FDA boasts better approval rates than Europe
pharmafile | November 4, 2011 | News story | Medical Communications, Research and Development | FDA, approvals
US regulator the FDA has approved more drugs and at a faster rate than its European counterpart.
A new report by the FDA shows that approval times in the US were faster when compared to the regulator’s counterparts around the globe.
When looking at its European counterpart the EMA, the report found that 24 of the 35 approvals occurred in the US before they did in the European Union.
This is generally because pharma firms will submit their drugs in the US before Europe, but it is now acknowledged that the regulator is faster than the European Medicines Agency, especially in approving new cancer drugs.
The report covers the FDA’s fiscal year ending 30 September 2011, and the 35 approved drugs is the one of the highest total in its history, second only to the 37 approvals in 2009.
Margaret Hamburg, commissioner of the FDA, said: “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients.
“We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century.”
New cancer drugs were a particular highlight for the regulator and it made specific mention to Roche’s melanoma drug Zelboraf, and Pfizer’s lung cancer treatment Xalkori as two highly innovative medicines that had been passed by the FDA.
Hamburg said there had not been a higher number of submissions than in previous years, but they had been of higher quality, making approval more likely.
In a call to reporters Hamburg said: “The point we’re trying to make is that when high-quality science, good applications come before us, we are able to act swiftly and surely, and we are able to apply considerable regulatory flexibility in our application review process.”
Ben Adams
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