While the Food and Drug Administration (FDA) is charged with supervising a wide array of public health concerns that include blood transfusions, radiation-emitting devices, tobacco products and even cosmetics, many know the government agency for the regulation of prescription and over-the-counter drugs—something they have aggressively done since their creation in the early part of the Twentieth Century through the consumer protection laws known as the Pure Food and Drugs Act (PFDA) and the Federal Food, Drug and Cosmetic Act (FFDCA). In fact, today’s modern era of drug regulation has been following the same framework first established with amendments to the FFDCA in 1962.
One of the agency’s efforts is the prohibition of drug marketing for uses that have not gone through clinical trials and received FDA approval. Such “off-label” use has always been a prerogative of the prescribing physician, but history has shown the FDA to be fairly aggressive in legally pursuing any drug manufacturer that promotes unapproved uses (not listed on the product’s label). Yet, this could all change with the FDA’s new commissioner, Scott Gottlieb. Appointed in May, Gottlieb advocated for the loosening of off-label restrictions when he was a physician and resident fellow at the American Enterprise Institute. In a move that could be mirrored by other states in the near future, Arizona became the first to allow drugmakers to communicate directly with doctors by passing the Free Speech in Medicine Act—allowing pharmaceutical companies to relay off-label information, regardless of FDA approval, as long as it’s deemed as “truthful promotion.” This relatively new law exemplifies two important aspects of most proponents’ argument for relaxed restrictions; that the practice of medicine should be state regulated and that members of the pharmaceutical industry have the right to free speech.
Yet there are many who believe that lifting or loosening such restrictions could be a big mistake that might put patients more at risk. Aaron Kesselheim, director of the Program on Regulation, Therapeutics and Law at Harvard Medical School points out that, “There have literally been dozens and dozens of examples of off-label uses of drugs encouraged by pharmaceutical companies in reckless ways that have led to substantial patient morbidity and mortality.” Others point to the growing trend of off-label usage that could skyrocket if safe checks are not kept in place. Currently it is estimated that 20 percent of prescriptions currently written by doctors are for off-label uses. Some studies even point to certain conditions as experiencing even higher rates of non-FDA-approved usage as doctors seek new treatments. For example, tricyclic antidepressants (TCAs) are approved to treat depression, but many doctors choose them for patients suffering from nerve-related (neuropathic) pain—in many cases, it’s their first drug of choice for this off-label use.
For many, what’s really being questioned here is not government agency process, availability of information or the rights of corporations—it’s the issue of public safety. If manufacturers were able to demonstrate the safety of their products and proceed through the proper channels, wouldn’t they do just that? Any effort to communicate a drug use beyond what’s approved by the FDA, seems like an obvious attempt at skirting such objective evaluation.
“If [such] approval by someone with no financial interest is necessary to protect patients, then marketing a drug for unapproved uses is the same as marketing an unapproved drug,” says Allison Zieve, a representative for a consumer watchdog group called Public Citizen. To allow drugmakers to do so, she said, would undermine the whole system of FDA drug approval.
Derek T. Braslow is a partner of Pogust Braslow & Millrood, LLC. He is one of the first attorneys to file suit on behalf of families who lost a child, spouse or parent to suicide as a result of psychotropic medication and one of the first to file a suit against investigators, sponsors and institutional review boards for conducting unethical human clinical trials. Derek was voted by his colleagues as a Rising Star and SuperLawyer in the area of Pharmaceutical and Mass Tort litigation.