HHS ruling on Plan B introduces new risk for drugmakers.

摘要

In December, US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius made headlines when she nixed the decision by the US Food and Drug Administration (FDA) to make the emergency contraception pill Plan B One-Step available to girls 16 and younger without a prescription. Taking the long view, some fear that the secretary's decision to publicly overrule the FDA-an unprecedented action-could have a chilling effect on the development of other controversial medicines. "The message to the industry is clear," says Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development in Boston. "If you're developing a drug or considering developing a new medicine in an area that might be politically charged, you should think again."