The impact of the government shutdown is affecting FDA operations unevenly. The regulator announced Tuesday that it had approved Bayer’s blood pressure drug Adempas (riociguat), which is for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH).
The Center for Drug Evaluation and Research’s head of cardiovascular and renal drug products said in a statement that the Bayer drug is the first in its class for pulmonary hypertension and the first of any class “shown to be effective for patients with CTEPH.” The heading of the FDA’s approval notice explains how the approval got through the shutdown: user fees covered it.
Merck and Stallergenes were not so lucky. The regulator cancelled its November advisory committee panel review of their respective allergy medications Grastek and Oralair. FierceBiotech noted that Merck and Stallergenes lost out because their offerings were not new pharmaceutical products or medical devices, which means no user fee support them.
Regulatory Focus added that some recent FDA meetings which have occurred “could have benefited from the bulk of FDA’s review work for those applications already completed,” and notes that the 2013 user fees could run out before a budget is passed.
Reviews scheduled for this month include Gilead’s sofosbuvir and Johnson & Johnson’s simeprevir.
