Magazine article Drug Topics

How Does a Drug Achieve OTC Status?

Magazine article Drug Topics

How Does a Drug Achieve OTC Status?

Article excerpt

A mini-case

Again, it may be helpful for pharmacists to gain some insight into the process by which a drug product achieves (or in this case does not yet achieve) OTC status. The drug is cholestyramine resin, a cholesterol-lowering drug.

In 1995, an FDA advisory panel met to consider a switch but voted against it. In a 1997 review of new data, the result was the same, although resistance was not as strong. The nature of the decision process (as reported in OTC, June 1997) provides some idea of the considerations used in switch decisions.

The drug in question is, of course, one for longterm use and not for acute attacks. The condition treated does not have overt symptoms. Yet cholesterol levels are very much in the public eye and vocabulary.

Some of the information presented in support of the switch seems compelling:

More than 1.5 billion doses of the drug had been taken by nearly 80 million patients with good safety and efficacy records.

Fifty million Americans have elevated cholesterol but only six million are under medical care.

American consumers spend $100 million annually on dietary products aimed at lowering cholesterol. …

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