'Emergency Contraception' Could Still Gain FDA Approval
WASHINGTON — Mary Smith, a junior at the University of North Texas in Denton, is worried. She's taken Plan B, the so-called morning-after pill, in the past and is afraid that the Food and Drug Administration may make it easy for others to repeat her mistake.
“It was terrible,” she said. Smith fought nausea, stomach cramps and dizziness — the same symptoms for ectopic pregnancy — for more than 24 hours.
The FDA on May 6 rejected a pharmaceutical company's request for Plan B to be made available without a prescription. Barr Laboratories failed to prove that women under 16 can use Plan B safely for emergency contraception without professional supervision, the FDA reasoned.
But that wasn't the end of the story. The FDA offered Barr two alternative approaches for winning approval for Plan B's over-the-counter status. The company could “provide additional data demonstrating that Plan B can be used safely by women under 16 years of age without professional supervision.” Or it could supply additional information in support of permitting the marketing of the drug as a prescription-only product for women under 16 and a nonprescription product for women 16 years and older.
Plan B can cause early abortions. It consists of two high-dose birth-control pills that either interfere with ovulation or prevent implantation of a fertilized egg. It can be taken up to 72 hours after sexual intercourse or contraceptive failure, such as condom breakage.
Rejection of Barr's request surprised the medical world and abortion/ contraception advocates. The agency went against the advice of an outside advisory panel that in December recommended Plan B being available without a prescription.
Dr. Steve Galson, acting director of the FDA's Center for Drug Evaluation and Research, acknowledged that he overrode the opinion advisory committee's 23-4 vote as well as that of his staff.
Galson said he was concerned about the lack of information about “the younger age group between 11 and 14, where we know there is a substantial amount of sexual activity.” Barr's application only included study data on 29 women aged 14 to 16 and none under 14.
“Wide availability of safe and effective contraceptives is important to public health,” Galson wrote in his letter to Barr. “We look forward to continuing to work with you if you decide to pursue either of these options.”
Bruce Downey, Barr's chairman and chief executive officer, is hopeful.
“While we are disappointed the FDA did not approve our application at this time, we are encouraged by the FDA's suggestions and look forward to working with the agency toward approval of Plan B for over-the-counter use,” he said in a statement. “In the meantime, we remain committed to providing Plan B as a prescription-only product and to increasing awareness among the health-care-provider community and women of this safe and effective option.”
The reaction of a Catholic bishops' conference spokeswoman focused on the temporary victory rather than the FDA's conciliatory attitude toward Barr.
“We are pleased the voice of reason prevailed,” said Cathy Cleaver Ruse, director of planning and information for the U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities. “A drug that can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf.”
Another close observer of moral issues in public policy, Tony Perkins, president of the Family Research Council, commented: “This is a prudent decision to say that we must consider the consequences if teens use this drug as a means of birth control.”
But Judie Brown, president of American Life League, said the FDA's action is far from satisfactory.
“The FDA should never have approved the various concoctions described as morning-after pills, erroneously labeled as ‘emergency contraceptives,’ in the first place,” she said. “These pill regimens are known to cause abortion during the first seven days of a human being's life, [and] there are no studies indicating the long-term side effects of these pills when used by adolescents.”
And a Concerned Women for America spokeswoman predicted that “broad availability of Plan B would allow people to slip the medicine to women without their knowledge.”
“The morning-after pill is a pedophile's best friend,” said Wendy Wright, senior policy director of the pro-family women's organization, in written testimony to the FDA. “Morning-after-pill proponents treat women like sex machines.”
Next to Hair Spray?
Nationally, there are more than 1.3 million surgical abortions each year, and approximately 1.5 million women purchase emergency contraception annually.
Kathy Morgan, a Texas Catholic pharmacist who works for a large-chain pharmacy she did not want identified, wants women to receive screening by doctors who can take down their history.
“Imagine women who smoke taking this pill. They're going to have serious complications,” she said.
Morgan is also concerned that making Plan B available over the counter would leave women vulnerable to potentially fatal complications with no medical supervision.
In a letter to the FDA last year, 44 members of Congress urged rejection of Barr's petition “to make the morning-after pill as accessible to our nation's teen-age daughters as aspirin or hair spray.” If Plan B goes over the counter, the members of Congress asked, what stops teenage girls from using these pills as regular birth control?
Barr had until May 16 to respond to the FDA's letter.
Six states — Alaska, California, Hawaii, Maine, New Mexico and Washington — allow women to buy Plan B from certain pharmacists without a prescription. The FDA's decision does not affect those programs.
“Although we did not have sufficient data to approve this application now,” Galson said, “I will be working toward the expeditious evaluation of Barr's response to [the FDA's] letter.”
Colleen Hammond writes from Valley View, Texas.
- May 23-29, 2004