The U.S. Food and Drug Administration announced last month that it will be holding a meeting to discuss off-label drug use with the public, addressing concerns from pharmaceutical companies that their First Amendment right invoking free speech is being violated.
Drug companies have been calling on the FDA to ease restrictions of off-label drug use, with efforts gaining steam after a court decision in 2012 overturned the conviction of a drug sales representative who promoted off-label use for Xyrem, a narcolepsy drug. Under current rules, doctors can prescribe medications off-label for any condition but pharmaceutical companies cannot promote their products for uses not approved by the FDA.
A coalition of drug companies, which includes GlaxoSmithKline, Pfizer, Johnson & Johnson, Novartis AG and Sanofi, filed a petition citing the 2012 case to get the FDA to relax restrictions and come up with a more appropriate regulatory ruling. Should the agency cave, pharmaceutical companies are looking at billions of dollars in sales because medications may be made available for more than their intended use.
However, this also means a dramatic weakening in the FDA's regulatory authority.
According to Karen Rile, a spokesperson for the agency, the FDA decided to have a public meeting to take stock of the wide-ranging views that different stakeholders have and to take into consideration underlying issues with public health.
Over the last 10 years, 17 companies were forced to pay over $16 billion in fines to settle for promoting off-label drug use. In September, for instance, Shire Plc settled charges for overstating benefits of Adderall XR, paying $56.5 million for claiming that the drug for attention deficit disorder can prevent sexually transmitted disease, traffic accidents and criminal behavior.
According to the American Medical Association, off-label drug use represents up to 20 percent of prescriptions, most of which in the areas of rare pediatric diseases and oncology. The AMA itself supports the importance of doctors having access to unbiased and accurate information regarding off-label drug use but still wants to ensure that promotions sponsored by manufacturers meet standards set by the FDA.
"People do not realize that the consequences of this new ideological approach to the First Amendment will be measured in lives," said Joshua Sharfstein, former principal deputy commissioner for the FDA. Sharfstein is now the associate dean for the Johns Hopkins Bloomberg School of Public Health.
Critics also pointed out that if pharmaceutical companies are allowed to promote off-label drug use, they won't find incentive in conducting clinical trials to ensure products are safe and are working for their intended purpose.
Photo: Tom Gillin | Flickr
