FDA Energized, Approves 26 New Drugs
fda

The new Obama administration has managed to inject some speed into the FDA, following a list of complaints concerning various food items and drugs - from blood thinners to peanut butter. Commissioner Margaret Hamburg has declared that the FDA will come down heavily on companies not following regulations. In the meanwhile, the FDA has managed to clear a lot of backlog and has approved 26 new drugs this year, as compared to 25 it had last year.

There are still some major deadlines – 32 to be precise, that have been overshot. These delays convey internal conflicts sending wrong messages to public and the industry. Analysts feel that some tight measures are required to meet these deadlines.

Drug companies pay user fees to the FDA annually to help speed drug-approval reviews. The Agency implements Risk Evaluation and Mitigation Strategies to help speed up approvals, but in fact this program is slowing the whole process.

Among the approved drugs are GlaxoSmithKline’s Votrient, Novartis AG’s Afinitor, Daiichi Sankyo’s Effient, Lomb’s pink eye medicine, Besivance and the heart rhythm restorer, Multaq from Sanofi-Aventis SA. Advanced metastatic kidney cancer patients will finally be able to acquire Roche Holding AG's Avastin.

However, there is still some wait for Amgen Inc.'s postmenopausal-osteoporosis drug Denosumab and Novo Nordisk’s diabetes drug, Liraglutide.

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