NCPA - National Center for Policy Analysis

What To Do When The FDA Pulls A Drug?

February 2, 2001

What should federal regulators and pharmaceutical manufacturers do when a useful drug turns out to have significant side effects? A case in point is Lotronex, which was taken off the market by the Food and Drug Administration just 10 months after the agency approved it. Lotronex was the only drug in its class designed to treat irritable bowel syndrome (IBS), which afflicts approximately 40 million Americans.

  • Before it was withdrawn about 300,000 people had taken it.
  • About 70 patients had developed severe problems.
  • Some needed surgery.
  • There were five deaths including three possibly linked to the drug.

Critics argued that it makes no sense to use a drug with potentially life-threatening side effects for a disease that is debilitating but does not kill. Nonetheless, several thousand patients have contacted the FDA asking them to bring Lotronex back. The demand was higher than that for any other recalled drug. Now officials are considering ways to bring the drug back in a limited way.

FDA officials suggested ways to keep the drug on the market, but limit access to it to minimize risks and track problems more effectively. These processes would be cumbersome, however:

  • The drug would be available through specialists certified by the manufacturer.
  • Off-label prescribing would be prohibited -- which would disqualify men from receiving the drug since it was only approved for use by women.
  • The manufacturer would have to police prescribing physicians.

Alternatively, the drug could be brought back by classifying it as an investigational new drug, but the monitoring and reporting are cumbersome. More important, drug companies must provide investigational drugs for free, or in some cases at cost.

Source: Denise Grady, "FDA Pulls a Drug, and Patients Despair," New York Times, January 30, 2001.


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