NEJM outlines FDA to-do list

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The new commissioner and deputy of the FDA named by President Barack Obama this week will take over an agency with serious systemic problems that urgently need to be addressed, according to an editorial published in the March 14 issue of the New England Journal of Medicine.

On Sunday, during his weekly address to the nation, Obama named former New York City Health Chief Margaret A. Hamburg, MD, as FDA Commissioner and Batimore Health Commissioner Joshua Sharfstein, MD, as her deputy.

Hamburg, 53, is a physician and bioterrorism expert who served as an assistant health secretary during the Clinton administration. Hamburg's appointment requires Senate confirmation. Sharfstein, 39, is a pediatrician who has served as Baltimore's health commissioner and who worked as a health policy aide to Rep. Henry A. Waxman, D-Calif.

In recent years, various reports have portrayed an FDA burdened by ever-expanding responsibilities in the face of a mostly flat annual budget, much of which comes from fees paid by the industries the agency regulates. A 2007 report prepared for the FDA Science Board concluded that the agency "cannot fulfill its mission" to ensure that the foods, drugs, medical devices, vaccines, and other products that it regulates are safe and effective, because it lacks modern scientific expertise, is critically underfunded and understaffed, and has a dangerously outmoded information-technology infrastructure, according to Susan Okie, MD, author of the NEJM editorial.

The to-do list for both Hamburg and Sharfstein, if confirmed, could include a restructuring of the agency, its work force and a re-evaluation of the medical device and drug approval process.

Restructure and rebuild

The FDA's problems have prompted calls for restructuring, including proposals to remove it from the Department of Health and Human Services (HHS) and elevate it to Cabinet-level status, to make the position of the commissioner a six-year appointment (not subject to curtailing by the president except in cases of misconduct), to split off responsibility for food safety, perhaps into a new federal agency, and to separate drug-safety research and monitoring activities from the FDA branch responsible for approving new drugs.

More than 40 percent of the FDA's work force of approximately 10,000 is over 50 years of age; new employees must be recruited and trained to fill vacancies, and staffing must be expanded in critical areas. Also, the agency's IT system must be replaced with one that allows it to collect, manage and study essential data, according to the editorial.

Improve medical device, drug approvals

The 1976 law granting the agency authority to regulate medical devices allows it to approve certain new devices without clinical testing of safety and efficacy, provided they are deemed substantially equivalent to devices already on the market. Despite 1990 legislation ordering the agency to begin requiring more extensive clinical studies of class III devices (those implanted in the body) before approval, most are still approved with minimal testing.

Regarding drugs, the FDA must continue to focus on striking the right balance between safety and efficacy and on promptly sharing emerging safety concerns with doctors and the public. There is consensus on the need for companies to conduct more postmarketing studies of newly approved medicines to look for adverse effects and measure long-term effectiveness, and the FDA has begun working with organizations that maintain large databases of information on patients to establish the Sentinel System, in which a drug's safety profile can be efficiently evaluated by epidemiologists. The goal is to have 25 million records available for such studies by 2010, an FDA official said.