The FDA recently released a draft of guidelines that would allow drugmakers to distribute reprints of peer-reviewed journal articles that suggest off-label uses for their medications. Doctors have always been able to prescribe drugs as they see fit and off-label prescription is commonplace throughout the medical field, but drugmakers have never been allowed to promote medications for any use other than those the drug was specifically approved for. The new guidance could give drugmakers a whole new way to market their products.
The guidelines prohibit several flavors of publications, including special supplements, letters to the editor, early-stage trials in healthy patients, and articles that are “inconsistent with the weight of credible evidence.”
Many believe that articles relating to effective off-label uses significantly broaden the scope of medicine and may even constitute a medically recognized standard of care.
Others are not pleased with the new guidance. Congressman Henry Waxman is one of the staunchest opponents of the proposal. He believes that drug companies will use their freedom to curtail the approval process. He is concerned that companies will design clinical trials to favor their products and in turn circumnavigate FDA regulation for additional uses.