Executive Briefing Series (formerly The Food & Drug Letter)
July 27, 2012
President Barack Obama on July 9 signed into law the latest reauthorization of the Prescription Drug User Fee Act, P.L. 112-144. The creation of this law was perhaps the most transparent process yet leading to major changes in the way the FDA does business. The law changes the way the agency reviews new prescription brand-name drugs by lengthening the review periods by two months and boosting formal and informal communications between agency reviewers and drug sponsors. It sets up new user fees for generic drugs and a program to reduce the agency’s backlog of generic approvals. In addition, the law puts into place a new user fee program for biosimilars, which are expected to grow exponentially in the next decade, and it gives the agency more powers to control suspect imports and require supplier agreements – both being tools to help bolster the quality of the drug supply. This issue of The Food & Drug Letter reviews the main points of the new law, the 2012 FDA Safety and Innovation Act.
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