NCPA - National Center for Policy Analysis


August 31, 2005

The Food and Drug Administration (FDA) drags its feet when it comes to making prescription drugs available over the counter (OTC), leaving consumers poorer and sicker than they otherwise might be, says Kerry Howley of Reason.

Prior to 1938, nonnarcotic drugs required no prescription. The Food, Drug and Cosmetic Act, passed in 1938, was intended to require clear labeling on drugs in order to better inform consumers. However, the FDA's exemption to the rule applied not to harmless drugs, but to drugs labeled "prescription only," in order to force patients to consult doctors before taking them.

However, the FDA can switch prescription drugs to OTC status. When it does so, consumers save money. For example:

  • A 1997 study by Kline & Company found that Americans saved about $13 billion a year by using over-the-counter medicines that had been switched from prescription-only status.
  • According to economist Peter Temin, doctors visits for the common cold dropped by 110,000 a years between 1976 and 1989, when cold and cough medicines became available over the counter.
  • When it became available over the counter, the price of Claritin plummeted from $1,066 to $365 for a year's supply.

Additionally, the statin drug Mevacor would benefit an additional 10 million Americans, if it was available over the counter. The full price for Mevacor is about $800 per year, and while patients with health insurance coverage don't pay the full price, it is prohibitively expensive for the 24 percent of Americans who lack drug coverage.

The last switch from prescription to over the counter occurred with the drug Prilosec in 2003. Since then, two drugs which were up for OTC status have been rejected, says Howley.

Source: Kerry Howley, "Locking up Life-Saving Drugs," Reason, August/September 2005.

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