FDA Commissioner Margaret Hamburg Puts Prevention at the Core of Public Health

VIDEO

Prevention is a core principle of public health, key to facing challenges from food safety to tobacco, Food and Drug Administration Commissioner Margaret Hamburg told a packed auditorium in her keynote remarks during the University of Miami Global Business Forum, held Jan. 12–14, 2011.

Margaret Hamburg, Commissioner, Food and Drug   Administration

Food safety has been a hot-button topic for the FDA, with Hamburg deeming it an “enormous ongoing challenge.” She called the recently passed food safety bill, which gives the FDA unprecedented authority to monitor the food industry, “historic.” Among the bill’s requirements: food production facilities must have written plans to prevent safety problems; the FDA must establish science-based standards for safely producing and harvesting produce; and the FDA is authorized to mandate the recall of unsafe food. It also directs Hamburg’s agency to inspect domestic and foreign facilities more frequently, and improve its ability to track domestic and imported foods — a critical function, as more than 80 percent of the nation’s seafood and 40 percent of its produce are imported from other countries.

“Congress is calling on the FDA to put into place a whole new approach to food safety based on prevention,” Hamburg explained. “It’s much more cost-effective and much more effective in terms of reducing unnecessary illness to try and identify points of vulnerability ahead of time, address them, and prevent problems from happening in the first place.”

UM President Donna E. Shalala, a former U.S. Secretary of Health and Human Services, joined Hamburg for the keynote session, which took the form of an informal interview of Hamburg by Shalala. Shalala questioned the commissioner on everything from bioterrorism to regulatory science, the discipline that studies the science and tools used to evaluate product safety, efficiency, potency and quality. Hamburg believes it is critical to further develop regulatory science; advanced medical therapies in particular would benefit, she said, as it would help identify which products and therapies will work earlier in the development process, enhancing the country’s competitiveness in the global economy.

“It saves time, it saves money, and it saves preventable problems in the human clinical studies as well,” Hamburg said, explaining to attendees that almost 90 percent of drugs in development never make it to the marketplace.

She also suggested that better regulatory science can help in the development of advanced therapies such as stem cells, nanotechnology and drug delivery options. She called on scientists not only to focus on new technology but also to explore long-term safety issues from the early stages of their research. “We need not only to develop the science that underlies the opportunity, but we also have to make sure that we can turn those ideas into viable products that are stable and reproducible and delivered safely,” she said, noting that this partnership will “streamline and modernize” the regulatory pathway and allow products and therapies to reach the market faster.

Shifting gears into current on-market drugs, Hamburg noted the FDA’s own limited authority for drug recalls. She called for drug companies to have stronger systems in place for monitoring and checking quality, and for them to have a transparent relationship with the FDA. To that end, she spoke of a new initiative that will make it easier and clearer for industry to understand FDA expectations and avoid possible legal intervention.

Hamburg, who was at one time the New York City health commissioner and who also worked for Shalala at the Department of Health and Human Services, sees the FDA as far more than a regulatory body. She believes that the “much beleaguered, chronically underfunded” agency has an “important and unique mission,” with public health at its core, and consistently encourages her employees to consider the public health outcome of any initiative.

“At the end of the day we are involved in so many issues that directly impact on public health,” said Hamburg. For example, she briefly described new legislation that gives the FDA, for the first time, the ability to examine tobacco products and their components, in hopes of understanding the underlying science and the health risks they may present. It will also allow the agency to regulate the types of products that reach the public. One of the first results of the FDA’s efforts was the removal of candy and fruit-flavored “cigarettes” from the market in an attempt to block the recruitment of younger smokers. The agency will also be introducing new practices in marketing and advertising, centering on nine different risk-based messages along with graphic warning labels covering 50 percent of cigarette packaging.

The FDA, Hamburg continued, is a key part of the public health infrastructure — but one that doesn’t always get the attention it requires. “Public health is public safety, and it needs to get the attention and support and respect of other components of health and medical care,” she said. “But more importantly, [it needs the same attention as] our broader concerns about national and international security.”