Acting Chief Is Nominated to Lead FDA

President Bush, after a lengthy search, on Monday nominated acting Commissioner Lester M. Crawford to head the Food and Drug Administration, despite drug safety problems on Crawford’s watch that have undermined the agency’s reputation and credibility.

The appointment of an FDA commissioner had been keenly anticipated by consumer groups and lawmakers, some of whom have criticized the agency for responding too slowly to the discovery that prescription drugs -- including painkillers, antidepressants and acne medications -- were approved by the FDA even though they had dangerous side effects.

By sticking with Crawford, 66, a pharmacologist and veterinarian who has run the agency for almost a year, Bush disappointed those who had hoped for a blue-ribbon nominee who might bring dramatic reforms. The president essentially sent a signal that he believed nothing was fundamentally wrong at the FDA, although incremental changes may be needed to strengthen the agency’s drug safety office.

“I do not think [Crawford] should be confirmed unless he is able to articulate some strong priorities that will restore confidence in the FDA,” said one critic, Janell Mayo Duncan, a lawyer for Consumers Union and an assistant FDA chief counsel for enforcement from 1996 to 1998.

“There has not been a clear message out of the agency that it is playing the safety role that it should,” she said. Consumers Union publishes Consumer Reports magazine.

“The administration could have brought in somebody with a reputation as a tough-minded reformer whose top priority is public health, but instead they are appointing somebody who has been a bureaucrat in the agency, and who does not have a strong record of calling for needed reforms,” said Michael F. Jacobson, executive director of the Center for Science in the Public Interest, which focuses on health and nutrition.

But an administration official said, “I think the FDA has gotten a bum rap, and some people may be trying to transfer that bum rap to Dr. Crawford.”

“Les Crawford is very well prepared to be commissioner,” said the official, who asked not to be identified. “If we went outside to find someone new or different, that person would not have the length and breadth of experience he has.”

Crawford joined the agency as deputy commissioner in February 2002.

As acting commissioner, a post to which he was named last March, he has launched an independent scientific evaluation of the FDA’s drug safety program and won White House approval for an increase of about 20% in the safety office’s budget.

Nonetheless, Sen. Charles E. Grassley (R-Iowa) signaled that his Senate confirmation -- while considered likely -- might not go smoothly.

“I want to hear statements that prove he understands why public confidence has been shaken, and a commitment to enacting reforms inside the FDA to keep the agency focused on public health and safety,” Grassley said in a statement.

Grassley, who chairs the influential Finance Committee, held hearings last year on Merck & Co. Inc.’s decision to recall the arthritis painkiller Vioxx after a study confirmed that taking the FDA-approved drug could lead to heart attacks and strokes. Grassley faulted the FDA for ignoring one of its own scientists, Dr. David J. Graham, who had repeatedly warned of Vioxx risks.

The senator questioned whether the agency had become “too cozy” with the drug industry.

With 10,000 employees, the FDA is charged with ensuring that medicines sold in the United States are “safe and effective.” It also has major responsibilities for the safety and security of the food supply.

During the 1980s, as the AIDS epidemic swept the country, the agency was widely criticized for being too slow in reviewing new drugs aimed at emerging diseases.

Congress responded by creating a system for expediting decisions on new drugs, heavily funded through user fees paid by drug makers. Now that system is being criticized for allegedly overriding safety concerns that could keep drugs from going to market. The FDA may be on the verge of another round of reforms mandated by Congress.

Two recent debacles have heightened concerns.

In one case, the FDA moved to warn of increased risk of suicidal behavior in teenagers taking antidepressants only after regulators in other countries had acted.

And late last year, the agency was overwhelmed by evidence of heart risks with Vioxx, Celebrex and other painkillers known as Cox-2 inhibitors. Doctors and patients were thrown into confusion by a series of studies, each documenting a new problem.

The FDA has scheduled a major conference this week that could lead to stricter warnings about the drugs, or an outright ban.

Bush’s selection of Crawford puzzled some pharmaceutical experts.

“If he was going to take a person from the inside, one would have thought he would have done it a long time ago,” said Dr. Brian L. Strom of the University of Pennsylvania. “It just seems funny to leave somebody as interim for such a long time.”

The president also broke with a tradition of sorts by not naming a medical doctor to lead the FDA, as had been the case since 1981.

Crawford “is just not qualified,” said Dr. Sidney Wolfe, who directs the drug safety program for the Public Citizen advocacy group. “The nominee should be a physician or the dean of a pharmacy school.”

Privately, administration officials disdain such criticisms as elitist.

Crawford previously served in several government posts and headed an academic program partly funded by the food industry.

In a personal statement with his biographical entry in Who’s Who in America, Crawford noted his belief in God and his fondness for St. Francis of Assisi, patron saint of animals and animal lovers.

“I believe that every person carries a divine spark, and that the function of leadership is to ignite that spark,” he wrote. “I furthermore believe that a Franciscan love of and respect for animals is a prerequisite for membership in the human race.”

Jacobson, of the nutrition group, said his organization had been able to maintain a good relationship with Crawford, who was often described as low-key and unflappable.

“We’ve always found his door open, and he’s always been cordial,” Jacobson said.