Barely Breaking Even
Despite Hamburg's vigorous campaign to strengthen science at FDA, the commissioner has limited resources to carry out her
plans. The Obama administration's FDA budget plan for 2011 provides $25 million for an Advancing Regulatory Science initiative—an
amount that reflects the overall squeeze on FDA funding for next year. Only by collecting $1.5 billion in user fees does FDA's
total budget reach $4 billion, representing the 25 percent increase highlighted by the White House. With just a 6 percent
rise in appropriations, FDA barely breaks even, explained consultant Steven Grossman.
Moreover, much of that $25 million is targeted to specific projects, such as improving FDA expertise in nanotechnology and
stem cell research, and setting standards for biosimilars. FDA chief scientist Jesse Goodman would have $3 million to oversee
research and collaboration. But there's a paltry $4.5 million allocated for FDA's much larger Critical Path Initiative, which
has been struggling to support biomarker validation collaborations and to modernize clinical research.
The proposed amount will enable FDA to bring in a handful of scientists to bolster these initiatives, expand staff training,
and provide support for research projects. There is talk of forming a network of academic "centers of excellence," and of
an independent research entity to help FDA answer tricky questions about product efficacy and safety—but those require much
more money to move off the back burner. At the IOM workshop, HHS deputy secretary Bill Corr emphasized the administration's
commitment to these efforts, describing the admittedly modest funding of science at FDA as a "foundation for more to come."
However, some policymakers are skeptical that FDA needs more resources to do its job. Rep. Rosa DeLauro (D-CT), chairman of
the House Appropriations subcommittee that oversees FDA funding, declared that "FDA has many problems that won't be solved
by throwing money at it." DeLauro is unhappy that drug safety issues continue to erupt, and that FDA has trouble implementing
programs that are already on the books.
One optimistic note, observed Eli Lilly vice president Gail Cassell, is that other government agencies such as NIH and BARDA
are becoming more aware of FDA's importance in developing new therapies and countermeasures against biological threats. Cassell
recently chaired another IOM meeting on strategies for developing medical products for public health emergencies, which examined
FDA's critical role in facilitating access to such treatments and to products with low commercial viability.
Hamburg acknowledged that current initiatives don't provide enough money to do all that needs to be done, "but it's a start."
At a minimum, the commissioner hopes to systematize how the agency addresses regulatory science and expands collaborations
with external partners. The larger task of restoring the confidence of policymakers and the American people in FDA requires
sustained funding and autonomy to do its work without being "buffeted by outside forces."
But even modest funding for regulatory science will draw the attention of academia, noted New England Journal of Medicine
editor Jeffrey Drazen. And, he added, it may help get the politicians off of FDA's back.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at email@example.com