Jan. 7, 2000 (Washington) -- Should consumers be able to pick up cholesterol-lowering medicine when they go to the grocery store or drugstore? That's basically the question that the FDA will address later this year when it reviews its present policy of requiring that all cholesterol-lowering drugs be sold with a doctor's prescription.
For three years, the FDA's official policy has been that the cholesterol-lowering drugs are not safe enough for direct use by consumers. The rationale has been that the diagnosis of high cholesterol requires a blood test that needs medical interpretation and that the drugs are potent and require ongoing medical supervision, including liver function tests, to be used safely.
The FDA has been pressured by drug companies to change this policy. The companies maintain that most people with high cholesterol now do not get the appropriate medical diagnosis and treatment, and that the availability of the drugs without needing a prescription would expand the number of people who would benefit from them. They believe that the drugs are safe enough to be used without medical supervision.
The drug companies propose that the labels on cholesterol-lowering drugs instruct consumers to take them only after taking a blood test, or only after being diagnosed with high cholesterol by a doctor. Cholesterol blood tests are available at many health fairs.
Treating high cholesterol is much more complicated than taking a simple blood test, however, and that's one issue the FDA will take into consideration. Blood tests need to be taken with some regularity, the dose of the drugs may vary from consumer to consumer, and consumers should avoid taking the drugs entirely if they have liver problems.
For now, the FDA has decided only to reconsider its policy, not to change it. The agency's policy-makers understand that permitting the over-the-counter (OTC) sale of cholesterol-lowering drugs has many implications for physicians and how they take care of their patients, and also possesses potential safety issues for consumers.
The decision also carries significant financial impact for drug companies, for advertising agencies, and for managed care:
- Cholesterol-lowering drugs are a multibillion-dollar market. All the drug companies that make them -- Merck, Bristol-Myers Squibb, Novartis, Bayer, and Warner-Lambert -- will advocate for the switch, as they believe they can sell more products directly to the consumer.
- Millions of dollars are now being spent advertising the drugs directly to the consumer. This advertising would increase substantially if they are moved to OTC status and companies have to compete even more aggressively for consumer market share.
- Managed care spends billions on cholesterol-lowering drugs, which are among the most frequently prescribed medications. If the entire category were to go OTC, the costs of the prescription drugs could be shifted to the consumer's own pocketbook.
The FDA will decide if there is a net public health benefit to permitting the cholesterol-lowering drugs to be sold OTC. It must decide whether the availability of the drugs without prescription would encourage more people to lower their cholesterol, and whether this benefit is balanced by the risk from consumers taking the drugs with little or no medical supervision.
It's going to be a tough call.