"Bolar exemption" repeal threatened by Sen. Faircloth if Pryor GATT amendment goes forward.
"BOLAR EXEMPTION" REPEAL THREATENED BY SEN. FAIRCLOTH in response to efforts to amend the Waxman/ Hatch Act to overturn FDA's position on approval of generic drugs during the GATT "delta period." Faircloth (R-N.C.) is considering legislation that would repeal the so-called "Bolar exemption," which allows generic companies to conduct research on patented pharmaceuticals to prepare ANDA applications in time to allow them to come to market upon patent expiry, Faircloth's General Counsel John Lepore wrote in an Oct. 4 letter to the National Association of Pharmaceutical Manufacturers.
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