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Scientific Integrity Makes a Comeback

Court Ruling on Plan B Signals Break With Bush Administration Approach

hand holding emergency contraception SOURCE: AP/FINDLAY KEMBER A federal court ruled Monday that an FDA decision to limit access to emergency contraception was based on politics and ignored scientific advice. The move highlights the importance of Obama administration directives to protect scientific integrity in the policymaking process. Above: Levonelle, an emergency contraceptive.

On Monday a federal court ruled that Food and Drug Administration decisions to prohibit access to the emergency contraceptive Plan B to women below age 18 “were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” In short, the court determined that the FDA “repeatedly and unreasonably delayed issuing a decision on Plan B,” and then bypassed scientific review and issued a Not-Approvable letter, imposing the age restriction, for political reasons.

There are two reasons to celebrate this decision. The FDA’s own scientific review shows Plan B to be a safe and effective contraceptive for women, including young women. Thus, the decision is a victory for women’s health and liberty. In addition, this decision is perfectly timed to highlight the point of two actions that President Obama took earlier this month. On March 9, the president issued an Executive Order that lifts the Bush administration’s restrictions on funding for human stem cell research. He also issued a Memorandum on Scientific Integrity. The memorandum grants the director of the Office of Science and Technology Policy responsibility for ensuring the highest level of integrity in the federal executive departments and agencies, and instructs him to propose a plan based on a set of principles. The principles are not novel. The first two state:

(a) The selection and retention of candidates for science and technology positions in the executive branch should be based on the candidate’s knowledge, credentials, experience, and integrity;
(b) Each agency should have appropriate rules and procedures to ensure the integrity of the scientific process within the agency;

In fact, the court’s decision is based on the findings that the FDA has violated its own standards, which substantially reflect these principles. The court’s decision shows the extent to which the previous administration had set them aside.

The court’s opinion should also raise a red flag for the Obama administration. One of the major actors in delaying Plan B approval and imposing the age restriction was Steven Galson, M.D., M.P.H. Galson is presently the acting Surgeon General and Acting Assistant Secretary for Health. In 2003 through 2005, the critical time period for the FDA’s actions on Plan B, Galson was the director of the Center for Drug Evaluation and Research at the FDA. The court’s findings of fact state: “the pressure coming from the White House appears to have been transmitted down by the Commissioner’s office in such a way as to significantly affect Dr. Galson’s position” on Plan B. One of Galson’s subordinates testified, “Dr. Galson . . . told me that he didn’t have a choice, and . . . that he wasn’t sure that he would be allowed to remain as Center Director if he didn’t agree with the [Not-Approvable] Action.” In other words, Galson caved to political pressure.

The pressure—in this case on his career—was significant. But consider the action of one his colleagues. Dr. Susan Wood was then Assistant Commissioner for Women’s Health and Director of the FDA Office of Women’s Health. In September 2005, she resigned her position in protest over the FDA’s actions on Plan B. Galson saved his job, but abrogated scientific integrity, sacrificed women’s health, and violated the law in the process. It appears that he was and continues to be well rewarded.

In its holding, the court remanded to the FDA “for reconsideration of whether to approve Plan B for over-the-counter status without age or point-of-sale restrictions.” The FDA’s scientific process has already recommended over-the-counter distribution of Plan B to young women. Now is it time to honor those recommendations, and perhaps to do a little housecleaning, as well.

Lisa C. Ikemoto is a professor at the University of California Davis School of Law.

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