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GDUFA Implementation Will Be Overseen By Mylan’s Representative in the House

 
• By Michael McCaughan

Mylan played a pivotal role in crafting the formula to create Generic Drug User Fees. The selection of Rep. Tim Murphy (R-Pa.) to chair the House Energy & Commerce Oversight Subcommittee should help assure that Mylan’s perspectives continue to play an important role.

It is safe to say that the Generic Drug User Fee Act would look very different—and may not have happened at all—without Mylan. And now it is safe to assume that the House Energy & Commerce/Oversight Subcommittee will do everything it can to make sure that FDA’s implementation of GDUFA aligns with Mylan’s vision for the new program.

At the very least, the newly named subcommittee chair, Rep. Tim Murphy (R-Pa.), will have to take Mylan’s calls. That’s...

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