WASHINGTON – Former FDA commissioner Andrew von Eschenbach, MD, was not a popular figure on Capitol Hill during his relatively short stay at the agency's helm, but he got in a joke or two at the expense of his erstwhile tormentors during his address to this year's joint session held by FDA and the Food and Drug Law Institute (FDLI; Washington). The former director of the National Cancer Institute spoke on a range of topics, including the 510(k) process, which he said could use tweaking.

Von Eschenbach told the largely FDA audience, "it's a pleasure to see so many familiar – and friendly – faces." Regarding Rep. Henry Waxman's (D-California) inability to deliver a lunchtime address to the crowd, which was attributed to a string of votes held on the floor of the House of Representatives, von Eschenbach quipped, "I thought I had scared him off."

Von Eschenbach, now a senior advisor at Greenleaf Health (New York), said "I did not understand ... the depths of the challenges and the opportunities at the agency" when he left the National Cancer Institute for the FDA job. He also said that unless one is inside the agency and is "vested with your head and your heart, you do not appreciate the core reality" of the agency's mission and the effort required to fulfill it.

Upon taking the FDA post, von Eschenbach said he quickly realized that "the challenge was to literally resuscitate and transform the agency," which he said had been neglected – presumably a reference to perennially puny funding – "and was desperately paddling to stay alive and to deal with the critical challenges that were constantly facing it.

"A tremendous amount of progress has been made," the former physician said, citing recent boosts to the agency's budget and a 30% increase in the workforce. Von Eschenbach also mentioned a fellowship program that he said may eventually yield 1,000 fellows working at the agency each year.

One of the members of the audience asked what von Eschenbach would say if the FDA commissioner nominee asked his advice. "If Dr. [Margaret] Hamburg called and asked my advice, I would tell her 'get a dog,'" he joked. On a more serious note, he said he would urge Hamburg to "make that investment as deep and as rich as you can,"

Medical Device Daily asked for von Eschenbach's view of the 510(k) program. His response was "I think it's time to take a step back and take a look and ask if it's appropriate" for some devices to be cleared based on similarities to predicates. He questioned whether that approach is "aligned" with 21st Century science," adding that the process "may be creating problems that may be addressed" by tweaking the mechanism.

Asked to describe the job of FDA commissioner, von Eschenbach suggested that the audience "think of the most exhilarating and terrifying ride you've ever been on in an amusement park." Two questions occur to the rider, he said. "One is 'what the hell was I thinking, and two when is this going to end?" All the same, he said he would do it again. Regarding the reputation of FDA, he said that it had not received its due, and "frankly, they deserve better."

— Mark McCarty, Washington Editor

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