WASHINGTON – The Food and Drug Administration has no immediate plans to seek establishment of a new, behind-the-counter class of drugs, agency officials said at the conclusion of a day-long meeting on the topic in November.

FDA Deputy Commissioner for Policy Dr. Randall Lutter told reporters that he realized that by holding the meeting the agency had likely raised expectations that it would take action. But, he said, the FDA was merely soliciting views and comments on which, if any, pharmaceuticals might be moved to a special status by which they could be dispensed directly by a pharmacist after counseling, but without a physician's prescription.

The agency accepted comments until Nov. 28, and would decide afterward “whether additional action is appropriate,” said Dr. Lutter. He added that the FDA had no specific timetable in mind.

This is the fourth time the FDA has broached the idea of following the lead of several other nations, including Canada and the United Kingdom, by creating a third class of drugs.

At the public meeting, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, contended that the agency's latest foray had been “precipitated by drug companies who make statins and want to switch them to [over-the-counter].”

Merck & Co. has sought permission to sell lovastatin (Mevacor) over the counter in the United States. An FDA panel was due to review that request on Dec. 13.

Dr. Lutter said, however, that agency officials convened the meeting “on our own initiative,” and not at the behest of any drug maker. The agency decided to take another look at BTC (behind the counter) drugs because consumers increasingly are involved in their own health care and frequently use the Internet not just to access information, but also to buy products without a physician's advice or counsel, Dr. Lutter said.

A BTC class of drugs might be one way both to empower consumers and to ensure that they get safe and effective medications, he said.

Not surprisingly, pharmacists who spoke at the meeting were in favor of creating a new BTC class, while physicians were opposed. There was a mixed response from consumer advocates.

Joseph Cranston, Ph.D., a pharmacist and director of science, research, and technology for the American Medical Association, said that the AMA opposes creation of a BTC class. The FDA does not have the statutory authority to create such a class, he said, adding, “thus, it is perplexing that this meeting is even being held today.”

Dr. Cranston said that the AMA was concerned that insurers might require use of BTC medications before covering prescription medications, and that it wasn't clear if moving drugs behind the counter would increase or decrease access or costs.

Also, pharmacists do not have the training to make the same types of patient management decisions as physicians, he said.

The National Community Pharmacists Association said that BTC drugs could reduce consumer health care costs, increase patient convenience, and perhaps add yet another avenue to track postmarket drug safety. An early November survey of its membership found that 97% of members were in favor of the new BTC class, according to Stephen L. Giroux, who serves as NCPA president.

Dr. Giroux also cited polling data that showed that patients would support a BTC category.

Michael Moné, director of regulatory compliance for Medicine Shoppe International and a member of the American Pharmacists Association (APhA) board of trustees, said that having a BTC class of drugs would benefit consumers and public health. “With increased access to medications, combined with a pharmacist intervention, a patient is less likely to go untreated or incorrectly treated, and therefore is less likely to deal with more advanced symptoms or the adverse effects of inappropriate usage,” he said.

All pharmacy groups that presented at the meeting said that if BTC were to become a reality, standard protocols for dispensing and counseling should be established, and that pharmacists should be reimbursed for their services.

Some consumer advocacy groups expressed concern that insurers not only would not reimburse pharmacists, but that they would also drop coverage altogether of products that were moved behind the counter. Laurie Tansman of Mount Sinai Medical Center, New York, said that diabetes patients who could get oral agents BTC might forego hard lifestyle changes and perhaps skip needed physician visits.

The Consumer Healthcare Products Association, whose members make OTC products, argued against creation of a new class, saying that consumers were well served by the current two-class system. OTC switches have mostly been a success, said David C. Spangler, CHPA senior vice president for policy and international affairs.

George Quesnelle, president of GlaxoSmithKline Consumer Healthcare, echoed the CHPA position. GSK makes and markets Nicorette. Mr. Quesnelle said significantly more people have quit smoking since nicotine replacement products were moved OTC.

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This idea was 'precipitated by drug companies' that want to switch statins to OTC status. DR. WOLFE

FDA Not Yet Ready to Get Behind the Counter