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FDA Decision on Plan B Irritates, Disappoints Pro-Lifers
Age Restriction on Over-the-Counter Access Difficult to Enforce, They Say
By Jody Brown and Mary Rettig – August 24, 2006
(AgapePress) – The FDA has taken what pro-life groups consider an ill-advised step by approving Plan B — also referred to as the “morning-after” pill — for over-the-counter access for women 18 and older. At least one of those groups contends the federal agency has overstepped its authority in the decision, and that the non-prescription availability of the emergency contraception will have a “detrimental effect” on women and parents.
Plan B, manufactured by Barr Pharmaceuticals, contains the same ingredient used in prescription birth-control pills, only in higher dosage. Today’s decision by the U.S. Food and Drug Administration makes the drug available without prescription to women over the age of 18; it remains available as a prescription-only product for women 17 and younger. Those opposed to the change have pointed out that the FDA has no authority to enforce the age restriction, and that Barr has no intention to do so. Perhaps in response to that criticism, Barr has stated it will implement a “rigorous labeling, packaging, education, distribution, and monitoring program” for Plan B.
Enforcement of Age Restriction
Ultimately, though, enforcement of the age restriction will have to occur at the distribution level — that is, by pharmacists. Part of Barr’s distribution program includes keeping both the OTC and prescription versions of the drug behind the counter because it cannot be dispensed without a doctor’s prescription or proof of age. Wendy Wright, president of Concerned Women for America, says if the FDA thinks such an approach will validate their decision, “then they are living in a dream world.”
Says Wright: “Enforcement requires a penalty for violating the restriction. The FDA has no authority or ability to enforce an age-restriction, and Barr … has neither the ability nor the willingness. The most [Barr] could do is not supply the drug to a violator.” And that, she claims, is “something that will never happen.”
Barr says it will also provide labeling and education about the appropriate use of Plan B, as well as a toll-free number for consumers; make sure distribution is handled only through licensed drug wholesalers, retail pharmacies, and clinic (no convenience stores); and monitor the “effectiveness” of the age restriction. But because there is no actual law behind the FDA’s decision, Wright predicts a repeat of another similar situation involving an abortion-causing drug.
“There would only be an agreement between the FDA and Barr [about the age-restriction placed on Plan B] and we’ve seen how useless that is,” she says. “For example, the FDA made a deal with the owner of RU-486 to apply restrictions on that drug. Those restrictions have never been followed, women have died, yet no one has been punished nor the drug approval pulled.”
The CWA president also is greatly concerned that despite the age restriction, young teenage girls will be able to obtain a high-dose drug without their parents’ knowledge or a physician’s oversight. Parents, she says, should be “horrified” that a high-dose drug will be more easily obtainable than a low dose of the same drug.
“Their young daughters will now have this super-dose of hormones easily available, without any requirement for parental consent or medical oversight,” Wright observes.
But how could that happen with an age-restriction on purchasing the drug? “Any adult male who is having sex with a minor could walk into a pharmacy, buy the drug, and coax the girl into taking the pill,” Wright counters. She accuses the FDA of taking “irresponsible” action that removes from parents their right to oversee their child’s medical needs and places it in the hands of “ill-intentioned perpetrators.”
Propelled by the President?
The associate executive director of the Christian Medical & Dental Associations (CMDA) says he’s surprised and disappointed in recent events surrounding the Plan B contraceptive. Among those events are comments made by President George W. Bush earlier this week that essentially endorse the FDA’s decision announced today.
Dr. Gene Rudd of the CMDA says he is not sure why the president said what he said, but that it may simply be a political statement to move forward his nominee to head up the FDA, Dr. Andrew von Eschenbach. Rudd is generally complimentary of Bush’s pro-life record, but questions his seeming approval of Plan B access.
“I don’t know whether President Bush is just generically supporting his nominee or not, [and] I don’t know what he knows about the product,” says Rudd. “But I certainly think the people at the FDA who [made the decision on OTC access] would look at the science and determine that this is bad public health policy.”
The Christian obstetrician says he really wonders what the people at the FDA are thinking. He maintains that approval for easy access to what he calls “an inferior product” is going to allow women to bypass a healthcare system that offers counseling and disease screening as well as access to birth-control methods he says are better than Plan B. But by granting OTC access to the morning-after pill, “we’re just allowing them to be out of that system that’s going to be the best for them,” he says.
Judie Brown of American Life League, acknowledging the drug’s deadly effect on unborn children but also citing her concerns for women, calls Plan B a “risky drug regimen” that should never have been approved by the FDA in the first place and should not have been made readily available over the counter.
“If the FDA, the president, or anyone who supported this decision truly cared about the health and well-being of women, they would have demanded that the drug be pulled from the market at once,” she says. “Thanks to this reckless decision on Plan B, preborn children and young women are in peril.”
Brown is convinced that President Bush’s recent comments helped to speed along the decision to approve Plan B for non-prescription access to women over 18.
By Jody Brown and Mary Rettig, AgapePress – Copyright, 2006. All Rights Reserved.