Expanding the Universe of Over-the-Counter Drugs Is Weighed
It was regarded as a radical idea nearly 30 years ago when the Food and Drug Administration decided to allow certain prescription drugs to be sold over the counter.
But since 1972, hundreds of medicines--from pain relievers to anti-fungal agents--have moved from behind pharmacists’ counters to store shelves and into consumers’ hands with little adverse consequence.
Now the FDA is considering expanding the scope of so-called OTC (over-the-counter) medicines to include such products as cholesterol- and blood pressure-lowering drugs, birth control pills, even antibiotics.
The suggestion is provoking as much controversy now as it did then.
Proponents argue that, given the public’s current obsession with health, further empowering Americans to make their own decisions about what medicines to take is a natural.
More Consumer Awareness Cited
“There is a higher level of consumer awareness, with people much more interested in self-care,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, explaining the agency’s decision to begin exploring the issue. “Also, we have safer medicines today.”
Those who raise the red flag warn that many of these drugs--especially those used to treat chronic conditions, often with no symptoms--cannot be used safely unless a physician monitors them. And in the case of antibiotics, experts worry that the already growing problem of bacterial drug resistance will only worsen with more indiscriminate use of such drugs.
The “already troublesome” problem of drug interactions and unexpected toxic side effects--which often can be detected only by laboratory tests--could be even more dangerous without physician involvement, warned Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, at a two-day public hearing on the issue last week.
The debate was prompted by two drug manufacturers who are seeking over-the-counter status for their cholesterol-lowering drugs. The agency plans to look specifically at their case later this month. If FDA officials decide to allow them to make the switch, it could open the door for numerous other prescription-only drugs to become more easily available.
Wolfe, who opposes OTC status for cholesterol-lowering drugs, argued that cholesterol drug treatment requires close physician supervision, including periodic checkups and blood tests. He fears that these safeguards would wane with dangerous consequences if such drugs became available without a doctor’s order.
“Medical checkups are needed for determining if the drug is working and for assessing other aspects of disease progression,” including the possibility of liver toxicity, he said.
Reliable Dosing Seen as Benefit
But Dr. Jeffrey Anderson, chief of the division of cardiology at the University of Utah, argued that giving OTC status to Merck’s anti-cholesterol drug Mevacor (also known by its chemical name lovastatin) is safer, given the current consumer tendency to use unregulated nutritional supplements for every ailment, including those, such as red yeast rice, touted to lower cholesterol.
If Merck’s drug were made available over the counter, it would ensure “reliable dosing and purity” in a “regulated, educational environment,” which is not necessarily the case with diet supplements, he said.
Also, having the drug available over the counter could benefit those with mildly high cholesterol who generally are not considered candidates for higher-dose drug therapy.
“There is now evidence for benefit and safety” of these drugs among such consumers, he added.
The FDA will convene a panel of scientific experts this month to consider the requests of Merck & Co. and Bristol-Myers Squibb, who want to market low-dose versions of their cholesterol-lowering drugs. With their patents running out, both companies want to encourage brand loyalty among patients.
The FDA is expected to consider other classes of drugs as well--birth control pills for “morning after” use--likely to incur the wrath of abortion opponents--and antibiotics. Just the thought of putting antibiotics on drugstore shelves makes many infectious disease specialists extremely nervous.
“Some infectious diseases . . . are actually worsened by antibiotics,” said Dr. Robert T. Schooley, head of infectious diseases at the University of Colorado Health Sciences Center. There also often are unexpected and potentially fatal side effects to some antibiotics. And, experts believe, consumers already demand antibiotics too often for the wrong reasons--such as viral infections, which antibiotics do nothing to cure, and which contribute to the serious problem of microbial resistance to drugs.
“People end up taking antibiotics for 2.7 days every time they have a cold or mistake hay fever for pneumonia,” Schooley said.
For its part, the FDA says that it will not make a sweeping policy change but instead will consider each drug separately.
“We will take the drugs one at a time, and we will be making case-by-case decisions on each drug that comes up,” Woodcock said, pointing out that it is up to drug manufacturers to ask the FDA for such a change in status. “They have to apply, and there is an extensive process.”
Wary of unsupervised drug use but eager to empower patients, some health advocates have proposed an alternative to over-the-counter medicine: the creation of an in-between status, unofficially dubbed “under the counter.”
It would make drugs available without a prescription, but they would not be on store shelves. Consumers would have to ask for them, ensuring the involvement of a pharmacist.
Pharmacists like the concept--they increasingly view themselves as an information bridge between physicians and consumers, particularly in the managed-care era when doctors have less time to spend with patients.
When over-the-counter status is questionable, “the use of a system of marketing products through pharmacists should be considered,” said Rebecca Chater, a North Carolina pharmacist speaking for the American Pharmaceutical Assn., the professional society of pharmacists.
This, she said, “would expand access beyond the traditional system, while maintaining health professional interaction.” Also, data gathered from the experience “could be used to support the transition from prescription to full-OTC availability.”
But the pharmaceutical industry is cool to the idea, fearing that it could signal a pullback of some products now enjoying OTC status.
And the FDA’s Woodcock said the agency had not yet explored this new option, adding: “It would probably require legislation or regulation.”
