Executive Briefing Series (formerly The Food & Drug Letter)

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.

As House and Senate leaders agreed on a final Prescription Drug User Fee Act (PDUFA) reauthorization package, members of Congress provided the agency with most of the increased supply chain oversight powers it asked for.

Language redefining current good manufacturing practices (cGMP) in P.L. 112-144, the omnibus FDA user fee legislation, appears to give the agency new authority to require drugmakers to make supplier quality agreements, a compliance expert says.

The FDA should be able to handle the additional requirements of the new iteration of the Prescription Drug User Fee Act (PDUFA V) with little worry of a repeat of the infamously slowed drug reviews from five years ago, agency officials say.

Drugmakers will need to take extra care to submit complete marketing applications to the FDA under the new Prescription Drug User Fee Act included in P.L. 112-144, as the agency plans to place more emphasis on this requirement, experts warn.

Despite pharma stakeholder support for a track-and-trace program, consensus could not be reached on a method for implementing a U.S. system so the requirement was dropped from the final bill reauthorizing the Prescription Drug User Fee Act (PDUFA) due to resistance from some members of the drug industry and dickering over the language of the provision.

P.L. 112-144, the new law reauthorizing user fees for prescription drugs, also creates new user fee programs for generics and biosimilars.

The FDA is seeking drugmaker comment on an upcoming independent assessment of its new lengthened review program under the newly reauthorized Prescription Drug User Fee Act (PDUFA).

The editors of The Food & Drug Letter provide here a smattering of documents in case readers wish to delve deeper into the new PDUFA law.