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As FDA delays ruling, legal and legislative action is piling up

The "morning-after pill" has triggered a series of lawsuits and legislative acts in the last year, with pharmacists, employers and legislators clashing over how the controversial pill that prevents pregnancy within hours of intercourse should be dispensed.

And lawyers claim that as long as the U.S. Food and Drug Administration continues to stall making a decision on whether to allow the pill to be sold without a prescription, lawsuits and proposed state laws will continue to emerge.

"I think there will be, for a while, ongoing litigation sort of pecking away at various sides of this issue," said Simon Heller, staff attorney at the Center for Reproductive Rights, who is suing the FDA for failing to make the morning-after pill available without a prescription.

In the last 18 months, the FDA has twice held off granting over-the-counter status for the pill, most recently delaying action by citing concerns about minors using the drug. Lawyers maintain the FDA is stalling and thereby upping the stakes in an already contentious debate about emergency contraception.

In Illinois, seven pharmacists and a handful of pharmacies are challenging a new state regulation that requires all pharmacies that stock oral contraceptives to also sell the morning-after pill. Menges v. Blagojevich, No. 3:05-CV-03307 (C.D. Ill.)

In New York, nine individuals and two women's groups are suing the FDA for failing to make the pill available over the counter. Tummino v. VonEschenbach, No. 1:05-CV-366 (E.D.N.Y.).

And on the legislative front, eight states -- the most recent one being Massachusetts -- have passed laws that allow patients to get the drug without visiting a doctor. On the flip side, Arkansas, Georgia, Mississippi and South Dakota passed laws that give pharmacists the right to refuse to dispense emergency contraception on moral grounds.

"We've got a lot of different areas of the law coming together around a cultural issue," said attorney Valerie Munson, who chairs Pittsburgh-based Eckert Seamans Cherin & Mellott's religion and law practice group from its Philadelphia office.

Munson noted that while an FDA ruling would clear up some problems for pharmacists, it wouldn't be a cure-all. If over-the-counter status is granted, anti-abortion activists will still object. If it's denied, pro-abortion-rights activists will object. "This issue isn't going to go away because the abortion issue isn't going to go away. It's all the same ball of wax," Munson said.

FDA spokeswoman Susan Cruzan would not comment on the lawsuits targeting the FDA, nor on whether the FDA is stalling on a decision involving the morning-after pill. "The FDA has reviewed the issue. We have received 10,000 [public] comments, which are now under review," Cruzan said.

Meanwhile, attorney Frank Manion, who is representing seven Illinois pharmacists in a morning-after pill lawsuit, maintained that the debate is not about abortion. It's about preserving a person's right -- in this case a pharmacist's -- to exercise his or her religious and moral beliefs without fear of discrimination.

"Our clients are not trying to have this stuff taken off the market. They're just saying, 'We have a right to choose. Just keep us out of it,' " said Manion, senior counsel for the American Center for Law & Justice in New Hope, Ky.

On Dec. 19, Manion filed a lawsuit challenging a new Illinois regulation that requires pharmacies that stock oral contraceptives to also offer the morning-after pill. He said that the rule led to the firing of five pharmacists who refused to sign a policy with Walgreens that mandates all employees will dispense the pill.

Manion claims that the new rule, which went into effect in August and was ordered by Illinois Gov. Ron Blagojevich, is unconstitutional and violates a state Right of Conscience Act, which bans the discrimination against health care workers who refuse to participate in a health care service on moral or religious grounds.

But Abby Ottenhoff, spokeswoman for Blagojevich, said that the conscience act does not apply to pharmacists. Moreover, she argued, the new rule is directed at pharmacies, not pharmacists.

"Pharmacies don't have a right to get to choose which FDA-approved contraceptives should or should not be dispensed," Ottenhoff said.