Pro-Family Voices Condemn FDA's Reconsidering Plan B for OTC Sales
by Jenni Parker
August 1, 2006
(AgapePress) - - Pro-life and pro-family leaders are reacting strongly to Monday's announcement by the Food and Drug Administration (FDA) that it wants to meet within seven days with Barr Pharmaceuticals Inc., maker of the emergency contraceptive known as Plan B, to discuss allowing women 18 and older to buy the drugs without a prescription.Barr's application for dual status for Plan B, also known as the "morning-after pill," would essentially make it an over-the-counter (OTC) product for women 18 and older while still requiring minors to have a prescription for the contraceptive drugs. The two-pill series, which contains a high dosage of a synthetic hormone used in some birth-control pills, is designed to be taken within 72 hours of having unprotected sex in order to prevent pregnancy.
Reportedly, when the FDA meets with Barr to reach a final decision, the pharmaceutical company will be required to provide details on how its program will enforce the age restriction on sales of the drug. However, some opponents of the plan have noted that the FDA has worked with a pharmaceutical company in the past to put restrictions on another counter-reproductive drug -- the abortion pill RU-486; these critics argue that those restrictions were promptly ignored once the drug was approved.
The FDA rejected Barr's initial application for OTC status for Plan B because the drug had not been proven safe for adolescent girls. Barr resubmitted the application for women ages 16 and older, a request that has been pending review. Advocates of Plan B claim it could lower the rate of unintended pregnancies; but pro-family critics of efforts to give the emergency contraceptive OTC status cite several reasons for objecting to this move.
The reasons pro-family and pro-life advocates give for opposing FDA approval of Barr's application, even for women 18 and older, include questions about the safety of Plan B and the likelihood that easier access to it would promote sexual promiscuity and increase the incidence of sexually transmitted infection. Other issues raised include ethical concerns related to use of the emergency contraceptive and evidence of its ineffectiveness in reducing unwanted pregnancies and abortions.
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Tony Perkins |
Critics Note Likely Problems With Enforcing Plan B Restrictions
Tony Perkins of the Family Research Council (FRC) says the FDA should reject Barr's application for a number of reasons. He says although the FDA has the legal authority to approve the marketing of a drug for prescription or non-prescription use, it does not have the authority to do both, which would be unprecedented."Furthermore," Perkins notes, "the FDA does not have the enforcement authority to ensure that store clerks are checking age ID for dual status drugs." He believes granting OTC access to Plan B to women 18 and older could lead to many problems, including the possibility that it could "make it easier for statutory rapists to hide their crimes."
A week has not passed since President Bush signed "an excellent bill" -- the Adam Walsh Child Protection and Safety Act of 2006 (H.R. 4472) [see bill info] -- designed to protect minors from sexual predators, Perkins points out. He feels it is incongruous for the administration now to be entertaining the idea of making it easier for statutory rapists to get Plan B by giving it OTC status for adults.
Perkins feels it is significant that Senator Hillary Clinton has been holding up the confirmation of Dr. Andrew von Eschenbach to head the FDA because that federal agency has not yet approved Barr Pharmaceuticals' application. The FRC president believes Bush administration officials are only considering this proposal now because they think approving the measure will help get the President's nominee confirmed.
Concerned Women for America (CWA) is also sharply criticizing the FDA for its sudden reopening of the debate over whether to give the morning-after pill even limited OTC status. And like Perkins, the group's spokeswoman is convinced that the federal agency's move was politically influenced.
Wendy Wright | |
Wendy Wright, president of CWA, says the FDA "needs to stop playing games with women's lives." Any scheme based on who buys the drug is "absolutely meaningless," she contends, since any person over 18, male or female, could buy the drug and then turn around and give it to a minor, even right there in the store."Neither the FDA nor Barr, the Plan B drugmaker, has the ability to penalize those that would sell or give the drug to a minor," Wright asserts. Nor is it believable, she says, that the federal agency or the pharmaceutical company could enforce a gender restriction on sales so that only women could buy it but men could not.
