U.S. Device Approvals "as Fast or Faster" than in Europe, says FDA's Hamburg

In a Q&A session at TEDMED, Larry Brilliant, president and CEO of Skoll Global Threats Fund, asked FDA commissioner Margaret “Peggy” Hamburg, MD how she envisions balancing regulatory responsibilities “with the need to move innovative products through the pipeline.” Achieving that balance is one of the agency’s highest priorities although it remains a challenge, she said.

Hamburg stressed the importance of “smart regulation” in levelling the playing field for developers of innovative technologies while improving quality and utility of products. To help make “smarter” regulation possible, it is necessary to work closely with the scientific community and innovators.

Incidentally, former FDA commissioner Andrew von Eschenbach, MD shared a similar perspective on “smart regulation,” last month at Calbio, an annual conference for Californian life sciences companies. Von Eschenbach, however, called for a “radical reformation of the agency's regulatory framework.” Hamburg stopped short of prescribing such big changes.

Hamburg did, however, acknowledge the need to get products through the FDA a “little faster,” stressing that the agency has made progress in this area and is “making great strides forward.” The agency will strive to work more closely with sister regulatory authorities throughout the world while working with them to harmonize standards .

As for drug approvals, the agency has made great progress in improving review times, she said, adding that the United States leads the worlds in terms of drug review times.

“For devices, it is a little more complicated,” Hamburg said. She went on to defend the speed of device approvals, which have been frequently criticized as being unreasonably slow. “For the majority of devices that we review, we are as fast or faster than our European colleagues.” She also stressed the importance of understanding that the regualtory process in the United States is markedly different than it is in Europe, which makes comparing the approval processes of the two different. 

For medical devices requiring pre-market approval, the United States is “a bit slower” than Europe—sometimes significantly slower, which is something the agency is working to improve. 

In November of 2010, Josh Makower, MD, MBA, released a somwhat controversial study that compared regulatory timelines in Europe and the United States. The survey found that FDA approvals are about two years slower, on average, for most medical devices than they are in Europe. While approval of Class III in the United States took, on average, 3 ½ years longer than in Europe.

In any case, Hamburg acknowledged the need to make improvements to device approval timelines, which, she acknowledged, began to slow in around 2002. “But 2011 was the first year that we started to see a turning around.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

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