As safety concerns regarding use of blockbuster human painkillers reignited in late 2004, so too did reform rhetoric surrounding
approval and post-approval monitoring of drugs.
At the center of this political maelstrom sits a highly respected, decorated and likeable 66-year-old veterinarian and pharmacologist,
Dr. Lester M. Crawford, who arguably remains the most influential DVM in public service as acting commissioner of FDA. With
its 10,000-plus army of regulators and scientists, FDA acts as gatekeeper to an array of human and veterinary products that
constitute an estimated 20 percent of all household products.
Dr. Lester M. Crawford
The issue? Preliminary results from studies are showing an increased risk of cardiovascular events in various situations to
Vioxx, Celebrex, Bextra and the Cox-1 inhibitor Aleve. Throw in Food and Drug Administration (FDA) whistleblower David Graham,
and the volume from critics is turned up on FDA reform.
But if you ask Crawford, his vision for FDA is quite clear; it's all about safeguarding public health. And while human medicine
takes up a majority of his time, his tenor for the agency intuitively impacts veterinary medicine.
Initially opposed to user fees, Dr. Lester M. Crawford, acting commissioner of FDA, says he is a believer now. As a result
of the Animal Drug User Fee Act, FDA’s Center for Veterinary Medicine continues to expand its staff to meet review demands.
In an exclusive interview with DVM Newsmagazine, Crawford talked about the most recent human drug and vaccine safety problems, his goals for FDA, user fees, balancing consumer
safety with expeditious product approvals, his career and interactions with President Bush.
Crawford is no stranger to FDA, tough politics or congressional hearings.
He has worked with seven FDA commissioners during his career and has testified before Congress 134 times.
The veterinarian says the process is decidedly American.
It's a time when Congress questions government agencies about issues or practices — an important form of checks and balances.
In the past three months, lawmakers have been asking a lot of questions. The focus has been on drug safety and contamination
of flu vaccine leading to a shortage for 2004.
"It is a serious matter that goes on. Some people say it's just theater. There are theatrical elements to it because you are
trying to put your best foot forward as they are. But it is about the rebirthing of the Republic," Crawford says of congressional
hearings. "Sometimes it feels like an appendectomy without anesthesia, but it's part of the job," he smiles.
"The system works. It doesn't look like it works sometimes either to the public or the people involved in the maelstrom, but
it does work," he adds. "Without that freedom of expression, we would not be the country we are today."
For Crawford, the ordeal meant answering a blistering array of media and congressional inquiries in the aftermath of the flu
vaccine shortage, which at times was described in news reports as nothing short of volatile. More gasoline was thrown on the
political fire when studies questioned the safety of four leading human painkillers, starting with the recalled Vioxx. The
consumer headlines taunt that FDA's approval policy "pits speed against safety," and that FDA has become "a pawn to big pharma."
Don't tell that to Crawford, who says FDA's mission hasn't wavered. It's always been about public health, and safety and security
of drug products, he says.
As the lead regulatory body, FDA remains caught in the middle of a paradox. Consumers want safe, efficacious, and greater
access to drugs. Pharmaceutical companies, after satisfying safety and efficacy requirements, want speedier reviews.