As part of his strategy to be confirmed as the head of the U.S. Food and Drug Administration (FDA), nominee Dr. Andrew von Eschenbach threw his lot in with those who are lobbying to get Plan B, the so-called morning-after pill, available as an over-the-counter drug not requiring a doctor’s prescription or supervision. Since late July 2006, Eschenbach and the FDA have been working with Barr Laboratories to pave the way for Plan B to be sold over-the-counter (OTC) instead of requiring a doctor’s prescription (RX) before the drug can be dispensed. This week, that possibility came closer to reality when President Bush announced his support for the Eschenbach plan — allowing OTC sales for 18-year-olds, but requiring an RX for teenaged girls.
The major problem with the proposed compromise is that it is totally unworkable. It makes about as much sense as acting as though a car with air bags wouldn’t need to have its brakes serviced and kept in good repair.
How can the FDA monitor a 2-track marketing strategy for the drug? How can the FDA enforce the age restriction? The regulatory issues and monitoring ramifications would be daunting. Worse, the plan would unleash a Pandora’s Box of problems related to the conflicting roles of doctors and pharmacists in such a commercial arrangement.
In short, providing Plan B over-the-counter is beyond-the-pale.
Since birth control pills require a prescription and a doctor’s supervision during use, how can the FDA or the drug manufacturer condone providing Plan B (a mega-dose of the same drugs) over-the-counter? Widespread access to Plan B would expose women to the health risks that heretofore were acknowledged by doctors who screened women before prescribing birth control pills and then monitored them for the wide variety of contra-indicators for their use. Some of the health risks associated with birth control pills — life-threatening ectopic pregnancies, for instance — are a clear danger for some women with Plan B, too. Also, some physicians are concerned about the long-term effects of high-dosage birth control pills (Plan B) and others worry about their effect on adolescents and the fact that there are no constraints that would prevent repeated use of Plan B for “emergency contraception.”
Having Plan B available over-the-counter is beyond-the-pale, too, because already those targeted for its use (under 25-year-olds) are experiencing an epidemic of sexually transmitted diseases. Plan B would offer no protection against STDs, of course, but would provide a false sense of security for those involved in risky sexual behavior and thus increase their risk of STDs. Several countries (Scotland and the United Kingdom, for instance) have discovered that STDs increased and abortions increased when Plan B was made easily available. In the United States, Planned Parenthood clinics that tracked their Plan B prescriptions also reported an increase in abortions.
Of equal concern is the fact that any 18-year-old could buy Plan B OTC and give it to anyone else — even underage girls — without parental consent or knowledge. The ramifications of such distribution include sexual abuse and sexual exploitation. The amount of misinformation about Plan B is astounding. Those advocating OTC availability are touting the drug as a “silver bullet” for birth control. Yet, the easy availability that would come with OTC sales extends to those who are incapable of understanding the risks involved in any high-potency drug. Highly vulnerable potential users would include young teens as well as those of limited intelligence or education who might not understand the dangers of using Plan B routinely.
The legal can-of-worms that Plan B unleashes is equally troubling. When something goes wrong, as it inevitably will, where will the victims turn? To the drug store? The pharmacist? Barr Laboratories? The FDA? Sadly, there will be no recourse for those who fall victim to this social experiment. America’s women and girls are, once again, subjected to medical experimentation at the urging of those who want to be free of the consequences from sexually promiscuity regardless of the cost to their own or other women’s health and well-being.