New FDA commissioner sees transparency in agency's work as good for public, industry

CLEVELAND, Ohio — Dr. Margaret Hamburg took over as commissioner of the U.S. Food and Drug Administration four months ago.

Agreeing to take the top job at the nation’s food, drug — and now tobacco — regulator, not to mention an agency that has been underfunded, understaffed and criticized forÂ food and drug safetyÂ failures for years, “wasn’t an absolutely easy decision,” Hamburg told a post-lunch audience at the Cleveland Clinic’s annual medical innovation summit, which concluded Wednesday afternoon.

Known for herÂ work in reducing the spread of HIV, bio-terrorism defense and cutting offÂ resurgent tuberculosis as New York City’s top public health official, Hamburg saidÂ her first priorityÂ is to “restore trust and confidence in the FDA as a science-based, science-driven agency.”Â

She wants to do that by “opening ourselves up” aboutÂ how the FDA does its work ofÂ approving and regulating the drug, medical device and biologics industries, among other jobs. Bringing transparency to the agencyÂ involves “providing much more insights into our standards, expectations and our decision-making,” Hamburg said.

“It involves being a vocal advocate for the agency, both in terms of explaining its important and unique mission to all of our critical stakeholders, and also advocate for the resources that we need,” she said. “It’s stunning how underfunded we are, given the importance of what we do, and given the uniqueness of what we do.”Â

Another priority is “responding to the changing realities of the world we live in,” said Hamburg, who began her career in medicine in internal medicine and research. “One is science. It’s a period of revolution in biosciences, life sciences, howÂ the agency is equipped to both understand that science and to put in place the programs and policies to be able to translate that science into meaningful products.

“And also, And then, globalization. We have to be able to operate in a global world. Not only FDA responsible for import safety, that includes drugs and medical products being distributed from literally hundreds of thousands of sites all over the globe … but we also have to be able to work with a scientific enterprise that’s global.”

FDA also regulates the nation’s food supply. “We live in a world of risks. There will always be problems, and there will always be a crisis for us to respond to,” she said. “But there is a great deal more we can do to prevent those problems … and improve how we respond.”

Hamburg has been talking with industry leaders, policy makers and the public to get over the steep learning curve of taking over an agency that has many moving parts. She will continue the conversations because “it’s in everyone’s interests to have a strong, well-functioning FDA,” she said.

She hopes to step up inspections of food and medical products produced in other countries by partnering with sister agencies to share the responsibilities. Â She also feels responsible for helping to educate agencies in developing countries because that’s a “matter of our own safety here at home.”

This summer, legislators and President Obama putÂ FDA in charge ofÂ regulating tobacco products. One of Hamburg’s first duties was appointing a head for the Center for Tobacco Products. “We’ll be examining the composition of cigarettes and other tobacco products in ways that haven’t been possible before,” she said.

There was a lot of discussion about the FDA taking on the regulation of tobacco. “To me, there was no other agency that could take it on,” Hamburg said. “There is no other science-based regulatory agency with a public healthÂ mission. Tobacco and its use is easily the most preventable death in the country. So this is a historic opportunity for us to fulfill our public health mission and apply our regulatory expertise.”

HamburgÂ already sees some of the limitationsÂ her agency’s drug approval process. “We have to take a multi-faceted approach. We need additional resources targeted to some aspects of the review process. We also need to look at how we can streamline and make more efficient our regulatory process,” she said. “Some of that involves closer work with the entities bringing products before us … so that we can build into the process … a well-defined and understood regulatory pathway with clear standards and expectations.”

HamburgÂ is investing in regulatory science. “We need to rethink some of the ways that we do our reviews and evaluations,” she said. “We need to look at new strategies for clinical trials … strategies for how to develop and implement biomarkers …and other strategies for more rapid assessment of whether something looks promising or not. That is something that FDA badly needs.

“It’s also something where we won’t be able to do a good job unless we do it in partnership with academe and with industry,” she said. “And I think there’s enormous opportunity, and I think real scientific excitement about what is possible.”

To do that, Hamburg will have to commitÂ “appropriate resources to build regulatory science,” she said. “And it’s also stepping out of an old, outmoded paradigm.”

HamburgÂ thinks the FDA can free up resources for companies to invest in innovation, which was the theme of the Clinic summit. “I think the more we can expand our reach and work with companies that are producing medical products … the more we can support those industries, make those industries more efficient, in terms of complying with our standards of practice and performance, and hopefully [enable] those same companies to be able to target resources for innovation.”