WASHINGTON - Nominee Mark McClellan easily jumped the first hurdle in becoming the next commissioner of the FDA from a largely absent Senate committee.
McClellan, President Bush's candidate for the vacant post, sat before the Senate Health, Education, Labor and Pensions Committee Monday afternoon to explain how he would lead the agency in the coming months and years if confirmed. Following a markup session later this week, McClellan then must receive a majority vote of approval from the Senate before being confirmed.
Washington insiders have suggested that the confirmation likely will sail through the Senate with ease. Monday's hearing appeared to validate that notion because only three Senators were present for the initial phase of questioning, indicating little or no opposition to McClellan. What remains to be seen, however, is whether the confirmation will occur in the remaining days of this Congressional period or after the new year.
"This nomination to a major public health position is long overdue. The question before the committee today is whether Dr. McClellan has the training, experience and independence to serve as the head of the country's most important public health regulatory agency - an agency that serves as the gold standard for the rest of the world," Sen. Edward "Ted" Kennedy (D-Mass.) told members of the committee during opening remarks.
Kennedy is chair of the powerful committee and has publicly expressed his desire for the next commissioner not have ties to the pharmaceutical industry. McClellan fits that qualification. "Dr. McClellan has an impressive background. He's both an economist and a physician," said Kennedy during the hearing.
The 39-year-old physician and researcher currently serves as a member of the President's Council on Economic Advisors. He also serves as a senior policy director for health care and related economic issues for the White House. Prior to joining the White House staff, McClellan was an associate professor of economics at Stanford University, associate professor of medicine at Stanford Medical School, a practicing internist, and director of the Program on Health Outcomes Research at the school.
McClellan's research has focused on improving the quality of health care while determining the economic and policy factors influencing medical treatment decisions. He has studied the relationship between health and economic well-being.
Kennedy primarily was interested in McClellan's leadership ability for an agency grappling with major changes. "Questions have arisen lately about the FDA's willingness to maintain this mission, this history and this tradition. We have learned that agency morale has suffered in the absence of a commissioner, and in the aftermath of a series of recent FDA decisions that suggest a less exacting, less rigorous approach by the agency in carrying out its mission," Kennedy said.
"The issue is leadership. In this time of medical breakthroughs and as new threats to public health arise, the FDA faces enormous challenges. The American people increasingly depend on the FDA to safeguard public health. Now is not the time for FDA to retreat from these challenges, or surrender its authority over public health," Kennedy added.
McClellan echoed the need for leadership at the agency during his remarks to members of the Senate committee. "One of FDA's key goals is making safe and effective new treatments available as quickly as possible, but FDA's responsibilities for achieving this goal are becoming more complex and important than ever before," McClellan said to committee members.
Being the next commissioner would be a special privilege for McClellan because the opportunity comes at a time when "Congress and the president have just given the FDA the most significant new resources and tools to fulfill these responsibilities in more than a generation," he said. The tools McClellan referred to are the bioterrorism legislation, re-authorization of the Prescription Drug User Fee Act and recent movement on the animal drug and medical device user fees.
"It is my strong hope that the Senate will be able to complete the year's impressive legislative achievements for supporting FDA in meeting the challenges ahead by enacting the Medical Device User Fee and Modernization Act and the Animal Drugs User Fee Act. I understand that the House intends to pass a bipartisan agreement on HR 3580 as soon as today. The administration strongly supports action this year to resolve remaining issues, so that Senate action can also occur this year," McClellan said.
McClellan responded to most questions by deferring to existing regulations or laws on issues affecting the FDA. When asked by Sen. Judd Gregg (R-N.H.) about whether he supported direct-to-consumer advertising on drugs, McClellan stated that the advertising has provided patients with alternate treatment options. "Consumers have learned about new treatments for hypertension and depression, for example, but it's up to the FDA to ensure that the information in the ads is appropriate," he said.
When asked by Kennedy if McClellan would push for increased benefits for Medicare patients, McClellan was clear that he supported Bush's goals. "My first goal is the president's priority that Medicare patients need a prescription drug benefit. It's also important to remember that whenever physician payments are increased, it usually means an increase in the premiums Medicare patients must pay," McClellan said.
Kennedy concluded the hearing by stating his support for McClellan and his intent to vote for his approval.