Nov. 11 (Bloomberg) -- U.S. Food and Drug Administration Commissioner Mark B. McClellan has won friends among companies regulated by the FDA in his first year on the job.

McClellan, 40, whose agency oversees industries with about $1 trillion in annual sales of everything from lipsticks to artificial limbs, is speeding up reviews of new medicines. He has made it easier for food companies to promote their products' health benefits. He has spoken out against price controls by Germany and other countries. And he has battled moves by politicians to buy cheaper drugs in Canada for sale in the U.S.

``He is looking at his mission in a broader way than most of his predecessors,'' Eli Lilly & Co. Chief Executive Sidney Taurel said in an interview. ``He is looking at how we accelerate innovation in America.''

McClellan is so focused on making the FDA work for business that his tenure may mark a turning point at the agency as it seeks to make regulation less burdensome on companies, say analysts such as Ken Kaitin, head of the Tufts Center for the Study of Drug Development, a research group associated with Tufts University.

``He is without question the best thing that ever could have happened to the pharmaceutical and biopharmaceutical industries,'' Kaitin said. McClellan is a medical doctor and an economist, and his knowledge of both medicine and business will be a model for future FDA commissioners, Kaitin said.

Single Study

That prospect alarms critics such as Sidney Wolfe, head of a health-research group at Public Citizen, a consumer-advocacy organization.

``I cannot remember an FDA commissioner who was so loved by industry,'' said Wolfe, who has been tracking the FDA for more than 30 years. ``If he were doing his job, industry would be saying, `This guy is really tough on us.'''

McClellan, a former economic adviser to President George W. Bush and older brother of Bush's chief spokesman, Scott McClellan, has started more than half a dozen initiatives that please food and drug companies since being sworn in last Nov. 14 to head the agency and its more than 9,000 employees.

On Dec. 18, 2002, little more than a month after taking office, he announced a plan to allow food companies to make claims about their products based on a single study. The decision was hailed by the Grocery Manufacturers of America, which represents companies such as General Mills Inc. and had lobbied for the change for a decade.

`Why Not Approve It?'

For the agency's drug reviews, he has sought to eliminate what he sees as flaws that can delay approvals for years. He directed his staff to work with drugmakers to reduce the number of applications that are sent back for further drug development.

In May, the FDA approved an AstraZeneca Plc drug for lung cancer, Iressa, although the medicine failed to show a significant benefit for patients in two large studies. The drug had showed some benefit to patients in earlier tests, such as in containing tumor growth, the FDA said at the time.

``McClellan has said that if a drug has medical efficacy and practitioners want to have it and it is safe, why not approve it?'' said John Farrall, an analyst with National City Wealth Management, which manages about $30 billion and owns shares of drugmakers such as Pfizer Inc. ``That's a major change.''

McClellan, who earned an economics doctorate from the Massachusetts Institute of Technology, and medical and master's degrees from Harvard by the age of 30, said he has also taken actions that displeased industry. These included proposing tougher monitoring of complications caused by medicines, he said.

`No Matter What I Do'

``No matter what I do, I am going to get criticized,'' he said in an interview. ``That's actually freeing a bit, because we can really focus on what we think is the right thing to do from the standpoint of public health.''

McClellan, whose mother is a former mayor of Austin, Texas, and is now state comptroller, cites a saying of his grandfather, Page Keeton, a former dean of the University of Texas law school: ``If you haven't made anybody mad, you haven't done anything.''

One of those he has riled up is Gil Gutknecht, a Republican congressman from Minnesota who's sponsoring a bill to legalize imports of Canadian drugs. Gutknecht said McClellan is using his post to protect drugmakers' profits.

``McClellan and his senior leadership have tried to undermine a legislative initiative the American people desperately want and need,'' Gutknecht said in a September statement.

Suing the FDA

Public Citizen and the Center for Science in the Public Interest have sued the FDA over the plan to revise rules on food- health claims, saying it puts consumers at risk. Public Citizen also says McClellan failed to protect people from products linked to heart attacks and deaths, such as the ephedra weight-loss aid made by Metabolife International Inc. and Abbott Laboratories' Meridia diet pill.

Still, McClellan takes the time to listen to his critics.

