Medical Device Daily Washington Editor

WASHINGTON – The presentation by FDA commissioner Andrew von Eschenbach, MD, last week at the National Press Club (NPC; Washington) was billed as a discussion of follow-on biologics, but it more often covered the things FDA has to do to stay abreast of its mission, including a challenge to Congress to give the agency more authority to mandate food recalls.

However, the contentiousness of von Eschenbach’s confirmation hearings and the recent call for his resignation by Rep. Bart Stupak (D-Michigan), chairman of the Energy and Commerce Oversight subcommittee, are feeding questions about whether he will be on the job to see agency goals met after January 2009 if a Democrat wins the presidency.

(And regarding any contact from the Clinton and Obama campaigns, and whether either of them, if elected, would leave him in the job, he told Medical Device Daily, “I haven’t heard from them.”)

In remarks introducing von Eschenbach, Sylvia Smith, president of NPC, hinted that the job of FDA commissioner isn’t for the faint-hearted.

“We couldn’t have invited the chief of a more news-making agency,” she said, including the recent news of the toxic heparin produced for Medtronic (Minneapolis) in China. But she said that the news the agency generates is good as well as bad.

Stepping up to the podium, von Eschenbach tried to reassure the audience that he and everyone at FDA are aware of the size of the task that faces them.

“About 100 years ago,” he said, “when science was unraveling the secrets of the atom,” changing technology offered greater development for pharmaceuticals. As was the case with the science of the atom, pharmaceutical science embodied both promise and peril. “One response [to those changes] was the Food and Drug Act of 1906,” which led to the formation of FDA.

As scientist pried open the atom and its nucleus, he said, further “revolutionary progress has opened our understanding of the cell and its nucleus ... enabling us to clone animals, modify crops, and make X-ray devices that can see living processes.”

Over the course of the 20th century, FDA has evolved and become recognized as the gold standard, von Eschenbach said, but during that time, urbanization, industrialization and mass production of food have coupled with medical technology to serve as sources of “great promise and great peril.”

“Society must respond and recreate FDA” in response, he said, because the FDA of the 20th century “is not adequate to meet the challenges of the 21st century.

“This is a time in which the wind of change in healthcare ... is not a gentle breeze, but a jet stream.”

The “peril” of new technologies “is now even greater,” he said, because drugs and devices have grown massively more complex. He included in this group of more complex systems cardiac pacemakers “that are susceptible to breakdown and failure simply because of their complexity,” and nanoparticles “that present challenges because they are unknown.

“Today, the peril is great, but the promise is unlimited,” he asserted.

von Eschenbach said that it is his “charge” to forge a new agency for the 21st century, acknowledging that the agency has many fine employees, but “their task is daunting.”

He said the prospect of influenza pandemic called for a pandemic response plan, which adds to the agency’s work and has interrupted the development of an overall, comprehensive agency plan. However, the exercise carried out in developing this plan increased from three to six the number of firms licensed to make vaccines.

“As a result, instead of a shortage of vaccine, we now have a surplus,” he said.

In his discussion of food safety, von Eschenbach said that in order for the agency to be able to deal with tainted food, it needs a statutory fix allowing it to issue mandatory recalls to deal with tainted food.

And the FDA chief essentially laid down the gauntlet for Congress on new legislative rules giving it broader food recall authority: “I call on Congress to authorize those by Memorial Day.”

In proposing an overhaul of FDA operations, von Eschenbach outlined several essential steps.

• The first, he said, is that “the principles of the systematic and systemic change include” a greater focus on priorities such as drug and food safety, as well as on information technology IT.

• “Second, a disciplined process for” rewiring the agency’s operations is needed, mentioning the FDA Science Committee’s use of outside experts to review the agency’s operations.

• Third, “for each of these, we developed a strategic plan, including milestones” to make clear just how much progress the agency is making on its objectives.

• And the agency’s workforce assessment calls for more and better-trained employees, von Eschenbach said.

“We’ve embarked an aggressive recruitment and retention effort” for 700 new employees, thanks to the FDA Amendments Act of 2007, as well as development of “a fellowship program [that] will attract 2,000 fellows.”

As for FDA’s notoriously second-rate IT infrastructure, he said, “We will spend approximately $250 million to acquire servers and software,” part of which will go to beef up operations at the integrated data center at the agency’s White Oak, Maryland, campus, which is “also the place of the development of our state-of-the-art labs” for drugs and devices.

“FDA can no longer simply be a gatekeeper ... or simply rely on inspections to verify quality,” he said. “We are engaging in the total lifecycle of the products.”

And he added a comment that FDI chiefs are loathe to make when in the witness chair in congressional hearing rooms, testifying on new budget needs: “It’s no secret in Washington that as FDA’s mission has grown [FDA’s resources} have not kept pace. We are on a trajectory of budget increases,” and this trajectory “must continue and must accelerate.”