Former Surgeon General Richard Carmona's admission that he was muzzled and subjected to political interference from political appointees in the Bush administration on important public health issues comes as no surprise to us, given our experience in uncovering wholesale political interference with the FDA's handling of efforts to make the emergency contraceptive drug Plan B (commonly known as the "morning-after pill") available over-the-counter so that women can avoid unwanted pregnancy.
In the course of our lawsuit against the FDA first filed in 2005, we discovered that one high-ranking FDA official told a subordinate that the Plan B over-the-counter application was being rejected in order to appease the Bush administration's constituents. Another high-ranking scientist within the FDA testified that the decision to reject over-the-counter status for Plan B was made in consultation with the White House. All the FDA scientists who would ordinarily make the decision whether to make Plan B available without a prescription strongly favored that action, but their authority to make the decision was taken away from them early on in the process when the agency's Commissioner began to express vague concerns about easier access to Plan B for young women. We also know that scientists at the FDA were fearful that their positions in the agency would be in jeopardy if they did not fall in line behind the Bush administration's political opposition to wider access to Plan B.
Former FDA Commissioner Mark McClellan admitted that he spoke from time to time about the Plan B application with the White House, but claimed that this was simply to update the White House about a controversial matter so that it could respond to press inquiries. We find this explanation for his repeated contacts with the White House highly suspect, especially in light of Dr. Carmona's testimony before the House Committee on Oversight and Government Reform yesterday. McClellan's appointment calendar also reflects that he spoke with Dr. Carmona about Plan B within days after the application was filed with the FDA in 2003. And we now believe it is likely that this conversation passed on instructions from the White House to Dr. Carmona to adhere to the White House's ultra-conservative positions against women's access to this important drug.
The FDA's handling of Plan B, especially in light of Dr. Carmona's frank testimony, is a case study in politics trumping science, with American women bearing the devastating consequences of unwanted pregnancies and, sometimes, subsequent abortions.
Simon Heller, Senior Attorney, and Vivien Labaton, Staff Attorney, Center for Reproductive Rights Counsel, Tummino v. von Eschenbach, a case the Center has against the FDA for failing to make Plan B available without a prescription to women of all ages.