FDA Lightens Message to Cody Laboratories

Mon, 04/13/2009 - 6:38am
CODY, Wyo. (AP) — Federal regulators are easing recently announced restrictions on the manufacture of a liquid drug produced by Cody Laboratories. The labs and parent Lannett Co. of Philadelphia last week received U.S. Food and Drug Administration orders to cease production of painkilling morphine sulfate in a dosage not federally approved. The agency was concerned about a 20-milligram-per-milliliter concentration of the drug used to ease pain in people who are dying. Cody Laboratories and Lannett have since been informed they will be allowed to produce the dosage until an authorized revision or alternative therapy is available. Lannett CEO Arthur Bedrosian had expressed confidence in the company's products and said Lannett would work with FDA to resolve concerns. FDA spokeswoman Rita Chappelle said the agency estimates that about 2 percent of all prescriptions written in the United States are for drugs not approved. Critics of the FDA had questioned the need to crack down on a prescription drug used to relieve extreme pain in the dying, while over-the-counter products such as "miracle" weight-loss pills appear largely unregulated. "We just took a separate action against nearly 80 dietary supplements," Chappelle said. She said FDA enforcement is based on risk analysis. "If the product has had serious adverse events associated with it and public health could be at risk, those are the products we will prioritize," she said. Chappelle said the FDA has been reaching out to manufacturers of unauthorized products and "trying to get them to come in and work through the process." She would not comment on the likely cost or timetable for obtaining FDA approval of any drug, but said that because other forms of liquid morphine have been approved in different dosages, action on the 20 milligram-per-milliliter dosage might follow an abbreviated process.

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