OTC Plan B Seen as Bad for Public Health, Worse for Sanctity of Life
Worse yet, the CWA president points out, OTC access to Plan B does not reduce the numbers of pregnancies or abortions. "Just the opposite," she says. "In fact, Scotland made the morning-after pill non-prescription in 1999 and in 2005 the country reported its highest number of abortions since abortion was decriminalized in 1967."
Countries that make the morning-after pill easy to get show no drop in either pregnancies or abortions but do experience "skyrocketing" rates of sexually transmitted diseases, Wright asserts. "Common sense and care for women -- especially minor girls -- requires medical oversight of this drug," she adds.
Pro-life advocate Judie Brown, president of the American Life League (ALL), says her group is "aghast" that the FDA has caved to mounting political pressures regarding the OTC availability of Plan B. She describes the emergency contraceptive as "a deadly cocktail of drugs that -- even according to its manufacturer -- can act to take the life of newly conceived babies in the days immediately following fertilization."
Brown says Plan B has "proven dangerous for the women and girls who take it." The FDA should never have authorized any use of Plan B in the first place, she asserts, and it certainly should not make it readily available over the counter now. And while that agency claims the age restrictions for its OTC sales would be strictly enforced, she says such enforcement is a "near impossible scenario," because abortion providers like Planned Parenthood have time and time again "proven their willingness to bend the rules when it comes to abortion and contraception, and there is no guarantee that such rule bending would not take place with Plan B."
The ALL spokeswoman says it is "disgusting" but not surprising that the FDA has given way to politics where Plan B -- which is basically a high-dosage of an ingredient commonly used in birth-control pills -- is concerned.
"This particular federal agency has been lying to women for over 40 years regarding the fact that the birth-control pill can kill preborn children prior to implantation," Brown notes. And while it is no secret that this is one of the ways the pill can work, the pro-lifer adds, "the American public continues to fall for the line that the pill cannot kill a newly conceived child."
The American Life League is once again imploring the FDA to "do the right thing and remove this deadly drug from the market at once," Brown says. Meanwhile, the group is urging concerned citizens to contact the FDA immediately and insist that OTC sales of Plan B not be permitted.
Other Pro-Life Plan B Concerns: Conscience, Care, and Informed Consent
Dierdre McQuade, pro-life spokeswoman for the U.S. Conference of Catholic Bishops, notes that even proponents of the morning-after pill admit that it works both before and after conception, making its use ethically problematic for those who oppose abortion -- including consumers who purchase the drug and pharmacy workers who may be required to provide it.
Making Plan B available OTC would "place additional pressure on pharmacists who conscientiously object to dispensing drugs that can kill humans at their earliest stages of development," McQuade contends. And many women, she notes, are unaware that the emergency contraceptive can cause abortion. She feels women and girls have a right to be made aware of this fact and informed as well about how their own health can be affected by use of Plan B.
"Over-the-counter availability would allow these drugs to be used routinely," the Catholic spokeswoman observes, "despite the fact that they are not approved for such use." She notes that one physician who supports OTC access for Plan B concedes that "repeated use of [emergency contraception] wreaks havoc on a woman's cycle" with "resulting menstrual chaos."
Making Plan B available without a prescription could place women and their newly conceived children at risk, McQuade insists. Doing so would mean women, particularly those for whom "this powerful, abortifacient drug" is dangerous, would not have the benefit of any clinical advice to alert them to the risks.
It is senseless, McQuade suggests, to put individuals' consciences, women and girls' health, and preborn babies' lives even more at risk by granting Plan B over-the-counter status, particularly when there is no benefit in doing so. She notes that a study co-authored by a Planned Parenthood doctor and appearing in the Journal of the American Medical Association showed that having Plan B on hand did nothing to reduce pregnancy rates as compared to pregnancy rates among those who obtained the drug from a pharmacy.
