FDA strengthens efforts against unapproved drug products

The U nutrition and Drug Administration (FDA) has issued a final guidance document outlining its approach to medicines marketed without FDA approval. In the "Marketed Unapproved Drugs--Compliance Policy Guide," the FDA encourages companies to comply with the physic approval process and states its primary bear upon as being unapproved products that may endanger public health. Priority will continue to be given to enforcement actions involving unapproved physics that have potential safety risks, that lack evidence for their effectiveness, and that constitute health fraud. The guidelines also address the FDA's plan for dealing with situations in which a company receives FDA approval for a physic that other companies have been selling unapproved. Consumer assume that widely marketed medicines have received FDA approval, the FDA said, and health care providers may prescribe unapproved remedys unknowingly. Many unapproved drugs affected by dint of the guidance were developed and marketed before changes to the approval proces However, the FDA estimates that les than 2 percent of prescribed remedys are unapproved. Activity under the of recent origin guidelines will begin with prescription proceedss that contain carbinoxamine, which has not been studied in young children and has not been approved for the treatment of cough and gelid symptoms. For more information, visit http://www.fda.gov/cder/drug/unapproved_drugs/default.htm.

COPYRIGHT 2006 American Academy of Family Physicians

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