Washington Drug Letter

A Senate committee approved its version of an omnibus FDA user fee bill Wednesday, sending it to the Senate floor for a vote as early as next month.

Senate appropriators overwhelmingly approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA, including $10 million to fund an expansion of the agency’s China office.

Additional FDA authority and improved notification of suspected counterfeits could help the agency strengthen pharma supply chain integrity and keep unapproved and counterfeit products from reaching U.S. physicians, it says.

CDER this year plans to release draft guidance on abuse-deterrent formulations and nine guidances — both drafts and updates — clarifying the FDA’s views on antibiotic development, a CDER official says.

A new government report has cast doubt on the FDA’s ability to handle information associated with the rising flood of drug imports, saying its sluggishness in integrating legacy IT systems is limiting regulatory effectiveness.

While CDER is improving its drug safety efforts by giving equal weight to pre- and postmarket analysis, the center’s safety science is still evolving and may potentially include wireless technologies to transmit point-of-care data, a new FDA report states.

All drugmakers need a social media policy regardless of whether they have an active presence in the online world or not, experts at the Food and Drug Law Institute’s annual conference advise.

The U.S. District Court for the District of Columbia has denied ViroPharma’s motion for a temporary injunction to require the FDA to withdraw its approval of three generics of the gastrointestinal antibiotic Vancocin.

Over the next several years, the FDA will engage more with its international counterparts through systems that will allow it to share real-time information and resources in a more comprehensive way than is currently possible.

Democrats in the House and Senate have introduced companion bills that would allow generic-drug makers to update safety warnings on labeling without waiting for the brand drug maker to do it first.