The agency move that pro-lifers had warned against for months occurred three days afterwards, leaving pro-lifers upset with a president whom they had campaigned and voted for.
The president was asked at an Aug. 21 press conference whether he supported the intention of FDA Acting Commissioner Andrew von Eschenbach to approve over-the-counter sales of the so-called emergency contraceptive, known commercially as Plan B.
“I believe that Plan B ought to be — ought to require a prescription for minors, is what I believe,” Bush responded. “And I support Andy’s decision.”
The decision, announced Aug. 24 by the FDA, allows pharmacies to sell Plan B to women (and men) 18 and over without a prescription. The new plan will take effect by the end of the year.
Plan B is a backup method of birth control manufactured by Barr Pharmaceuticals of Woodcliff Park, N.J. Women who take the medication within 72 hours of sexual intercourse reduce their chances of becoming pregnant by 89%.
The contraceptive acts in a variety of ways. It can stop the release of an egg from the ovary, prevent fertilization or prevent the implantation of an embryo, should the egg become fertilized.
Aside from the risk to a woman’s health, it’s the last-named action that has many pro-life advocates on edge.
“While Plan B can prevent fertilization, the manufacturer admits it may also prevent a newly conceived embryo from implanting and surviving in the womb. This is properly understood as causing an early abortion,” said Deirdre McQuade, director of Planning and Information for the Secretariat for Pro-Life Activities at the U.S. Conference of Catholic Bishops. “We find the FDA’s unprecedented decision to make Plan B available without a prescription completely unacceptable.”
The Colorado Springs, Colo.-based organization Focus on the Family was shocked by the decision.
“Selling this drug over the counter to any adult who wants to buy it virtually guarantees that it will end up in the hands of teenage girls without their parents’ knowledge or their doctor’s supervision,” said Carrie Gorden Earll, senior bioethics analyst with Focus on the Family.
While supporters applauded the decision, they did not render a standing ovation. The Planned Parenthood Federation of America hailed the decision as a victory, but didn’t think it went far enough in making the medication available to teens.
“Today’s announcement is an important victory and long overdue,” said Cecile Richards, president of Planned Parenthood. “Women need timely access to backup birth control,” she said, citing that Planned Parenthood provided more than 1 million women with emergency contraception last year. “While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers. … Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy.”
Supporters believe that the medication will reduce teen pregnancies and the need for abortion. Opponents of the drug disagree, saying research shows just the opposite.
Earll, of Focus on the Family, described Plan B as an “invitation for adult men to pressure underage girls … with the promise of an easily accessible magic pill to prevent or abort a pregnancy.”
According to Wendy Wright,
president of the
“Despite exaggerated claims to the
contrary, Plan B will not realistically reduce abortion rates,” said McQuade. “Research in Europe and the
Opponents of the FDA’s decision suggest that it places women’s health at risk, that the age restrictions are useless, and that it makes no sense for the FDA to make a medication available over the counter when the birth control pill still requires a prescription.
Author Dawn Eden, who often criticizes Planned Parenthood on her blog, the Dawn Patrol, questioned the wisdom of making such a powerful contraceptive available over the counter when its less powerful cousin still requires a prescription.
“Why do oral contraceptives still require a prescription, seeing as they’re so safe that you can take 40 times the prescribed amount anytime you want?” she asked.
“This is the first time in the history of the agency that they have granted OTC (over-the-counter) status to a drug when a lower dose of the very same drug still requires a prescription,” said Father Thomas Euteneuer, president of the Front Royal, Va.-based Human Life International.
Pro-life groups also suggest that the age restriction is meaningless.
“The FDA made a deal with the owner of RU-486 to apply restrictions on that drug,” said Wright, referring to the abortion pill developed by French pharmaceutical company Roussel-Uclaf. “Those restrictions have never been followed. Women have died, yet no one has been punished nor the drug approval pulled.”
