Off Label Documentary about FDA

This documentary offers a glimpse into the practice of using drugs like Provigil for purposes that they weren’t originally intended for.

Off Label”, a film by Portland, Oregon filmmakers Michael Palmieri and Donal Mosher, has been selected by the influential Tribeca Film Festival for its upcoming competition event in mid-April in the category of best documentary. The film’s title refers to the increasingly common practice of using prescription drugs in ways not approved by the U.S. Food and Drug Administration.

Palmieri and Mosher have interviewed “misdiagnosed patients, professional guinea pigs, recreational drug users, and soldiers struggling with PTSD”, according to the Festival’s synopsis, and “exposes the breadth of off-label drug use (in) an overmedicated, misdiagnosed, and drug-addled America.”

For instance, the drug Modafinil, developed in France in the 1970s but more widely known after 2001 as the brand name Provigil, was originally meant for the treatment of narcolepsy and other related sleep disorders. That remains its sole, narrowly-defined, FDA-approved use.

But the wide array of off-label medical uses for Modafinil include treatment of ADD, Parkinson’s,cocaine dependence, an entire subcategory of psychological conditions from depression to schizophrenia, and the treatment of symptoms of multiple sclerosis. It’s been known to be used as a sports doping agent. It’s even prescribed for jet lag. It’s evidently widely used by medical students to reduce the need for sleep. Studies suggest that it can reduce appetite effectively, and there are a half-dozen other experimental uses.

However effective and promising, though, every script written by a doctor for off-label use of Modafinil undermines the role of the FDA as gatekeeper. This means potential abuse and increased risk to patients. In the United States it is perfectly legal for physicians to prescribe medications in dosages, or for uses, which are not FDA approved. The practice of medicine is regulated by the states. The drug companies, however, cannot promote off-label use. It hasn’t escaped the drug companies’ attention that the expensive and enormously time-consuming drug approval process keeps them out of some very lucrative markets for their products. They’ve responded by breaking FDA regulations, for instance the illegal off-label marketing of Bextra and three other drugs, for which Pfizer paid a criminal fine of $1.2 billion in September 2009. This was the largest criminal fine of any kind in American history. They’ve also responded with a U.S. District Court challenge filed last October, claiming that restricting their marketing of off-label uses of their products amounts to a restriction of their right to free speech under the First Amendment.