- The Washington Times - Friday, August 25, 2006

The manufacturer of the “morning-after” pill, along with some women’s groups, Democratic lawmakers and medical organizations say the government’s decision to allow over-the-counter sales of the drug to those 18 and older is only a partial victory and that they will push for unrestricted access for younger girls as well.

The 60,000-member American Academy of Pediatrics (AAP) called the Food and Drug Administration’s (FDA) ruling Thursday allowing adults to buy the pill, called Plan B, without a prescription “an important first step” that “only goes halfway.”

“Emergency contraception will remain out of reach for sexually active teens 17 and younger because they will still be required to obtain a prescription for the medication,” AAP said.

Plan B lowers the risk of pregnancy by 89 percent if taken within 72 hours of unprotected sexual intercourse.

And Bruce L. Downey, chairman and chief executive officer of pill manufacturer Barr Pharmaceuticals Inc. said the company “still feels that Plan B should be available to a broader age group without a prescription.”

“We will continue our efforts with the FDA to reduce the age restriction on the [over-the-counter] use of Plan B,” Mr. Downey said.

The FDA’s decision came after a three-year fight between advocates of the drug, who say its wider availability is necessary to reduce unwanted pregnancies among teenagers, and social conservatives, who contend that easier access to Plan B will increase sexual promiscuity, especially among teens, who will have a false sense of security if they have unprotected sex.

Some pro-life groups, including the Traditional Values Coalition, insist that Plan B is an abortifacient.

“Privatizing abortions, as this decision does, thwarts all the good work that has been done to require parental consent” for teen abortions, said Andrea Lafferty, the group’s executive director. She called the FDA decision “medically unsound and politically schizophrenic.”

Opponents also say the decision is a “dream come true” for sexual predators. They foresee adult males, who can show a pharmacist proof of their age, buying the drug and giving it to young girls with whom they are having sex in order to cover up their criminal activity.

Those on both sides of the Plan B debate are planning legal or legislative action in a bid to either expand the pill’s availability without a prescription or to strike down the FDA’s so-called “dual-status sales” policy.

One of the harshest statements about the FDA ruling from Plan B supporters came from the New York-based Center for Reproductive Rights.

“The FDA essentially denied true [over-the-counter] access by limiting its availability to women 18 and over and placing it behind the pharmacy counters,” said Nancy Northrup, the organization’s president.

Last year, the center filed a lawsuit to do away with all age restrictions for over-the-counter purchases of Plan B, and Ms. Northrup said the lawsuit will continue.

Cecile Richards, president of the Planned Parenthood Federation of America, said her group also is “troubled by the scientifically baseless restriction imposed on teenagers,” given the country’s high teen-pregnancy rate. “Making it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy,” she said.

The FDA said Barr Pharmaceuticals showed that Plan B is safe and effective when used by women 18 and older, but data on whether the pill is safe in 17-year-olds who are not under doctor’s supervision is not definitive. FDA officials said their decision to restrict over-the-counter sales to those 18 and older was largely a “practical” one based on the fact that 18 is commonly associated with maturity.

A number of Democratic women in Congress, including Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington and Reps. Carolyn B. Maloney and Louise M. Slaughter of New York, have said the FDA needs to re-examine the age restrictions.

“Politics is driving this issue,” said Mrs. Maloney, who added that she plans to further her legislative efforts “to reduce the arbitrary age restrictions on the [over-the-counter] use of Plan B.”

Tony Perkins, president of the Family Research Council (FRC), said his group could battle the FDA either in court or in Congress.

FRC hopes to convince Republican leaders on Capitol Hill that the FDA “overstepped its powers and encroached on the authority of Congress” by approving this “dual-status” sales system for Plan B without hearings or “normal rule-making procedures,” Mr. Perkins said.

Both legal and moral concerns about the new Plan B policy are likely to be raised during the upcoming Senate confirmation vote for Dr. Andrew von Eschenbach as FDA commissioner. Mrs. Clinton and Mrs. Murray said after Thursday’s decision that they will drop their months-old block on his nomination.



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