DVM support of Crawford for FDA's top post overwhelming

DVM support of Crawford for FDA's top post overwhelming

Jan 01, 2002

Washington, D.C.-You think you have a few friends?

The White House, inundated with letters of support, recently asked groups to stop sending correspondence to President George W. Bush in favor of Dr. Lester M. Crawford leading the Food and Drug Administration (FDA).

Simply put, he has a lot of backing from a variety of sectors and officials say his nomination to the post "just makes sense."

He is a veterinarian, pharmacologist, world-renowned expert in food safety and has amassed such a broad range of experiences in government, academia and industry.

Dr. Franklin M. Loew, president of Becker College in the Boston area, says, "I think very highly of Les Crawford, and I think he would be excellent for the post. He is an experienced, seasoned guy."

Crawford is currently director of the Center for Food and Nutrition Policy, formerly at Georgetown and now at Virginia Tech. He has served in top posts for FDA's Center for Veterinary Medicine, Food Safety and Inspection Service of USDA, executive director of the Association of American Veterinary Medical Colleges and executive vice president of the National Food Processors Association.

Dr. Niall B. Finnegan, director of the American Veterinary Medical Association (AVMA) Governmental Relations Division, says the association has been closely watching developments to this key political appointment.

If smoke is any indication of fire, it would be the first time in history that a veterinarian would become an FDA commissioner.

At presstime, Crawford's nomination remains just speculation, even though industry insiders say an announcement is imminent. However, at presstime, on Dec. 19, the White House remained mum.

Crawford himself initially downplayed any interest in the job and has since declined comment.

FDA's top official currently is a veterinarian, Bernard A. Schwetz, who serves as acting deputy commissioner.

Support building

The pounding of the drums for the next commissioner has been building for almost a year when the post was vacated with the exit of the Clinton Administration's Dr. Jane Henney. Washington insiders say they are getting tired of the beat.

Finnegan says, "The process has taken so darn long that everybody to this point, is saying just put somebody in there and let's get the job done."

Last year the world was sent into turmoil. Its legacy was marked with anthrax and smallpox bioterrorism, which was preceded by an unrelated foot-and-mouth disease scare in Great Britain. Washington insiders say it may help politicos see the light on a Crawford commissionership, since he has such a diverse background in government and academia.

Crawford's credentials are all-encompassing, but the prospective job is even bigger.

It is estimated that FDA has oversight of 25 percent of the gross domestic product in this country.

Whoever is named to the post will have a workforce of more than 9,000 employees and a fiscal 2002 budget of more than $1.4 billion, up $123 million from 2001 levels. The next commissioner reports directly to Tommy Thompson, Secretary of Health and Human Services. It's big government.

And in scientific circles there isn't a whole lot of opposition to a Crawford appointment.

Profession weighs in

"There is a person who is imminently well-qualified to do this if anyone in the veterinary profession were," says Dr. Peter Eyre, dean of the Virginia-Maryland Regional College of Veterinary Medicine. "We need someone who understands the interconnection between animal health, agriculture and human and public health." Eyre adds, "We are all part of the same ecosystem. We are all part of the same world and the connectivity between animal diseases."

Veterinarians bring a unique perspective to public health.

"I do believe veterinarians see the world of medicine in a much broader context than human physicians, just by the very nature of their training," Eyre explains.

His real strength, supporters say, comes from the diversity of his background in academic circles, industrial circles and government circles. "There are not many people who can walk that mile among all those different agencies and still enjoy the same level of respect that he does. It is the nature of politics, you work with one group, and it alienates another group," Eyre says.

"He has the scientific credentials and the political skills to move easily among these different constituencies, and they are very different from one another," Eyre adds. "This is where science, policy and politics all come together."

Officials agree the next commissioner will have his work cut out for him, and there will certainly be no shortage of issues facing the agency.

Challenges at FDA

Antimicrobial resistance, Internet pharmacy sales in human medicine, lag time for veterinary drug approvals, failure to keep up with science behind new drug discoveries are all ranking as serious issues facing FDA.

Frankie Trulla, executive director for the Foundation for Biomedical Research, says that keeping up with biotechnology will be a key issue for the next FDA commissioner.

"It has taken a lot of time to get out of the gates, but biotechnology is the new approach to medicine. Are they ready? That is going to be a big challenge for Dr. Crawford," she says.

The National Institutes of Health (NIH) play a critical role for FDA. A lot of the research and development of new drugs is happening out of NIH, and, therefore, there needs to be a strong relationship and strong communication between these two institutions.

"NIH has to have the research nailed down, and FDA understand enough about it not to be an obstacle when it comes to making sure this reaches the public," she says.

Trulla adds the biomedical research community has been very consistent in its praise of Crawford as a possible commissioner.

Consider this: Congress and public health has been completely focused on food safety and bioterrorism since the Sept. 11 attacks in New York and on the Pentagon.

"These agencies are going to have to work together to coordinate who does what. Because he has experience both at USDA and at FDA, he knows how these agencies work," Trulla says, "Every agency has a different culture. His background in veterinary medicine is very helpful."

Slumped approvals

Ron Phillips, vice president of legislative and public affairs for the Animal Health Institute (AHI), says that by the very nature of this appointment, it may place much more emphasis on FDA's food safety responsibilities than has ever been done in the past.

"Dr. Crawford is a veterinarian. So, it's easy to look at it and say, gosh, wouldn't that be great for our issues. Indisputably, this guy is steeped in experience with the stuff that we want to be talking about; presumably that would be a positive."

Phillips adds that the slowdown of FDA approvals from the Center for Veterinary Medicine (CVM) remains a monumental challenge for the agency.

At presstime, the agency had not approved one new chemical entity for 2001.

Phillips explains, "A fantastic year is three, one or two is pretty typical. We are at zero."

Phillips likens the drug approval logjam to going back to the days before enactment of the Animal Drug Availability Act in 1996, legislation designed to speed up the FDA approval process for veterinary drugs.

If Crawford gets the job, the message is simple-his plate will be full.

Inside the selection

Trulla explains there is method to the madness of a political appointment.

First, HHS Secretary Thompson sends off his pick to the White House, where they most likely have four or five names for the position. The White House or Thompson may launch a trial balloon for a potential candidate just to see where and how much opposition surfaces on a rumored candidate. The idea is to count the number of arrows being launched at the balloon as a way to gauge whether or not the candidate will have a difficult or speedy confirmation.

Finnegan describes it as a "very soft political game."

The New York Times reported that in early July, the Bush administration put forth Michael Astrue, general counsel for Transkaryotic Therapies, a Cambridge-based biotech company.

Opposition to Astrue, though, was led by seven Democratic senators including Edward M. Kennedy, who objected to the possible nomination because they said it would be unprecedented to appoint the next commissioner from an industry regulated by FDA.

Trulla says that the process is typically carefully orchestrated before the nomination takes place. "They do not want to get into public fights if they don't have to."

So who could possibly be against a Crawford appointment? Trulla says consumer groups will most likely be the first in line to contend with the appointment, and a main reason is because they don't want an FDA commissioner to have ties to the industry it regulates. Crawford worked for American Cyanamid during his career.

If Crawford is nominated and confirmed, he will make U.S. history by becoming the first veterinarian to take the post of FDA commissioner. Even if he isn't tapped, he was one of a few in the nation even being considered for the post.