Drug Industry Daily

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

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 allegedly monitored the personal emails of employees who voiced product safety concerns to Congress, lawyers for six aggrieved agency staffers say.

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.

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’s targeted lung cancer drug Xalkori significantly improved the time patients lived without their disease getting worse in a late-stage trial designed to snag full marketing clearance for the drug, which received accelerated approval last year.