FDA advisory committee vetoes OTC status for low-dose anti-cholesterol drugs

Although the decision was hailed by some patient advocacy groups, some minority health specialists were disappointed.

By Victoria Stagg Elliott, amednews staff. Aug. 7, 2000.

An advisory committee of the Food and Drug Administration has recommended that the government regulatory agency reject over-the-counter status for two low-dose cholesterol-lowering drugs.

The panel was not convinced that the two drugs -- lovastatin, marketed by Merck & Co. as Mevacor, and pravastatin, marketed as Pravachol by Bristol-Myers Squibb Co. -- could be used safely and effectively by patients without physician supervision, said David Orloff, MD, deputy director of the division of metabolic and endocrine drug products at the FDA.

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"What came out of the studies is that there are potential problems with self-selection, long-term adherence to the therapy and follow-up with the physician," Dr. Orloff said.

But the advisory committee did not rule out future approval of a cholesterol drug for over-the-counter use.

The lower-dose drugs were developed for patients with mild to moderately elevated cholesterol whose conditions are not severe enough to warrant prescription treatment. There were significant questions, however, about the effectiveness of low-dose pills and possible inappropriate use of the drugs by large numbers of people who don't need them.

Approving such drugs over the counter would result in targeting low-risk people in vast numbers, many of whom are not likely to develop arteriosclerosis, Dr. Orloff said.

Most OTC drugs target conditions for which there are symptoms. High cholesterol does not exhibit overt signs, yet the drugs need to be taken long term. "Cholesterol drugs are not intended for short-term use for relief of symptoms but rather for lifelong use in risk management of potential late complications of an asymptomatic condition," Dr. Orloff said.

The decision was hailed by some patient advocacy groups.

"The drugs are overprescribed to begin with," said Arthur Levin, MPH, director of the national nonprofit Center for Medical Consumers. "If it was made available over the counter, there's the possibility of self-prescribing unnecessary drugs" without a blood test or physician monitoring.

But the move to shift cholesterol-lowering drugs to OTC status received significant support from minority health organizations trying to increase drug access for populations that account for a significant number of uninsured and underinsured.

Over-the-counter cholesterol-lowering drugs would be "more accessible to patients," said B. Waine Kong, PhD, chief executive officer of the Assn. of Black Cardiologists. "Consumers are very sophisticated. They know when to go to a physician."

OTC drugs are usually cheaper than their prescription counterparts. Although this is also believed to increase accessibility, some questioned whether a change would result in any cost savings. "If you don't need it, it's expensive," Levin said.

Some hoped that OTC approval would improve patient education about heart disease and the benefits of lowering cholesterol in neglected communities.

"Cholesterol is a big problem in our community," said Rene Rodriguez, MD, president of the Interamerican College of Physicians and Surgeons. "We believe very strongly that if pharmaceutical companies are going to do something like this, they will invest the money in creating a very large education campaign in the community, which no one has done."

He said it would be easier for patients -- even those without insurance -- to monitor their cholesterol. And blood test results would lead to adherence to the drug regime. "If we teach patients how to take the drug and that they have to check their cholesterol every year, and they see that their numbers are higher, they will continue to take the drug," he said.

The committee's recommendation is not binding, but the FDA usually follows its panels' counsel. A spokeswoman for Merck & Co said the firm would continue to develop its application. A spokeswoman for Bristol-Myers Squibb said the company was considering its options.