On Saturday, The Washington Post reported that, "after 28 months of growing controversy, the Food and Drug Administration yesterday indefinitely postponed its decision on whether women should be allowed to buy the 'morning-after pill' Plan B without a prescription." The FDA advisory panel "concluded the drug could be safely used as an over-the-counter drug by women older than 17. But in an unexpected twist, [FDA Commissioner Lester M.] Crawford also said the application raised complicated and unresolved issues about whether current regulations allow a drug to be legally sold by prescription only for teenagers but over the counter for all others."
There may be more at work than concern that OTC status will increase the drug's availability to teenage women. According to The Post, "many social and religious conservatives oppose easier access to emergency contraception and have flooded the White House with their views in recent days. ...Rep. Tom DeLay (R-Tex.) and 45 other members of Congress wrote President Bush to lobby against easier access to Plan B, and... even some pro-choice Republicans have backed away from their previous support for the proposal."
The medication, which delays or prevents ovulation and inhibits the fertilized egg from implanting into the uterus, has been derided by the Religious Right as an "abortion pill." Concerned Women for America's Wendy Wright, who has been spearheading opposition to the new regulations, warned in a press release that Plan B encourages promiscuous sexual behavior, "increase[s] sexually transmitted disease rates," and allows pedophiles to more easily rape their victims. This May, W. David Hager, a conservative Evangelical doctor, was asked to write a "minority report" outlining the rationale for rejection of OTC status for Plan B.
If this evidence paints an accurate picture, the FDA decision was based on the Religious Right's political opposition to the morning-after pill, not on the scientific evidence. This indefensible misuse of a regulatory agency's authority impedes medical progress at the expense of personal liberty and privacy rights. The agency should be in the business of determining the safety and efficacy of drugs, not making judgments on their moral implications. "FDA" stands for "Food and Drug Administration," not "Food, Drug and Morality Patrol."
posted by Alex from The League: Reassembled

I definitely agree that the FDA should be making its decisions based on scientific evidence regarding the safety of a drug, not moral arguments. However, the opinion that the drug "can be used safely by those over 17" seems to me to imply that it may be unsafe for teenagers. And, not only did they question the legality of making a drug "prescription-only" for teenagers but OTC for others, I would imagine that this would be difficult to enforce. In theory, it's easily solved by checking ID, but how often is that actually done for all the other things for which it's required now (such as using a credit card or even buying Sudafed)?
Also, it seems odd, when Plan B drugs contain the same hormones found in birth control pills, that Plan B should be OTC while birth control is by prescription only. Of course, this could just be that many side effects of birth control pills are related to prolonged use.
My point, I suppose, is that there does seem to be at least some medical basis for the FDA's decision, or lack thereof.
Posted by: Kelly Tessena | September 02, 2005 at 09:32 PM