If Bush waged a war on science then yesterday the war crime tribunal spoke. The U.S. District court of the Eastern District of New York ruled that the Bush administration had politicized a once respected regulatory agency, the FDA, for bending the law to its right wing purposes. The court's condemnation was comprehensive and brutal, all but labeling the Bushies political criminals. At issue was the FDA's decision to overrule its staff recommendation and restrict access for adolescents to one of the most effective methods of preventing unwanted pregnancy, emergency contraception. The Court, in one excoriating stroke, reversed the first (and let's hope last) ideological decision the FDA ever made.
The decision could not have been more dismissive of the Bush administration's maneuverings. Mincing no words, the Court concluded that the FDA "acted in bad faith and in response to political pressure," "departed in significant ways from the agency's normal procedures," and engaged in "repeated and unreasonable delays." The court also found that the FDA's justification for denying over-the-counter access to minors "lacks all credibility," and was based on "fanciful and wholly unsubstantiated 'enforcement' concerns." The Court ordered the FDA to reconsider it's decision based on scientific evidence alone. In the meantime, it ordered the agency to make the contraceptive available over-the-counter to 17-year-olds within 30 days as it now does for adults.
The decision comes amidst news that US teen birth rates are spiking for the second year in a row. Those Bush era virginity pledgers are shifting smoothly into teen motherhood -- the legacies of ignorance-only sex education and restricted access to and information about contraception.
The decision was prompted by a case, Tummino v. von Eschenbach, brought by the Center for Reproductive Rights (CRR) in 2005. The plaintiffs in the case were a grassroots groups called the Morning After Pill Conspiracy along with over 70 medical and public health organizations, scientists, and parents. For those who did not follow the case closely it's worth reviewing not only how the Bushies imposed their theological agenda, but how they indifferently bent regulatory procedures. The administration ruthlessly ignored the facts and coerced FDA scientists to implement its anti-science agenda. According to a CRR press release, "Before its action on Plan B (emergency contraception) the FDA had never restricted a non-prescription drug based on a person's age, nor had the Bush Administration ever been consulted by the FDA about an over-the-counter drug application. Depositions of senior FDA officials by the Center in 2006 indicated that the Bush Administration sought to unduly influence the agency during the Plan B application review process. Testimony also indicated that officials involved in the decision-making process were concerned about losing their jobs if they did not follow the administration's political directives." It was in other words, get with the program.
CRR continued: "Other evidence uncovered during the lawsuit showed that the agency repeatedly departed from its own established procedures during the FDA case, from filling the reproductive health committee with political "operatives" to making a decision to reject over-the-counter access to Plan B before completion of the standard review."
For years, I've been following the right's takeover of what had been a scientifically driven process. In researching a book, How the Pro-Choice Movement Saved America, I studied the violation of the FDA in detail. One fundamental thing I learned: anti-contraception crusaders were not just interested in limiting access for minors. Their true intent was to prevent all women from easy access to the pregnancy prevention method. Their more uncensored leaders, like Judie Brown of the American Life League, admitted as much, explaining, "the best thing the FDA can do now for the American women and their progeny is to take the next logical step and remove these pills for the market altogether."
In the service of this goal, it seemed that nothing was off limits, not scientific integrity nor the will of the majority. The decision to limit minors' access to emergency contraception was based on phony arguments put forth in particular by Bush appointee to the FDA panel, David Hager, a long-standing opponent of contraception. Hager's supposed concern was that the proven usefulness of the medication would be overshadowed by 9 and 10 year olds who would "abuse" the drug, as if it were some sort of crack for kids. During the application review process, Hager called for unavailable research to quell his "concerns" that the drug would be abused by pre-teens. "The plans for introduction of Plan B into the non-treatment setting need more evaluation if it is going to be generalizably available to a nine year old regardless, a ten year old regardless of, you know; there's no restriction," Hager explained.
This line of argument shocked other panel members. One, Dr. Abbey Berenson, a professor of pediatrics and ob/gyn at University of Texas, countered, "I would just like to make a point that it is extremely rare that the nine or ten year old has menstrual cycles and so if we're going to talk about adolescents, let's talk about the mean age of menarche in this country is 12, and I can't imagine where a nine-year-old would get $40 to go buy Plan B over the counter and who would buy it for this nine year old."
The drug had been studied as part of the effort to determine whether EC was safe. Females from twelve to fifty had been sampled, including sixty-six between the age of twelve and sixteen years old. Adolescents understood 60 to 97 percent of the drug-product package directions and materials, at a comprehension level similar to that of women as a whole and one that easily met standards previously accepted for the approval of the other over-the-counter drugs.
Hager continued to create a straw man, or in this case, straw girl, that defenseless nine or ten year old, and then imagined that she was taken advantage of. It was an argument that none of his illustrious fellow panel members thought had merit. Hager nonetheless persisted: "Well I'm sorry, but there are young women that age [under twelve] who do start menstrual cycles and although the numbers aren't large, it is enough of a concern that if there's an 11-year old who is having a menstrual period and becoming sexually active, then she chooses to access this means of emergency contraception, and my only point is not the number. It's that we don't have any information available on that younger age population."
Of course, less than six percent of girls younger than age eleven have started their menses, and 4.2 percent of girls under age thirteen are sexually active. Take that microscopic demographic and divide it by the percent that know EC even exists and who also have $40 to drop and you have the nearly non-existent basis for Hager's, and what would eventually be the FDA's, argument against extending over-the-counter access to EC for minors.
After the FDA decision to restrict minor's access to the contraceptive method, several panel members who favored over-the-counter access expressed their outrage at the decision, writing, "If groups with moral objections wish to prevent the sale of a class of drugs, they should proceed through the legislative process. They should not corrupt the scientific review process of the FDA to achieve their ends. We believe it will be very hard to put this genie back in the bottle. We squander public trust at out peril."
Today, the US district court finally got the anti-contraception genie, and some of the bullying lawless politics of the Bush era, back in the bottle, at least for now. As for the public's trust, that'll take a little longer to fix.
For breaking news on threats to birth control access and information visit birthcontrolwatch.org.