FDA panels vote against OTC status for statin drug

Concern that patients would be taking the medication inappropriately led to a decision to continue to have physicians supervise patients who could benefit from Mevacor.

By Susan J. Landers — Posted Feb. 7, 2005

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Washington -- Helping people lower their artery-clogging cholesterol is an admirable goal, but selling a popular statin drug without a prescription is not the way to go, said two Food and Drug Administration advisory committees during a joint meeting in mid-January.

The panelists voted 20-3 against over-the-counter distribution of 20 mg tablets of Mevacor (lovastatin). The FDA generally follows the advice of its committees.

The lopsided vote does not reflect the difficulty of the decision the panelists wrestled with during the two-day hearing, as officials from Merck & Co. and Johnson & Johnson presented the case for OTC sales of Mevacor for people with certain risk factors for heart disease.

"At times I've thought [statins] should be in the drinking water," said panel member Frank F. Davidoff, MD, editor emeritus of the Annals of Internal Medicine. Dr. Davidoff praised the pharmaceutical companies for bringing the matter forward, but he ultimately voted against their proposal. "While OTC statins may be the right thing to do, I don't think we're there yet," he said.

While the FDA committees voted such access down, doubtless there will be an opportunity for another go-round as Bristol-Myers Squibb Co. is likely to seek approval for OTC sales of its statin Pravachol (pravastatin), in the near future.

At the heart of the panelists' Mevacor decision was their concern that approval would undermine the role that many primary care physicians play in steering patients toward healthier lifestyles as well as determining the correct dose of a statin to reduce patients' risk of heart disease.

Many physicians share the FDA committees' views.

The American Medical Association strongly opposed the switch to OTC for Mevacor. "The use of a statin to lower LDL cholesterol may be only one part of a more complex patient management strategy, and the physician should decide which statin and at what dosage," AMA Executive Vice President Michael D. Maves, MD, told the FDA in a letter. "The management of hypercholesterolemia is more than just drug therapy with a statin."

Mary Frank, MD, president of the American Academy of Family Physicians, also found OTC statin sales an alarming idea. "I have a real concern that people will go buy Mevacor OTC without even knowing what their cholesterol is and assume that, because they are taking it, they don't have to exercise, they don't have to watch what they eat, lose weight or stop smoking, all of which are risk factors."

On the other hand, Roger S. Blumenthal, MD, director of Johns Hopkins Ciccarone Preventive Cardiology Center in Baltimore, said there were still some positive aspects to an OTC statin. "It's probably a reasonable idea as long as we can get people into care and decide whether the medicine they are on is satisfactory."

Alastair J.J. Wood, MD, who chaired the joint panel, voted in favor of OTC status for Mevacor. The drug has been determined to be safe and effective and, with vast numbers of people receiving no treatment, the option should be available to them, he explained.

The statin discussion was an unusual one for the FDA's Nonprescription Drugs Advisory Committee, which heard the proposal along with the Endocrinologic and Metabolic Drugs Advisory Committee, Dr. Wood acknowledged.

New territory

The nonprescription panel more frequently discusses drugs for conditions such as allergies with symptoms patients can clearly identify and treat with an OTC medication. But statins target cardiovascular risk, which represents a statistical probability rather than a symptom, said Dr. Wood, associate dean of Vanderbilt University School of Medicine in Nashville.

"In other words, this represents a new model for OTC drug use, namely seeking group benefit while trying to assess and, of course, minimize individual risk."

Most of the panel members said they would have approved the switch if the nation had a system similar to that used in Great Britain, where the OTC sale of 10 mg of Zocor (simvastatin), was approved in May 2004.

Great Britain has two classes of OTC drugs: those available for purchase on open shelves, similar to this country's OTC sales, and a pharmacy or P class, which requires the supervision of a pharmacist who reviews a patient's request before handing over the drug. Simvastatin was approved for sale only in the later class.

Discussion of a "behind-the-counter" category of OTC drugs for the United States has been taking place in various venues for at least 10 years, said Joshua Cohen, PhD, senior research fellow at Tufts University's Center for the Study of Drug Development in Boston.

But such a change must come from Congress, rather than the FDA, and so far congressional interest has been lacking.

The switch to OTC availability has been occurring with increasing frequency in recent years, said Dr. Cohen, who published a paper on the subject in the Jan. 1 issue of BMJ, formerly known as the British Medical Journal.

Driving this increase are pharmaceutical companies' desire to gain market exclusivity for a drug, attempts to reduce prescription drug bills for consumers and a growing self-care movement, according to the study.

Merck and Johnson & Johnson also noted this trend of people taking health care matters into their own hands. They pointed out that many consumers are self-medicating with a variety of supplements, such as vitamin E and garlic, which are of questionable value for heart health.

In contrast, Mevacor has a good overall benefit/risk ratio, noted Jerome D. Cohen, MD, professor of internal medicine, Division of Cardiology at St. Louis University School of Medicine, in testimony for Merck and Johnson & Johnson. "The time is right for this important OTC option to be available to consumers in the United States," Dr. Cohen said.

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Considering the risks

While debating whether to recommend a switch from prescription-only to over-the-counter status for Mevacor (lovastatin), Food and Drug Administration advisory panel members grappled with the following issues:

  • Assessment of the drug's relative safety.
  • Adverse events associated with therapy, including the risk of serious muscle injury and the risk of liver injury.
  • Conditions that could increase the chance of adverse events, including underlying liver injury, risks to women who are pregnant or of child-bearing age, and potential drug interactions.

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External links

Food and Drug Administration's Jan. 13 -14 hearing on over-the-counter sales of Mevacor (link)

Recommendations for women on heart disease from the AMA's Women Physicians Congress (link)

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