President names his selections for top posts at FDA

After months of speculation, President Barack Obama has named his picks for the top two jobs at the embattled Food and Drug Administration (FDA). Dr. Margaret Hamburg, a former New York City health commissioner, has been tapped for FDA commissioner, with Dr. Joshua Sharfstein, Baltimore's health chief, as the deputy chief. If Hamburg is confirmed by the Senate, the duo will face the daunting task of taking over the helm of an agency that the government's own investigators have judged to be "at risk."

The FDA has a riddled past when it comes to leadership, having been without a leader for half of the past dozen years. After having served just two years, the most recent commissioner, Dr. Andrew C. von Eschenbach, resigned shortly before President Obama was sworn in. After considering numerous candidates, Obama is hoping that Hamburg's strong bioterrorism background coupled with her public health experience will set the agency on the right course.

Hamburg is currently employed as a senior scientist at the Nuclear Threat Initiative in Washington, D.C. Her entire resume is impressive, including a stint as assistant director of the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health, and later serving as an assistant health secretary under former U.S. President Bill Clinton.

In addition to his position in Baltimore, Dr. Sharfstein is a pediatrician who has challenged the FDA on the safety of over-the-counter medicines for children and pioneered a program to ensure that people with disabilities have access to prescription drugs. He has also served as a health policy aide to Democratic Congressman Henry Waxman, who plays a leading role in overseeing the pharmaceutical industry. The deputy chief position at the FDA does not require Senate confirmation.

Obama could not delay the appointment a moment longer, as the agency is still reeling from the recall of hundreds of products tied to salmonella-tainted peanuts that have sickened more than 500 people, including numerous children, in at least 43 states and has possibly led to eight deaths. Public confidence is at an all-time low in the FDA's ability to keep the population's food and drug supply safe.

A Government Accountability Office (GAO) report issued in January 2009 stated that the FDA "is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products." The new commissioner also will have to deal with a move to split off the FDA's food safety division, creating a completely new agency. The GAO report lists other challenges for the FDA, including improving inspections of foreign drug-manufacturing plants and ensuring that drug companies that win provisional approval to market products deliver on promised safety studies.

President Obama has publicly stated that that "the FDA is underfunded" and that the agency needs "needs new technology." The fact is that the FDA oversees and regulates approximately $1 trillion worth of products (drugs, medical equipment and about 80 percent of the food supply), yet operates on the relatively miniscule budget of $2 billion per year.

While still awaiting confirmation of Kathleen Sebleius as the secretary of the Department of Health and Human Services (HHS), which oversees the FDA, President Obama has tapped former Massachusetts Public Health Commissioner Howard Koh to be HHS' assistant secretary for health. Koh, an associate dean for public health practice and director of the division of public health practice at the Harvard School of Public Health, would oversee major health agencies such as the Centers for Disease Control and Prevention, the FDA and the National Institutes of Health. He would also serve as the leading health adviser to the HHS secretary.

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