Von Eschenbach Resigning In January With BTC Debate In His Legacy

FDA Commissioner Andrew von Eschenbach will return to Texas upon resigning his post Jan. 20, leaving a legacy that includes restarting discussions on whether a third class of drugs is needed.

Von Eschenbach announced his intention to resign as commissioner in an e-mail to FDA staff Dec. 15. "As a public official appointed by President Bush and confirmed by the Senate, I serve you but at the pleasure of the president. I will do so until January 20, 2009, when a new president takes office and a new administration begins."

So far, von Eschenbach has remained mum on his post-FDA plans, but there has been some speculation that a deanship is in the works at the University of Texas M.D. Anderson Cancer Center in Houston (¹ The IN VIVO Blog, Nov. 10, 2008).

Von Eschenbach served as the Anderson Center's executive VP and chief academic before being named director of the National Cancer Institute in December 2000 and moving to FDA in 2006 (² (Also see "Von Eschenbach Slated For Nomination As Permanent FDA Head" - Pink Sheet, 13 Mar, 2006.), p. 7).

The resignation is not a surprise as von Eschenbach was expected to leave FDA after President-elect Barack Obama takes office.

Indeed, in the e-mail he said departing at the end of the Bush administration "has always been my plan and the expectation of my family from the time of my confirmation as" commissioner.

What is a bit unusual for an FDA commissioner - at least based on the last two White House transitions - is that von Eschenbach chose to announce his departure more than a month before Inauguration Day.

However, given the expectation that von Eschenbach would leave along with Bush, his early warning can be viewed as a courteous gesture to the incoming administration.

The last two White House transitions have not followed that path. In the month before Bush took office in early 2001, then-Commissioner Jane Henney made quite clear her interest in staying on at FDA. In the end, the Bush administration requested Henney's resignation (³ (Also see "FDA's Schwetz Is Acting Commissioner Following Henney Resignation" - Pink Sheet, 22 Jan, 2001.), p. 8).

The transition to President Clinton in 1992 was a different scenario. Then-FDA Commissioner David Kessler, appointed under President George H.W. Bush, was asked to stay on under the new administration. In the end, Kessler served as commissioner through Clinton's first term in the White House.

Nonprescription Legacy

Von Eschenbach's tenure spanned multiple FDA decisions or actions with significant impact on the nonprescription market.

The Center for Food Safety and Applied Nutrition in 2007 published the good manufacturing practices required under the Dietary Supplement Health and Education Act of 1994 (⁴ (Also see "Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing" - Pink Sheet, 25 Jun, 2007.), p. 3).

Although the process for switching Barr Pharmaceuticals' Plan B emergency contraceptive started before von Eschenbach headed FDA, he was acting commissioner when the agency decided to allow BTC sales of the product to consumers 18 and older while requiring prescriptions for younger girls (⁵ (Also see "Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing" - Pink Sheet, 28 Aug, 2006.), p. 3).

The commissioner suggested in March 2007 that the drug industry pursue the development of a regulatory process for a behind-the-counter class of drugs (⁶ (Also see "Von Eschenbach Promotes Behind-The-Counter Drug Class" - Pink Sheet, 19 Mar, 2007.), p. 3).

FDA has not proposed a rulemaking to establish a third class, but the topic is discussed frequently at the agency and among stakeholders (⁷ (Also see "Behind-The-Counter Guidance Stalled, But Interest Grows To Expand Access" - Pink Sheet, 30 Jun, 2008.), p. 5).

Choosing A New Commissioner

The selection of von Eschenbach's successor has been the subject of intense speculation. Much of the focus has been on a short list of candidates, including academics, public health officials or internal candidates (⁸ (Also see "With Democrat In White House, “More Aggressive” FDA Comes Into Focus" - Pink Sheet, 10 Nov, 2008.), p. 3).

While the choice of a permanent commissioner is likely months away, von Eschenbach expressed hope that at least part of his senior team will remain intact.

"As with any transition, there will likely be changes for other senior managers as well, although all current deputy commissioners and the chief of staff are career civil servants who have served me and FDA well," von Eschenbach said in his e-mail to agency employees.

The principal deputy commissioner, Frank Torti, likely would be asked to stay on - although there has been resistance from some in Congress to an internal candidate (⁹ (Also see "FDA Commissioner Must Not Come From Agency, Stupak Advises Obama" - Pink Sheet, 8 Dec, 2008.), p. 12).

Torti, who has a strong academic background, has focused on overseeing FDA's fellowship program (¹⁰ (Also see "FDA’s Chief Scientist Has Full Plate To Concentrate On: Clinical Research" - Pink Sheet, 21 Apr, 2008.), p. 6).

Other senior officials in the commissioner's office include Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter, Chief Operating Officer John Dyer, Deputy Commissioner of International and Special Programs Murray Lumpkin, and Chief of Staff Susan Winckler.

The chief medical officer position has been vacant since Janet Woodcock returned to the Center for Drug Evaluation and Research as director last fall (¹¹ (Also see "Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss" - Pink Sheet, 24 Mar, 2008.), p. 14).

A Bumpy Tenure

Von Eschenbach's time at FDA has rarely been smooth, beginning with how he abruptly joined the agency in 2006 after Lester Crawford was forced to resign (¹² (Also see "Crawford Pleads Guilty Of Failing To Disclose Stocks In Firms FDA Regulates" - Pink Sheet, 23 Oct, 2006.), p. 5).

The commissioner began with an optimistic focus on personalized medicine and the Critical Path Initiative, but was quickly bogged down by one crisis after another - drug safety issues, adulterated heparin and contaminants found in products from infant formula to pet food.

But von Eschenbach has had some successes as well. During his tenure, FDA received more money to hire employees and gained new drug safety authorities under the FDA Amendments Act (¹³ (Also see "FDA Sheds Cumbersome Hiring Process To Beef Up Scientific Capabilities" - Pink Sheet, 5 May, 2008.), p. 14).

Von Eschenbach also oversaw the opening of the first FDA offices in China and the much-anticipated move to a new facility in the White Oak area of Silver Spring, Md., a Washington suburb. He mentioned those accomplishments in his farewell to FDA staff.

"In mid-November I had the special privilege of participating with [HHS Secretary Mike Leavitt] in the opening of three new FDA locations in China as the first step in establishing FDA's presence beyond our borders. Then this month, my immediate office moved into the newly renovated and historic Building One at FDA's White Oak campus, the site of modern state-of- the-art facilities for the FDA."

- Kate Rawson ([email protected]); Malcolm Spicer ([email protected]) contributed to this article.