WASHINGTON - FDA Commissioner Mark McClellan took center stage Monday during a Senate Finance Committee hearing, fielding constant questions about how he plans to handle different aspects of the new Medicare law if he is confirmed as administrator of the Centers for Medicare and Medicaid Services.
McClellan was one of four presidential nominees called before the committee chaired by Sen. Charles Grassley (R-Iowa). The others were Treasury Department and Internal Revenue Service nominees who sat quietly while Sens. Bill Frist (R-Tenn.), Orrin Hatch (R-Utah), Max Baucus (D-Mont.) and John Breaux (D-La.) kept the conversation going with McClellan.
McClellan, an internist and economist, has served as FDA commissioner for a little over a year, but recently President Bush nominated the Texas native to head the CMS following the resignation of Thomas Scully, who joined the law firm Alston & Bird in Washington.
As CMS administrator, McClellan would be responsible for overseeing implementation of the massive $534 billion Medicare law, which includes a reimportation provision allowing Americans to bring FDA-approved drugs in from Canada. The Bush administration, including McClellan, has made no secret about safety concerns related to that practice.
Nevertheless, the law supports reimportation as long as Tommy Thompson, secretary of Health and Human Services, certifies that it is safe. (Biologics are not included.) Thompson recently named McClellan chairman of a task force mandated by Congress to determine if there is a safe way of reimporting those supposedly less-expensive prescription drugs. (See BioWorld Today, Feb. 27, 2004.)
"This is no longer just bus trips to Canada," Grassley said. "Now you can log on to the Internet and get prescription drugs."
FDA officials have long argued that they cannot police the reimportation of drugs due to a lack of resources and limited authority. For that reason, McClellan told the senators, former HHS Secretary Donna Shalala and Thompson he refused to support the practice.
But Grassley believes he can address those problems through his pending bipartisan legislation that would give the FDA some of the funding and authority it needs.
But when pressed by Hatch as to exactly how much money the agency would expect, McClellan would not answer, saying the task force will look into such issues.
Beyond that, Hatch asked to what extent the criminal element has entered the prescription drug reimportation business, seeking answers about whether U.S. patients should be wary of buying counterfeit drugs off the Internet or from foreign pharmacies. That is another issue that would be reviewed by the task force, McClellan said, adding that authorities have uncovered certain sophisticated criminal elements involved in the trade.
As FDA commissioner, McClellan made quite an impression during his year-plus stay, winning kudos for implementing innovative, industry-friendly policies designed to improve efficiency and speed the drug-review process.
On hearing that McClellan was considering the position at CMS, Richard Pops, CEO of Cambridge, Mass.-based Alkermes Inc. and chairman of the Washington-based Biotechnology Industry Organization, told BioWorld Today the commissioner's move would be a loss for the biotech industry. He described McClellan as a "superstar." (See BioWorld Today, Feb. 23, 2004.)
Prior to the hearing, the American College of Physicians sent a letter to the Senate urging prompt confirmation of McClellan. "We believe that it would be highly unfortunate if Dr. McClellan's confirmation as administrator of CMS is delayed because of differing opinions on the issue of reimportation of prescription drugs from Canada," Munsey Wheby, president of the Washington-based organization, said.
Meanwhile, across town at the FDA, Lester Crawford, the deputy commissioner and veterinarian who temporarily headed the agency before McClellan took the job in late 2002, is expected to resume his role as interim commissioner.
So it's back to the drawing board at the FDA.
During the first two years of Bush's term, the FDA went without a permanent leader while lawmakers and the administration looked for the right person.
Indeed, William Testerman, former senior health policy adviser for Frist, the Senate majority leader, said it is possible that the FDA might go without a leader for some time. Before McClellan was named to the post, Testerman said Frist's office sent several names to the White House and all were rejected. Not to mention, Testerman said, the pending election may slow the process.
Testerman, principal at Ernst & Young in Washington, was among the speakers at the recently held National Medicare Prescription Drug Congress here.