FDA Nominees Need to Focus on Drug and Device Safety

President Obama has announced the nomination of Dr. Margaret Hamburg, former New York City health commissioner and assistant health secretary during the Clinton administration, as the new commissioner of the Food and Drug Administration, with Baltimore health commissioner Dr. Joshua Sharfstein to serve as chief deputy commissioner. Curiously, the President, in announcing these appointments, focused solely on the need to improve food safety regulation and oversight, and failed to deliver a clear message on the need for adult supervision of the pharmaceutical and medical device industries. While there certainly have been problems with the FDA’s oversight of food safety, the agency’s oversight of drugs and devices, or lack thereof, has been severely detrimental to the American public. Under the Bush administration, these industries were allowed to wreak havoc on consumer health, the Medicare and Medicaid systems, and private health and welfare funds. American taxpayers have seen billions of dollars wasted on drugs and devices that have caused outright harm to human health, do not work, or have been wrongfully marketed.

A key Supreme Court decision this month questions the integrity of the FDA under the Bush administration, leading to questions about whether the FDA has been acting in the interest of consumers or on behalf of big pharma. In Wyeth v. Levine, decided on March 4, 2009, the Supreme Court dealt with the issue of whether damages awarded in favor of a plaintiff who sued a pharmaceutical company could stand in light of an argument that the company could not be held liable as long as the FDA had approved its product. The argument rested on the constitutional doctrine of preemption. The defendant drug company had argued that a regulation promulgated by the FDA in 2006 contained a “preamble” making it clear that the Federal Food, Drug and Cosmetics Act established both a “floor” and a “ceiling” with regard to labeling and thus preempted any state effort to regulate in this area. Writing for the majority, Justice Stevens rejected the FDA’s pronouncement as being authoritative on the question of preemption. Stevens wrote: “In 2006, the agency finalized the rule and, without offering States or other interested parties notice or opportunity for comment, articulated a sweeping position on the FDCA’s preemptive effect in the regulatory preamble. The agency’s views on state law are inherently suspect in light of this procedural failure.”  Stevens further noted that the preamble reversed the FDA’s longstanding position without citing a reason. Writing in favor of the Plaintiff and rejecting the preemption defense, Justice Stevens stated: “The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.”

Last week, Valerie Jarrett, Senior Advisor to the President, explained that President Obama’s foray into education reform will not distract from his efforts to fix the economy. Jarrett told reporters that everything is tied to the economy. Such is the case with the FDA and its oversight of the pharma and device industries. We cannot be competitive where our health care costs continue to skyrocket because we are paying for drugs and devices that do not work  For the President’s two new nominees, pharma and medical device oversight must be a priority, not an afterthought.

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