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The FDA is now considering over-the-counter sales of emergency contraceptive Plan B. However, not everyone agrees that the drug should be that readily available – or available at all.
The FDA released a statement Aug. 26 announcing that its decision to approve or deny over-the-counter sales of Plan B would be delayed.
Some citizens, including members of Congress and many women’s health organizations, view the delay as politically motivated, with the FDA’s concerns about age just an attempt to lessen political pressure.
The FDA considers Plan B a back-up method to birth control because it is used in the event a contraceptive fails or after unprotected sex. It is taken in the form of two pills containing the hormone progestin, which has been used in birth control for over 35 years. According to research and the FDA, Plan B can effectively prevent unintended pregnancy within 5 days following unprotected intercourse, although it is most effective within 72 hours.
Plan B acts primarily by preventing the release of an egg from the ovary, but can also prevent the sperm from fertilizing the egg. If fertilization does occur, Plan B may prevent the egg from attaching to the womb. It has been available by prescription to all women through hospitals, health clinics and doctors’ offices since January 1999, when the FDA approved it for prescription use.
Barr Laboratories submitted an application for over-the-counter (OTC) status of Plan B to the FDA on April 16, 2003. On May 7, 2004, the FDA issued a “Not Approvable” letter to Barr Labs, claiming in a statement it was due to a “lack of data concerning OTC use of the product among adolescents younger than 16 years old.”
In a statement, Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said that though the FDA did not approve the OTC sales initially, he would be working on an expeditious evaluation of the response by Barr Labs.
“If Plan B is approved for nonprescription use, it would dramatically increase access to this product and will represent an important incremental step forward,” Galson said. “I look forward to supporting CDER’s important continued role in ensuring improved availability of these products.”
The FDA was set to make a decision on the resubmitted application on Sept. 1, 2005, but announced the delay just days before.
The delay cited “unresolved regulatory and policy issues” as an explanation, and the FDA said in the statement that these issues should be considered in an open, public process, maintaining that the decision was “too profound to be made behind closed doors.”
Susan Wood, the Director of the FDA office of Women’s Health, resigned in protest of the delay. In an email to her colleagues, Wood stated “The recent decision announced by the Commisioner about emergency contraception, which continues to limit women’s access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advocating women’s health.”
The issues in question, according to the statement, surround the proposed status of Plan B as available OTC to women 16 years of age and older, and available through prescription only to women under 16 years of age, making Plan B both a prescription and nonprescription drug.
Van Gravitt, executive director of the Mountain Maternal Health League, a Planned Parenthood affiliate in Kentucky, believes there is no question that the decision was influenced by politics.
“The FDA is becoming more political and less concerned about public health,” Gravitt said. Because of the recommendation to take the drug within 72 hours of unprotected intercourse, Gravitt believes there is a necessity for reliable and fast access to Plan B.
“Women should have the right to control their bodies in a safe and effective way,” he said.
But there are those who believe Plan B shouldn’t be available at all.
Many “Right to Life” organizations, including the University of Louisville’s Louisville Cardinals for Life and the Kentucky Right to Life, believe that emergency contraceptives amount to abortion. They consider fertilization to be the moment of conception.
Matt Foushee, a U of L student and member of LCL, agrees. He opposes emergency contraceptives in any form, with or without a prescription.
“The purpose of emergency contraceptives is to destroy life,” he said. “Normal birth control can kill a life.”
“Even in the event of rape or sexual assault, emergency contraceptives should not be an option,” Foushee maintained.
A joint advisory committee consisting of the FDA Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health, as well as the CDER, completed a review of the OTC application and concluded that the available scientific data was sufficient to support the safe use of Plan B as an OTC product.
Disagreement among some members of the committee led the FDA to announce the delay. This decision comes at a tumultuous time for women’s health in a divided government. The president is pro-life and two new Supreme Court Justice seats have opened up since the death of Chief Justice William Rehnquist and the retirement of Justice Sandra Day O’Connor.
Three states, California, Maine and New Mexico, currently allow pharmacists to provide emergency contraceptives to women without a prescription through state-approved protocol. Hawaii, Alaska and Washington allow pharmacists to distribute emergency contraceptives through a collaborative practice agreement with physicians. Pharmacists are given training in the application and use of emergency contraceptives in order to be able to effectively and safely distribute them. Women in 38 countries worldwide, including Canada, the United Kingdom, Morocco and Israel, have access to emergency contraceptives without a prescription.
The FDA, in its Aug. 26 statement, said that it would renew the decision-making process in 60 days. Until then, American women can receive a prescription for emergency contraceptives, including Plan B, from health clinics, hospitals and doctor’s offices.
