News Articles

LIFE DIGEST: FDA delays decision on ‘morning-after’ pill

WASHINGTON (BP)–The latest delay by the U.S. Food and Drug Administration on over-the-counter (OTC) sale of a “morning-after” pill appears to be either an act of keeping faith with the American public or just bad faith.

At least some pro-life organizations hailed the FDA’s Aug. 26 announcement postponing action on non-prescription sale of what they consider an abortifacient as a sensitive response to the reservations of Americans. Meanwhile, some pro-choice senators and organizations attacked the decision as a broken promise to Congress and the American public.

The FDA informed Barr Pharmaceuticals Inc. it had decided to delay action on the firm’s application to sell the “emergency contraceptive” Plan B without a prescription. The FDA’s Center for Drug Evaluation and Research had decided current scientific evidence supports the distribution of Plan B over the counter for women 17 years of age and older, the agency’s commissioner, Lester Crawford, announced. The agency, however, will seek public comment for 60 days on OTC sale of the drug for this age group and prescription sale for females 16 and under, Crawford said.

But only six weeks before Crawford’s announcement, it appeared the FDA had set a Sept. 1 deadline for deciding whether it would permit over-the-counter sale of Plan B. Michael Leavitt, secretary of the Department of Health and Human Services, said in a letter to U.S. senators the agency should have a decision by that date. After Leavitt’s disclosure, Democratic Sens. Hillary Clinton of New York and Patty Murray of Washington announced they would release their hold on Crawford’s nomination as FDA commissioner. The Senate subsequently confirmed Crawford.

Plan B works by restricting ovulation in a woman. Supporters argue it will prevent unplanned pregnancies and abortions. Foes of “emergency contraception” say the method also can work after conception, blocking implantation of a tiny embryo in the uterine wall. In such a case, an abortion occurs, pro-lifers point out.

Clinton and Murray reacted to Crawford’s announcement by charging Leavitt and the FDA with breaking their promise to Congress and Americans after more than two years of delays.

“It is a breach of faith to have this administration give their word that a decision would be made and have that promise violated,” Clinton and Murray said in a joint, written statement. “A delay is not a decision. For six months we have asked for a simple answer –- yes or no.

“Today’s move serves only to increase questions about FDA’s status as an independent agency,” the senators said. “The FDA has shirked its duty to serve as an independent agency beholden to no other goal than the promotion of sound science and the well-being of the American people.”

Crawford, however, said there were “unresolved regulatory and policy issues” that need to be addressed, especially regarding concurrent OTC and prescription use for the same purpose and in the same package. “We are beginning a process that will address the regulatory questions today, but we believe we can only decide these issues in an open, public process,” Crawford said.

Barr Chairman Bruce Downey said in a written statement, “While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B” as an over-the-counter product.

The FDA rejected a request from Barr in May 2004 for OTC sales, citing a lack of evidence about the pill’s effect on girls 16 and younger. It gave the company an option of reapplying for OTC sales for females 16 and older and prescription sales for girls 15 and younger. Barr resubmitted its request under those guidelines.

The American Association of Pro-life Obstetricians and Gynecologists called over-the-counter sale of Plan B “bad medicine for women.” The lack of medical care for women purchasing the pill OTC would also be problematic, resulting potentially in untreated sexually transmitted diseases and undiagnosed conditions, such as infertility and ectopic pregnancies, the AAPLOG said in a written statement. “And certainly 17 year olds would procure it for 13 year olds, so the OTC age limit, in practice, is unworkable,” the AAPLOG said.

Care Net President Kurt Ensminger commended the FDA for “listening to the safety concerns” about Plan B. “The staff and volunteers at the more than 2,000 pregnancy resource centers across this nation are especially thankful,” he said in a written statement. “From what history and research tell us, the ‘morning-after pill’ approach will only increase the traffic of hurting people coming through the doors of pregnancy centers looking for help.” Care Net supports 850 crisis pregnancy centers.

Kim Gandy, president of the National Organization for Women, an abortion rights group, criticized the FDA, saying it had made “another in a long line of decisions that make women’s health secondary to right-wing politics. This administration is determined to turn the FDA into an arm of the Republican Party –- carrying out the fondest desires of Bush allies who oppose women’s use of contraception.”

The “morning-after” pill is basically a heavier dose of birth control pills. Under the regimen, a woman takes two pills within 72 hours of sexual intercourse and another dose 12 hours later. In addition to Plan B, the FDA has approved prescription use of another “morning-after” pill, Preven.

Citizens may comment on the Plan B application by clicking on “FDA Takes Action on Plan B” under FDA News at www.fda.gov. They may link to the comment form at the end of the news release.

ABORTION V. BIRTH -– Russia has more abortions than live births each year, the country’s leading obstetrician says.

According to Moscow News, Bloomberg.com reported 1.6 million women had abortions in 2004, while 1.5 million gave birth, said Vladimir Kulakov, vice president of the Russian Academy of Medical Sciences. He said “many more” abortions went unreported.

The reason for the inordinate number of abortions vs. births is economic, Kulakov said.

“The appearance of a first child pushes many families into poverty,” he told the state’s official newspaper, Rossiskaya Gazeta, according to Moscow News. “Potential parents first try to start a career, stand on their feet and so forth.”

The margin of abortions over births is better than it once was, however.

In 1990, shortly before the fall of communism, the World Health Organization reported there were 1,971 abortions per 1,000 live births, the International Herald Tribune reported in 2001. In 2000, there 1,696 abortions for every 1,000 live births, according to the newspaper.

KANSAS A.G. SUES GOV –- Kansas Attorney General Phill Kline has challenged abortion again, this time filing suit against the state’s governor to block government funds for the procedure.

Kline is abiding by the Kansas House of Representatives’ direction, a spokesman for the attorney general said. In 2002, the Kansas House passed a measure instructing the attorney general to gain a court opinion on whether the state can fund abortions, according to the Lawrence Journal-World.

Gov. Kathleen Sebelius’ office said she is required to abide by a federal law that permits Medicaid funds for abortions in the cases of rape, incest or a threat to the life of the mother, the Journal-World reported.

Earlier this year, Kline launched an effort to gain abortion clinic records on 90 women who asked for abortions at least 22 weeks into their pregnancies.

Sebelius is a Democrat, Kline a Republican.