By Lisa Seachrist
WASHINGTON - Jane Henney, newly sworn-in FDA commissioner, reaffirmed her commitment to implementing the FDA Modernization Act (FDAMA) and expanding the agency's science base.
Henney took the oath of office Tuesday and made her first public appearance as FDA commissioner at the Food and Drug Law Institute's Annual Educational Conference.
The first female head of the agency took the opportunity to outline five general goals for her tenure at the agency.
"Much has been made of my managerial experience in large, complex organizations - it is my forte," Henney said. "Being the FDA commissioner is much more than management. It's really about leadership. It's very clear to me as I return to the agency that, although it is very familiar, it is vastly different from the one that I left four-and-a-half years ago."
Henney has returned to the agency after serving as the vice president of the University of New Mexico Health Sciences Center, in Albuquerque. She highlighted, as her chief priorities as commissioner, the full and effective implementation of FDAMA; strengthening the science base at the agency; food safety; ensuring the safety of the blood supply; and the appropriate regulation of tobacco.
Stakeholder Meetings A Critical Part Of FDAMA
She noted that the agency has already taken enormous steps toward implementing FDA reform, and she credited FDAMA's section 406(b), which requires the agency to meet with stakeholders, as a critical piece of the legislation.
"This type of listening to all quarters within and outside the agency, I believe, needs to be done if we are to maximize our effectiveness," Henney said. "Not just one time, but in some iteration on an ongoing basis."
Henney said that she was committed to both the letter and the spirit of FDAMA; nevertheless, she promised that she wouldn't be shy about pointing out areas where and why FDAMA can't be implemented as drafted.
"There are very strong traditions, throughout the agency, [of] protecting and promoting the public health," Henney said. "These traditions need to be preserved, and I intend to respect those values."
One of the greatest traditions is the scientific expertise of the FDA's staff. Henney pledged to strengthen that science base further.
"This is an urgent issue," she said. "It is quite clear that the investments made in both basic and applied research by the National Institutes of Health and the pharmaceutical, biotech and medical device industries will result in a burgeoning of products that will need to come to the market. We need to have the scientific expertise to review these products."
Henney noted that, in implementing FDAMA and initiating the administration's food, blood safety, and tobacco priorities, the agency was fulfilling its obligations without any concomitant increase in appropriations. In fact, she said, the agency has not received any increase in funds to cover the increase in the agency's responsibilities.
"As you can see from this abbreviated list of issues, the FDA's plate is very full," Henney said. "And, as you all know, our resources are very constrained. The FDA's core budget has not risen in concert with its rising responsibilities and workload."
As a result, Henney said, the agency will need to make tough choices on how to use those resources in the most efficient way possible.
"We are a 'can do' agency, but it is clear that we can't do everything," Henney said. "In times of such constraints, it is necessary to be focused on our priorities."
Sen. Hatch 'Pledges' To Push For More FDA Funding
Henney's focus on the resource constraints of the agency was echoed by Linda Suydam, associate commissioner for strategic management for the FDA, who offered a FDAMA update. Suydam said that, over the past several years, the agency has endured a chronic erosion of funding, which resulted in fewer dollars to perform core responsibilities. Because new programs were dictated by the administration and Congress without additional funds, the agency has, in effect, received less money to cover its responsibilities.
Several industry representatives have expressed fears that the agency would not be able to effectively implement FDAMA as a result. Suydam confirmed those fears.
However, Sen. Orrin Hatch (R-Utah) offered to be Henney's congressional advocate in the quest for adequate funding for the agency.
"I can't think of a recent FDA budget that was adequate," said Hatch, a four-term senator. "We simply have to do better."
In the meantime, Henney will spend her time getting her bearings and readying to move the agency to full compliance with FDAMA.
"It's fair to say that I am still settling in," she said. "While it's not the time to make policy pronouncements, I can simply tell you that it is good to be back." *