Lester Crawford was no sooner in as the new head of the FDA than he was out, with no clear, satisfactory explanation of what had spurred the sudden exit. As the new interim commissioner, Dr. Andrew von Eschenbach, took over, he outlined the agency's responsibility to adapt and handle the emergence of personalized medicines. Meanwhile, the agency's top women's health official, Dr. Susan Wood, resigned in protest to the evident way that politics trumped science in the FDA's handling of Plan B, a controversial morning-after contraceptive.
This has been a turbulent year for the FDA. Drug developers devoutly hope that the FDA will spend 2006 demonstrating its commitment to science rather than to social conservatives, and a more clearly defined path to evaluating the safety of a drug is being warmly received. More is being done to clarify the type of data that regulators will find persuasive without adding greatly to the already considerable expense of proving a new drug's effectiveness. It's a tricky path to navigate. This is one story that will definitely continue into the New Year.