Washington Drug Letter

The Senate overwhelmingly approved the omnibus FDA user fee bill 96–1 Thursday, rejecting a series of controversial amendments offered for vote on the floor.

The Senate-passed omnibus FDA user fee bill includes a proposed track-and-track system, but lawmakers need to hammer out details with the agency and stakeholders or risk seeing the proposal jettisoned from a final bill.

Meeting specific review goals for drugs and biologics is generally not a criterion in FDA reviewers’ performance plans, according to a Government Accountability Office (GAO) report requested by Congress.

An FDA advisory panel voted 6­­–4 Wednesday, with one abstention, against recommending approval of a new indication for Janssen’s oral anticoagulant Xarelto in patients with acute coronary syndrome (ACS).

Generic-drug makers are contributing to review delays because, intentionally or not, their ANDAs too often fail to provide a full list of personnel and facilities involved in drug manufacturing and testing, FDA officials say.

Eight major pharmaceutical companies are calling on drugmakers to publicize all clinical trial results — including unfavorable results — to address a “credibility gap” for industry-sponsored research.

The FDA is reviewing a study that found patients treated with Pfizer’s antibiotic Zithromax may be at a slightly higher risk for cardiovascular death than those taking amoxicillin, Bayer Healthcare’s Cipro or no drug.

CDER’s discovery of an autoimmune mechanism that leads to serious drug-induced adverse reactions in some patients taking HIV drug Ziagen could give drugmakers new methods to more quickly identify a drugs’ potential to cause severe reactions.

To promote more thorough ANDA filings and faster reviews, the FDA’s Office of Generic Drugs (OGD) plans to extend its quality-based review (QbR) process to Type II drug master file (DMF) submissions, FDA officials say.

Johnson & Johnson (J&J) subsidiary McNeil Consumer Healthcare is modifying some of its packaging equipment after blister unit tears led to a recall of one lot, 53,892 packages, of diarrhea drug Imodium from wholesalers.