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How the FDA’s Plan B Decision Puts Minors At Risk



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Big Pharma and sexual predators, not teenage girls, will benefit from the Food and Drug Administration (FDA) decision to eliminate the involvement of a health-care provider in the distribution of the so-called “emergency contraceptive” known as Plan B, making it available over-the-counter to girls as young as 15.

For one, over-the-counter availability of Plan B removes the important opportunity for a health-care provider to identify and intervene in cases of abuse. 

Research that shows that teens are often preyed upon by older men. The 2004 report “Statutory Rape: A Guide to State Laws and Reporting Requirements,” prepared for the Office of the Assistant Secretary for Planning and Evaluation at HHS, noted that half of children born to minors are fathered by adult men, and sexual partners of these adolescents are often three to six years older.

Planned Parenthood acknowledges in its fact sheet on “reducing teenage pregnancy” that “teenagers who have been raped or abused experience higher rates of pregnancy — 4.5 out of 10 pregnant adolescents likely have a history of abuse.” The group also notes that “teenage girls with a history of abuse are more than twice as likely to become pregnant as peers who do not experience abuse.” Among women younger than 18, the pregnancy rate among those with a partner who is six or more years older is 3.7 times as high as the rate among those whose partner is no more than two years older. These issues just underscore the importance of a health-care provider’s involvement in obtaining Plan B.

The FDA decision also irresponsibly undervalues the grave implications of this powerful drug, which can end the life of a developing human being.

Advocates of Plan B deceptively claim the drug as simply “designed to stop pregnancy.” This is one of the favorite bait-and-switch tactics of abortion advocates. They respond to concerns that some “contraceptives” do not merely prevent conception (the function that the term “contraception” implies) by stating they do not end “pregnancies.” Relying on a definition of pregnancy that begins at “implantation,” this argument is a nonresponse to the concern that these drugs and devices work after conception, by blocking the implantation of a developing human embryo. They might not end a “pregnancy” as abortion advocates define it, but they do end the life of a unique human being.

HHS secretary Kathleen Sebelius has admitted that the FDA’s definition of “contraception” is not limited to a drug’s ability to prevent conception. “The Food and Drug Administration has a category [of drugs] that prevent fertilization and implantation. That’s really the scientific definition,” she says.

The FDA’s labeling acknowledges that Plan B can prevent implantation.

The consequences of “inhibiting implantation” are more serious than this sterile description might imply. Inhibiting implantation is deadly. Dr. Warren Wallace, a physician at Northwestern University Medical School who has “prescribed emergency contraceptives,” and who was called to testify in Morr-Fitz, Inc. v. Quinn in support of a law that would restrain conscience rights pertaining to their provision, testified under oath that “there is a new unique human life before” implantation of an embryo.

That “new unique human life” dies when a drug like Plan B prevents its implantation.

In his most recent study on so-called “emergency contraception,” Dr. James Trussell, whose research has been cited by the FDA, states that, “to make an informed choice, women must know that [emergency contraception pills] . . . may at times inhibit implantation.” Over-the-counter access of Plan B removes the opportunity for teens to be informed by a health-care provider about all of Plan B’s mechanisms of action, including its ability to end life.

Advocates for freer access, in addition to understating the implications of Plan B, have also overstated its effectiveness. Recent studies suggest that Plan B “prevent[s] fewer pregnancies than reported by the [World Health Organization].” Even proponents of so-called “emergency contraception” are acknowledging that “increased use [of Plan B] has not reduced rates of unintended pregnancies.” (See this 2010 article in The Lancet.)

Thus, Plan B, a drug which does nothing to prevent sexually transmitted diseases, creates a false sense of security. The convenience of over-the-counter access may encourage teens to engage in risky behavior that will have life-long consequences.

In early April, in the case Tummino v. Hamburg, a federal district court acknowledged that few minors were included in “actual use” studies on the safety of Plan B. Instead, the FDA vote to approve the use of Plan B by minors was based on study data from older age groups. Significantly, given the relative newness of the drug, it is impossible to know the long-term effects Plan B may have on minors’ developing bodies.

Of course, the abortion lobby is up in arms about the FDA’s decision because, in their view, it did not go far enough. They want the drug available to minors of any age and without the requirement to show ID.

Supporting Secretary Sebelius’s 2011 decision to reject the FDA recommendation to make Plan B available over-the-counter, President Obama said the following: “The reason Kathleen made this decision is that she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could have an adverse effect.” He correctly added, “I think most parents would probably feel the same way.”

Abortion advocates such as the Center for Reproductive rights will continue to fight, against the best interest of young girls, for completely unrestricted access to Plan B. Importantly, its effort to normalize Plan B as nothing more serious than bubble gum sets a dangerous precedent for “ella,” another so-called emergency contraceptive that can end human life even after implantation that may be marketed and sold the same way.



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