Magazine article The American Prospect

The War on Facts Hits Prescription Drug Regulation

Magazine article The American Prospect

The War on Facts Hits Prescription Drug Regulation

Article excerpt

The FDA's authority was under legal attack even before Trump. Now the agency faces a triple threat.

Regimens of "regulatory relief" have begun to course through Washington's veins, to treat a presumed diagnosis of severe governmental constipation. President Donald Trump has vowed to purge "over 75 percent" of the regulations governing the approval and manufacture of prescription drugs.

His nominee for commissioner of the Food and Drug Administration, Scott Gottlieb, a physician at the American Enterprise Institute, has argued that many of the current requirements that oblige manufacturers to demonstrate that their drugs are safe and effective represent excessive big-government impositions on the creative elan of pharmaceutical manufacturers.

Two other worrisome developments in these directions predate the election and are likely to further transform the medications landscape. The first is a legal movement to undercut the FDA's authority to regulate drugmakers' marketing claims. The second is legislation passed by Congress in December and signed by Barack Obama that could diminish the rigor of clinical trials needed to demonstrate the safety and efficacy of drugs in patients. These developments and the advent of the Trump presidency pose a triple threat to the protection of patients' interests and the public health.

The legal movement against the regulation of drug marketing is based on a claim that the FDA violates a company's rights of "commercial free speech" when it prohibits marketing statements that fail to meet the agency's standards of scientific accuracy. Before 2011, the constitutionality of federal regulation of commercial claims about drugs was no more in question than the regulation of drugs themselves. The justification for that regulation has been clear. Even physicians are in a poor position to evaluate commercial claims about drugs. The terabytes of clinical and pharmacological data provided to the FDA by manufacturers for all new drugs are too complex for individual doctors or patients to evaluate adequately. Some of that data, moreover, is owned by the pharmaceutical company, and no one outside the FDA is permitted to see it. Stripping the FDA of authority to regulate pharmaceutical claims for accuracy deprives the public of a basic protection.

Nonetheless, that is exactly what is happening. In 2011, a federal appeals court invoked the First Amendment in overturning the conviction of a pharmaceutical sales representative who had told doctors that an obscure neurological drug also worked for chronic pain, fibromyalgia, and chronic fatigue syndrome. None of those uses had been demonstrated to the FDA's satisfaction, and the drug had not been approved for those purposes. The FDA, however, did not appeal the decision, apparently fearing that it could lose in the Roberts Supreme Court.

The assault on the FDA's authority over promotional statements has continued. Last year, the agency settled with a tiny Ireland-based drugmaker that insisted on its right to promote its only product, a fish-oil derivative, on the basis of an unproven claim that it is useful for lowering moderately high blood triglycerides to prevent heart disease. The FDA, by now in active retreat, sent a conciliatory letter to the manufacturer saying the company could do pretty much what it wanted. If the trend continues-and under Trump it probably will-the door will open wider to unfettered pronouncements by manufacturers about the purported benefits and safety of their drugs. …

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