McClellan's Friendlier, Speedier FDA

It's streamlining drug approvals -- and winning industry favor

These days, drugmakers and their stocks aren't just getting a boost from news of promising anticancer treatments. The industry is also benefiting from a friendlier, faster-acting Food & Drug Administration. In recent weeks, with the strong support of cancer doctors and patients, the agency has approved controversial drugs such as Iressa, which has shrunk tumors in just 10% of patients, and Fabrazyme, which the agency had declined to approve in two prior submissions. Execs give the credit to Dr. Mark B. McClellan, who became commissioner in November. "The new FDA director has made a world of difference in changing the agency's processes, procedures, and attitude," says William A. Haseltine, chairman and CEO of Human Genome Sciences (HGSI ) Inc. in Rockville, Md.

McClellan brings stellar credentials to the job: an M.D. from Harvard University, a PhD in economics from Massachusetts Institute of Technology, and close ties to President George W. Bush. As a Stanford University professor, he was a rising star in health economics, using innovative approaches to assess the benefits of new medical technology. When he took charge at the FDA, industry execs hoped the 39-year-old wunderkind would reverse a trend toward more caution and slower drug approvals. Seven months later, the cautious optimism has turned into raves. Says Peter Barton Hutt, FDA chief counsel during the Nixon Administration and unofficial dean of Washington food and drug lawyers: "He's unequivocally the best commissioner" in three decades.

FDA watchers believe McClellan's economic ideas will create more efficient rules and lift unnecessary burdens. That will speed not just approvals but also the larger process of drug development. "What McClellan has brought to the table is the recognition that the cost of R&D has gone out of sight," says Washington lawyer William W. Vodra. Indeed, McClellan explained to BusinessWeek: "I'm worried about the affordability of treatment and the conflict between the potential for innovation and rising costs."

The best ways to slash costs are to shorten development time and reduce failure rates of experimental drugs. McClellan believes the FDA can help on both counts. With cancer, for instance, many drugs work only in a small subset of patients, so big, expensive trials often show little benefit. But if companies could use genetics technology to identify those who would actually benefit and test a drug on them, the trials would be shorter and cheaper -- and the drug could be used far more effectively.

The FDA is reviewing the technology to do just that, but approvals are already speeding up. One example: Millennium Pharmaceuticals Inc.'s cancer drug Velcade, cleared for multiple myeloma patients. The agency skipped the traditional, often-lengthy review by an outside advisory panel and worked closely with experts at the National Cancer Institute. The drug got approval, on May 13, in less than four months.

McClellan and FDA staffers insist that speed doesn't lower standards. But they say that the agency is willing to accept a higher level of risk to get drugs to patients who need them -- as long as measures are in place to understand and control those risks. That's why the FDA is asking for additional trials after a drug is approved. And McClellan has started pilot programs to ensure the agency is instantly informed of dangerous side effects.

The FDA chief does have some critics. "The fact that industry thinks McClellan is doing a good job should be worrisome to the public," says Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. He objects to the swift approval of Iressa, a drug with limited efficacy and some dire side effects. He also blasts the agency for not yet banning ephedra, and for failing to crack down on misleading drug advertising.

Yet McClellan has been willing to go against industry's positions. He has suggested requiring some drugs to switch from prescription to over-the-counter and allowing generic versions of biotech drugs -- both of which would help achieve his larger goal of keeping health-care costs in check.

And he's rapidly earning a reputation for being endlessly inquisitive and tireless. Top agency officials worry about turning in too early each night, fearing they might miss an 11 p.m. e-mail from their BlackBerry-wielding chief. "He's a typical doc," says one top FDA official. "He thinks he's smarter than anyone else and can do things better than anyone else -- and he probably can."

By John Carey in Washington

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