There’s a Blurry Line Between Rx and O.T.C.

Interesting piece by Gina Kolata on the way prescription meds get reclassified for over-the-counter sales. The article accurately states:

At the heart of its decisions, the FDA says, are straightforward scientific and medical questions. Is there a low potential for abuse or misuse? Can consumers use it for self-diagnosed conditions? Can the drug be adequately labeled? Are doctors needed for its safe and effective use?

It also says:

The decision to sell a drug by prescription, experts say, may involve factors that have nothing to do with science or patient safety. Marketing and financial considerations, politics, doctors' concerns and consumer psychology all may play a role.

How can both statements be true? Consider the morning-after pill, which an expert panel has recommended to FDA Commissioner Mark McClellan be made available as an OTC drug, and the competing social agendas at work:

If the morning-after pill were sold over the counter, doctors who opposed the change said at the F.D.A. hearing, teenagers would avoid counseling on responsible sexual behavior. Some also said that making the drug over the counter would interfere with their relationship with their patients. Those favoring the change said that teenagers are going to have unprotected sex in any case and needed a safe way to avoid pregnancy.

And then there's the impact of insurance:

In other cases, straightforward commercial considerations can determine how a company wants a drug classified. For example, drug manufacturers know that patients with drug coverage often prefer prescriptions to paying the full cost of over-the-counter drugs.

Doctors say they see this insurance effect all the time. Dr. James Osborne, an internist in Greensboro, N.C., says when patients with occasional heartburn ask for a prescription for Nexium, he often suggests they buy Pepsid, which costs 24 cents a day for the four pills needed to equal prescription strength, or about 17 times less than Nexium. "They say, 'It doesn't matter, doc. I have a drug card,' " Dr. Osborne said.

You can stay abreast of developments in the drug field by monitoring the home page of the FDA's Center for Drug Evaluation and Research, which also features a handy daily or weekly e-mail update service. There's also an OTC information page there.