The FDA is being sued by a prescription fish oil company that wants to market its product for an unapproved off-label use, as well as several doctors who say they want information on the off-label use of this prescription fish oil to lower triglycerides (read full story here).
This has been ongoing debate as drug companies continue to litigate what they see as their First Amendment right to truthful and non-misleading promotion of drugs for off-label uses.
To be clear, doctors have always been allowed to use their judgment and prescribe a drug for an off-label use when they deem it appropriate. Pharmaceutical companies, however, are not currently allowed to promote and market drugs to doctors for off-label use.
The Federal, Food, Drug and Cosmetic Act (FDCA) only permits a drug to reach the market if it undergoes a rigorous approval process to show that it does what the pharmaceutical company says it does and that the benefits of the drug outweigh the risks. The purpose of the FDCA is to protect the public and ensure that pharmaceutical drugs are safe and effective for their intended use. An off-label use is one for which the drug did not undergo this rigorous process. In other words, the pharmaceutical company has never done the required clinical trials to show that the drug is safe and effective to treat the off-label condition nor that the risks of using the drug for that purpose outweigh the benefits.
Allowing pharmaceutical companies to promote and market drugs to doctors for off-label use would let them circumvent this costly and necessary approval process. In theory, once a drug is approved for a particular use, it could be marketed for other uses where there is evidence that it may be effective for those off-label uses, but where limited or no clinical trials have been done proving safety and effectiveness. Although costly, the pharmaceutical companies can clearly afford to do the required clinical trials for purposes of getting a drug approved for a particular use. According to the authors of a report in the British Medical Journal in 2012, for every dollar pharmaceutical companies spend on "basic research", $19 goes toward promotion and marketing.
First Amendment rights are not absolute. Here, protection of commercial speech does not outweigh the government's strong interest in protecting public health. The restrictions on off-label promotion and marketing of pharmaceutical drugs should remain intact.
Learn more about the off-label drug marketing debate here.