Late Breaking News
FDA Recommitting to Regulatory Science
BETHESDA, MD—Efforts in basic science at FDA have, in recent years, been “underappreciated, under resourced, and underfunded,” even though they are an essential component of the agency, FDA Commissioner Margaret Hamburg, MD told the members of FDA’s Science Board at a recent meeting.
“We cannot do our tasks as efficiently as possible if we do not harness advancements in science and technology in new ways,” she declared.
The 21-member board provides advice to the commissioner on emerging issues within the scientific community, industry, and academia. The August meeting focused on updates on various scientific issues, but included a message from Hamburg, who said that FDA was recommitting itself to regulatory science.
The last year has been spent getting a team in place to move FDA forward, Hamburg said, with now being the time to begin framing out critical areas for the near and long term. The end-goal is to position FDA in a way that it can tackle 21st century problems.
“There are three realities that have come to shape how I think about my role at FDA,” Hamburg explained. “The first is restoring trust and confidence in FDA and in the important mission that we have as a science-based regulatory health agency. The second is strengthening science within FDA and continuing to build out the field of regulatory science.”
The third, she explained, is globalization. “I just returned from visiting our new FDA offices in China. FDA was created many years ago, and when we first began, it was possible to screen products when they came over the borders. That has long since been an impossibility. The impact of globalization is so enormous now that we need a new [way of thinking]. We also need to engage in science in a much more international way. Science is a global enterprise.”
Science being at the center of each of those concerns is no coincidence, she explained. There is a continuum of scientific activity—from basic science into disease processes to trials of new drug agents on humans—that is important to the health of the nation and to the health of the US economy. FDA needs to take an active part in that process, and not relegate itself to the immediate pre- and post-market arena.
“This is not just an FDA problem, clearly,” Hamburg told her advisors. “It’s an issue for the scientific community as a whole. Some of the most cutting edge science is in arenas that deal with regulatory science.”
That science includes work on discovering biomarkers for toxicity; application of genomics for real-world products; and clinical research and innovative trial designs that can help scientists get answers in time frames that require less waiting and fewer patients.
Partnering on Science
The 2011 budget is the first to include FDA funding targeted specifically for regulatory science—$25 million. “I think this is very encouraging,” Hamburg declared.
To make sure that money is spent well, FDA needs to partner with industry and academia, Hamburg said. “FDA is really focused on building out these partnerships and we’re hoping that over time we’ll get the support to build some centers for excellence at academic institutions and [tap into the] regulatory science being done. We also want to engage students as they pursue their education and training to think about careers in regulatory science.”
Partnership with NIH
One of the most important partnerships will be with NIH. The two agencies have already formed a partnership to pool resources on regulatory science, with NIH and its much larger budget providing the bulk of project funding. The two agencies have also formed a joint NIH/FDA Leadership Council, the full membership of which will be announced soon. However, the council will be co-chaired by Hamburg and NIH Director Francis Collins, MD, PhD, and will involve senior leadership from agencies, center directors, and NIH intramural directors.
The two agencies have put together a new joint request for applications for regulatory science grants. Jesse Goodman, MD, FDA’s chief science officer, said he hopes the coming months will see the first awards announced. “I think this leap forward is an important symbol of what’s going on,” Goodman said. “We want to engage the outside community in this kind of science. All of this work in basic science, at the end of the day, will impact and improve the products that we have available.”
After impressing upon her science board their importance, and the importance of science as a whole to the agency, Hamburg left them to continue their work, saying, “I see these next couple of years as formative years. They’re going to be tough times, to be honest, in terms of the budget that we’re operating in. But they will be exciting times when it comes to science, the sense of eagerness when it comes to collaboration, and the sense that FDA must move forward, to strengthen trust and confidence, and strengthen the science that must underlie all that we do.”