Three and a half years after the original application to make the morning-after birth control pill available without a prescription, the FDA continues to stall.

Emergency Contraception known as Plan B is displayed at Planned Parenthood in Springfield, Ill.  Credit: AP Photo/Seth Perlman

Last week, those who mustered the intestinal fortitude to watch ABC’s “The View” were treated to token conservative co-host Elisabeth Hasselbeck’s melt-down over the possibility that an emergency contraceptive might be made available over the counter in the US. “To me it is the same as birthing a baby and leaving it on the street,” she blathered.

The screed of the former 3rd runner up on “Survivor: Australia” is a bellwether of how misinformed the public is on this issue and how the politicization of the FDA has permeated our culture.

What set Hasselbeck off was an announcement that the FDA planned to approve over the counter sales of the emergency contraceptive Plan B, if the manufacturer, Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, altered its application to limit the drug’s availability to women 18 years and older. The agency also made the unprecedented move of requiring Duramed to come up with a plan to police pharmacies, assuring “they comply with the restricted distribution plan.”

What made the announcement even more bizarre was that it came one day before the Senate confirmation hearing for Acting Commissioner Andrew von Eschenbach. 

Plan B is a higher-than-normal dose of the synthetic hormone progestin, which has been safely prescribed as a birth control pill for more than 35 years. The drug functions mainly by preventing ovulation and does not induce abortion—the abortion pill is a completely unrelated drug, RU-486. Further, there is no scientific evidence that Plan B can cause abortions, or that it can prevent the implantation of an embryo in a woman’s uterus. Also, Plan B is available over the counter in 45 other countries.

The American Medical Association recommended that emergency contraceptive medication be made available over the counter in 2000.

Religious conservatives have vigorously opposed Plan B on several grounds. One argument is that access to emergency contraception would result in irresponsible behavior in young women. But, a 2005 study published in the Journal of the American Medical Association clearly showed that access to emergency contraception does not change young womens’ sexual behavior. A second objection, this one voiced by von Eschenbach himself, is that there is insufficient data on the safety of the pill when used by teens—hence the decision to limit access to women 18 years or older. However, there are no reports of serious adverse side effects from Plan B in any age group in the 45 countries where it is legal. 

Another argument against Plan B is that there is no evidence that it does not occasionally cause abortion or prevent implantation of embryos. This is actually true, but such studies are not possible since we do not experiment on pregnant women. There is however data that shows that it is ineffective in women who have already ovulated before taking the pill. Ignoring the scientific evidence, one opponent even argued that a statutory rapist could use Plan B to “cover up his abuse.” 

In December 2003, an FDA advisory committee recommended the approval of the application for over the counter status for Plan B by a vote of 23 to 4. One of the opposing members, David Hager, a Bush appointee and practicing, pro-life OB/GYN, was asked by senior FDA brass officials to write a minority report expressing his dissenting opinion. This was an unprecedented move, and neither Hager nor the FDA will say who requested the report.

In his report, Hager argued that there was insufficient data to be certain that Plan B was safe for teens. He also said that there was no information on what cognitive effects the pill would have on young women. He also noted that there was no data to prove that Plan B does not cause abortions. Hager later gave a speech at the evangelical Asbury College in Kentucky, claiming he “argued [against Plan B] from a scientific perspective. And God took that information, and he used it through his minority report to influence a decision.” Soon after his speech his former wife of 35 years accused him of forcibly sodomizing her on a regular basis during their marriage.

In the entire history of the FDA, Plan B was the first over the counter application to be rejected after the advisory committee recommended approval. The unusual treatment of its application caused the now-infamous resignation of the FDA Director of Women’s Health, Susan Wood, following another tabling of a decision on the drug in 2005. 

FDA Acting Commissioner Andrew C. von Eschenbach, M.D.  Credit: FDA

Last November, the Government Accountability Office released the results of its investigation of the non-decision on Plan B. The report showed the FDA’s process for Plan B was different from all 67 other prescription to over-the-counter decisions made between 1994 and 2004, especially with respect to its consideration of the cognitive development of adolescents who might take the drug. They also found that the directors that reviewed the application had refused to sign the letter declaring that Plan B was not approvable, and that the FDA’s high level management was more involved in its review than that of any other over the counter application. And the GAO report included—but could not confirm—reports that the decision to reject the application was made before the scientific review began. 

The blatantly political decision to announce renewed discussions with Duramed on the day before Dr. von Eschenbach’s confirmation hearing caused Sen. Patty Murray (D-WA) and Sen. Hillary Clinton (D-NY) to issue a statement reading, “[The] administration is continuing to play a game of smoke and mirrors the day before Dr. von Eschenbach’s Senate confirmation hearing. Today’s announcement is nothing more than another delay tactic.” 

Sen. Tom Harkin (D-IA) expressed his dismay directly to von Eschenbach at the August 1 hearing stating, “I think we all know what is going on here. It is a disregard of science for ideological concerns.” He also expressed his dismay at the very idea that taking two pills 12 hours apart would be too burdensome for 16 and 17 year old women, noting the implication is that “our young women are stupider than the girls in these countries, that they are more illiterate, that they can’t even read a label. But the young woman in Togo can?”

Senator Murray then noted that von Eschenbach’s predecessor, Lester Crawford, had sent her a letter a year ago stating that it was safe to allow over the counter access to Plan B for 17 year old women. (Crawford resigned from the FDA two months after a contentious Senate confirmation. In April, a grand jury began investigating Crawford amidst accusations of financial improprieties and alleged false statements to Congress.) 

Listening to von Eschenbach’s testimony, you wouldn’t believe that there were any problems at the FDA. He flatly denied that there was any connection between the announcement and his confirmation hearing and added that “our every single action, decision or activity must be directed to preserving their lives and protecting their health.” 

Two days after the confirmation hearing, the Center for Reproductive Rights released transcripts of depositions from its lawsuit against the FDA for its Plan B review process. FDA scientist Florence Houn testified in July that Janet Woodcock, then-acting deputy commissioner of the FDA, told her the agency needed to satisfy the “administration’s constituents” by “rejecting over-the-counter status for women of all ages, and then approving it down the road with an age restriction.” Woodcock testified earlier that she was “not aware of any political pressure.” The group is now subpoenaing e-mails between the FDA and the White House.

There is another issue with arbitrarily setting an age restriction on access to Plan B: It is probably unconstitutional. In 1977, the Supreme Court found in Carey v. Population Services International that a New York State law banning the sale of nonprescription contraceptives by persons other than licensed pharmacists, banning the sale or distribution of contraceptives to minors under 16 and banning contraceptive display and advertising “clearly burdens the right of such individuals to use contraceptives if they so desire, and the provision serves no compelling state interests.” 

This means that if the FDA has its way, a lawsuit will probably follow.

It is unlikely that von Eschenbach will receive a Senate confirmation during this session of Congress, but there is another option: He can accept a recess appointment by President Bush later this month. After all, in the last five and a half years, there has only been a confirmed FDA Commissioner for a total of 18 months. 

But a recess appointment won’t clear up the fallout from Plan B.

Michael Stebbins is the Author of Sex Drugs & DNA: Sciences Taboos Confronted and the Director of Biology Policy at the Federation of American Scientists.

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Originally published August 9, 2006


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