FDA Mulls Direct Pharmacist-to-Patient Drug Sales

TUESDAY, Nov. 13 (HealthDay News) -- Experts at the U.S. Food and Drug Administration are meeting Wednesday to hear arguments on whether or not pharmacists might someday bypass doctors and directly provide consumers with certain drugs that now require a prescription.

If this plan were to go ahead, it would create a new class of drugs that could be sold by pharmacists "behind-the-counter." Such drugs might include birth control pills, cholesterol drugs and migraine medicine, experts said. Their sales would require that patients discuss these purchases with the pharmacist first.

"We believe having certain drugs behind the counter, but available only after a consultation with a pharmacist, could significantly increase patient access," Ilisa Bernstein, the FDA's director of pharmacy affairs, told theLos Angeles Times.

Wednesday's hearing marks another chapter in the behind-the-counter saga. In 2005, the agency rejected a proposal to allow the cholesterol-lowering drug Mevacor to be sold without a prescription. At the time, however, some of the FDA's scientific advisers said it might be possible for pharmacists to sell the drug if they could help select which customers bought the pills.

But the issue finds arguments both pro and con.

Several industry groups support the proposal.

"The whole notion of having some medications behind the counter is a wonderful way to improve medication use and advance patient care," said James Appleby, chief operating officer of the American Pharmacists Association.

He sees the proposal as a way for druggists to be reimbursed by the health insurance industry for dispensing advice and medications to consumers.

"If behind-the-counter medications are going to be a true health-care experience, the American Pharmacists Association would envision a situation in which insurers and third-party payers would pay pharmacists, much the way they pay physicians for physician visits," Appleby said.

But the country's largest organization representing physicians, the American Medical Association, does not endorse the plan.

"We are opposed to it for a variety of reasons," said Joseph Cranston, AMA's director of Science, Research, and Technology. "First of all, we don't think FDA has the legal authority to establish it without legislation."

His group also does not believe there's even a need for this new form of dispensing medicine, Cranston said.