ABC's "Closer Look" at Plan B controversy aired conservatives' safety concerns, ignored FDA scientists' rejection of them

In a report on the "morning-after" pill, or Plan B, on the May 8 broadcast of ABC's World News Tonight, correspondent David Muir included a conservative group's claims that allowing sales of Plan B without a prescription would be unsafe -- but omitted the fact that staff scientists of the Food and Drug Administration (FDA), as well as its outside advisory panels, have recommended that the FDA approve allowing over-the-counter sales. Reporting on the American College of Obstetricians and Gynecologists' (ACOB) call for the FDA to approve such over-the-counter sales, Muir reported that "conservative groups say women, particularly young women, should not be giving themselves a high dose of birth control unsupervised." Muir then aired a clip of Wendy Wright, president of the conservative Concerned Women for America, saying: "In any circumstance in which a woman would be using this drug, she needs to have medical oversight." But while Muir's report offered no scientific support for Wright's concerns about safety, it also omitted any mention of the findings by the FDA's own scientific panels that, contrary to Wright's claim, offering Plan B without a prescription would be safe and effective.

By contrast, in an NBC Nightly News report on ACOG's campaign that also aired on May 8, NBC News chief science and health correspondent Robert Bazell noted the findings of the FDA's scientific panels:

BAZELL: Plan B is actually two pills. Taken within 72 hours of unprotected sex, it prevents pregnancy. But some people, mostly political conservatives, think it should not be readily available, especially to teenagers.

JOSEPH SCHEIDLER (national director, Pro-Life Action League): It's a morning-after-type thing, and so, they feel safe that they can -- they can be promiscuous and patch it up the next day.

BAZELL: Plan B is sold by prescription. The FDA's external and staff scientific advisers have said it should be sold over the counter but the agency is refusing to allow that.

While the FDA's Center for Drug Evaluation and Research (CDER) did issue, on May 6, 2004, a "Not Approvable letter" rejecting Barr Pharmaceuticals' application to allow Plan B to be sold without a prescription, that decision conflicted with the view of a majority of staff scientists and outside panels involved in the FDA approval process. According to the May 8, 2004, edition of the Los Angeles Times, then-acting CDER director Dr. Steven Galson "rejected his staff's recommendation for over-the-counter sales -- as well as an advisory panel's 23-4 vote favoring nonprescription availability -- out of concern that not enough was known about the possible effects of the pills on the sexual activity of young girls." A June 14, 2004, Washington Post article reported that, according to "internal agency documents," "top agency [FDA] scientists dismissed the reasoning that was used to justify the rejection as unfounded." The Post's report stated that the internal documents "contain the scientific conclusions of three separate levels of FDA reviewers" and "show that the scientists disagreed in particular with the contention that there was not enough information to assess how easier availability of the drug would affect the sexual behavior of young teenagers." The Post article further noted a key FDA official's critique of Galson's decision:

One top official wrote that by raising the issue of teenage use, former commissioner Mark B. McClellan and Center for Drug Evaluation and Research acting Director Steven K. Galson appeared to be introducing a different standard for evaluating Plan B than the FDA had applied to other contraceptives.

"The agency has not [previously] distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential, and I am not aware of any compelling scientific reason for such a distinction in this case," wrote John Jenkins, director of the FDA's Office of New Drugs, which oversees all drug reviews for the agency.

A November 14, 2005, Government Accountability Office (GAO) report -- as summarized by a November 15, 2005, article in the Los Angeles Times -- found that "[f]ederal drug regulators compromised their usual science-based decision-making process when they ruled in 2004 against letting the 'morning-after' birth control pill be sold without a prescription." From the GAO report:

Fourth, the rationale for the Acting Director of CDER's [Galson] decision was novel and did not follow FDA's traditional practices. Specifically, the Acting Director was concerned about the potential impact that the OTC marketing of Plan B would have on the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity compared to older adolescents. He also stated that it was invalid to extrapolate data from older to younger adolescents in this case. FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency has considered it scientifically appropriate to extrapolate data from older to younger adolescents.

[...]

There are no age-related marketing restrictions for safety reasons for any of the prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. All FDA-approved OTC contraceptives are available to anyone, and all FDA-approved prescription contraceptives are available to anyone with a prescription. For hormonal contraceptives, FDA assumes that suppression of ovulation would be the same for any female after menarche,13 regardless of age. FDA did not identify any issues that would require age-related restrictions in its review of the original application for prescription Plan B, and prescription Plan B is available to women of any age.

From the May 8 broadcast of ABC's World News Tonight:

ELIZABETH VARGAS (co-anchor): We're going to take "A Closer Look," tonight, at a controversial form of contraception: the morning-after pill. Today, the nation's largest group of gynecologists and obstetricians launched a major campaign to get women to fill a prescription for a drug that prevents a fertilized egg from implanting in the womb. They hope that that would reduce some of the unintended three million pregnancies in the U.S. each year, but as ABC's David Muir reports, the doctor's campaign has some powerful opponents.

MUIR: Tired of what it considers a federal roadblock to the morning-after pill, the nation's largest group of obstetricians and gynecologists is now telling women to get a prescription for it ahead of time to have it in their medicine cabinet before they actually need it.

DR. SUSAN F. WOOD (Former FDA assistant commissioner for women's health): When women need emergency contraception, they need it now. They don't need it tomorrow or two or three days from now, they need it when they need it.

MUIR: Dr. Susan Wood left her post with the Food and Drug Administration in protest after the Bush administration failed to make the pill available over the counter.

WOOD: It is not RU-486, which is an abortion pill. It acts just like regular birth control pills.

MUIR: And doctors say the pill has no effect if the woman is already pregnant. But conservative groups say women, particularly young women, should not be giving themselves a high dose of birth control unsupervised.

WRIGHT: In any circumstance in which a woman would be using this drug, she needs to have medical oversight, especially in the case of rape.

MUIR: Not only is Wright against the campaign, women across the political spectrum have found the message questionable.

Today, the American college of obstetricians and gynecologists said it's giving some 49,000 doctors copies of this poster. They're asking them to hang it in their waiting rooms. It reads: "Accidents Happen. Morning afters can be tough" -- with a picture of spilled coffee on a daily planner.

WRIGHT: It's very in-your-face. And it's meant to be a political statement and using the doctor's office to convey that political statement.

MUIR: Political, perhaps. But proponents say, necessary, because the morning-after pill, or Plan B, as it is also called, cuts the chances of pregnancy by up to 89 percent if used within 72 hours. Twenty-eight-year-old [local resident] says as a young woman, she already considered getting a prescription for the morning-after-pill, before ever needing it. But finds the poster flip.

LOCAL RESIDENT: I think "accidents happen" makes light of it. Yeah.

WOOD: It may be flip but that's not offensive to me.

MUIR: And Dr. Wood is simply hoping that this kind of debate will find its way to the doctor's office. David Muir, ABC News, New York.

VARGAS: Our "Closer Look" for today.