Rewriting Science Fiction: Editing Politics from Plan B (Nancy Northup’s Blog, The Huffington Post, March 19, 2009)

“After eight years of the Bush administration undermining women’s health, Nancy Northup’s new blog on the Huffington Post looks at the need for President Obama to restore scientific integrity to federal policy decisions.”

The Huffington Post, March 19, 2009
Nancy Northup, President, Center for Reproductive Rights

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.

Read the blog on the Huffington Post &gt,