Washington Drug Letter

The House Wednesday approved a bill reauthorizing the Prescription Drug User Fee Act (PDUFA), sending it on to the Senate with a voice vote this week.

Congress is pointing a finger at the FDA for spurring the increase in drug shortages through stepped up enforcement actions, despite the agency’s efforts to mitigate the trend.

BOSTON — 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.

A provision in the 2007 FDA Amendments Act (FDAAA) intended to limit the use of citizen petitions to block approvals of generic drugs has failed to change the behavior of brand companies, whose use of the petitions continues to rise, according to a new study.

The FDA appears to be taking steps to launch its much-delayed Secure Supply Chain Pilot Program (SSCPP), coincidently the same week that efforts to authorize a federal track-and-trace system in an FDA user fee bill died.

Pfizer has received a complete response letter from the FDA on its neuro drug Vyndaqel (tafamidis) after a negative advisory panel meeting, with agency staff and advisers raising concerns about the drug’s efficacy.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11–0 with one abstention to recommend approval for Onyx Pharmaceuticals’ Kyprolis for patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy.

A new memorandum issued by the U.S. Office of Special Counsel (OSC) instructing federal agencies to ensure their electronic surveillance policies and practices do not deter whistleblowing “confirms” the FDA broke the law when it monitored the personal emails of employees who voiced product safety concerns to Congress, lawyers for six aggrieved agency staffers say.

The House Appropriation Committee approved $2.481 billion in fiscal 2013 FDA appropriations, knocking the agency’s funding down $16 million — or nearly 1 percent — from what it is currently receiving.