Before being sworn in as commissioner, he spent hours with Public Citizen's Wolfe, discussing the state of the agency.

Wolfe said he told McClellan, ```You have a tough act to follow,''' referring to David Kessler, who was appointed by President George H.W. Bush to head the FDA in 1990. By the time Kessler resigned in 1997, he had banned silicone breast implants and had tried unsuccessfully to regulate tobacco.

The FDA commissioner's post was vacant from the time that Jane Henney, an appointee of President Bill Clinton, left the job in January 2001 until McClellan took over.

McClellan hasn't been shy about urging individuals to take a stronger hand in looking after their own health, advice he tries to follow himself by going for a run or taking his 5-year-old twin daughters out to play.

Making Voice Heard

His office has issued more than 120 press releases this year -- three times as many as Henney did in 2000, her last full year in office. He has appeared at scores of medical meetings, some investor conferences and at least one radio call-in show.

In September, McClellan used his first international speech, in Mexico, to call on other countries to pay higher prices for medicines. Countries such as Canada and Japan set their prices so low that the U.S. and poorer nations such as Poland end up footing most of the bill for pharmaceutical research, he said.

The FDA has also stepped up enforcement actions against companies that supply U.S. consumers with Canadian medicines, sending warning letters to firms such as CanaRx Services Inc., then issuing press releases about these actions.

Drugmakers have struggled in recent years to bring new medicines to market to make up for sales lost to generic competition for some of the industry's biggest products. The Standard & Poor's 500 Pharmaceutical Index has fallen about 3.4 percent this year, while the S&P 500 Index rose 19 percent.

Merck & Co., the second-biggest U.S. drugmaker after Pfizer, last month said it plans to cut about 4,400 jobs after its third- quarter net income fell. Merck shares have fallen about 19 percent this year.

McClellan, whose days often begin with a 7:30 a.m. meeting and continue late into the night at home exchanging e-mails on his Blackberry device, was the first doctor to serve on a U.S. president's Council of Economic Advisers, from July 2001 to October 2002. He's also the first economist to run the FDA.

He has described his mission as bridging the gap between policy makers and the doctors affected by those policies.

``There is no other place in the world where you can be as much on the cutting edge of a broad range of difficult issues in science and in medicine,'' McClellan said in the interview.

`Boy Genius'

McClellan had earned tenure at Stanford University in the economics and medicine departments before he joined the White House as an adviser to Bush. He spent four days a week doing research on health-care costs and one day seeing patients.

``Dr. McClellan has gotten a lot of press about being a boy genius, and when you meet with him, he does seem really smart and also quite personable,'' said Cynthia Pearson, executive director of National Women's Health Network. ``He's a down-to-earth guy, willing to make jokes at his own expense.''

McClellan once deflected a question about the FDA's July decision to approve a human growth hormone for use treating shortness without a medical cause. He said the agency wouldn't be weighing in on the moral implications of using the medicine, with a ``commissioner who is 5 foot 7.''

Pearson met with McClellan to discuss concerns that he would limit access to the RU-486 abortion pill and emergency contraceptives. McClellan told Pearson he wants the FDA to make its decision based on science, not politics, she said,

Reassuring

``He was reassuring,'' Pearson said. ``But, of course, when we got down to specifics about the abortion pill or emergency contraception pills or some of the other issues that are important to the religious right, he then got non-committal like any good politically appointed person would.''

McClellan had sought a career in medicine, intending to also pursue a doctorate in science. He found that research done in the laboratory wasn't for him.

``The experience I had was a little bit too far removed from people,'' he said in the interview. ``I enjoy having much more personal interactions that are more closely related to having an impact on the public health.''

There's speculation that he would be in line for a promotion if Health and Human Services Secretary Tommy Thompson resigns, said Mike Astrue, the chief executive officer of Transkaryotic Therapies Inc., a biotechnology company. Astrue, a one-time candidate for FDA commissioner, once was general counsel for the department. McClellan declined to comment on that.

``My biggest concern is that he may be promoted to be secretary of HHS after Tommy Thompson leaves,'' Astrue said. ``I'd like to see him stay as FDA commissioner for the next five years.''

Last Updated: November 11, 2003 00:06 EST