FDA to Decide Status of Morning-After Pill
How Safe Is Plan B? continued...
Few argue that Plan B is unsafe for adult women. But some of the panelists expressed concern that the drug had not been tested in enough teenage girls. And panel chairman Louis R. Cantilena Jr., MD, PhD, worried that tests of Plan B -- designed to mimic actual use of the drug -- did not reflect the way the drug would be used in real-life nonprescription situations.
"My concern [with the Plan B actual-use safety study] is that it doesn't accurately reflect what will likely be the most common setting for this product based on what we've heard," Cantilena said in the transcript. "So the actual use [study] was not as close to possible to what we think will actually happen with the drug." Cantilena voted with the minority to disallow nonprescription sales of Plan B.
Panel member Susan A. Crockett, MD, a San Antonio ob-gyn, said in the transcript that she believed Plan B would decrease the number of planned abortions and that Plan B "is a health care advancement for women who have access to it." But she worried that over-the-counter sales would discourage women, especially young women, from seeing their doctors for birth control counseling.
"I'm going to go down kicking and screaming before I allow somebody to break that relationship between myself and my patients because I value the education component so much in that relationship I have with my patients," Crockett said. She voted against nonprescription sale of Plan B.
Plourd disagrees. "It is important for doctors to talk to patients," he says. "But it is patriarchal and cruel to women to withhold these pills until they come in to see me. Their primary need is to prevent that pregnancy. It is almost like coercion to say I won't prevent your pregnancy until you come in to my office."


