Washington Drug Letter

The House voted 387-5 to pass its omnibus FDA user fee bill late Wednesday, giving lawmakers most of June to iron out differences between it and the version the Senate passed last week.

The FDA conducted 949 bioresearch monitoring inspections in fiscal 2011 — 220 fewer inspections than the year prior — with the decrease spread among all relevant agency centers as they move to a more risk-based approach.

Bayer HealthCare has submitted applications to the FDA and European Medicines Agency for its metastatic colorectal cancer treatment regorafenib.

Drugmakers could bring breast cancer treatments to market a decade earlier with new FDA guidance on trial designs for evaluating pathologic complete response (pCR) to support accelerated approval of drugs to treat high-risk, early-stage breast cancer.

FDA statistics show more than one-third of all drug recalls last year were due to stability failures — a figure that suggests the generic industry’s call for stability testing flexibility in a forthcoming guidance is unwarranted, agency officials say.

Agency inspectors found Impax Laboratories failed to reject drug products that did not meet established standards and specifications, an FDA Form 483 states, shedding light on the quality issues found at the company’s troubled Hayward, Calif., facility.

Pharma lobbyists managed to stave off price controls for Medicare Part D, and imports of cheaper drugs from Canada, in 2009 healthcare reform talks with White House officials, a congressional investigation finds.

Rogue online pharmacies looking to cash in on drugs in short supply are peddling counterfeit versions of Teva’s attention-deficit/hyperactivity disorder drug Adderall, the FDA warns.

The FDA has handed Johnson & Johnson (J&J) a complete response letter on its sNDA for a once-daily formulation of HIV drug Prezista.

The FDA has outlined provisional trial designs, study endpoints and efficacy analyses that can be used for testing and assessing new irritable bowel syndrome (IBS) drugs until a well-defined and reliable patient reported outcome (PRO) tool — the ideal efficacy assessment instrument — can be developed.