Rewriting Science Fiction: Politics Out of Plan B

Nancy Northup

The FDA, under Dr. Margaret Hamburg's leadership, should take a fresh look at the agency's over-the-counter policy on Plan B to ensure that the policy is based on medical evidence, not ideology. Update 3/24/09: Court rules in favor of evidence!

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.

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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.

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