Kerry Could Look To Kessler To Help Tap FDA Head; Wood A Possibility?

Former FDA Commissioner David Kessler may figure prominently in the selection of a new commissioner in the event that a Kerry administration takes over the White House in November.

Kessler, who served as commissioner from 1990 to 1997, has been mentioned as a likely consultant in the event of a new commissioner search, according to one person in the Kerry camp who would be involved in the selection of nominees.

The idea of Kessler's having a hand in the process likely will raise concerns among stakeholders in the pharmaceutical and medical technology industries.

Kessler originally was tapped by President George H.W. Bush. The Harvard-trained physician and University of Chicago-trained lawyer was widely viewed at the time as an academic who would keep a low profile at FDA.

However, soon after taking the reins, Kessler led an aggressive public campaign against tobacco manufacturers. He attempted to put regulation of nicotine-containing products, such as cigarettes and smokeless tobacco, under the purview of FDA.

The Supreme Court ruled against giving the agency regulatory authority over tobacco products in 2000.

Ironically, what Kessler fought for may happen now, partially as a result of lobbying efforts by tobacco interests (¹ (Also see "Crawford Says Carb Rule To Come Out Shortly; Outlines FDA Agenda" - Pink Sheet, 9 Aug, 2004.), p. 8). Legislation passed the Senate in July giving FDA authority over tobacco and currently is in conference.

Although Kessler's standoff with big tobacco may have won him favor in the eyes of the general public, he drew the ire of key players in the pharma and medical device industries as review times for new products increased dramatically under his tenure.

Kessler now is the dean of the University of California, San Francisco School of Medicine.

Alastair Wood: Second Time's A Charm?

Nevertheless, while Kerry's advisors will have a long list of qualified candidates, a few names that have already been through the vetting process may resurface.

For example, Nonprescription Drugs Advisory Committee member Alastair Wood, MD, may come under consideration.

Prior to the nomination of Mark McClellan, MD/PhD, in 2001, the Vanderbilt pharmacologist was considered a favorite for the position and made it through to the late stages of the selection process.

He reportedly received the nod from key senatorial figures but was withdrawn from consideration after an interview with White House staffers.

The drug industry aggressively opposed his nomination and reportedly put pressure on the Bush Administration to drop Wood from consideration.

Wood's published opinions on direct-to-consumer advertising and drug safety have been cited as possible reasons behind the Administration's withdrawal of his candidacy (² (Also see "Bush Seeking New FDA Commissioner Candidates With Wood Cut From List" - Pink Sheet, 25 Feb, 2002.), p. 8).

The Kennedy Factor

During his first go-around, Wood gained the approval of Sen. Edward Kennedy (D-Mass.), who has long taken an active part in the commissioner selection process.

Due to his relationship with Kerry and his position as ranking member on the Senate Health, Education, Labor & Pensions Committee, Kennedy would play a pivotal role in shaping Kerry's HHS department if his Massachusetts junior colleague were to become President.

Kennedy effectively blocked the nomination of Michael Astrue, then VP-administration/general counsel at Transkaryotic Therapies Michael Astrue due to his position with the biotech firm (³ (Also see "Sen. Kennedy Warns Against Picking FDA Commissioner From Industry" - Pink Sheet, 23 Jul, 2001.), p. 17).

A lack of direct industry connections remains a primary qualification for a commissioner, according to Kennedy's office.

Wood's Three-Point Plan

During an Aug. 16 interview with "The Tan Sheet," Wood said that despite losing out on the position, he found the process relatively positive and would consider the position if asked again.

He outlined changes at FDA he would like to see under any commissioner, but surely issues he would champion if nominated for the top spot himself.

Wood maintained the agency should create an environment that improves incentives for drug companies to develop therapies where there currently is no reliable treatment, for example, prevention of Alzheimer's.

He suggested use of staged approvals, allowing firms a certain period of exclusivity based on reaching a surrogate endpoint. Upon achieving an actual endpoint, exclusivity would be extended.

