December 13, 2006

The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.

The agency has undertaken a broad array of actions to enhance enforcement of its policy on unapproved drugs, ranging from issuing new guidance and scheduling workshops to issuing warning letters. The FDA has taken these actions as a prominent agency critic, Sen. Chuck Grassley (R-Iowa), has urged the FDA to provide more information on what it is doing to reduce the marketing of unapproved drugs.

The FDA is ordering firms that manufacture unapproved products containing quinine to stop and is warning consumers about off-label uses of the drugs, according to a Federal Register notice published Dec. 13. These companies must stop manufacturing these products 60 days from the date the notice was published and may not ship the product in interstate commerce 180 days from that point. These actions represent "a direct challenge to the drug approval process," the notice said.

The move is the "latest step in an aggressive FDA initiative" to stop unapproved drugs from being sold, Deborah Autor, director of CDER's Office of Compliance, said during a Dec. 12 conference call. The agency is also planning to take an even more aggressive approach next year. "Next year, we will move even more quickly" to address unapproved drugs, she said. While quinine is approved for the treatment of malaria, nearly all of its prescriptions are for the off-label treatment of leg cramps, she said.

"This summer, when the agency began its aggressive efforts to remove unapproved drugs from the market, we vowed to target the products with the most serious public health risks," CDER director Steven Galson added. "We believe unapproved quinine products represent a serious health risk because of the widespread use of this product for treating leg cramps."

The move drew support from some of the agency's critics, such as Rep. Edward Markey (D-Mass.). The agency's announcement "is a signal that FDA may finally be taking serious its responsibility to ensure that only safe and effective drugs are sold to the American people," Markey said.

"The FDA should not sit idly by while companies market products that could be worse than snake oil. I am hopeful that this action is the first of many to ensure that all drugs are evaluated and all companies that continue to mislead the public are punished."

The notice is available at www.fda.gov/OHRMS/DOCKETS/98fr/06n-0476-n000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06n-0476-n000001.pdf).