Publication: FDA Consumer
Publication Date: 01-JAN-07
Delivery: Immediate Online Access
Author: Meadows, Michelle
Article Excerpt
Most prescription drugs marketed in the United States have been reviewed and approved by the Food and Drug Administration as required by law. Thousands of unapproved prescription drugs, however, are still being prescribed and sold. The FDA, as part of its drug safety efforts, is bolstering its efforts against unapproved drugs in the United States.
"Although we estimate that less than 2 percent of prescribed drugs are unapproved, we believe that some unapproved products raise safety concerns that warrant regulatory action," says Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research (CDER).
There are several reasons why an unapproved drug may be available. One example is when only one company may have approval to market a drug, but other companies are illegally marketing their versions of the drug without having gone through the FDA's approval process. Another scenario is that a combination of ingredients is approved by the FDA, but a company is marketing a single ingredient without approval.
Some older products continue to be marketed illegally for historical reasons. "Many drugs were marketed before Congress made changes to the law requiring drugs to undergo FDA review," Autor says. There are unapproved drugs whose makers claim the drugs are "grandfathered" under older standards and therefore don't require approval under the current regulatory framework. "But the truly 'grandfathered' drugs represent only a few, at most, of all the unapproved drugs being marketed," Autor says. "Most unapproved drugs do require FDA approval."
Some drugs have been sold for so many years that physicians and pharmacists may not know they are unapproved. They even may be unaware that unapproved drugs are advertised in medical journals and listed...
NOTE: All illustrations and photos have been removed from this article.
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