Getting Out From Behind the Counter

So close, and yet so far away.

That pretty much sums up the prospects for a behind-the-counter drug class—products that could be sold without a prescription but with more restrictions than OTC medications (such as the oversight of a pharmacist).

Despite interest from both industry and FDA on a behind-the-counter drug class for products like statins and oral contraceptives, questions about the agency’s regulatory authority have slowed any momentum on the creation of an intermediate class of drugs.

Unfortunately, the passage of the FDA Amendments Act last year didn’t make things any clearer. Indeed, although the creation of a behind-the-counter class would fit perfectly with the intent of the agency’s new risk management authorities under FDAAA, the actual legislation explicitly limits that authority to prescription-only products. And FDA has so much to do in implementing FDAAA that any further work on a formal guidance on a third class of drugs will have to wait.

So how can interested companies move forward on a behind-the-counter class?

As reported in “The Tan Sheet” this week, one former FDA deputy commissioner, Scott Gottlieb, recommends simply asking the agency. “The best alternative right now for them is to encourage sponsors to come in on an ad hoc basis with plans for using risk-management proposals as a way to carve out a third pathway for select drugs.”

“In the absence of a guidance spelling out a formal process, the best [FDA] can hope for is that enough sponsors will come in with proposals that they will essentially carve out a pathway by example,” Gottlieb said.

One obvious opportunity for a behind-the-counter product is lovastatin (Mevacor); Merck has applied for an over-the-counter switch of the statin on three separate occasions, but has not been able to convince FDA that patients can safety use the drug without the supervision of a physician.

Office of New Drugs director John Jenkins referred to Mevacor in response to a question about behind-the-counter drugs during a town hall session at the Drug Information Association’s annual meeting last week.

“So far, no one has been able to package that type of therapy into a program that can work in the traditional over-the-counter paradigm that we have in this country,” Jenkins said. “The consumer needs to be about to self-select, self-diagnose and self-treat without the involvement of a health care provider.”

“That has led people to question, ‘could you improve access and maybe have improved outcomes by making some of these treatments for chronic, asymptomatic conditions available without a prescription?’ I think it’s an area that’s clearly still in discussion and debate.”

For companies interested in marketing products behind the counter, there’s still some hope for a formal pathway. As Jenkins noted, “we’re about to change administrations. That will probably have some impact on thinking about this issue. So I think it’s still very much up for discussion.”