The approval rate, which contrasts with 30 in 2011 and just 21 in 2010, comes shortly after John Jenkins, the director of the Office of New Drugs at the FDA Center for Drug Evaluation and Research, told an industry conference that the FDA has been meeting or exceeding nearly all PDUFA goals for application review. PDUFA, you may recall, refers to established deadlines (read more here and here).
The implications, of course, are favorable for the pharmaceutical industry, which has complained bitterly in recent years that the FDA has been too slow to issue approvals in the wake of several safety scandals, an accusation echoed, at times, by some Republican members of Congress and patient advocacy groups.
Now, though, various drugmakers are poised to ring the register with a growing number of approvals, including eight issued last month alone. These included a new medicine from Johnson & Johnson called Sirturo for drug-resistant tuberculosis, the first new TB drug in decades, and Eliquis, the latest in a new round of bloodthinners that is from Pfizer and Bristol-Myers Squibb.
The last time, by the way, the FDA exceeded this number of approvals was in 1996, when the agency endorsed 53 new drugs.