DVM support of Crawford for FDA's top post overwhelming

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

The White House, inundated with letters of support, recently asked groupsto 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 officialssay his nomination to the post "just makes sense."

He is a veterinarian, pharmacologist, world-renowned expert in food safetyand has amassed such a broad range of experiences in government, academiaand 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 beexcellent 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 postsfor FDA's Center for Veterinary Medicine, Food Safety and Inspection Serviceof USDA, executive director of the Association of American Veterinary MedicalColleges 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 closelywatching developments to this key political appointment.

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

At presstime, Crawford's nomination remains just speculation, even thoughindustry 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 hassince declined comment.

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

Support building

The pounding of the drums for the next commissioner has been buildingfor almost a year when the post was vacated with the exit of the ClintonAdministration's Dr. Jane Henney. Washington insiders say they are gettingtired of the beat.

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

Last year the world was sent into turmoil. Its legacy was marked withanthrax and smallpox bioterrorism, which was preceded by an unrelated foot-and-mouthdisease scare in Great Britain. Washington insiders say it may help politicossee the light on a Crawford commissionership, since he has such a diversebackground in government and academia.

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

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

Whoever is named to the post will have a workforce of more than 9,000employees and a fiscal 2002 budget of more than $1.4 billion, up $123 millionfrom 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 aCrawford appointment.

Profession weighs in

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

Veterinarians bring a unique perspective to public health.

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

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

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

Officials agree the next commissioner will have his work cut out forhim, 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 sciencebehind new drug discoveries are all ranking as serious issues facing FDA.

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

"It has taken a lot of time to get out of the gates, but biotechnologyis the new approach to medicine. Are they ready? That is going to be a bigchallenge 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 communicationbetween these two institutions.

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

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

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

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

Slumped approvals

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

"Dr. Crawford is a veterinarian. So, it's easy to look at it andsay, gosh, wouldn't that be great for our issues. Indisputably, this guyis 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 forVeterinary Medicine (CVM) remains a monumental challenge for the agency.

At presstime, the agency had not approved one new chemical entity for2001.

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

Phillips likens the drug approval logjam to going back to the days beforeenactment of the Animal Drug Availability Act in 1996, legislation designedto 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 WhiteHouse or Thompson may launch a trial balloon for a potential candidate justto see where and how much opposition surfaces on a rumored candidate. Theidea is to count the number of arrows being launched at the balloon as away to gauge whether or not the candidate will have a difficult or speedyconfirmation.

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

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

Opposition to Astrue, though, was led by seven Democratic senators includingEdward M. Kennedy, who objected to the possible nomination because theysaid it would be unprecedented to appoint the next commissioner from anindustry regulated by FDA.

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

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

If Crawford is nominated and confirmed, he will make U.S. history bybecoming the first veterinarian to take the post of FDA commissioner. Evenif he isn't tapped, he was one of a few in the nation even being consideredfor the post.