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In late September, the FDA announced that it intends to start cracking down on manufacturers of unapproved drugs that are being marketed in the United States.
The Agency announced in particular that it was focusing on companies that are marketing and distributing unapproved cough medications that include the active ingredient hydrocodone. This same ingredient is included in the narcotic drug Vicodin, a drug that has been the source of wide abuse and misuse. Currently, there are seven cough medications containing hydrocodone that have been approved for sale by the FDA. Manufacturers of approved cough medications have also been directed to stop marketing their medications for use by children under the age of 6, since there is insufficient evidence and data to show that such use in young children is safe. The FDA has also targeted drugs containing carbinoxamine, an antihistamine that causes drowsiness. The Agency has received reports of the deaths of at least 21 children that may be associated with ingestion of cardinoxiamine-containing drugs. Studies have never been conducted to adequately assess whether this ingredient, like hydrocodone, is safe for use in young children, who metabolize drugs differently than older children and adults and also require different doses of medication.

This latest announcement targeting unapproved cough suppressants is part of a larger initiative first announced in 2006. The FDA published its Marketed Unapproved Drugs — Compliance Policy Guide in June of 2006 notifying marketers and manufacturers that they would need to become fully compliant with federal laws requiring approval of their medications, including medications that may have existed before drug regulation was implemented years ago. The FDA announcement of the program indicates that there are perhaps “thousands of unapproved prescriptions drugs” being marketed in this country, which equates to approximately 2% of drugs on the market. The Agency noted 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,” says Deborah Autor, Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER). 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.”

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.

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