Outspoken about safety: Margaret Hamburg Credit: Associated Press

Industry leaders and consumer advocates anticipate a shift in the focus of the US Food and Drug Administration (FDA) under the leadership of Margaret Hamburg as commissioner of the agency.

Hamburg was nominated by US President Barack Obama on 14 March, but as Nature Medicine went to press, she was still awaiting Senate confirmation. In the interim, Joshua Sharfstein, whom Obama appointed as deputy FDA commissioner, took the temporary position of the agency's acting head on 30 March.

Both Hamburg and Sharfstein are former health commissioners of large cities (New York and Baltimore, respectively) and therefore “understand public health issues from the street level—how policy impacts people,” says Peter Pitts, a former FDA associate commissioner for external affairs who currently serves as president of the New York-based Center for Medicine in the Public Interest, which receives biopharmaceutical industry funding.

The new FDA leaders are likely to put more emphasis on ensuring the safety of all medical products, rather than focusing on approving as many new medical products for use as soon as possible, as the FDA has been doing for the last few years, says Diana Zuckerman, president of the National Research Center for Women & Families in Washington, DC.

According to Jerry Avorn of Harvard Medical School, Hamburg and Sharfstein have the advantage of joining the agency after the enactment of the Food and Drug Administration Amendments Act of 2007, which gives the agency expanded authority to require post-marketing studies and clinical trials. Avorn predicts the legislation will give the new leaders clout when it comes to tracking the safety of approved drugs.

Some pharmaceutical insiders have voiced concerns in news articles that Sharfstein, who worked under drug industry critic Representative Henry Waxman, will crack down on the industry.

And John Calfee, a resident scholar at the American Enterprise Institute based in Washington, DC who has consulted for the drug industry, argues emphasizing safety too much could substantially hinder the approval of useful drugs.