A U.S. District Judge has ordered the Food and Drug Administration (FDA) to make a high-dose drug available without a prescription to 17-year olds. But he based his ruling on talking points that are oh-so-yesterday. This is what happens when politics drives health care.
Judge Edward Korman ordered that the controversial morning-after pill Plan B be made available to 17-year-olds without a prescription. (It is currently available over-the-counter to those over 18.) He also told the FDA to reconsider making the drug available to girls of all ages without a prescription. With scathing denunciations that could have been cut-and-pasted from an abortion lobbyist’s press release, Korman failed to check some basic facts.
Chief among them is the assumption that the FDA’s rules require that, if requested, a drug should be switched from prescription to over-the-counter. But in every discussion that I’ve had with activists and FDA officials, not one has responded to this simple fact: The FDA has never approved that a high-dose of a drug be available non-prescription when a low dose of the same drug requires a prescription.
The low dose of Plan B is a birth control pill. It requires a prescription because, for a variety of reasons, women need medical oversight when taking it. It can cause blood clots, heart attacks and strokes. Women who are sexually active should be regularly tested for conditions that may not produce symptoms. And under-age, sexually-active girls deserve counseling and help in case they are in a coerced or abusive relationship.
Making the morning-after pill over-the-counter for teenagers denies medical counseling and testing to girls who need mature guidance. A thirteen-year-old who may be pregnant is also a girl who may be sexually abused and at risk of contracting a sexually-transmitted disease.
Conspicuous for passing its expiration date is Korman’s argument that easy access to the drug — and even the drug itself — reduces pregnancies. He repeats the myth that Plan B is 89 percent effective.
Even long-time advocates for the drug don’t buy that anymore.
In 2002, Elizabeth Raymond stated, “Easier access to and wider use of emergency contraception could dramatically lower the high rates of unintended pregnancy and induced abortion in the United States.”
James Trussell stated in 1998, “We decided that making emergency contraception widely available was the most important step we could take in the United States to reduce the incidence of unintended pregnancies.” For years he harshly criticized the Bush Administration and the FDA for “allowing politics to trump science.”
Buckling to intense pressure from these and other abortion advocates, the FDA made Plan B non-prescription to buyers over 18.
Then, in a medical journal article published in 2007, Trussell and Raymond admitted that easy access to the drug does not result in fewer pregnancies and abortions. They conceded that “no study found an effect on pregnancy or abortion rates.” Instead, access to the morning-after pill showed that “previous expectations that improved access could produce a direct, substantial impact on a population level may have been overly optimistic.”
And they question the morning-after pill’s effectiveness, noting that “the published efficacy figures calculated from currently available data on this regimen…may overstate actual efficacy, possibly quite substantially. Clearly, if the method is only weakly efficacious, it is unlikely to produce a major reduction in unintended pregnancy rates no matter how often women use it.”
On one hand, advocates for the drug say that the FDA should not take into consideration whether easy availability will affect behavior (i.e. will it increase sexual promiscuity or allow statutory rapists to buy the drug to cover up their abuse of minors). On the other hand, activists argue (and FDA officials believe) that the cost of the drug would deter women from using it multiple times. Time for a reality check.
Since the FDA approved non-prescription use of Plan B, pregnancy counselors report more women relying on it as a regular form of birth control. If the FDA approved it, it must be safe and effective, they think, giving them a false sense of security. Yet the morning-after pill has a lower efficacy than any other form of birth control. And it has not been tested to discover what happens when it is used multiple times.
Korman’s ruling puts politics above women’s health and intrudes into parents’ ability to protect their minor daughters. Minors need permission to go on a field trip, get a piercing, or use a tanning booth. But now, by one judge’s order, girls will be encouraged to rely on an ineffective drug without medical oversight or parental involvement.
This is what happens when politics trumps the real world.