By Susan Brinkmann, OCDS
Staff Writer

In a move that surprised no one, the Food and Drug Administration (FDA), decided not to appeal a federal judge’s order to remove restrictions on over-the-counter access to the emergency contraception drug known as “Plan B” which will now allow  17 year-olds to access the drug.

The FDA announced April 22 that it would not appeal the ruling of U.S. District Judge Edward Korman who ruled in a New York lawsuit to remove the restrictions placed by the Bush Administration that limit over-the-counter access to women over 18 with younger women required to get a prescription first. Judge Korman also asked the agency to evaluate the clinical data to determine whether or not  all age restrictions should be lifted.

However, this latest move does not make Plan B immediately available to 17-year-olds. The manufacturer must first submit a request.

Pro-abortion groups have long contended that the decision to restrict access to Plan B was based on politics rather than ideology.

Nancy Northrup, president of the Center for Reproductive Rights, which filed the lawsuit, praised the FDA’s decision to the Associated Press: “It’s a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science.”

However, pro-life groups make the same claim about the latest move and denounce the decision  because it puts ideology before the safety of young girls and undermines parental rights.

“This decision is driven by politics, not what is good for patients or minors,” said Wendy Wright, President of Concerned Women for America. “Parents should be furious at the FDA’s complete disregard for parental rights and the safety of minors.”
 
As Wright explains, Plan B is a high-dose of the same birth control pills that require a prescription in lower doses for all women. Birth control pills can cause blood clots, heart attacks, and strokes in healthy women.

“The FDA violated its standards when it made the high dose Plan B available non-prescription to adults. But now the FDA is making the drug available to minors without parental consent,” Wright said. “Parents should be furious that the FDA is putting their minor daughters at risk.”

Although advocates say its use will reduce pregnancies and abortions, these numbers have actually skyrocketed in other countries where Plan B is readily available to teens of all ages.
 
“Pregnancy counselors report that women are relying on Plan B as a regular form of birth control because it is easy to get,” Wright says. “They are not aware that it is less effective than other methods of birth control and that it has not been tested to determine the effects of using it multiple times.”

She went on to say:  “His (Judge Korman’s) decision was based on false information — that the drug is more effective than it has proven to be and that the FDA somehow violated its policies by not making the drug non-prescription. Just the opposite is true — the FDA violated its standards by making a high-dose drug non-prescription when a low dose of the same drug requires a prescription.”

Dr. Charmaine Yoest, President & CEO of Americans United for Life (AUL) shares these concerns.

“The federal agency tasked with protecting public health has abdicated its responsibility by not appealing the court order,” she said. “The maker of Plan B has not researched what happens when adolescents take Plan B.  In addition, neither the maximum safe dose nor the effects of overdose have been determined by scientific study on any age group.”

Dr. Yoest also points out that Judge Korman’s ruling does not permit the FDA to undertake another internal review of the drug’s safety record or to receive evidence on the increased need to protect minors from dangerous medications or even sexual abuse.

Denise Burke, AUL Vice President of Legal Affairs said, “With this decision, an unsafe drug could be used by sexual predators and even the victims themselves to hide the abuse from parents and the authorities.”

Wright concludes: “Women, parents, and children who rely on the FDA to do their job deserve better than this shoddy decision.”

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