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By Brian Reid

November 15, 2002 | After a wide-ranging, 20-month search to find someone to fill the commissioner’s post at the FDA, the Bush White House finally found its man -- Mark McClellan -- in its own midst.

McClellan, an economist and a doctor, a servant to former president Bill Clinton, and an advisor to current president George W. Bush, sailed through his Senate confirmation hearings last month. He won praise from both Republicans and Edward Kennedy, the powerful Massachusetts Democrat whose disapproval had derailed some of Bush’s past commissioner candidates.

While his appointment to the key post seems all but assured, he must get approval from the full Senate, and it was unclear whether that would happen before Congressional adjournment, which was expected toward late October. If McClellan moves into the commissioner’s traditional suite of offices at the FDA’s Rockville, Md., headquarters, he’ll inherit an agency that has drawn increasing ire from industry in the months since former commissioner Jane Henney stepped down. Approval times have risen from their late-1990s lows, and executives have worried publicly that a leaderless FDA has been more cautious.

“First, just having a commissioner is a good thing. No doubt about that,” says Eric Schmidt, a biotechnology analyst at New York City-based S.G. Cowen Securities Corp. “We’re looking forward to having someone at the top to say ‘we need some of these new drugs in spite of a risk-reward profile that can never be 100 percent reward.’”

But the agency is also in a state of change. An ambitious plan is being worked out to move drug-reviewing responsibility for biotechnology-derived drugs from one arm of the agency’s bureaucracy to another. Officials are hammering out bioterrorism action plans. And on the IT front, the FDA is becoming increasingly interested in refining the electronic filing process. All of this, say experts, should keep McClellan’s attention for the early part of his FDA tenure.

“I would suspect that a substantial portion of his first few quarter will be spent on those structural matters,” says Steven Harr, who covers the biotechnology industry for Morgan Stanley.

For the industries that the FDA regulates, the move toward a permanent FDA commissioner is almost as important as the man holding the position. The FDA commissioner spot has been the last of the nation’s public health jobs to be filled: replacements for Clinton-era leaders at the National Institutes of Health, the Surgeon General’s office and the Centers for Disease Control and Prevention were all filled first.

McClellan has been warmly received. The Biotechnology Industry Organization’s president, Carl Feldbaum, applauded Bush’s move, calling McClellan an “exceptional candidate.”

Though McClellan, who serves on Bush’s Council of Economic Advisors and worked in Clinton’s Treasury department, is no stranger to Washington, analysts say his FDA leadership philosophy won’t emerge for months after his appointment, when he has settled into the job.

Trained as an internist, McClellan has made the economics of health care -- an area of little interest to the FDA -- his chief focus in recent years.

“As far as his track record on drug development -- he doesn’t have one,” says Harr. McClellan, however, has signaled that he will look kindly on the well-funded  solutions coming out of biotechnology. In an article written for Health Affairs last year, McClellan concluded that medical technology “often leads to more spending, but outcomes improve even more.”

 





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