Generic/pediatric exclusivity
Executive Summary
FDA should review its policy that generic 180-day and pediatric exclusivity run concurrently, Sen. Kennedy (D-Mass.), Sen. Rockefeller (D-W.Va.), Rep. Dingell (D-Mich.), Rep. Waxman (D-Calif.) and Rep. Brown (D-Ohio) write in a March 27 letter to FDA Acting Commissioner Schwetz. "Congress did not intend the pediatric exclusivity under FDAMA to nullify or abrogate the generic exclusivity under the Waxman-Hatch Act," the letter states