When it comes to grading the FDA on its performance in bringing new drugs to market, more than half the voters on a recent GEN poll gave the agency top grades. FDA received an A from 22.2% of respondents, a B from 37.8%, a C from 15.6% each, a D from 8.9%, and an F from 15.6%.
During 2011, FDA approved 35 new medicines, a number the agency has trumpeted as among its highest number of approvals over any year in the past decade, surpassed only by 37 approvals in 2009. Of the 35 drugs given the go-ahead, two were approved with a molecular test, making them the first companion drug-diagnostic sanctions. Seven newly sanctioned medications provided advances in cancer treatment, and 10 were for orphan diseases. Notably, the first new therapy for lupus in 50 years was green-lighted this past year.