Bread, Milk, and Cholesterol-Lowering Drugs?
Should consumers be able to pick up cholesterol-lowering medicine when they go to the grocery store or drugstore?
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
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
- 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
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.