FDA Says No Thanks to OTC Statin

By NCL Staff

At a public hearing last week, the Food and Drug Administration heard a variety of opinions about the possibility of a cholesterol-lowering prescription drug being made available in an over-the-counter, non-prescription form. After the hearing, the agency held a vote, and the verdict is in: Mevacor will not become an OTC drug, and consumers will continue to have to go to their doctors for diagnosing and treatment of cholesterol – at least for now.

Over the years, the FDA has granted OTC status to other Rx drugs, like medications for heartburn, yeast infections, and other conditions consumers can self-treat. The FDA weighs the pros and cons, including risks of side effects, consumers’ ability to self-diagnose and monitor, and other safety issues. We wanted to know what consumers would think of an OTC statin, so we surveyed adults with moderately-risky cholesterol levels to find out. We told FDA committee members at the public hearing last week that the consumers surveyed had mixed opinions. Many said they’d be interested in the OTC version, but some others thought that they’d prefer to have a doctor’s prescription to treat their cholesterol. Turns out, as we expected, that OTC drugs are seen as safer and Rx drugs are seen as more trustworthy. Interesting stuff!

Now that the FDA has made its ruling, consumers who want to treat their cholesterol without having to go to the doctor first will just have to wait. There’s definitely a plus side to this ruling: FDA advisers noted that at $1 to $1.50 a day, an over-the-counter version would cost more for the insured than the typical $4 to $15 for a month’s supply of prescription statins.

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