The FDA is considering creating a new class of drugs called “behind-the-counter” medicines, which would fall somewhere in between over-the-counter drugs and prescription drugs. Like OTC, consumers would be able to purchase these drugs without a script from their doctor. But it would first require a consultation with the pharmacist. This new category could include drugs for cholesterol management and migraines, as well as birth control pills.

Pharmacists and drug companies like the idea; doctors think it’s dangerous. If approved, the drug classification could go into effect as early as next year.

“We believe having certain drugs behind the counter but available only after a consultation with a pharmacist could significantly increase patient access,” said Ilisa Bernstein, the FDA’s director of pharmacy affairs.

But doctors are on alert. Dr. Anmol Mahal, a Fremont gastroenterologist and president of the California Medical Assn., said the federal agency’s proposal was ill-conceived and unsafe for consumers.

“Patients are not clinicians,” he said. “Allowing people to self-diagnose and self-treat is not in their best interest. Nothing could be farther from the truth.”
Los Angeles Times 10/05/07

From a pro-consumer standpoint, behind-the-counter drugs would be more accessible and convenient for those who take routine, low-risk prescriptions. They also could offer significant cost savings if consumers could get the drugs they need without paying to see a doctor (especially if they’re uninsured!), and because non-prescription drugs are generally less expensive.

But doctors have valid concerns.

Mahal, of the California Medical Assn., said a main worry was that patients would buy medication and then lack supervision to ensure that their treatment was safe and effective. Another worry: that women who skip regular doctor visits to get prescriptions for birth control pills may also forgo gynecological examinations.

Several European countries, Canada and New Zealand already offer a wider variety of behind-the-counter drugs. So is the US appropriately cautious, or are we behind the times on behind-the-counter drugs?