If the Food and Drug Administration can’t regulate how pharmaceutical companies market their drugs to doctors, its ability to protect the public will be severely diminished. A federal court ruling last week makes this scenario possible, and it will take a concerted effort by the FDA to continue setting limits on eager pharmaceutical salespeople.
The court decided that free-speech protections give drug companies the right to market off-label uses of their medications as long as the information they provide is accurate and not misleading. Off-label use refers to prescriptions of FDA-approved drugs for ailments or populations they weren’t explicitly approved for, such as using chemotherapy created for one type of cancer for other types, or prescribing adult medications for children. In this case, the company, Amarin, sought to promote a product approved for patients with severely elevated triglyceride levels as useful for patients with less extreme levels, which would dramatically increase the product’s potential customer base.
A study had found the product — prescription-grade omega-3 fatty acid — useful in treating those with lower triglyceride levels, but the FDA would not approve that use unless there was evidence that it would actually reduce the risk of heart attacks for that population. Amarin argued that it should be allowed to show doctors the study.
It’s legal, and often good for patients, for doctors to investigate and try new uses of prescription drugs, and to share the results in journals or online. But the FDA takes a dim view of pharmaceutical companies using that information to market their products without the agency’s specific approval, and for good reason. The companies and their sales staff have a strong financial incentive to expand the possible uses of each drug, whether or not it’s particularly helpful. Off-label uses can also have as-yet-undiscovered risks.
The meaning of “truthful” and “not misleading” can easily become obscure when money is at stake. A drug rep could present a doctor with a small-scale study of a product or say that other doctors he deals with have had success with a specific off-label use, which might be true but is evidence of very little.
The FDA has been working on setting standards for the kinds of information that pharmaceutical companies can promote to doctors. It might make sense, for example, to allow drug reps to show doctors high-quality, published studies whose results have been replicated. That’s better than restricting all promotion or allowing a marketing free-for-all.