Off-label Prescription Drugs: Legal and Safety Issues

Legal issues surrounding the marketing of prescription drugs for off-label uses have been in the news in the past year. The term off-label refers to medications used for a purpose not approved by the U.S. Food and Drug Administration (FDA).

It is important to note that lack of FDA approval for a particular use does not mean that any other use is specifically disapproved. The most common reason that not all uses are included in a drug's labelling is that obtaining approval for every possible use of a medication is a laborious and time consuming process. Many pharmaceutical manufacturers do the studies and submit the results for FDA approval only for the uses that will make the drug profitable quickly. They may or may not seek approval for additional uses later.

Many drugs are commonly prescribed off-label based on a physician's knowledge of the drug and scientific research reported in the medical literature. In fact, one in five prescriptions is estimated to be for off-label uses. Common examples of off-label prescriptions include beta blockers used for heart failure, cancer drugs approved for one type of tumor and used for others, antidepressants for chronic pain, and antipsychotics for ADHD.

Prescribing drugs for off-label use is entirely legal, although promoting off label use by manufacturers is not. However, off-label prescriptions expose patients to risk of injury, and doctors to potential lawsuits. An example of the dangers of prescribing off-label medications is the drug Fen-Phen.

Fen-Phen is actually two drugs, each of which was separately approved by the FDA for short-term weight loss treatment. However, doctors began prescribing the combination drug, with significant negative consequences. Patients began developing serious heart-valve defects, and a multi-billion dollar lawsuit resulted. The FDA finally ordered that Fen-Phen be removed from the market in 1997.

The prescription drug industry has been the defendant in numerous other lawsuits charging promotion of medications for off-label use. GlaxoSmithKline paid a $3 billion fine in July 2012 for promoting off-label use of antidepressants and other drugs. Just one month later, Johnson & Johnson settled a consumer fraud claim with 36 states and the District of Columbia for marketing the anti-psychotic Risperdal for off-label uses.

However, the tide may be turning in favor of drug manufacturers, if a recent federal appeals court decision signals the start of a trend. A three-judge panel of the Court of Appeals for the Second Circuit in Manhattan threw out the conviction of a sales rep who had been charged with selling a drug for off-label purposes. Two of th e judges on the panel said that the FDA's ban on marketing drugs for off-label use violated the rep's free speech rights. A third judge dissented.

The representative was caught on tape discussing off-label uses of the drug Xyrem with a physician who was a government informant. The drug, at the time manufactured by Orphan Medical, had been approved for treating narcolepsy, but the sales rep was charged with promoting it as appropriate for insomnia, fibromyalgia and other non-approved conditions. He was convicted in 2008.

The court ruling said that while the FDA allowed the prescription of drugs for off-label use by doctors, it suppressed information from drug companies that would help prescribers make informed decisions about off-label prescriptions. Although the decision only applies to the states covered by the Second Circuit - New York, Vermont and Connecticut -- it is quite possible that the issue will be the subject of litigation elsewhere, even in the U.S. Supreme Court in the not-too-distant future.

If you believe that you or a loved one were injured by an off-label prescription drug, one of the attorneys and Elk & Elk Co., Ltd., can advise you about your options.