WASHINGTON – Sitting before the Senate Committee on Health, Education, Labor and Pensions, acting FDA commissioner Lester Crawford yesterday fielded a range of questions during the first hearing considering his nomination to that post.
"This is a critical time for the nation's health," Crawford told the committee. "We face exciting opportunities from new cross-cutting science and biomedical innovation, but at the same time we are confronted with profound challenges of every shape and size – emerging diseases, product safety concern, the threat of bioterrorism and much, much more."
A number of senators seized on the issue of drug safety, rather than showing an ongoing concern with medical device safety – a good sign for the med-tech sector perhaps, but hardly good news for those taking drugs. The safety of pharmaceuticals has been a growing concern over the past year and, significantly, during Crawford's "watch" as acting commissioner of the agency.
Questions surrounding the COX-2 inhibitor class of pain drugs, as well as the pediatric and adolescent use of antidepressants, have swirled and remain at the forefront of public attention.
"If a similar disaster had happened through fire or flood or terrorism," Sen. Edward Kennedy (D-Massachusetts) said of the COX-2 inhibitor issue, "we'd be moving heaven and earth to make sure that such a catastrophe never happened again. Yet the FDA has so far recommended only minimal adjustments to its procedure."
Other senators pointed to the FDA's lack of oversight concerning flu vaccine manufacturing, part of the miscue last fall by Chiron (Emeryville, California), costing the country about half its expected flu vaccine stockpile. Still others pointed to charges of stifling internal critics and agency whistleblowers.
"It is essential to address these serious issues," added Kennedy, the committee's ranking minority member, "and for Dr. Crawford to present a clear plan to restore the nation's trust in the ability of the FDA to do its job."
That type of reminder was a common theme throughout the hearing, played out before a standing-room-only crowd and the senators intent not to be outdone by the concurrent, high-profile House of Representatives hearing on steroid use by major league baseball players.
The Senate committee meeting wasn't used as a forum to criticize the 66-year-old Crawford, but rather as an occasion to repeat the need for the agency to be upheld as a "gold standard," a mantra long used in describing the FDA and invoked frequently during the hearing.
"The role of pharmaceuticals in healthcare has never been as vital to our health as it is today," said Sen. Michael Enzi (R-Wyoming), the committee's chairman. "That is why people need to be reassured that they can trust the FDA."
Crawford noted that the agency is taking a "multi-pronged approach" toward improving its image as a public safeguard, while also upholding its role in approving needed therapies. "My vision for the future of FDA is one of transformation," he said.
To that end, he mentioned its newly instituted Drug Safety Oversight Board as an independent body that will deliberate its actions publicly. Along those lines, a drug watch program would allow for further public accessibility. Lastly, the agency has engaged the National Academy of Sciences' Institute of Medicine (Washington) to "evaluate the FDA's culture." He added that such consultation would result in a system "that's more transparent for decision making, and also want it to lead to a greater system so that minority opinions are involved."
"The stakes could not be higher," echoed Kennedy. "No patient who takes a pill should have to worry whether the drug is safe or whether decisions to approve the drug were based on politics or profits."
Additional drug safety-related issues included improvements in post-approval data collection. Also, Crawford stood by the Prescription Drug User Fee Act (PDUFA), by which drug companies pay to have their products move through the regulatory process, despite criticism that the FDA is too entangled with the drug industry because of it.
"That has worked well for the FDA," he said, noting that the approval times have shortened in the years since PDUFA passed. "I think, on balance, that it is working well."
Other issues beyond drug safety were addressed.
Asked about drug reimportation, Crawford said the agency remains improperly equipped to ensure the safety of such products. A number of committee members who represent agricultural states stressed the importance of cattle food safety, in light of its relationship to mad cow disease, while others talked about the regulation of nutraceuticals.
Several committee members pressed him on the FDA's reluctance to clear the way for emergency contraception for women, such as use of the RU-486 pill. Among them, Sen. Hillary Rodham Clinton (D-New York) and Sen. Patty Murray (D-Washington) sought assurances that Crawford would meet directly with them to discuss the matter, outside of a public forum, before the committee reconvenes on his nomination.
The appointment remains subject to confirmation by the full Senate, which will take its vote following another committee meeting scheduled for April 13.
Crawford, who has a lengthy background at the FDA, received President George Bush's nomination last month. His previous experience includes stints as the agency's deputy commissioner and as its administrator of the food safety and inspection service. The FDA has been without a permanent commissioner since Mark McClellan left almost a year ago to serve as administrator of the Centers for Medicare & Medicaid Services (Baltimore).
Crawford's background includes a five-year term as the director of the Center for Food and Nutrition Policy at Georgetown University (Washington) and Virginia Tech (Blacksburg, Virgina), and he has served as an adviser to the United Nations' World Health Organization (Geneva, Switzerland) for almost 20 years. He is a member of the National Academy of Sciences' Institute of Medicine, a Fellow of the UK's Royal Society of Medicine and a Fellow of the International Society of Food Science and Technology.
His educational background includes a Doctor of Veterinary Medicine from Auburn University (Auburn, Alabama) in his home state, and a PhD in pharmacology from the University of Georgia (Athens). Senators from both states offered high praise for Crawford.
"He brings with him personal experience in academia, government and private practice," said Sen. Jeff Sessions (R-Alabama). "Most importantly, he combines openness with good humor and a commitment to the common good."