Von Eschenbach sworn in as FDA commissioner; 2007 may be year of reform at agency

Dr von Eschenbach's installation ended a period of more than a year in which the agency went without a fully vested leader, and his approval should have a stabilizing effect on the agency, according to former FDA Commissioner Jane Henney, MD, now senior vice president and provost for health affairs at the University of Cincinnati, Cincinnati, Ohio.

"Once you get a commissioner that is confirmed, it adds predictability to who's going to be there, and that person then can start setting some of the strategic directions for the agency and sort of the values by which they will work," Dr Henney said. "It's just like a company-when you don't have a CEO, people are still able to come into work every day and work diligently and hard, but it's just not as clear. Anytime that you have leadership uncertainty, it's not good for the organization."

The approval ended a 9-month wait since Dr von Eschenbach, the former director of the National Cancer Institute, was nominated, including some last-minute objections and a filibuster from Sen Charles "Chuck" Grassley (R-Iowa) before the vote in December.

Industry response to Dr von Eschenbach's approval was largely positive, with representatives from industry groups including PhRMA and the Biotechnology Industry Organization (BIO) supporting the confirmation.

"This confirmation will enable him to provide effective leadership and vision for the FDA and is a critical step toward strengthening the FDA," Jim Greenwood, BIO president and CEO, said.

Sen Edward Kennedy (D-Mass), incoming head of the Senate Committee on Health, Education, Labor and Pensions, also voiced support for Dr von Eschenbach, noting before the confirmation vote that the incoming commissioner helped to resolve the issues surrounding over-the-counter availability of Plan B.

Sen Kennedy said Dr von Eschenbach's confirmation is merely an initial step toward helping the agency better fulfill its mission.

"To do the job we expect it to do, the agency will clearly need additional resources," Sen Kennedy stated. "It's time for Congress to give FDA the support it needs to make the right decisions on ever-more complicated scientific and health issues."

Dr von Eschenbach's performance as acting commissioner was not without criticism.

Sen Grassley's objections to the nomination stemmed from FDA's noncompliance with 2 congressional subpoenas involving the safety of the antibiotic telithromycin last year. Sen Grassley said, before a cloture vote that overcame the holds he and another Republican senator had placed on the nomination, that the agency under Dr von Eschenbach's leadership had displayed a "disrespect for congressional authority and the law."

"A vote for this nominee would be an endorsement of the stonewalling and disrespect he has shown for congressional oversight," Sen Grassley said.

Democratic senators also had placed holds on the nomination earlier in the year, which were lifted when FDA resolved the over-the-counter Plan B controversy.

Dr von Eschenbach succeeds Lester Crawford, DVM, PhD, who was the last fully vested commissioner. Dr Crawford began his time as commissioner in July 2005, but stepped down after just 2 months on the job. In October 2006, Dr Crawford pleaded guilty to federal misdemeanor charges for conflicts of interest stemming from stock investments in industries regulated by FDA that he retained while serving as commissioner.

EYES ON REFORM

With a new leader in place and a new party controlling Congress, 2007 may turn out to be a year of change for FDA. Democrats have been out of power for 12 years and could be looking to make an impact on pharmaceutical-related issues such as importation of medications, which could place Congress at odds with standing FDA policies. Since at least 2004, FDA has opposed any relaxation of standards on drug importation.

Although Republicans lost control of the House of Representatives and Senate in November, Democratic gains were not sufficient to override a presidential veto, so bipartisan compromise will be necessary in order for any initiative, pharmaceutical-industry related or otherwise, to progress.

"Like President Clinton, President Bush probably needs to remind members of Congress that he's not obsolete or irrelevant here, and thus set the agenda in the budget document that will go to the Congress," said Marc Scheineson, JD, LLM, former FDA associate commissioner for legislative affairs, and head of the food law practice of Alston & Bird in Washington, DC.

One of the most important issues related to FDA's continued function will be the renewal of the Prescription Drug User Fee Act (PDUFA), which expires September 30, 2007, and could serve as a potential catalyst for change.

Sometimes known as the Prescription User Fee, the act expires every 5 years and authorizes the agency to collect payments from drug manufacturers in exchange for timely product review-providing a sizable portion of the agency's funding in the process.

"That has to pass or FDA loses $400 million of funding and has to lay off a third of its workforce," Scheineson said. "Practically speaking, that's not going to happen, but that creates a vehicle to reforming FDA. There will be a major push by anyone who has proposals that affect FDA-regulated products to piggyback onto that bill."

Dr Henney agreed, saying that PDUFA will be at the top of the agenda, but what sorts of reforms legislators will have in mind while the act is negotiated remains to be seen.

"One assumes that it [PDUFA] will be renewed, but what specific things will be either put in or negotiated will have to play out," Dr Henney said. "When you are at an agency like the FDA where it's 'the hottest seat in town,' who knows what else will come along? You have to be prepared for most anything."

Potential areas of concentration in the pharmaceutical realm may include drug safety, especially following a report by the Institute of Medicine (IOM) commissioned by FDA that suggested various reforms at the agency were necessary to improve its function, especially in the area of medication safety (Formulary. 2006; 41:607–611).

"Currently there's a lot of concern about risk management in general," Dr Henney said. "The report that the IOM put forward this past fall has given more fodder for that concern and potential recommendations in terms of solutions."

Postmarketing surveillance, direct-to-consumer marketing, and the consideration of biogenerics or biosimilar generics also could be on the radar for reform-minded congressional leaders, according to Scheineson.

"I think there's going to be a broad new FDA reform package of legislative changes rolled into PDUFA," he said.

SOURCES BIO statement on confirmation of von Eschenbach as FDA commissioner [press release]. Washington, DC: Biotechnology Industry Organization; December 7, 2006. Available at: http:// http://www.bio.org/news/newsitem.asp?id=2006_1207_02. Accessed January 5, 2007.

Floor statements of Senator Grassley in opposition to the nomination of Dr. Andrew von Eschenbach to be FDA commissioner [press release]. Washington DC: December 7, 2006. Available at: http:// http://www.grassley.senate.gov/index.cfm?fuseaction=pressreleases.detail&pressrelease_id=5226/. Accessed January 5, 2007.

Statement of Edward M. Kennedy on the nomination of Dr. Andrew von Eschenbach to be FDA commissioner [press release]. Washington, DC: December 7, 2006. Available at: http://kennedy.senate.gov/newsroom/press_release.cfm?id=fc1d0098-7ff4-4265-9737-5fe73acdd09d. Accessed January 5, 2007.

PhRMA applauds confirmation of FDA commissioner [press release]. Washington, DC: PhRMA; December 7, 2006. Available at: http:// http://www.phrma.org/news_room/press_releases/phrma_applauds_confirmation_of_fda_commissioner/. Accessed January 5, 2007.