Rewriting Science Fiction: Politics Out of Plan B


Editor’s note: The United States District Court ruled yesterday that the FDA acted improperly and unreasonably in its failure to issue a timely decision, back in 2006, on allowing emergency contraception ("Plan B") to be available without a prescription. The court decision also ordered the FDA to make emergency contraception available to women 17 years old and older within 30 days, as well as to reconsider the availability of emergency contraception to all women. 

Science was glaringly absent the past eight years in policies created
by the Bush administration’s federal agencies, such as the
Environmental Protection Agency and the Department of Health and Human
Services. Increased emissions of the most significant forms of air
pollution were touted as "clear skies." The birth control pill was
defined as abortion, and receptionists in health-care facilities were
empowered to turn women away for reproductive medical treatment simply
because they disapproved.

With President Obama in office, we are seeing welcome change. He
proposed to repeal Bush’s eleventh-hour HHS regulation which gives
health care workers personal views over medical care. In a recent
directive, President Obama declared that politics would no longer play
a role in U.S. science policy, stating "we make scientific decisions
based on facts, not ideology." And he nominated former New York health
commissioner Margaret Hamburg as the head of the Food and Drug
Administration. Dr. Hamburg has rejected the idea of having abstinence
be the main focus of HIV education, saying that "only the best medical
and scientific information" should dictate the curriculum not "moral
judgment."

A fitting next step for the new administration in reversing Bush
policies based in fictional science would be for the FDA, under Dr.
Hamburg’s leadership, to take a fresh look at the agency’s restrictive
over-the-counter policy on the emergency contraceptive Plan B to ensure
that the policy is based on medical evidence, not ideology.

The journey of Plan B’s 2003 application for over-the-counter
status–mired in years of inexplicable delay, unprecedented White House
involvement, and decisions that run contrary to the agency’s own
scientific experts–reads like a story of intrigue and conspiracy. The
plotline would make for compelling entertainment if the stakes weren’t
the health and lives of women throughout the U.S. The Bush
administration’s complete disregard of objective scientific evidence
played a starring role, with FDA leadership stacking a reproductive
health advisory committee with "operatives" and radically departing
from typical agency practice. The story ends with unfounded age
restrictions for Plan B–the first time age has ever been used to
restrict a non-prescription drug.

Access to Plan B is critically important for women who want to avoid
pregnancy. But it’s most effective the sooner it’s taken–within 72
hours after sex it reduces the risk of pregnancy by 89%, and the odds
are even greater when it’s used in the first 24. The FDA has deemed the
contraceptive safe and effective, but it’s not always readily available
despite its recognized value and the importance of timely access.

Since 2003, Plan B’s manufacturers have tried to make the drug
available without a prescription for women of every age, only to be
repeatedly rebuffed by the FDA for no scientific reason. In 2005, the
Center for Reproductive Rights, on behalf of women’s health
organizations and individuals, filed a federal lawsuit arguing that the
FDA was not only ignoring the science in its foot-dragging on Plan B,
but also violating the law. The government tried to get the case
dismissed a number of times, but the judge overseeing the case refused,
even remarking that the inertia on Plan B smacked of "an administrative
filibuster."

Finally in 2006, the FDA announced that it would approve the
distribution of Plan B without a prescription, but only for women 18 or
older and only behind pharmacy counters. It didn’t matter that the
medical evidence overwhelmingly supported over-the-counter use for
every age, or for that matter, that overwhelming scientific opinion
within the FDA recommended as much. As one agency scientist puzzled,
the FDA never "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."

In the meantime, months of testimony in the federal case uncovered a
web of deceit behind-the-scenes–replete with high-level FDA officials
kowtowing to outside political influence, circumventing agency
regulations, and ultimately, conspiring to grant only limited access to
Plan B. Court testimony revealed that one official confessed to his
coworker that he had to reject the Plan B application for fear of
losing his job. Another told a colleague that the plan was for the
agency to postpone making any decision on the drug for as long as
possible, and when push came to shove, approve it with an age
restriction–all in order to "appease the [Bush] administration’s
constituents." During the case, the judge has said more than once that
there was a "strong showing of bad faith" on the part of the FDA, but
at this time, we are awaiting a decision.

At the beginning of the year, the CDC released data showing
significant increases in teen birth rates in most of the country. Was
that supposed to be part of the Bush administration’s storyline? While
Plan B’s road to over-the-counter status has had many twists, turns and
set-backs, the story can have a happy ending. The new administration
can save the day by re-instating science as the underlying narrative at
the FDA.

This post first appeared on Huffington Post.

Like this story? Your $10 tax-deductible contribution helps support our research, reporting, and analysis.

To schedule an interview with contact director of communications Rachel Perrone at rachel@rhrealitycheck.org.

  • invalid-0

    What is the problem? States like New York and a few others already allow abortions without parental notification, a teen could just go there anyway.

    All this does is simplify the process, as long as the drug is legal there is no problem. Notice, Plan B recommends that women over 35 are at greater risk, yet it says NOTHING about 13-17 year olds, because historically for hundreds of thousands of years human beings reproducing at that age was considered normal and still is considered normal in MOST COUNTRIES around the world, excluding the Western world and Japan only.

    The age of consent is 12 in Mexico and 14 in Puerto Rico. Before the dollar became the reserve currency at the end of WW2 it was actually not uncommon for 13-19 year old WOMEN(not CHILDREN) to be married and even bearing children.

