. "Savvy companies," he wrote, "are recognizing that how they interact with the FDA today may profoundly affect their pre-emption defenses in the future."

"They are trying to ensure their communications with the agency are as formal as they can be," he said, "in light of commercial considerations and the need to stay on the FDA's good side."

"More formal communications," he advises, "can help buttress a future case for why a particular state law claim should be pre-empted."

In the article, Mr. Troy brags that his filing of FDA briefs on behalf of Big Pharma "has reduced the negative consequences of the current pharmaceutical-liability regime."

But for once, he at least mentions that it cost the tax payers plenty. "FDA involvement in state-law cases is not an ideal solution," he writes, "not least because each instance of such involvement involves the costly investment of substantial agency resources."

It should be noted that two years before Mr. Troy filed his first brief as a kick-off for the preemption policy, the "costly investment of substantial agency resources" went for an FDA brief, in which the FDA acknowledged "the historic primacy of state regulation of matters of health and safety" and the appropriateness of a presumption against preemption where the state-law claims allege defective design, negligent manufacturing, or failure-to-warn in, Buckman v. Plaintiffs' Legal Committee, 531 US 341 (2001).

In the Legal Times, Mr. Troy goes on to explain that the new labeling rule is intended to limit the direct involvement of the FDA in lawsuits. "The preamble to that rule," he says, "makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases."

"If courts give appropriate deference to this statement of FDA's considered judgment," he notes, "FDA will not be forced to file briefs in individual cases."

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