FDA Career Staff Objections Ignored–Again

The House of Representatives Committee on Oversight and Government Reform has released its report about the Bush Administration’s imposition of new preemption policies within the FDA. Historically, the FDA viewed litigation brought by those harmed by medical devices or medications as a complement to the agency’s regulatory efforts to protect against the effects of unsafe devices and drugs. The agency recognized that these cases help to uncover the risks that were unknown to the agency (or hidden from the agency by the manufacturer) at the time the product and its labeling were approved, thereby providing another layer of consumer protection against unsafe products. In 1997, former FDA Chief Counsel Margaret Jane Porter stated: “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct layer of consumer protection. FDA regulation of a device cannot anticipate and protect against all safety risks to individual consumers….Preemption of all such claims would result in the loss of a significant layer of consumer protection.” This position was uncategorically reversed in the Bush Administration in favor of overt advocacy by the agency in support of preemption of litigation, effecting essentially a grant of immunity to the manufacturers of medical devices and drugs.

Internal agency documents obtained by the Committee now show that these regulatory changes were made by the FDA over the objections of key career officials who repeatedly warned that the central factual justification offered for the agency’s new directives was false.

For example, the preamble to the 2006 labeling rule asserted that the FDA has the ability to “carefully control” drug labeling and to continuously monitor the safety of pharmaceutical products, incorporating information into the labeling when appropriate. Dr. John Nenkins, the highest official in FDA’s new drug review process, strongly disagreed with these assertions, writing: “[M]uch of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false….We know that many current approved drug labels are out of date and in many cases contain incorrect information.”

Remarkably, the preamble to the 2008 labeling rule claims that the preemption revision merely conforms the language of the rule to the agency’s settled interpretation, a statement that is manifestly not the case. Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research, advised that, “[t]he rule is not, as it purports to be, consistent with the agency’s role in protecting the public health,” and was not, in fact, reaffirming the FDA’s long-standing interpretation.

Under the Bush Administration, the FDA has been suborned to act in a way designed to protect the manufacturers of medical devices and drugs from potential liability. It has done so by actively ignoring the objections of career FDA officials who understand the vital role the FDA plays in protecting the public in its use of food, drugs, and medical devices. The FDA’s mission should be to advance medicine and science, not to serve a political agenda illicitly designed to protect corporate interests over the protection of those they have sworn to protect,


House Committee Report, October 2008

FDA Preemption: Another Bush Legacy Wrecking The House

Stealth Tort Reform: AmBush At The FDA

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