WASHINGTON - Industry leaders got some relief Wednesday morning when the Bush administration nominated Texas-born internist Mark McClellan to serve as FDA commissioner.
While insiders here admit there's little detail known about the 39-year-old Bush adviser, on the surface they appear to be pleased with Bush's pick.
Since mid-summer, McClellan's name has been floating about Washington as topping the short list of candidates being eyed by the Bush team to fill the shoes vacated in January 2001 by Jane Henney, the commissioner named by President Bill Clinton.
McClellan is a member of the White House Council of Economic Advisors and once worked as a professor of medicine and economics at Stanford University. His brother, Scott McClellan, a White House deputy press secretary, announced the nomination.
A few eyebrows have been raised about Mark McClellan's apparent lack of regulatory experience, but Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, told BioWorld Today that McClellan's total professional experience should be considered.
"No candidate is going to have everything," Feldbaum said. "Based on what we know about Dr. McClellan, and having read most of his published works, we have a positive attitude toward his nomination. The rest is what a confirmation process is for, and the process for FDA commissioner is now akin to that of a Supreme Court justice - it has to be very thorough - so we will learn a great deal more about Dr. Mark McClellan."
The confirmation process will be run by Sen. Edward Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pensions committee.
Kennedy has long opposed any candidate fresh from the industry. In fact, it was rumored that Kennedy blocked the nomination last year of Michael Astrue, a senior vice president of Transkaryotic Therapeutics Inc., of Cambridge, Mass., by refusing to give Astrue a hearing. (See BioWorld Today, Nov. 2, 2001.)
Jim Manley, a spokesman for Kennedy in Washington, didn't tiptoe around the issue. Instead, he told BioWorld Today that the senator has "very serious concerns about someone with strictly industry experience."
If Kennedy feels that strongly, then McClellan might stand a chance.
McClellan graduated from University of Texas before earning a master's in public administration and an M.D. from Harvard University. He earned a Ph.D. in economics at the Massachusetts Institute of Technology. And, from 1998 to 1999, McClellan served at the Treasury Department as deputy assistant secretary for economic policy.
"I would agree that it appears that McClellan doesn't have ties to the industry," Manley said. "Sen. Kennedy thinks he has impressive credentials - both as a physician and an economist - and he's anxious to sit down and talk to Dr. McClellan some more about his views related to the FDA."
Manley wouldn't discuss a potential date for the committee hearing.
"I refuse to get pinned down on any time frames," he said. "We haven't even gotten his paperwork yet and there's a process to follow. He's undergoing an FBI background check and we'll get that, and move as quickly as possible."
Sen. Bill Frist (R-Tenn.), the only physician in the Senate and a member of the committee, released a prepared statement supporting McClellan.
"He's a doctor, an economist, and someone with a proven track record for working in a bipartisan way to improve health care," he said. "The FDA faces a number of challenges ahead that will require strong leadership, and Mark McClellan is the right person for the job. I hope and expect that he will be quickly confirmed."
Industry representatives, though, are just glad a candidate has been named.
Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America in Washington (PhRMA) told BioWorld Today that PhRMA would reserve comment until more information about McClellan becomes available. However, he did say PhRMA welcomes the nomination.
Bush has been widely criticized by the industry for failing to name a commissioner earlier in his administration. Many believe that the leaderless agency has been slow to approve products and hesitant about making decisions without a commissioner to set the pace.
However, the situation began looking better in January when Lester Crawford, a veterinarian and former director of the FDA's Center for Food and Nutrition Policy at Virginia Tech in Blacksburg, Va., accepted the position as the agency's deputy commissioner. Crawford led the agency in the reauthorization of the Prescription Drug User Fee Act and in upgrading the manufacturing oversight system. And just recently, Crawford's office announced a plan to speed the biologics approval process by transferring review responsibilities to the agency's drug division. (See BioWorld Today, Sept. 9, 2002; Aug. 23, 2002; and Feb. 28, 2002.)