FDA Commissioner McClellan? HHS’ Thompson Says Nomination Is Imminent

The Bush Administration appears ready to move forward with the nomination of health advisor Mark McClellan, MD/PhD, as FDA commissioner.

"The President is going to make an announcement by the end of this month or the first part of next month," HHS Secretary Tommy Thompson told the Bear Sterns conference in New York Sept. 17.

Although Thompson did not name or otherwise describe the potential FDA nominee, the optimistic timeline he outlined leaves little doubt the choice will be White House Council of Economic Advisors member McClellan.

McClellan was identified as the top candidate for the job in late July (¹ (Also see "Internist McClellan Placates Kennedy Industry Concerns; Is That Enough?" - Pink Sheet, 22 Jul, 2002.), p. 17).

Thompson predicted the FDA nominee would clear Congress before the end of the year, presumably during a lame-duck session after the elections.

"The Senate is going to make their decision relatively quickly, we think," Thompson said. "A commissioner should be in place before Congress adjourns for the year."

As McClellan already was confirmed by the Senate for the CEA post, it is at least conceivable he could take office as quickly as Thompson predicted. McClellan meets the criteria outlined publicly by Senate Health Committee Chairman Edward Kennedy (D-Mass.) to fill the job: he is a medical doctor with no direct industry ties.

Two other aspects of McClellan's background should also appeal to Kennedy: his graduate degrees and medical training all came from Massachusetts institutions (Harvard, MIT, Brigham & Women's Hospital), and he previously served in a Democratic administration (as deputy assistant secretary for economic policy in the Clinton Treasury Department).

McClellan does not have any direct experience with FDA. His primary focus in the White House has been working on Medicare.

Thompson's prediction that the new commissioner will be confirmed this year seems like a long shot. However, Kennedy previously has been accommodating in moving forward nominations he supports.

When David Kessler, MD, was selected for the commissioner post during the first Bush Administration in 1990, Kennedy agreed to waive the confirmation hearing in the interest of letting Kessler take office before the end of the year.

In this Administration, Kennedy allowed the nomination of Merck R&D exec Eve Slater, MD, as assistant secretary for health to move to the floor quickly. The White House announced its intent to nominate Slater Oct. 16, 2001 and she was confirmed Jan. 25.

The Health Committee says it has not been notified of a commissioner nomination. Kennedy is not commenting publicly on McClellan's qualifications, although presumably there has been ample opportunity for the Administration to gauge reaction in the two months since McClellan was identified as the leading candidate.

McClellan has picked up some public endorsements. Sen. John Breaux (D-La.) told a Pfizer Health Literacy Initiative conference in Washington, D.C. Sept. 19 that McClellan would be "terrific" as commissioner.

"He's a medical doctor and understands the medical profession and also the bureaucracy and how to deal with it," Breaux said. "I think he'd be a pretty good choice." Senate Health Committee member Bill Frist (R-Tenn.) also has offered public support to McClellan's candidacy.

Both Breaux and Frist have worked closely with McClellan on Medicare issues.

At 39, McClellan would be among the youngest commissioners ever. If McClellan were confirmed before the end of the year, he would be a month younger than Kessler was when he took office. The only person younger than Kessler to serve as commissioner was Carl Alsberg, MD, who took office in 1912 at age 35.

Kessler was a more familiar figure than McClellan within the FDA policy arena at the time he took office. Before he was nominated, Kessler served as a member of an HHS blue ribbon commission on FDA chaired by former Commissioner Charlie Edwards.

Thompson's appearance at the Bear Sterns conference offered a replay of his visit one year ago, when he first declared a commissioner candidate had been chosen and promised rapid action by the Senate.

Last year, Thompson indicated (without naming names) that the pick for the post would be Lester Crawford, PhD (² (Also see "HHS Pick For FDA Commissioner Is Crawford; Bush Announcement Pending" - Pink Sheet, 1 Oct, 2001.), p. 6).

However, the White House did not come forward with a nomination for the former Center for Veterinary Medicine director; instead, he was appointed deputy commissioner in February and has since been serving as acting commissioner.

Crawford joined Thompson at the Bear Stearns conference, and the HHS secretary offered an explanation for the failure of his prediction a year ago.

"Last year...I was pressed to answer and didn't realize naively that the press were also listening and I indicated that Dr. Crawford was my personal pick to become commissioner of FDA. Somehow the White House did not like that I was advocating someone before they announced it, and so I got in trouble."

"I apologize to you, Les," he added, "because I think I've spoiled your chance to become commissioner."

In 2001, Pfizer CEO Henry McKinnell followed Thompson's presentation by declaring the pick was "good for FDA and good for the nation."

The industry endorsement was important for the investor community, given the concern (driven in part by comments from Pfizer throughout the year) about a "slowdown" at FDA.

However, McKinnell's comments also may have served as a red flag for critics of the industry to look carefully at Crawford as a candidate. McClellan has less FDA experience than Crawford, but industry may feel less need to reassure investors that the Bush advisor is a good choice from their perspective, based on his clear support for the value of medical innovation.

McClellan, a board-certified internist, likely will be able to count on support from the American Medical Association for the commissioner post. One element that made Crawford's nomination difficult is the expectation in the medical community that the commissioner post should go to an MD. Crawford is a veterinarian with a PhD in pharmacology.

If McClellan is not confirmed this year, FDA will reach its second anniversary without a permanent commissioner. The post has been vacant since Jane Henney, MD, resigned at the beginning of the Bush Administration.

If the vacancy lingers much longer, the Administration may again face the complication of vetting FDA candidates while seeking to fill other health openings.