As a member of the Justice Department investigating the marketing and use of non-FDA-approved devices, what would you recommend?
I. Device companies should be financially punished for marketing products for non-FDA-approved uses. These practices are against the law.
2. Let's be practical and forget the law in this case. These devices represent "off-label" treatments that are helping people, and the goal of medicine is to help people.
3. It's unfair to allow doctors to use drugs or devices for off-label treatments, but then punish device firms for essentially doing the same thing. Decisions like this should be done on a case-by-case basis and this is a case where device firms should be left alone.
Some 250,000 people last year under went an operation in which tiny bits of heart tissue were burned into a maze pattern to reroute the heart's electrical system. This is done to fix the most common type of faulty heartbeat, a trial fibrillation. The devices widely used for this operation haven't been approved by the U.S. government to treat that condition. Yet today these products, which have sales of about $100 million a year, are used almost exclusively to treat atrial fibrillation, according to executives, doctors, and others familiar with the industry. These devices were approved for "ablation," or the destruction of tissue, which historically has often meant sealing a wound to stop bleeding. But the devices aren't specifically approved by the Food and Drug Administration for atrial fibrillation treatment, a more complex procedure. To get approval for treating "A-fib," as it's known, would require companies to conduct expensive clinical testing. The Justice Department is investigating whether companies that make these surgical-ablation devices have been violating the law by actively marketing them for non-FDA-approved uses, such as treating a trial fibrillation. Although doctors may use drugs or devices for off-label treatments, companies are allowed to market them only for the uses for which they have been FDA-approved. The idea behind this restriction is to limit the number of U.S. patients exposed to experimental, relatively untested treatments.