FDA Move To Allow "Plan B" Without A Prescription Is Unsafe And Unwise, Christian Medical Association
After intense political pressure from abortion activists and politicians including Sen. Hillary Clinton, who threatened to block Senate approval of Dr. Andrew von Eschenbach as FDA Commissioner, the FDA recently announced that it is prepared to reverse itself and approve over-the-counter sales of the powerful hormonal drugs to women aged 18 and older.
CMA Executive Director Dr. David Stevens said, "Politicians are trying to push FDA approval through with strong-arm tactics that have no place in evaluations of women's health and safety. We saw these same tactics deployed in the previous administration, when then-President Clinton's first official act was to order the FDA and the Department of Health and Human Services (HHS) to coordinate the marketing of the dangerous abortion drug RU-486.
"This move by the FDA appears to be based on political expedience and ideology rather than science. It makes no medical sense to offer over-the-counter access to a powerful hormonal drug when lower doses of those hormones in contraceptives require a physician's prescription," Stevens observed.
"Removing the so-called 'morning-after pill' from the protection of a doctor's prescription removes women from the protection of medical exams and counsel. The leading reason young women present for medical evaluation is to obtain contraception. Providing a contraceptive over the counter allows women to bypass the system that will give them the best care, provide sexual counseling, and diagnose and help prevent sexually related diseases. Sexually transmitted diseases are more likely to go undetected, resulting in morbidity including infertility.
"Over-the-counter use of these drugs is unsubstantiated by data," Dr. Stevens added. "'Emergency contraception' has been promoted as the regimen that would lower unwanted pregnancy and abortion rates, but hard data to back this claim is lacking. In the two largest 'advance placement' studies of which we are aware--peer-reviewed studies published in Contraception and the Journal of American Medical Association--neither happened. Because of a lack of studies on repetitive use, which is likely with many users, we do not know the long-term risks of these drugs.
Dr. Gene Rudd, an obstetrician and CMA's Associate Executive Director, noted, "The current packaging of these pills also violates the vital medical principle of informed consent. The FDA allows patient education material to claim that the product does not affect pregnancy or cause abortion. The drug's labeling falsely assures women that they are not taking the life of a human being when they take the pill. While some within the scientific community have obfuscated for political reasons the terms associated with early human development, a significant percentage of women still consider pregnancy to begin with fertilization.
"Adequate informed consent requires that information be appropriate for the patient--not the provider. No credible expert disputes that EC must have post-fertilization effects to be effective (especially since in real life it is often taken post-ovulatory). Many women will feel betrayed when they learn the scientific realities of the mechanisms of action."
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