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Over the counter or over-regulated?

by Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

July 3, 2000
Web posted at: 12:46 p.m. EDT (1646 GMT)

The Food and Drug Administration recently announced that it would reconsider the way it decides when drugs should be switched from prescription-only to over-the-counter availability, possibly making that transition easier. This is the first time these rules have been reconsidered in nearly 50 years, and it raises issues about how far the FDA should go in protecting the public, what drugs should be under the control of physicians, and what drugs should be regulated at all.

Why regulate drugs at all?

Nearly a century ago, the FDA was given responsibility for assuring that drugs and medical devices are both safe and effective -- that is, making sure they won't harm people who use them in the way they are intended, and that they actually perform the way they're marketed.

Center for Bioethics

What's your opinion?

This was in response to the widespread practice at the time of unscrupulous entrepreneurs selling worthless and sometimes harmful "remedies" for everything from cancer and other identified illnesses to more ambiguous diagnoses like "weak constitution." The age of quack medicines and devices gave us the term "selling snake oil" for selling worthless goods, since that ineffective animal product was one of the so-called patent remedies of the early 20th century.

So history is on the side of careful regulation of drugs, but such protections come at the price of limiting our freedom.

Nutritional supplements or drugs?

While the regulation of drugs is within the purview of the FDA, the agency has no oversight over health foods or nutritional supplements like herbs, vitamins, or the like. The distinction between these two has not always been crystal clear, and is becoming even less so with the proliferation of so-called natural remedies.

There is staunch opposition to the FDA regulating nutritional supplements, and so they do not necessarily undergo the same level of testing as do regulated drugs. This leads to access to a greater range of products, at lower prices than if FDA approval were required. But the trade off is an uncertainty about whether products can deliver as advertised, and about their purity and quality -- truly a situation in which the buyer must beware.

Protecting the public and preserving physician authority

Restricting the sale of drugs to physicians -- prescription -- is a way of controlling who gets drugs, how much they cost, and assuring that they can only be given as part of the delivery of health care. It is a way of protecting the individual patient and public health, while at the same time preserving physician authority.

But how much experience as a prescription drug is necessary before a drug can be sold over the counter? How willing are we to accept health risks associated with the public medicating itself in exchange for greater access to medicines? In a society that places such a high premium on individual decision-making and allowing people to control their own lives, it is somewhat ironic that access to drugs is so carefully controlled.

A combination of factors is responsible. First, it is a policy choice to err on the side of protecting the public; second, there is a strong medical tradition that sees prescribing drugs as an important part of a doctor's professional authority.

Access to many drugs is properly restricted to physicians. But once a drug has a track record of safety and effectiveness, continuing to require prescriptions creates a bottleneck that is difficult to justify, especially when the parallel market of nutritional supplements has no similar requirements.

We are allowed to take much greater risks in other parts of our lives, often with much less information available -- think of some of the things we do for recreation. So we must strike a balance between creating access to safe and proven drugs for which there is sufficient information for consumers to decide, and preventing unproven and risky remedies from flooding the market. If the past saw snake oil sellers on every corner, we need to avoid a present in which regulators take their place.


The FDA recently announced that it would reconsider the way it decides when drugs should be switched from prescription-only to over-the-counter availability. How much experience as a prescription drug is necessary before a drug can be sold over the counter? How willing are we to accept the health risks associated with the public medicating itself in exchange for greater access to medicines? In a society that places such a high premium on individual decision-making, should access to drugs be so carefully controlled?



Post your opinion here.


Visit the
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.


"Ethics Matters" is a biweekly feature from the
Center for Bioethics and CNN Interactive.


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