Distributors of the emergency contraceptive "Plan B" do not expect the Food and Drug Administration to approve their controversial proposal to sell the drug without a prescription, a decision that would reject the overwhelming recommendation of the FDA's expert advisory committee.
Such a decision would heighten the contentious political battle around the issue of making Plan B available on drugstore shelves, which social conservatives actively oppose and many physicians and women's groups strongly favor.
Carole Ben-Maimon, president of Barr Laboratories' research division, said the company's conclusion that its application will not be approved is based on communications -- and the absence of communications -- with the FDA. The agency, which has already delayed its ruling on the Plan B application by 90 days, has until May 21 to announce its decision.
"I think an approval is not a likely scenario," Ben-Maimon said in an interview yesterday. "But we're still hoping for an 'approvable letter' rather than an outright rejection." An "approvable letter" would allow the company to make the switch in the future, after additional conditions are met.
In December, an FDA expert advisory panel voted 23 to 4 in favor of the switch, concluding that the drug could be safely used without a prescription. But conservative members of Congress have lobbied the White House to oppose it out of concern that it would encourage teenage promiscuity and increase the spread of venereal disease, and the FDA has asked the company for information to address those concerns.
The FDA, which declined to comment yesterday, has denied that politics have played a role in deliberations, but officials said that the final decision would be made in consultation with the commissioner's office because it is a "thorny" issue. The nation's major organizations of doctors who treat women accused the agency yesterday of caving in to political opposition and disregarding science.
Politics "should not trump medical evidence for making Plan B available over-the-counter," the American College of Obstetricians and Gynecologists (ACOG) and Physicians for Reproductive Choice and Health said in a statement issued during their annual meeting.
At a news conference in Philadelphia, ACOG President-elect Vivian M. Dickerson said emergency contraception "does not increase promiscuity among teenaged women, nor does it cause women to abandon their regular birth control methods."
Plan B was approved by the FDA in 1999, but its use has been limited because of the prescription requirement. Advocates of the switch to over-the-counter status say that making emergency contraception more available reduces the number of abortions and unwanted pregnancies. Emergency contraception, which can be used for up to 72 hours after unprotected sex, involves taking high doses of birth control pills. The drugs prevent pregnancy by stopping ovulation, fertilization or the implantation of eggs in the uterus. The medical community does not consider emergency contraception to be abortion, but some antiabortion activists do.
Wendy Wright of Concerned Women for America, who testified against the Plan B switch at the FDA hearing, said the studies discussed by the advisory panel did not address the problems that she and others believe will flow from easier availability of emergency contraception.
In particular, she said, the panel ignored studies that indicate emergency contraception leads to reduced use of condoms and an increase in sexually transmitted diseases. She also said she believed there is insufficient information about the effects of repeated use of emergency contraception, and about the possibility of the drug being "slipped" to women without their knowledge.
"It's entirely appropriate for the White House to be involved in a decision like this because it has such impact on the public health," she said.
Ben-Maimon, of Barr Labs, said yesterday that the company did not think its application would be approved because the agency has not begun final discussions about package labeling, which would have happened by now if an approval was coming.
The likelihood that the Plan B switch will not be approved this month first came up in a company teleconference with investors last week. Chief executive Bruce L. Downey said then that the "most realistic outcome" is that the FDA will determine that the switch to over-the-counter status is "approvable."
Emergency contraception is available in 101 countries and does not require a prescription in 33.