The FDA wants to knock down obstacles to certain drug treatments. It's an idea doctors abhor and insurers cautiously embrace, and one the FDA has floated before, if in other forms. If it reclassifies drugs that pharma has repeatedly asked for permission to sell over-the-counter--such as cholesterol-fighting statins--then drugmakers will no doubt cheer.
Here's the proposal: FDA would free up some treatments for chronic conditions, such as asthma and diabetes, so patients could obtain them without a prescription. They wouldn't be over-the-counter products, available on supermarket shelves, but a new class of "safe use" drugs. Consumers would have to get clearance from a pharmacist--or a diagnosis via specially designed websites--to purchase them.
For obvious reasons, doctors aren't thrilled by the idea. No office visit required for an inhaler refill? They'd be out of the loop on a variety of everyday care decisions. But insurers could save big money if physician visits weren't required for run-of-the-mill complaints and ongoing medication monitoring. (They also might save on the drugs themselves, depending upon how they're classified; most health plans don't pay for over-the-counter treatments.)
In this case, cost savings for insurers could mean savings for the entire system. "Greater over-the-counter and behind-the-counter access will lower costs and make healthcare more accessible to consumers," former FDA commissioner Scott Gottlieb said via Twitter. "It's a good idea long overdue."
Given the power of the American Medical Association, the FDA will have a fight on its hands as it moves to turn its proposal into reality. Already the AMA has lambasted the idea in a USA Today op-ed, saying that patients need guidance from doctors. The doctors' association also points out that giving patients more control could complicate coordinating care--for instance, tracking all the drugs a patient uses to prevent interactions
But as The Washington Post points out, FDA sees the doctor's visit as a hindrance to care; some patients don't seek treatment if they have to see a physician first. For drugmakers, expanding treatment expands the market. "Obviously, it's much easier for you to go to your drug store and pick up an item than it is to make an appointment, take a prescription, drop it off and get it filled," Nancy Chockley, president of the National Institute for Health Care Management, told The Washington Times. "It dramatically increases access and will up sales of these drugs. It's like going from a boutique drug to mass distribution."