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State contraception plan imperiled

US eyes restriction on morning-after pill

Federal drug regulators may blunt the impact of a state plan that would allow women of all ages to get the morning-after pill without a doctor's prescription by restricting over-the-counter sales to those who are at least 17.

The US Food and Drug Administration has delayed a final decision on whether to allow over-the-counter sales of emergency contraception, saying it needs more time to figure out how stores can enforce an age restriction. The agency is concerned that younger teenagers require more guidance to use the pill properly.

State lawmakers and advocates on both sides of the controversial issue said a federal age restriction might trump the Massachusetts measure, which the Legislature approved overwhelmingly in July. Governor Mitt Romney vetoed the bill, but legislators are expected to override him this month.

''Generally, federal law takes precedence over state law," said Representative Douglas W. Petersen, a Marblehead Democrat who helped shepherd the bill through the House. ''I don't know whether we could [have a state law] without an age restriction or not."

Some Massachusetts abortion-rights advocates, who pushed hard for the state measure, worry that a federal age limit would give Romney the opportunity to make the state's law more restrictive. The Department of Public Health, which is under the governor's purview, is responsible for implementing it.

Sally Fogerty, the associate commissioner of the state agency, said that ''we have to go by what FDA guidelines are for dispending medication." She added, however, that the FDA's rules are not always specific.

''It may depend completely upon how they write it, and what the restrictions are," Fogerty said.

Romney spokeswoman Julie Teer said that after the FDA makes a decision, Romney ''will review any implications it may have for the citizens of Massachusetts."

Some bill supporters also worry that an FDA age restriction would make Massachusetts pharmacists wary of providing the pill to younger teens, because it could leave pharmacists vulnerable to lawsuits.

Others say it is possible that the proposed federal rules would mesh with the Massachusetts law in a way that makes emergency contraception more accessible here. Under the state law, only pharmacists who have entered into a special arrangement with a physician can dispense the pill without a prescription. But the FDA is considering allowing over-the-counter sales, meaning the pill would be stocked on store shelves, like aspirin or cough syrup.

Carmelo Cinqueonce, executive vice president of the Massachusetts Pharmacists Association, predicted that Bay State girls younger than 17 would be barred from purchasing the pill off store shelves, but that the FDA would allow them to get it under the arrangement envisioned in the state measure.

''I would assume the federal guidelines would take precedence over the state's," Cinqueonce said. ''However, there would still probably be an opportunity for pharmacists to enter into an agreement with physicians if they wanted to provide that to other patients under the age of 17."

The emergency contraception pill, also called Plan B, is a high dose of hormones that women can take to prevent pregnancy up to five days after sex. The pill is not to be confused with RU-486, which is used to end pregnancies up to 49 days after the beginning of the last menstrual cycle.

The FDA approved the use of Plan B as a form of prescription birth control in 1999. But the agency has refused to grant a request by the pill's manufacturer, Barr Laboratories, to sell it over the counter, despite the overwhelming vote of an advisory panel in 2003 recommending the move. Last month, the agency indicated it needs more time to figure out how to enforce an age restriction.

Dr. John K. Jenkins, director of the FDA's Office of New Drugs, was a dissenting voice at the agency. Jenkins noted in an April 2004 memo that ''senior officials" at the FDA ''expressed concerns about the potential for unsafe, ineffective, or inappropriate use of Plan B by adolescents if it were to be made available without a prescription." Jenkins acknowledged in the memo that letting young teens buy Plan B over the counter ''may be controversial from a societal perspective," but he added that, ''I cannot think of any age group where the benefit of preventing unplanned pregnancies and abortion is more important and more compelling."

Susan F. Wood, director of the FDA's Office of Women's Health, resigned last week to protest the agency's refusal to allow over-the-counter sales. And in the absence of federal action, seven states have allowed pharmacists to dispense the pill without a prescription.

According to the FDA, the pill mostly works by stopping the release of an egg from the ovary. But it also may block fertilization or prevent a fertilized egg from attaching to the womb. For those who believe life begins at conception, the latter amounts to abortion.

Supporters of the Massachusetts bill say the governor broke his word by vetoing it. On a questionnaire that abortion rights groups gave to the gubernatorial candidates in 2002, Romney answered ''yes" to the question, ''Will you support efforts to increase access to emergency contraception?" Critics accused the governor of changing his stance to burnish his conservative credentials for a possible presidential run.

But Romney, who describes himself as ''prolife," said he had to veto the bill to fulfill a campaign promise not to change the state's abortion laws. Because the Massachusetts bill does not have an age restriction and Plan B sometimes causes an abortion, Romney argues, the measure would undermine the state's parental consent laws.

The bill ''represents a departure from the public consensus that minor children should not act without parental involvement in these matters," he wrote.

Scott Greenberger can be reached at greenberger@globe.com.

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