FDA Commissioner addresses approval times, global competitiveness at AdvaMed

FDA Commissioner Margaret Hamburg

CHICAGO--FDA Commissioner Margaret Hamburg made it clear that she's concerned with boosting the American medical device industry's global competitiveness during her luncheon address Tuesday. The point resonated with attendees at the annual AdvaMed MedTech Conference in Chicago, where the fact that the U.S. was the 43rd country to approve Edwards Lifesciences' ($EW) transcatheter aortic valve replacement (TAVR) has been a common refrain.

While the audience agreed with the sentiment of her speech, many wondered whether her actions will prove sufficient. It remains to be seen if the agency's efforts to streamline the regulatory process, through programs like the recently proposed Expedited Access PMA pathway for certain critical medical devices, will boost competitiveness.

Another initiative is to make the clinical trial enterprise more attractive, so that more first in human trials are conducted in the U.S., Hamburg said. But the situation has gone "well beyond going to Europe or wherever for early clinical trials. And it's now to the point where we are actually just moving all of our early stage medical device activities lock, stock and barrel overseas," said Mark Deem, managing partner of The Foundry, a med tech incubator, during the panel discussion that followed Hamburg's remarks.

He acknowledged that the relationship the FDA and the device industry has improved in recent years, but added, "It's taken us long enough to get here, and the horse has largely left the barn."

Still, Hamburg mounted a defense of the typical three-year lag time between the granting of a CE mark in Europe and FDA approval, correctly saying that "in terms of market penetration, approval in Europe doesn't always mean that it [the device] is actually broadly available in the healthcare system of those countries." This difference makes the gap in approval times look more dramatic than it really is, she said.

Hamburg also pointed to the aforementioned Expedited Access PMA pathway, saying that she wants to make sure that the device arena is keeping up with the drug arena, where there are many accelerated approval pathways for pharmaceuticals. But she stressed that efforts to improve review times are not "a step away from scientific rigor."

Global harmonization was another focus of Hamburg's remarks. "We are finding ourselves now working much more closely with our regulatory counterparts and companies around the world," she said. "Mexico and some other South American countries actually use approval by the FDA as a basis for their own national approvals."

She also stressed the importance of the FDA engaging in and collaborating with companies around scientific research, for example by aiding in the computer modeling of devices: "We're seeing that this early, continuing engagement around important promising products can really reduce the research and development time as well as enable us to move more quickly once the product application crosses our threshold."

As expected, Hamburg stressed the importance of funding the agency adequately, but she also pointed to a different challenge, saying, "we still have serious issues about being able to recruit and retain all the people that we need."

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