FDA to Decide Status of Morning-After Pill
Agency Nears Decision on Over-the-Counter Sale of Drug Known as 'Plan B'
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
"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."