The War on Facts Hits Prescription Drug Regulation

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This article appears in the Spring 2017 issue of The American Prospect magazine. Subscribe here

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 élan 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.

Yet another pre-Trump development weakening drug regulation is the 21st Century Cures Act, passed by Congress and signed by President Obama in December. Based on the erroneous proposition that the FDA has an unacceptably sluggish transit time for new drug approval (it’s actually impressively rapid), the law instructs the agency to rely more on a new medication’s capacity to bring about changes in laboratory tests and other “biomarkers” as evidence that a drug works, rather than requiring controlled clinical trials to demonstrate improved outcomes for patients. In the hands of a new FDA commissioner bent on regulatory relief, the “Cures” act could open the floodgates to more prescription drugs coming to market without evidence that they make patients healthier.

In the coming year, the interplay of these developments linking the courts, Congress, and a new executive branch will bring agita to physicians, patients, and insurers alike. Sales pitches by prescription drugmakers have often been glitzy and over-hyped, but until now they at least had to satisfy the FDA’s high standards for scientific accuracy. Now, commercial free-speech rights may be invoked to give a pass to most statements a company chooses to make, even if there is no more than a grain of “truthiness” to them. At the same time, congressionally mandated looser criteria for FDA drug approval could undercut the agency’s long-established status as the internationally respected guarantor of drug effectiveness and safety. The new administration could well be forcing new products through the evaluation pipeline at a trot, before prescribers, payers, and patients get a chance to digest the necessary data on their effects.

During the presidential campaign, Trump said he would bring down the prices Americans pay for drugs—the highest in the world—but no movement in this direction is evident yet. The dismantling of the Affordable Care Act would make drugs even less affordable and lead to tragic, preventable, and costly clinical consequences for patients who need them.

Some countermeasures are available to both professionals and the public at large. We will all need to rely more on independent, noncommercial sources of information that assess drugs’ effectiveness, safety, and value. My colleagues and I have been trying to improve the dissemination of that kind of information for over a decade. Drawing on a team of clinicians who don’t accept any consulting dollars from drugmakers, we critically review all the treatments available to treat a given condition, package the conclusions in a manageable, user-friendly format, and then “market” this commercial-free information to prescribers in their offices much as companies’ sales reps do—but without any sales agenda.

In the 19th century, draconian purgative treatments and other useless drugs were a mainstay of clinical medicine. They were widely promoted until medical research showed they were both useless and dangerous, and the government stepped in to protect the public. Looser-is-better drug regulations will force us to relearn what Americans learned at great cost once before. Screening out dangerous and ineffective drugs is essential to public health and to our reliance on medications that genuinely deserve both our money and our trust.

 

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