Washington Editor

WASHINGTON - At the request of President Bush, FDA Commissioner Mark McClellan is expected to leave his current post to head the Centers for Medicare and Medicaid Services (CMS).

McClellan, an internist and economist, has made quite an impression during his year-plus stay at the FDA, winning kudos for implementing innovative, industry-friendly policies designed to improve efficiency and speed the drug review process.

Indeed, Richard Pops, CEO of Cambridge, Mass.-based Alkermes Inc. and chairman of the Biotechnology Industry Organization, described McClellan as a "superstar."

"I think CMS will benefit remarkably from his presence there because he's a leader and he's got the background, training and intellectual interest in areas that are key to CMS," Pops told BioWorld Today. "But I think this is a loss for the biotech industry in that he has set a tone of science-based regulation at the FDA."

And in a prepared statement, Carl Feldbaum, BIO's president, said, "We hope that Dr. McClellan's successor at the FDA will maintain his commitment to innovation and willingness to work with industry to ensure that new medicines proven safe and effective make their way to patients as quickly as possible."

For the time being, McClellan will be replaced by Lester Crawford, the deputy commissioner and veterinarian who temporarily headed the agency before McClellan took the job in late 2002. At CMS, McClellan will replace Thomas Scully, who resigned in early December to join the law firm Alston & Bird in Washington.

McClellan must be confirmed by the Senate. If his last confirmation hearing and vote provides any window into the future, McClellan shouldn't have a problem. The Senate unanimously approved his nomination in October 2002 after his painless hearing before the Health, Education, Labor and Pensions Committee during which only three members showed up to grill the doctor. (See BioWorld Today, Oct. 8, 2002, and Oct. 21, 2002.)

However, word around Washington revealed that a number of House republicans wanted to keep McClellan at the FDA.

As CMS administrator, McClellan will lead the agency through implementation of the new Medicare law, said Tommy Thompson, secretary of Health and Human Services.

On accepting the position at the FDA, McClellan essentially hit the ground running, taking over an agency that already was in a transition of sorts under Crawford's leadership after Bill Clinton's FDA Commissioner Jane Henney resigned following the Bush inauguration.

McClellan presided over several key moves at the agency, including the consolidation of certain functions of the Center for Biologics Evaluation and Research (CBER) with the Center for Drug Evaluation and Research (CDER). FDA officials believed the consolidation would help speed the drug review process. (See BioWorld Today, Sept. 9, 2002, and June 30, 2003.)

About a year ago, McClellan released a plan aimed at helping the industry save money by reducing the time it takes to make it through the approval process, which often takes years due to numerous cycles. (See BioWorld Today, Feb. 3, 2003.)

The cycles occur when an application is reviewed several times before it is approved, often because of poorly run trials or incomplete data. McClellan's plan sought to define the root causes of delays that then could be addressed before they end up costing companies millions of dollars.

Another element of McClellan's plan to improve the process involved a quality-systems approach in which best management practices were identified and implemented internally for the FDA's scientific review processes.

In 2003, CBER approved 22 biological license applications, compared to 21 in 2002 and 16 in 2001. The median review time for priority BLAs (six in total) was 12.1 months, up slightly from 12 months in 2002 (five in total). The median approval times for regular user-fee BLAs was 20 months, down from 28 months in 2002, and the median approval time for non-user-fee BLAs was nine months, compared to 13 in 2002.

Overall, the FDA said the median review time for BLAs in 2003 was 12.8 months, compared to 12.9 months in 2002 and 13.8 in 2001.

CDER, on the other hand, reportedly approved 72 new drug applications, compared with 78 in 2002 and 66 in 2001. Of the total approved, 21 were new chemical entities (NCEs), up from 17 in 2002. Priority approvals, or approvals for products of special medical importance, increased to 14, nine of which were NCEs, compared to 11 and seven in 2002, respectively.

The median total approval time for standard NDAs was 15.4 months, compared to 15.3 months for the previous year. The median approval time for CDER's priority NDAs was 7.7 months, compared to 19.1 months for 2002. The FDA said the higher 2002 figure could be attributed to a few applications with unusually long regulatory histories; when only a small number of applications are approved, older applications can have a notable impact on the median, the agency said.

McClellan also was in charge during implementation of the Prescription Drug User Fee Act III (PDUFA III), a law allowing the government to charge fees for drug application reviews. Under PDUFA III, firms pay higher fees but also are permitted to request advice from an independent consultant during FDA meetings on Phase III protocols.