US FDA claims more NDA approvals than other countries, with 35 in fiscal year 2011

The US Food and Drug Administration, which in the past has been criticized for slow approval on new drugs, has revealed that, over the past 12 months, it approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37).

Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.

In a report released yesterday, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained.
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The report shows faster approval times in the USA when compared to the FDA’s counterparts around the globe. 24 of the 35 approvals occurred in the USA before any other country in the world and also before the European Union, continuing a trend of the country leading the world in first approval of new medicines.