Is the U.S. ready for a third class of drugs?

February 7, 2005

The Food & Drug Administration advisory panel's recent recommendation against OTC status for Merck's cholesterol drug Mevacor (lovastatin) has drawn renewed support and calls from pharmacists and pharmacy trade associations for the creation of a third class of drugs. A third class of drugs would allow patients to buy a drug without a prescription, but only after speaking with a pharmacist. In May 2004, Britain began selling the statin Zocor under these rules.

The Food & Drug Administration advisory panel's recent recommendation against OTC status for Merck's cholesterol drug Mevacor (lovastatin) has drawn renewed support and calls from pharmacists and pharmacy trade associations for the creation of a third class of drugs. A third class of drugs would allow patients to buy a drug without a prescription, but only after speaking with a pharmacist. In May 2004, Britain began selling the statin Zocor under these rules.

The advisory panel, which gave a thumbs-down to the Mevacor switch in an overwhelming 20-3 vote, cited the need for patients to have medical guidance for treatment of a chronic condition that has no symptoms and that may require patients to take these drugs for life. Several members of the panel reportedly spoke in favor of having the option of a third class of drugs.

Janet Engle, Pharm.D., associate dean for academic affairs and clinical professor of pharmacy practice at the University of Illinois at Chicago, presented testimony to the advisory committee on behalf of the American Pharmacists Association. In doing so, Engle explained what the pharmacists' role would be in helping consumers use Mevacor appropriately as an OTC. "We would love to see a third class of drugs. Given all the new medications and the idea that consumers can self-medicate for certain circumstances-but that they might need help-may mean it's time for Congress to look at a third class of drugs," she said.

Jack E. Fincham, Ph.D., A. W. Jowdy Professor of Pharmacy Care, University of Georgia College of Pharmacy, served on the FDA advisory committee. Although he declined to discuss the details of the committee's decision until publication of the minutes, he stated that he has always supported a third class of drugs. Fincham said that instituting this option might take legislative action from Congress rather than regulatory action from the FDA. "I certainly would support a third class of drugs, and that implies a 'pharmacist-only' designation so that consumers can purchase the product, but only from a pharmacist while the pharmacy is open."

Noting that a third class of drugs is an option that has worked well in Britain and Australia, Fincham said that "certain sectors of the nonprescription market feel that if a drug is available as a nonprescription product, it should be sold anywhere. With some drugs, that is not a problem. But with other drugs for chronic disease, that's different."

Tim R. Covington, M.S., Pharm.D., Bruno Professor of Pharmacy and director of the Managed Care Institute, McWhorter School of Pharmacy, Samford University, Birmingham, Ala., seconded Fincham's call for a third class of drugs. "This drug is begging for [the establishment of] a pharmacist-only third class of drugs. Some of the panel members said that Mevacor needs oversight. Perhaps we can look at the pharmacist as the gatekeeper for the OTC version."

Covington insisted that there are at least a dozen drugs that need to be appropriately managed and that require clinical oversight from a professional, but not necessarily a doctor. Covington believes that a third class of drugs would increase patients' access to quality of care and would decrease the cost of care.

Since 1985, the ASHP has called for changes in federal statutes and regulations to establish an intermediate category of drug products that do not require a prescription but are available only from pharmacists and other public healthcare professionals authorized to prescribe medications.

William Greene, Pharm.D., department of pharmacy, Methodist University Hospital, Memphis, presented testimony to the FDA's advisory committee on behalf of ASHP. In stating ASHP's position, Greene said, "ASHP believes that consideration of OTC reclassification for statins presents an opportunity to explore the creation of an intermediary category of drugs."