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I start with the simple question: Does the Food and Drug Administration exist to protect the public health, or to shield pharmaceutical giants from responsibility for defective drugs or inadequate labeling?

After reviewing an astonishing report just submitted to Representative Henry Waxman’s Committee on Oversight and Government Reform, I regrettably conclude that for the last 7 years the current adminstration has carried on an unprecedented and relentless assault upon this agency with the sole purpose of removing any meaningful protections for the consuming public in favor of insulating pharmaceutical interests from responsibility for the harms their products cause. The article makes it plain that even the career administrative heads and scientists were helpless to defend against the politically motivated "sea change" in philosophy that the administration forced upon them. The goal was to wipe out , once and for all, civil responsibility for defective drugs and devices under the auspices of "Federal Pre-emption," and not to follow the FDA’s primary charter, "to protect the public health."

In the report entitled, "FDA Career Staff Objected to Agency Preemption Policies," it is first noted that the FDA’s regulatory role in approving drugs and labeling requirements has historically been viewed as only one arm of the consumer protection process. Before the Bush administration, the FDA always viewed private litigation in State courts as a complimentary and "additional layer of protection against unsafe drugs." After all, the FDA must rely on the sponsors of the drugs for their testing and truthful reporting to evaluate the drug’s effectiveness and dangers. Where the testing was inadequate, or the risks and hazards were concealed or understated, the results would be determined "in the field," i.e., when consumers were harmed or sickened by the drug.

In an effort to reverse this long-embedded viewpoint of the FDA, the Bush administration, through a series of modest regulatory changes, sought to make the FDA’s approval of a drug or device sacrosanct and unassailable. To do this, the new regulations prohibited manufacturers from disclosing any new safety risks to the public without obtaining FDA approval first. Prior to this, manufacturers had been encouraged to make immediate changes for the sake of public safety, with the requirement that the supplemental labeling be submitted afterwards for agency approval. The purpose of Bush’s new regulation was to offer support to the manufacturer’s protest that they should not be held liable for the inadequacies of a label when they had no power to change it. The power was in the FDA. And as the FDA was a Federal agency, the supremacy clause preempted state court actions.

At the time that these new regulations were being proposed, the justifications offered by the political bosses of the Department were rebuked by the highest ranking career officials and scientists of the FDA as being "false and misleading," "gross overstatements," and based upon an essential "false assumption" that "FDA approved labeling is fully accurate and up-to-date in a real time basis." These officials recognized that these changes would "undoubtedly help shield drug manufacturers from liability." That was their sole unvarnished purpose.

On November 3, 2008, the day before our country goes to the polls to determine the next administration, the case of Wyeth v. Levine will be argued before the U.S. Supreme Court. Potentially, this case will decide if the FDA has preempted the field and thereby nullified any ability on the part of individual consumers to recover for their injuries caused by defective drugs. The Supreme Court should look to the historical role that the FDA and state courts have had since 1906 and uphold and honor the protections that these complimentary forums have provided to the otherwise helpless individual. Should the goal be to protect the citizen, or the asset?

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