Washington Drug Letter

The FDA is asking a federal judge to dismiss a lawsuit brought by six agency scientists who say they were subjected to retaliatory personnel actions as punishment for reporting product safety concerns to Congress and the U.S. Office of Special Counsel (OSC).

During the coming year, the HHS Office of Inspector General (OIG) will continue examining the risk evaluation and mitigation strategies (REMS) program and expects to release findings next year, the office says in its fiscal 2013 work plan.

New fixed-dose drug combinations that include at least two INDs and target a serious or life-threatening disease could be eligible for an additional six months of marketing exclusivity and priority review under a new bipartisan-supported bill sponsored by Rep. Brian Bilbray (R-Calif.).

Generic-drug makers must submit self-identification information to the FDA by Dec. 3 to comply with the recently passed Generic Drug User Fee Amendments of 2012.

The FDA has outlined requirements that drugmakers submitting Type II active pharmaceutical ingredient (API) drug master files (DMF) must meet before the files are listed on the agency’s public website as available for reference to support an ANDA.

The FDA is considering elevating staff that deals with drug shortages from the Office of New Drugs to the Office of the Center Director, the agency says.

Mylan is suing the FDA over its refusal to grant 180-day exclusivity for the company’s four generic versions of Novartis’ high blood pressure drug Diovan.

Daiichi Sankyo and ArQule are discontinuing a Phase III trial of tivantinib in combination with erlotinib for patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC).

Drugmakers should use superiority trials when developing antimicrobial drugs for the treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), according to an updated agency guidance.

Novo Nordisk has discontinued development of one of its four hemophilia drug candidates following data from a Phase IIIa trial that found anti-drug antibodies and further potential risks for hemophilia patients with inhibitors.

Sponsors of treatments for acute bacterial otitis media (ABOM), an inflammation of the middle ear, may be able to use a single clinical trial to support an application under some circumstances, according to a final FDA guidance.

Endo Pharmaceuticals is petitioning the FDA to require generics referencing its crush-resistant pain drug, Opana ER CRF, demonstrate they are similarly crush-resistant.

A sharp increase in exaggerated or misleading comparative claims in drug advertisements has the FDA analyzing the issue and considering guidance on it to help stop the violations.

Clinical trials of drugs to treat complicated intra-abdominal infections (cIAI) should have a primary endpoint of complete resolution of symptoms at 28 days following randomization and the absence of clinical failure, according to an FDA draft guidance.