Here's an article from this morning's Boston Globe about McClellan:
Bush ready to nominate key adviser to lead FDA
By Michael Kranish, Globe Staff, 9/25/2002
WASHINGTON - After a tumultuous 20-month search, President Bush has decided to nominate Dr. Mark McClellan, his top health care advis er, to become commissioner of the Food and Drug Administration and could make the announcement as early as today, federal officials said yesterday.
[]
Drug industry officials, who have complained vehemently about the leaderless agency, hailed the expected announcement as a potential boon. They noted that drug approvals have been slower under the Bush administration than during most of the Clinton administration, due in part to inertia at the agency. The average drug approval time in 1999 was 11.7 months, compared with 16.4 months in 2001 under Bush.
''There is a general sense in the industry that without a leader, this agency is floundering,'' said Stephen Mulloney, director of government relations at the Massachusetts Biotech Council. Mulloney said that many biotech executives support McClellan because he could be in a unique position to build a bipartisan coalition that could boost the agency and speed drug approvals.
But a consumer group expressed disappointment that McClellan, a member of the Council of Economic Advisers, has no background in drug or food safety. The arm of Public Citizen, Ralph Nader's group, questioned his credentials to lead the FDA.
McClellan, 39, is a Texan with strong ties to Massachusetts. He is an internal medicine doctor and economist who has degrees from Harvard Medical School and MIT. He did his residency at Brigham and Women's Hospital.
In making the selection, Bush has tried to find someone who could pass muster with both Senator Edward M. Kennedy of Massachusetts and the pharmaceutical industry. Kennedy chairs the Senate committee that must approve the nomination and has blocked other candidates who have worked in the pharmaceutical industry.
The White House, in turn, has decided against other candidates because they were opposed by some pharmaceutical companies. The result has been a political standoff over an agency that directly affects the lives of millions of Americans because it has the final say over the approval of drug and experimental therapies.
While McClellan has not worked in the pharmaceutical industry, he is expected to follow the Bush administration's desire to try to ease the regulatory path for new drug approvals.
But McClellan is viewed as acceptable to the Democratic-controlled Senate in part because he previously worked in the Clinton administration as deputy assistant secretary for economic policy at the Treasury Department, where he helped formulate health and economic plans in 1998 and 1999 later adopted by that administration.
Former treasury secretary Robert Rubin, who was McClellan's boss at the department, said yesterday that he had a ''very favorable'' opinion of McClellan, whom he described as ''bright and practical'' in working on health care issues.
Harvard president Lawrence Summers, who also worked at the Treasury Department with McClellan, called him ''a great expert on health policy and all its complexities.''
Still, there is no doubt that McClellan is a stout Bush ally whose family has deep political ties to Bush. His mother, Carole Keeton Rylander, ran on the Republican ticket with Bush in 1994 and 1998 and was elected state comptroller, a post she still holds. She is also the former mayor of Austin. McClellan's younger brother, Scott, is a White House spokesman.
McClellan has been a point man for Bush on two health care issues that have riled the Democrats - prescription drug coverage under Medicare and the rights of HMO patients. Both bills have stalled in part because McClellan could not engineer an agreement between Democrats and the White House. On the prescription drug bill, for example, Democrats such as Kennedy wanted a $595 billion program while the White House suggested $400 billion, with the result that no bill has been passed in Congress.
But McClellan has no track record on the fundamental issues that he would face at the FDA, such as drug and food safety review, a consumer group representative said yesterday. Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, said that the FDA in recent years has had to withdraw drugs it approved too quickly. ''Our concern is they will put in some industry-friendly person, but the record is too blank to know,'' Lurie said.
White House officials declined to comment on McClellan, saying that no decision is final until the president makes an announcement. Bush's decision was confirmed separately by an administration official and a congressional official.
The FDA regulates one-fifth of the nation's economy, overseeing food, drugs, biotechnology, and medical devices. Nearly every hospital and medical school deals with the agency on a regular basis regarding drugs, clinical issues, grants, and other matters.
But the job as the agency's commissioner also may be the most political in American medicine. Bush has tried since becoming president to come up with a candidate who would please both industry and Kennedy and failed. Bush last year was expected to nominate Michael Astrue, the general counsel of Transkaryotic Therapies, a Cambridge biotechnology company. But even though Astrue was from Massachusetts, Kennedy objected to his ties to industry and Astrue withdrew from consideration.
Then, earlier this year, Bush appeared on the verge of nominating Dr. Alastair J.J. Wood, a Vanderbilt University expert in pharmacology who was recommended by Senator Bill Frist, a Tennessee Republican and heart surgeon. But industry allies lobbied hard against him, portraying him as a Kennedy crony, although Kennedy had never met Wood. Wood's downfall came when industry discovered he had proposed a drug-safety panel that would review whether drugs approved by the FDA turned out to be safe.
McClellan's selection in some ways parallels the way Bush chose his vice president, Dick Cheney.
Just as Cheney interviewed vice presidential prospects before getting the nomination, McClellan interviewed some candidates for the FDA job, although he was not the ultimate decision-maker. Some candidates who met with McClellan said later that they expected to get the position, only to learn that their nomination had been shot down. Astrue, for example, said McClellan was among those who interviewed him for the post. Nonetheless, Astrue said he is happy with McClellan's apparent selection, saying McClellan seems likely to boost the biotech industry.
''He has been dealing at a senior level of the White House with serious issues,'' Astrue said. ''I think he has a chance to be a great commissioner.''
Michael Kranish can be reached at kranish@globe.com.
This story ran on page A1 of the Boston Globe on 9/25/2002.
© Copyright 2002 Globe Newspaper Company. |
