By Marc Kaufman
Washington Post Staff Writer
Monday, February 27, 2006
Filling a void left by the Food and Drug Administration's inability to decide whether to make the "morning-after" pill available without a prescription, nearly every state is or soon will be wrestling with legislation that would expand or restrict access to the drug.
More than 60 bills have been filed in state legislatures already this year, and that follows an already busy 2005 session on emergency contraception. The resulting tug of war is creating an availability map for the pill that looks increasingly similar to the map of "red states" and "blue states" in the past two presidential elections -- with increased access in the blue states and greater restrictions in the red ones.
Many of the state bills intended to expand access give specially trained pharmacists in states including Maryland, New York, Kentucky and Illinois the right to dispense emergency contraception without a prescription. Other bills require pharmacies to stock and distribute the drug, and to ensure that the pill is made available to women who come into emergency rooms after a sexual assault.
But some bills would make it more difficult for many women to get emergency contraception, which is effective for only 72 hours after a woman experiences a contraceptive failure or unprotected sex. Legislation in New Hampshire, for instance, would require parental notification before the drug is dispensed, and more than 20 other states will consider bills that give pharmacies the right not to stock the drug and pharmacists the right not to dispense it, even to women with valid prescriptions.
"The FDA made this a major issue for state legislatures," said Sharon Camp, president of the Guttmacher Institute, a women's health research organization. "For the first seven years Plan B was on the market, this largely didn't happen."
"Basically, every state now has an effort going to either make Plan B more easily available or to slow it down or make sure that pharmacists don't have to dispense if they oppose it," said Edward R. Martin, a lawyer and lobbyist with Americans United for Life, who has helped put together some of the proposed "conscience" clauses.
The makers of the morning-after pill, known commercially as Plan B, asked the FDA for the right to sell the drug over the counter in April 2003, four years after it was first approved for use. The agency's staff and an advisory panel strongly favored the application, saying that unprotected sex often occurs when it is difficult to get a doctor's prescription. They said that easier and faster access to the drug would reduce the number of abortions.
But the FDA leadership first rejected and then deferred decision on the proposal. The agency has raised scientific and regulatory objections, but critics have pointed to the strong opposition from some social conservatives and antiabortion groups, who have lobbied the White House and Congress to make their position known. Plan B is officially listed as a contraceptive, and the medical community generally agrees that it stops a pregnancy from occurring rather than ending one. But many in the antiabortion movement disagree with that view and say that it amounts to a very early abortion.
The FDA's inaction on Plan B has been sharply criticized by most major medical societies and many in Congress, and led to a lawsuit by the Center for Reproductive Rights in New York. The federal magistrate judge hearing the case on Friday concluded that the center had established a "strong preliminary showing of 'bad faith or misbehavior' " on the part of FDA officials, and so ordered the case to go forward and ruled that top current and past FDA leaders should be interviewed under oath.
With the application in regulatory limbo, a growing number of states have passed bills that allow pharmacists working in conjunction with doctors to dispense Plan B to women who do not have a prescription -- with Maine, New Hampshire, Massachusetts, New Mexico and California acting most recently. The Massachusetts bill was passed last year over Republican Gov. Mitt Romney's veto.
"I think it's a tide that can't be stopped," said Vivion Maisenbacher, who directs 15 lobbyists for Barr Laboratories, the company that makes the drug. "I think we'll see a state or two each year joining the ranks, and will soon have a majority of women having access through pharmacies."
But Plan B usage is not determined by legislative and regulatory decisions alone. The company has found that extensive publicity about the drug has increased sales dramatically -- up more than 200 percent since the FDA first turned down the application for over-the-counter status in early 2004.
The effort to expand use of emergency contraception began well before Barr Labs made its applications to the FDA. As early as 1998, pharmacists conducting a study in Washington state began giving double doses of traditional contraceptives to women who had just engaged in unprotected sex and were worried about becoming pregnant.
Study leader Donald F. Downing, a University of Washington pharmacy professor, said the druggists found a "huge unmet need." Downing, often called the "grandfather" of the pharmacy access movement, helped establish a protocol in his state that allows pharmacists to give women emergency contraception, in the same way that pharmacists in some states can distribute emergency drugs for bee stings.
"What we've consistently found is that there's enormous interest among pharmacists in doing this, and there are thousands and thousands of women who need this service," he said. The FDA has not interfered in the practice because while it alone can decide which drugs need a prescription, states have the right to determine what constitutes a valid prescription.
Other Plan B advocates have also pushed to require hospital emergency rooms to stock and dispense emergency contraceptives to sexual assault victims -- a proposal opposed by Catholic hospitals -- and to require pharmacies that carry traditional contraceptives to carry emergency contraceptives as well.
While proponents are achieving some success in the more Democratic blue states, their efforts have not been as well received in Republican-leaning red states -- and Barr's lobbyist said the company spends little time pushing legislation in those more conservative states. The director of the Kentucky Right to Life Association said that a Plan B pharmacy access bill introduced this year is not expected to succeed.
"We're confident that our legislature will not approve the bill because we are strongly pro-life here," said Margie Montgomery. "Doctors tell us that Plan B can cause a very early abortion, and we oppose that."
Wendy Wright, president of Concerned Women for America, has testified against Plan B before the FDA and in numerous states because, she said, easier access jeopardizes women's health and welfare. Women need a prescription to buy birth control pills, she said, and it makes no sense for them to buy Plan B, a stronger version of the pill, without one.
While the Plan B debates in the states often involve traditional culture-war antagonists, they are not the only players. In Maryland, for instance, state Sen. Sharon M. Grosfeld (D) initially introduced a bill that would set up a collaboration between doctors and pharmacists that would allow the druggists to dispense Plan B without a prescription. That bill, however, ran into opposition from the state medical society as well as those opposed on religious grounds.
The bill Grosfeld then proposed would have the pharmacists work with the state Department of Health and Mental Hygiene, and would avoid the organized doctors that way. Her bill was narrowly defeated last year, and has been reintroduced this year.
The primary opposition to Plan B, however, has come from groups that contend that it can lead to very early abortions -- though experts say it acts in the same way as regular contraceptives. Efforts by antiabortion groups led to the passage last year of a Texas bill that eliminated the drug from a demonstration family-planning program, and to an Arkansas bill that kept emergency contraception off a list of protected contraceptives.
Jackie Payne of Planned Parenthood accused Plan B opponents in the states of mounting "an active attempt to blur the line and confuse people about emergency contraception -- saying it's abortion when it's not. Our job is to explain how emergency contraception avoids later abortions, and is in fact a win-win for everyone."