Second, the agency should be more involved in the drug review process at an earlier point, he said, thereby allowing FDA to guide sponsors in a positive direction, and improve efficiency of the process.

Wood allowed that sustaining the independence of reviewers working long-term on a particular product submission would present a challenge.

Third, safety needs to be treated as a joint endeavor between companies and the agency, he maintained. Too often, industry views safety as the agency's responsibility, he opined.

Wood has been outspoken in his criticism of FDA's decision not to approve Barr Labs' emergency contraceptive Plan B for over-the-counter use.

He served on the panel, along with the Reproductive Health Drugs Advisory Committee, that recommended Plan B for nonprescription availability.

In an April editorial in the New England Journal of Medicine, Wood expressed concern over the politicization of the drug approval process (⁴ (Also see "OTC Plan B Age Limits Would Reflect Political Taint In FDA Review – Wood" - Pink Sheet, 12 Apr, 2004.), p. 3)

This dynamic could hamper Wood as a Kerry selection in the likely event of a slim majority in the Senate for either political party after November.

Clintonian Influence

Whether or not Wood is given a second look if Kerry were elected, there are numerous academics ranging from a clinical trial specialist to a health economist who would carry the qualification to fill the position.

A commissioner search process under Kerry could follow the model of the Clinton Administration, given the degree to which the candidate has surrounded himself with former advisors and staffers of the previous President from the Democratic Party.

The Clinton search team cast a fairly wide net while looking to replace Kessler in 1997, and looked at people from a range of backgrounds, including food and drug law, academia, and FDA insiders.

Consultant Chris Jennings served as White House Special Assistant for Health Policy under Clinton and helped lead the search process in 1997.

Jennings has been named both as someone who Kerry's people would consult on a search and as a possible commissioner candidate himself

Jennings runs Washington D.C.-based Jennings Policy Strategies where he has worked as a lobbyist for the Generic Pharmaceuticals Association on Capitol Hill.

Kerry would work with a longer list than President Bush, according to the Kerry insider.

Alan Garber: McClellanesque

Stanford University professor Alan Garber, MD/PhD, would be a selection in the mold of former FDA head McClellan, with degrees in medicine and economics.

Garber is director of Stanford's Center for Primary Care & Outcomes Research and Center for Health Policy. He has in fact coauthored papers with McClellan on the costs of healthcare.

Despite his academic background, Garber does not lack Washington experience: he served on the HHS Panel on Cost-Effectiveness in Health & Medicine from 1993 to 1996. He also worked at the National Academy of Sciences' Institute of Medicine in the division of Health Promotion & Disease Prevention.

The health economist's background includes experience in both drugs and devices. He has written papers on the cost-effectiveness of various treatments, including statins, and has served on the Medicare Coverage Advisory Committee (⁵ (Also see "Statins' cost-effectiveness" - Pink Sheet, 29 May, 2000.), In Brief).

Garber may represent a candidate with across-the-aisle appeal. His interest in the cost-effectiveness of healthcare is likely to appeal to conservatives, especially in the wake of McClellan's popularity, while his academic credentials and lack of industry connections could appeal to Democrats.

Robert Califf: A Hearty Choice

One potential candidate popular with industry but likely to pass the Kennedy test is cardiologist Robert Califf, MD, director of the Duke Clinical Research Institute.

Califf is an expert in chronic heart disease, health outcomes and medical economics. He has served on FDA's Cardio-Renal Drugs Advisory Committee and several IoM panels. Califf was considered by the Bush Administration for FDA commissioner in 2001.

Stop Acting

Either potential administration looking for continuity at the agency could choose to look much closer to home: Acting FDA Commissioner Lester Crawford is rumored to be looking to remove the "Acting" from his title.

Crawford, a veterinarian, is well-liked in HHS and political circles in both parties. However, Crawford's lack of a degree in medicine reportedly has held him back from retaining the position permanently.

HHS Secretary Tommy Thompson is expected to step down after the election, which could pave the way for McClellan, now the Centers for Medicare & Medicaid Services administrator, to head the department in the event of a Bush reelection victory.