Marci A. Hamilton

The Recent Federal District Court Decision Regarding the "Morning After" Pill: How It Reveals Evidence of the Bush White House's Interference with the FDA, Where Religion Displaced Science to the Detriment of the Public Good

By MARCI A. HAMILTON
Thursday, April 2, 2009

The recent federal district court decision in Tummino v. Torti is a window into the corruption in the Bush Administration, as well as a window into our current culture. Judge Edward Korman held that the FDA had engaged in arbitrary and capricious decisionmaking when it refused to permit a form of emergency contraception, called "Plan B," to be made available over the counter (OTC) to women under 18. The sole question before the FDA involved whether Plan B, available by prescription, would also be made available over the counter. The evidence before Judge Korman has made quite clear that the White House itself interfered with the ordinary science-based processes of the FDA in order to restrict the availability of Plan B for irrational reasons.

The Facts About "Plan B"

Plan B is a "morning-after pill"; it can be used by women to avoid pregnancy after they have engaged in unprotected sex, and it is most effective if taken within 24 hours of intercourse. It is ineffective after 72 hours. Plan B is a high dose of a progesterone-like hormone that prevents ovulation and fertilization. It is not, however, an abortifacient – a fact that should have kept it out of the abortion controversy. (There were studies at one time that indicated that Plan B also prevented implantation of a fertilized egg, but those studies have been debunked in more recent studies.) Plan B is prescribed routinely for rape victims, and for women whose contraception has failed.

Plan B is the only emergency birth control available in the United States. In the rest of the world, by contrast, emergency birth control is widely available, without restriction according to age or prescription.

How the Bush Administration Blocked Plan B's Approval

In the United States, during the Bush Administration, the FDA, according to Judge Korman, "repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners."

When the first request for a decision on Plan B was submitted to the FDA, in 2001, the FDA stated that Plan B fulfilled all of its criteria for OTC distribution, yet an FDA doctor stalled its approval by citing "safety" concerns, including purported concerns about whether Plan B would displace other forms of birth control, whether adolescent girls could understand how to use it, and whether its use would dissuade users from getting tested for sexually-transmitted diseases. The FDA responded to that 2001 request by saying that it would let the petitioners know at some point. Five years later, on June 9, 2006, the FDA announced that it had denied OTC availability.

Between 2001 and 2006, FDA officials made a series of statements indicating that the real reason for the delay and the denial was that Plan B was politically sensitive. Moreover, those chosen to review the OTC-switch application were chosen based on politics, rather than according to scientific credentials. According to the court, "political and ideological factors played a determinative role in the nomination and selection process for membership on the Advisory Committee for Reproductive Health Drugs, which along with the Advisory Committee for Nonprescription Drugs . . . was empanelled by the FDA to make recommendations as to how the FDA should respond to the OTC switch applications." (The court referred to these combined committees as "the Advisory Committee.")

Those chosen for the Advisory Committee did not have the resumes that normally dignify such an appointment. Instead, the court found, they "'had very limited experience in product development, clinical trials. They were not well-published." Why? The Bush FDA was seeking not to find the finest possible doctors and scientists, but rather to achieve a "balance of opinion" on the Committee. Accordingly, the court found, "[M]any qualified nominees [were rejected] in favor of individuals who shared a common ideological viewpoint. . . . They were . . . people who were very active in the Right to Life antiabortion movement.'"

On December 16, 2003, the Advisory Committee voted 23-4 in favor of making Plan B available without restriction according to age or prescription. FDA officials, however, rejected the Advisory Committee's suggestion. Between 1994 and 2004, this was the only advisory committee suggestion regarding an OTC switch that was not followed by the FDA. The court cited evidence that the normal process was derailed by unusual interference by the Commissioner and the White House.

Although both staff and studies indicated that Plan B was safe for OTC use for women of all ages, FDA officials continued to refuse approval and to insist on a more restrictive OTC switch. At one point, there was movement toward permitting nonprescription use for women 17 and older, but on August 24, 2006, that proposal was rejected in favor of one allowing nonprescription use only for those over 18.

Members of Congress suspicious of the FDA's handling of Plan B requested that the Government Accountability Office (GAO) do an investigation. That investigation revealed that the Director and Deputy Director of the Office of New Drugs "'were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application.'" The GAO concluded, based on this and other information, that the FDA had failed to note any issues that would have justified placing an age restriction on Plan B's OTC availability.

The U.S. District Court's Findings Reveal Once Again What the Framers Well Knew: Government Processes Are Likely to Be Corrupted by Improper Influence

The court concluded that the FDA's Plan B OTC application process was infected with improper political influence and departures from standard policies, and that its denials of approval were unsupported by the record. Judge Korman also found that the restriction as to 17 year-olds was wholly without support and ordered that the FDA now make Plan B OTC available. With respect to younger women, the court remanded to the FDA for reconsideration, with the assumption that the new Administration's FDA officials will be capable of fair consideration of the issues involved. Finally, the court declined to reach any of the constitutional challenges raised.

This decision is remarkable in its detailed accounting of the corruption that religious viewpoints can wreak upon public policy. That the right-to-life community was able to derail the availability of emergency contraception so easily is a testament to how bad things truly were in the Bush Administration. It should be unnecessary to say this, but I will: Science, health, and healing should be the focus of the FDA. The pattern of conduct the district court decision reveals is lawless, not only with respect to FDA procedures, but also with respect to the constitutional right to obtain contraception established by the Supreme Court Griswold v. Connecticut. This is not the state's role. Indeed, the imposition by the Bush FDA of the religious beliefs of some upon others who do not believe is antithetical to our system. The core of the Establishment Clause is intended to prevent this sort of substitution of religious reasoning for sound public policy decisionmaking.

The antiabortion movement's members are free to seek to persuade others that their religious and moral beliefs with respect to contraception are correct. Masking those beliefs as science, however, is not a permissible shortcut to making one's case.

Will President Obama, Who Also Consults Regularly with Clergy, Repeat Some of Former President Bush's Grievous Errors?

This is not the first time we have learned of right-wing religious preferences in the Bush Administration. We already knew of the way in which the Bush Department of Justice hired individuals according to ideology, rather than talent, and the investigation continues into that Administration's political decisions to remove perfectly competent United States Attorneys.

President Bush seems not to have been able to make public decisions without reference to right-wing religious beliefs. That inclination was probably reinforced by his practice of having a weekly conference call with conservative Christian clergy.

It is troubling to learn that President Obama appears to have instituted the same practice of scheduled weekly consultation with clergy. While Presidents from the start have looked to their faith to give them courage and solace, and many have had a religious counselor for one-on-one discussions, the weekly call with a committee of clergy is quite different. It would be very hard to believe that the discussion does not veer away from spiritual counseling, and into public policy. And what other political interest groups get this kind of access to the President? Reading Judge Korman's well-reasoned and well-supported decision in Tummino, one is reminded that one cannot assume that religious advising is always, or even usually, politically-neutral. Moreover, it is never accountable to the people, by constitutional design. The President, however, is.

The Framers really were correct: Every human is likely to abuse whatever power is available, no matter the position.



Marci Hamilton, a FindLaw columnist, is the Paul R. Verkuil Chair in Public Law at Benjamin N. Cardozo School of Law and author of Justice Denied: What America Must Do to Protect Its Children (Cambridge 2008). A review of Justice Denied appeared on this site on June 25, 2008. Her previous book is God vs. the Gavel: Religion and the Rule of Law (Cambridge University Press 2005), now available in paperback.