McQuade agreed. “We’ve learned that the drug will be distributed to men over 18, as well as women,” she said. “This pretty much guts the whole age restriction, as older boyfriends will be able to get their hands on the drug and give it to their minor girlfriends, dates, or statutory rape victims.”
Plan B has had a long and
controversial history in the
Members of Congress asked the Government Accountability Office to examine how the FDA’s May 6, 2004, decision not to approve the switch from prescription to over-the-counter happened (see sidebar). The Government Accountability Office determined that the Plan B decision was not typical of the other 67 proposed prescription to over-the-counter switch decisions made by the FDA between 1994 and 2004, and that FDA high level management were more involved in the review of Plan B than in those of other over-the-counter switch applications.
Steven Galson, then-acting director of the Center for Drug Evaluation and Research, stated that he issued a “not approvable” letter for the switch, based on concerns about the potential behavioral implications for younger adolescents.
The Government Accountability Office found that the FDA has no age-related marketing restrictions for any prescription or over-the-counter contraceptives that the FDA has approved.
As a result of the federal organization’s delay, some Democratic senators took action to try to force a decision. Von Eschenbach has been serving as acting commissioner of the FDA as he awaits Senate confirmation. Sens. Hillary Clinton, D-N.Y., and Patty Murray D-Wash., who serve on the Senate Health, Education, Labor and Pension Committee, put a hold on his nomination until the over-the-counter decision had been made.
In a press release,
She also announced she would lift her hold on von Eschenbach’s nomination.
Culture of Life?
Many pro-life leaders view Bush’s support of the FDA decision as backtracking on his campaign promise to promote a culture of life.
“President Bush and his nominee to head the FDA, Andrew von Eschenbach, have turned the agency into a handmaiden of the abortion industry and powerful pharmaceutical companies,” said Father Euteneuer. “The president must demonstrate a consistent respect for the sanctity of all human life or he risks provoking a great divorce with the conservative Catholics that comprise a large part of his support base.”
“Based on his apparent willingness to see the Food and Drug Administration authorize the potentially lethal Plan B drug regimen for women over 18, the president is apparently doing anything but protecting innocent human life,” said Judie Brown, president of the Stafford, Va.-based American Life League. “It is unfortunate and sad that politics have once again trumped the innocent babies.”
Tim Drake is based in
July 1999: Plan B obtains FDA approval for use as a prescription emergency contraceptive.
April 2003: Over-the-counter application for Plan B is filed with the FDA.
Dec. 16, 2003: An FDA advisory panel votes 23-4 to recommend approval of over-the-counter application for Plan B.
May 6, 2004: The FDA sends a “not approvable” letter for Plan B because of concerns regarding teen use of the drug.
July 2004: The over-the-counter application is resubmitted with the proposed age restriction of 16-year-olds for over-the-counter sales.
Jan. 21, 2005: The Center for Reproductive Rights files a lawsuit against the FDA for its failure to approve Plan B.
April 2005: Sens. Hillary Clinton, D-N.Y., and Patty Murray D-Wash., state that they will block confirmation of Dr. Lester Crawford as FDA Commissioner until the agency issues a decision on Plan B.
July 18, 2005: Crawford is confirmed as the FDA Commissioner by the Senate.
August 2005-October 2005: Drs. Susan Wood and Frank Davidoff resign from the FDA in protest over the delay regarding Plan B. Commissioner Crawford also resigns. President Bush names Dr. Andrew von Eschenbach as acting commissioner.
Nov. 15, 2005: The Government Accountability Office releases a report describing the Plan B decision as “highly unusual.”
March 2006: Sens. Clinton and Murray say they will block confirmation of von Eschenbach until the agency issues a decision on Plan B.
July 31, 2006: The FDA announces that it does not need new rules to handle the age restriction on Plan B.
Aug. 21, 2006: During a press conference, Bush implies support for the FDA’s approval of over-the-counter Plan B sales.
Aug. 24, 2006: The FDA announces its approval for Plan B to be sold over the counter to women 18 and older.
— Tim Drake