NCPA - National Center for Policy Analysis


September 18, 2006

What looks like a Food and Drug Administration-approved drug and sounds like an FDA-approved drug might not really be an FDA-approved drug.  And that little-known fact means consumers -- not to mention doctors and pharmacists, who are often as ignorant of the drugs' status as patients are -- should beware, the FDA says.

Unapproved drugs, which the FDA says make up nearly 2 percent of all prescription drugs on the market, might not only be ineffective but also might actually be harmful.  Over the years, the agency has learned of dozens of deaths linked to some of them.  For now, the FDA says, it is targeting only the most dangerous because it lacks the resources to get all of them off the market.

  • The agency estimates that several hundred unapproved active ingredients, including antihistamines, narcotics and sedatives, are in prescription drugs sold in the United States.
  • Many of them have been used since before 1962, when an amendment to the Food, Drug, and Cosmetic Act required that drugs be proven effective; the original law, enacted in 1938, said only that drugs had to be proved safe.
  • Those several hundred unapproved active ingredients translate into a couple thousand or more unapproved prescription products.
  • They're marketed for a range of ailments including colds and coughs, ear infections, hot flashes, and pain; but their makers never submitted scientific data that convinced the FDA of their safety and effectiveness.

"We have concerns about their safety, about their quality, about their labeling," says Deborah Autor, the FDA's director of compliance.  "Just because people think something works doesn't necessarily mean that it does."

In their defense, makers of unapproved prescription drugs say the medications must be safe and effective or else doctors wouldn't keep prescribing them.  The companies say wading through the FDA's regulatory process would cost millions of dollars, an expense they'd have to pass on to consumers.

Source: Rita Rubin, "Hundreds of unapproved drugs sold by prescription; They may be ineffective or even dangerous, but FDA can't corral them all," USA Today, September 18, 2006.


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