New Deputy Commissioner, Acting Chief of Staff Cover Ins and Outs of FDA at March Luncheon

Two of FDA’s newest top-level officials discussed the Agency’s budget, IT infrastructure and relations with Congress, the media and stakeholders at an FDAAA luncheon March 9 in Rockville, Md.

John Dyer, FDA deputy commissioner for operations and chief operating officer, discussed the Agency’s budget and IT infrastructure at an FDAAA luncheon March 9 in Rockville, Md.	Susan Winckler, acting FDA chief of staff.

Ninety members and guests heard John Dyer, deputy commissioner for operations and chief operating officer, and Susan Winckler, acting chief of staff, give the “inside” and “outside” stories, respectively, about the Agency. Dyer and Winckler were filling in for scheduled speaker Commissioner Andrew von Eschenbach, M.D. who was unable to attend.

The fiscal year 2007 budget for the Agency “looks good,” Dyer said, as an additional $25 million “turned around” an earlier, more austere outlook. And the budget request for fiscal year 2008, which begins Oct. 1, calls for an additional $50 million to $60 million, including $10 million over the present mark for drugs and devices, he said. FDA’s request for 2008 totals nearly $2.1 billion, more than a 5 percent increase over the budget submitted to Congress last year. The request includes $1.64 billion in budget authority and nearly $444 million in industry user fees. Nevertheless, the foods program and field operations will be “still hurting,” according to the new deputy commissioner.

Dyer, who came to FDA in January from the Center for Medicare and Medicaid Services, also discussed FDA’s ongoing move to its new White Oak headquarters campus. The move is “on schedule,” he said, with the Office of the Commissioner expected to be on site by the end of 2008 and the other remaining offices following in 2009. “The money is in the budget,” he said.

Information technology is also a major issue facing the agency, according to Dyer, who has extensive experience in IT in both government and the private sector. He said he sees a “need to focus” on enhancing the Agency’s most important IT systems, such as drug safety data. Dyer said that FDA has not kept up with its IT needs in recent years. He bemoaned the lack of consolidation of similar systems. “It would have been a lot cheaper and more efficient to consolidate” but the Agency hasn’t done so. “We have two and a half data centers where we should have one,” he said. “We have to be more disciplined; to get there we’ve got to go to a more centralized approach,” which could “save massive amounts of money.”

Winckler, who joined FDA last September and became acting chief of staff in December, presented a more outward-looking view in describing her new duties. She said that Dr. von Eschenbach has tasked her to “protect and promote” FDA with Congress, the media and all the Agency’s stakeholders. “We need to have all of them understand the depth and breadth of responsibility” of FDA, she explained. One tactic to accomplish this will be brown-bag sessions with reporters “to help them better understand what we do,” she said. And to increase the Agency’s scientific expertise, she said the Commissioner is planning to expand FDA’s fellowship program to bring in more scientists.

In response to a question about the outlook for a single federal food safety agency, Winckler said there needs to be more discussion of that issue on Capitol Hill, leading to “more understanding of the complexities” involved. “Having everyone in the same building doesn’t necessarily solve all those problems,” she said.

Responding to another question about how she sees FDA’s approach in dealing with regulated industry, Winckler replied that “being a ‘cop’ doesn’t mean you don’t ever talk to those folks. In regulating industry you have to communicate what’s needed.”

More information about FDA Acting Chief of Staff Susan Winckler

More information about Deputy Commissioner for Operations John Dyer

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