FDA's Mevacor Decision Is Costly | National Center for Policy Analysis | NCPA

FDA's Mevacor Decision Is Costly

Consumers recently lost a money-saving opportunity when a Food and Drug Administration (FDA) advisory panel voted against over the counter (OTC) access to the prescription cholesterol-reducing drug, Mevacor.  They are likely to lose again in a couple of weeks when FDA Commissioners are expected to uphold the advisory panel's recommendation.

The decision is unfortunate because cholesterol control medications are the most widely used prescription drugs.  Including the cost of diagnostic tests and doctor visits to obtain prescriptions, Americans spend about $20 billion per year on them.

More than 100 million Americans have high cholesterol, but about 85 percent of them aren't receiving treatment.  Most don't even seek treatment because it's inconvenient and expensive to visit a doctor and pay for the prescription.    On balance, the benefit of cholesterol-lowering drugs, which also are called statins, far outweigh the risk.  For example, because they can reduce the risk of cardiac events, such as heart attacks, by nearly one-third, the British government approved an OTC version of the statin drug, Zocor, in 2004.

Consumers save money when medicines are sold OTC.  For evidence, we need look no further than the allergy drug, Claritin, which formerly was available only by prescription.  Before it was available OTC, a year's supply of Claritin cost about $1,066.  Today consumers can buy an entire year's supply of Loradatine, the generic version of Claritin which is available OTC, for as little as $31 at Costco or local dollar stores- no doctor visit is required.  In other words, consumers can save almost 98 percent compared to the cost of prescription Claritin in 2001.

Cash-strapped seniors currently pay as much as $1,500 annually on cholesterol control.  Mevacor costs about $800 per year exclusive of lab tests and doctor's visits.  Had the FDA approved Mevacor access OTC, within three years a generic version might also have driven costs down by more than 90 percent, saving many seniors an average of about $1,000 per year.

Experts had hoped that up to three cholesterol-lowering drugs would become available OTC during the next few years.   The FDA denial of Mevacor will certainly discourage pharmaceutical companies like Merck (whose patent on Zocor expires this year) or Eli Lilly (whose request to switch Pravchol was turned down in 2000) from further attempts to move their popular statin drugs to OTC status.

The FDA panel reasoned that elevated cholesterol is a medical condition without symptoms, making it difficult to self-diagnose.  Consequently, people seeking treatment should be monitored by a physician.  Another concern was that people with over-the-counter access might not visit their doctor for advice.

Selling cholesterol-reducing drugs OTC would not lead Americans to forgo a doctor's care.  But it would allow them to discuss treatment with their doctor when it is more convenient.  Consumers could obtain lab tests in more convenient, lower-cost settings, allowing them to save money while reducing cholesterol levels.

Even though millions of Americans suffer from high cholesterol, they can't do much about it on their own.  This means that people who could have benefited by starting drug therapy earlier in their lives will often wait until they have heart disease.  Many will suffer heart attacks and die prematurely.  And millions of Americans already taking a prescription statin drug will pay hundreds more per year than necessary.

If the market were allowed to develop with several competing OTC statin drugs, Americans would save plenty.  Including the annual cost of lab tests for cholesterol and liver function, OTC generic statin drugs might cost less than $100 per year.  Compare that to the estimated $1,000 total annual cost of therapy with prescription Mevacor.