Generics advocates suggest improvements to Hatch-Waxman at public hearing

At a public hearing Tuesday to solicit input on the Hatch-Waxman Act, FDA Commissioner Scott Gottlieb said FDA will issue two guidances to increase generic drug competition, while advocates for generics suggested ways FDA could accelerate generic drug approval and promote competition.

In his opening statement, Gottlieb said FDA will issue two documents by YE17 as part of the agency's recently implemented Drug Competition Action Plan. The first is a "Good ANDA Assessment Practices" document that will outline how FDA will increase the efficiency of its ANDA review process. FDA will also issue an ANDA guidance to help generic companies submit complete applications...