Washington Drug Letter

The House Energy & Commerce Committee voted 46-0 Thursday to approve its version of an FDA user fee bill, keeping on track to have the bill signed into law by the end of June.

Drugmakers and the rest of the scientific community can and should benefit from the careful disclosure of FDA review data that industry and the agency currently keep closely guarded, FDA Commissioner Margaret Hamburg says.

A federal appeals court has poked a hole in generic-drug makers’ preemption protection, ruling that companies should simply stop producing a drug if it is unsafe and the warning label doesn’t reflect all concerns.

Abbott Laboratories has agreed to pay $1.6 billion in civil and criminal penalties and submit to a five-year corporate integrity agreement (CIA) to resolve a Justice Department probe into its marketing of antipsychotic Depakote.

The Centers for Medicare & Medicaid Services (CMS) is sparing drug manufacturers and group purchasing organizations (GPO) from reporting payments made to doctors and hospitals in 2012 as the agency continues to lag behind deadlines for issuing final Sunshine Act regulations.

The Senate Finance Committee is investigating three drugmakers to find out if they encouraged nonprofit advocacy groups to promote misleading information about narcotic painkillers.

NDA and BLA supplements have created more headaches for pharma companies than standard new drug or biologic applications, finds a new study from the Tufts Center for the Study of Drug Development.

An agency advisory panel voted 18–4 with one abstention Thursday in favor of approval for Arena’s weight-loss drug lorcaserin.

An FDA advisory panel is recommending approval for Gilead’s Truvada as the first treatment to prevent sexually transmitted HIV in uninfected people.

The FDA is questioning surveys and other assessment methods drugmakers are using to evaluate whether risk evaluation and mitigation strategies (REMS) work. An initial review shows several shortcomings.