FDA allows deadline to seek rehearing to expire in off-label case

01/23/2013 | Pharmalot.com

The FDA didn't pursue a rehearing of the 2nd U.S. Circuit Court of Appeals' decision to overturn a former sales rep's conviction over the promotion of off-label uses of a drug before the Jan. 16 deadline. The decision suggests the FDA might not challenge the ruling though it still could seek a Supreme Court hearing, Ed Silverman writes. An FDA spokeswoman said the agency "does not believe that the decision will significantly affect the agency's enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act."

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