  • invalid-0

    Now girls and women have better opportunities in education and jobs than they did pre-WW2, Anonymous. Childbearing and marriage were often the only options for them, and a choice made when there are no other options is not a choice. The age of consent has little to do with what girls and women do for themselves when they are allowed to view life as more than marrying and making babies. We can do better as a society than thinking of girls, teenagers and women as breeders.

  • invalid-0

    Seems as if some of womenkind want another safty net as protection against their irresponsible sexual activities. Why not have a better Plan A rather than relying on a pill to correct their mistakes? Not to steal the motto from Nancy Reagan but just say no. Who knows whether another Einstein, Mozart, Bach, or Mother Teresa will not be allowed to join the human race. Such a loss for all of us.

  • invalid-0

    The better plan A is to use birth control, because sex is a biologically and hormone driven function, and it is unrealistic to think that teens and unmarried women won’t have sex. When birth control fails as it sometimes does, then plan B is a perfectly acceptable choice for teens and women to make. It is better than abortion, or Plan C. By the way, by your same logic, maybe serial killers and mass murderers, who are more likely to come into the world when born to a parent that would be forced to take care of a child that she doesn’t want if abortion was made illegal, would be more likely than the ones whose families wanted them that achieved things the great things that you described. Maybe the fetus would have been another Charles Manson or Son of Sam. Your straw man argument is a loser argument for sure.

  • invalid-0

    There was nothing scientific about Bush’s fictions. As a SF fan, I take (mild) offense.

  • invalid-0

    As a SF fan, I take (mild) offense.

    Think “sci-fi” as in Margaret Atwood’s The Handmaid’s Tale….

  • invalid-0

    The backlash to this decision has gotten ridiculous… they say making EC available to girls will make them have more sex, the same crap we’ve been hearing for years that has so many times been proven untrue. If they’re so ‘pro-life’, how come every time they open their mouths I die a little inside?!

  • invalid-0

    Seems as if some of womenkind want another safty net as protection against their irresponsible sexual activities.

    Irresponsible? I would say it’s the opposite. For example, I’m married and monogamous, and I have used Plan B before after a condom break.

    Birth control has nothing to do with being irresponsible, it is actually TAKING RESPONSIBILITY to control your fertility.

    Do you have something against safety nets? Seems if we are smart enough to make them, it only helps. We have a brain for a reason, let’s use them!

  • invalid-0

    it is unrealistic to think that teens and unmarried women won’t have sex.

    I’d also like to point out that it’s unrealistic to think MARRIED women won’t have sex or that they don’t have a need for birth control.

  • invalid-0

    Not to steal the motto from Nancy Reagan but just say no. Who knows whether another Einstein, Mozart, Bach, or Mother Teresa will not be allowed to join the human race. Such a loss for all of us.

    You do realize that if Einstein’s, Mozart’s, Bach’s or Mother Teresa’s mother (or father; it takes two) had “just said no”, they wouldn’t have been “allowed to join the human race” just as if she had aborted the pregnancy?

    Just imagine how many great human beings we’ve missed out on because of abstinence!

  • invalid-0

    I agree KatWA. Many women forget that antibiotics can interfer with birth control only to remember later after they have had sex. Plan B can come in very handy for those moments! Too bad it wasn’t avaliable OTC in 2000 when I had my own “oops” moment with my now ex-husband, it would have saved me weeks of worry.

  • invalid-0

    Fantastic I love it, plus all the fun that was missed out is a loss alone. That’s why you wrap it up and put an IUD in.

  • invalid-0

    You are absolutely right. Birth control is especially important to the married woman, as the huge families of yoesterday put a huge strain on the woman who bore all of the kids. She wasn’t thought of as a person, and it was often said by priests and the rest of the Patriarchial Catholic Hierarchy that her reward was in heaven. I have heard that some married women today, with the approval of their husbands, are terminating early pregnancies that they BOTH wanted, due to this horrible economic times and their dire economic situations. I support their choices, as I support all women’s choices. (that is what pro-choice means!) Birth control has kept families economically managable, and women sane, as I only have to look at my great grandma’s life,who had 12 children (8 survived) and how miserable and unhappy she was because she did not want all of those children. She was NOT a nice or good mother as a result. She suffered from extreme depression and horrible relationships with her children. Those kinds of relationships do not benefit society. Thank goodness that my grandmother had the sweet, kind, and loving father that she had, which is not often the case, who was willing and able to nurture his children, (but was limited in that, because he worked long hours in a coal mine.) Otherwise, who knows what would have happened with them.

  • invalid-0

    You make an excellent point about not being happy with so many children,being depressed and angry. No this situation is not good for anyone and could explain why there are so many messed up miserable humans out there.

  • invalid-0

    States like New York and a few others already allow abortions without parental notification, a teen? with the financial resources and access to transportation, and a support system that can facilitate such a journey could just go there anyway.

    • invalid-0

      They are obviously not pre-pubescent children. There are still many illegal 13-17 year olds immigrants in the country and they happen to get around, some of them even have children. Maybe some of the petite bourgeois sheltered suburban teens and maybe a few rural teens might have some trouble, however inner city teens (where the majority of the issue stems from) would have the street smarts to take care of themselves. Anyone can take a plane/train/bus or car, how is it a big deal? A prepaid debit card and prepaid cell phone can be used for travel as well.