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Aug. 25--A three-year effort to allow the Plan B emergency contraceptive to be sold without a prescription ended in a compromise Thursday when federal regulators approved over-the-counter sales to women 18 and older.
But the politically charged debate goes on.
Woodcliff Lake-based Barr Pharmaceuticals Inc. had been seeking approval to sell Plan B without a prescription to women 16 and older. The contraceptive, which will be available over the counter by the end of the year, can reduce the risk of pregnancy by nearly 90 percent if taken within 72 hours of unprotected sexual intercourse.
Those 17 and under will still need a prescription.
As the Food and Drug Administration delayed its decision, the agency found itself in the middle of a political and social argument that pitted social conservatives against women's reproductive rights activists.
That debate showed no signs of subsiding Thursday. Some Plan B supporters said the decision didn't go far enough, while critics continued to warn that over-the-counter access will promote promiscuity among teenagers and increase the risk of sexually transmitted diseases.
Local pharmacists appeared ready and willing to comply with the decision, notwithstanding their personal politics and religious convictions.
"If this is the career path you've taken, you have an obligation to provide the proper medication to patients," said Nadya Forgacz, a pharmacist at Gallo's Drug Store in Rochelle Park.
Earlier this year, the New Jersey Senate passed a bill that would require pharmacists to fill prescriptions, even if they objected on moral, philosophical or religious grounds. A similar bill in the state Assembly health committee extends this to medications in general.
"Even with this FDA ruling [on the morning-after pill], we still need this bill," state Sen. Loretta Weinberg, D-Teaneck, a co-sponsor of the Senate bill, said Thursday.
Barr has agreed to track whether pharmacists are enforcing the age restriction, if necessary, by sending decoy buyers into stores to purchase Plan B.
Stores not in compliance will be reported to the FDA. Males 18 and over can also purchase the over-the-counter version of the drug.
Pharmacists, who will be charged with verifying proof of age, seemed undaunted by the additional responsibilities.
Lynee DeCandia, owner of Richard's Pharmacy in Palisades Park, noted that druggists already seek proof of age on sales of anti-smoking treatments that contain nicotine, as well as for types of decongestants that can be used to make illegal stimulants.
"We're getting used to this sort of thing. That's the way it is now," she said.
Barr CEO Bruce L. Downey said in an interview on CNBC that he remains optimistic the age restriction will one day be eliminated. In a statement, Downey said, "While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the counter product. ... We will also continue our efforts with the FDA to reduce the age restriction on the OTC use of Plan B."
Proponents of the morning-after pill hailed its wider availability.
"I think it's a positive step for women's health care and well-being.
"It allows women to be in control of their own bodies," said Dr. Ruth J. Schulze, a gynecologist in Ridgewood and a former president of the Medical Society of Bergen County.
Women should still consult with their doctor about the potent pill, which contains a concentrated amount of the hormone progesterone and is intended for limited use, she said.
"This is meant obviously for emergency situations, not as a method of birth control," she said.
Schulze, who stressed she was voicing her own opinions as a doctor and a mother, said she does not think the morning-after pill will greatly influence adolescent sexual behavior.
"The issues of teenage sexuality are much more complex and multifaceted than whether Plan B is available," she said. "We should tackle that with ongoing education."
Other advocates said wider access to Plan B was long overdue.
"For almost three years, the Bush administration has attempted to bureaucratically derail this decision," said Jeffrey Bland of Planned Parenthood of Greater Northern New Jersey in Morristown.
"We finally have science overriding ideology."
Opponents criticized the FDA's action as immoral and potentially detrimental to women's health.
"This decision is unprecedented and irresponsible," said Marie Tasy, director of New Jersey Right to Life.
Medical information about the morning-after pill includes its ability to prevent fertilization and act as an abortive agent, "but, of course, it's not going to say [abortion] of a newly conceived human being," Tasy said in a phone interview.
Making Plan B available without prescription also allows women to unwisely forgo consultation with a physician, Tasy said.
"There are some people who should not be taking it," she said. These include women who are at high risk of blood clots, or who smoke after a certain age, and are not supposed to take birth control pills, she said.
Easier access to the morning-after pill could also increase promiscuity and the risk of sexually transmitted disease among young people, Tasy said.
Some reproductive rights activists also criticized the FDA ruling, calling it a politically motivated compromise that will restrict access to the pill to those who are most likely to need it -- young women.
With its ruling, the FDA "has not only acted unlawfully, but chosen to abandon young women --the most vulnerable population --and left them to jump through hoops to get access to emergency contraception," Nancy Northup, president of the Center for Reproductive Rights, said in a statement. The advocacy group sued the FDA to force action on Plan B.
The giant retailer Wal-Mart, which had refused to stock the pills in its 4,000 U.S. pharmacies until last March, issued a statement Thursday that read, "We are awaiting details of what was approved and specifically how the product can be sold. Once we have those details, we will consider carrying the product for OTC sale."
Wal-Mart has said it does not require employees who oppose Plan B's use to distribute it, but requires them to refer customers to another employee.
By Dunstan Prial and Bob Groves
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