PharmExec Blog

Hamburg Addresses Drug Regulation and FDA Challenges

The new commissioner of the Food and Drug Administration is mapping plans for turning around an agency that has been demoralized and buffeted about in the press, and has lost the trust of the American people. “Our mission is to protect the health of the people, using the best available science, in as transparent ways as possible, across all domains,” Margaret Hamburg told Pharm Exec in a media briefing last week that was part of her campaign to enhance communication about FDA policies and goals.

One lead initiative is to define FDA’s “global footprint” for dealing with food safety and drug and medical product development on an international basis. Establishing overseas offices is just one aspect of developing a comprehensive strategic approach to addressing global health issues, Hamburg explained. These hubs provide more on-the-ground understanding of local developments and will permit more “nimbleness” in a crisis, she pointed out. But FDA also needs to develop partnerships with sister regulatory agencies to promote harmonization and provide assistance and capacity-building in countries with less developed regulatory frameworks.

Tackling tobacco
A high priority for FDA is to develop a framework for regulating tobacco products. Hamburg feels strongly that FDA, as a science-based public health regulatory agency, is the appropriate organization to address the “important public health problems” raised by tobacco use. The agency is still developing staffing plans and the rollout for a new tobacco center, but Hamburg believes that the new legislation provides the necessary tools and authorities, and does not “overload the plate” at FDA. She does not expect to take resources from other areas to support tobacco regulation, or that broader organizational changes will be needed.

Despite the heightened focus on food safety and tobacco regulation, the drug and medical product area is crucial to FDA’s mission, Hamburg emphasized, adding that “I do not see us stepping away from that important component.” She regards industry as “absolutely key partners in what we do” and aims “to get more involved in issues of innovation and in providing swift reviews of new products.” This a good time, she feels, to take a new look at the Critical Path Initiative and at how FDA can leverage emerging science and technology to strengthen new product development and review, as well as postmarket surveillance and product communication.

In the marketing and promotion area, Hamburg said she “cares deeply about making sure consumers get access to appropriate and adequate information about the choices they need to make.” Yet she is concerned that in a world with such a wide array of media outlets such as blogs, Web sites, and 24-hour cable TV, “it is very easy for inaccurate information to get out there. We have a real responsibility to make sure that where we have authority and opportunity, we provide the clearest and most accessible public health message possible.” Hamburg wants to work more with drug companies and advertising firms to ensure that any information on medical products is accurate and reliable and reflects available scientific data.

Hamburg also anticipates a closer working relationship with the Centers for Medicare and Medicaid Services (CMS) to help move medical products “out of the review process and into the market place.” Early discussions can help CMS understand what new products will emerge, and which may enable them to streamline their own procedures for review and reimbursement, she explained.

The commissioner recognizes the importance of having the resources to attract and retain the expertise needed to accomplish these many goals. She hopes that her leadership will be marked by a “strong and clear emphasis on science-based decision making.” If there’s a question about the safety or efficacy of a drug on the market, though, “I will not have any hesitancy about examining it closely,” she warned.

Setting up a new tobacco center will take some juggling, Hamburg acknowledges, but it is a high priority. How FDA takes on these new responsibilities will be looked at as a measure of FDA’s leadership. “FDA needs to make significant strides in order to accomplish its mission in a global world,” said Hamburg

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