A Plan for Plan B: FDA and the Art of Illusion

Marilyn Keefe is Vice President of Public Policy for the National Family Planning and Reproductive Health Association

Any amateur magician seeking to master the art of illusion should contact the Food and Drug Administration (FDA) for lessons, as the agency has all but perfected its smoke and mirrors routine. For the past three years, FDA has succeeded in tricking the audience – in this case, the American public – into believing that it is taking real steps toward making Plan B emergency contraception available over-the-counter when in reality the agency has been standing still, a feat that may well rival any David Copperfield performance.

The audience, however, is finally starting to see through FDA's bag of tricks and recognize it for what it is: foot-dragging. On Monday, after a year of inaction, FDA suddenly announced that it is ready to re-engage in talks with Barr Pharmaceuticals on making Plan B available over-the-counter. The decision, FDA said, was the result of a "thoughtful and comprehensive" deliberative process to ensure that "the right policies are in place to promote [Plan B's] safe use." In other words, the last year of total silence from FDA on Plan B was worth it because, round of applause, they used the time to work through their issues and can now move forward.

Unfortunately, we've heard that line before. Those of us who recognize that Plan B, which is simply a concentrated dose of birth control pills, is a critical component of basic health care for women and is an important addition to the contraceptive options available to all women, have been ready to "move forward" since 2003, when a joint FDA advisory panel voted 23-4 in favor of approving Barr's application to make Plan B available over-the-counter for all women. FDA staff concurred with the advisory panel, but the acting director at the time issued a "not approvable" letter, claiming that more data was needed and suggesting to Barr that an age restriction might fix the problem and help move the process ahead.

Barr did as it was asked and amended its petition, requesting that FDA make Plan B over-the-counter only for women 16 and older, and keeping it prescription-only for women 15 and younger. That was in 2004. By 2005, FDA had still not issued a decision, so Senators Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) placed a "hold" on the nomination of Lester Crawford to be FDA Commissioner until the FDA issued a decision on the Plan B application. FDA assured the Senators that it would issue a decision quickly, so the Senators lifted their hold. Unfortunately, the agency's idea of issuing a decision was to instead issue a notice shortly after Crawford was confirmed asking the public to comment on whether the agency in fact had the authority to approve the two-tiered application it had solicited.

Since those comments were due to FDA nearly one year ago, the agency has not said one word about "moving forward," leaving all of us to wonder whether FDA would ever deal with Plan B again. Then Monday, out of thin air, FDA said that after spending the last year thoughtfully deliberating it was ready to talk. Really? Monday's announcement couldn't possibly have had anything to do with the confirmation hearing for Acting FDA Commissioner Andrew von Eschenbach, scheduled for Tuesday? Of course not, just like all the delays over the last three years had nothing to do with putting political ideology ahead of scientific facts.

Despite the abundant scientific evidence that Plan B is safe for all ages and could prevent as many as half of the three million unintended pregnancies in the U.S. each year, the current administration and right wing extremists don't want women to have access to emergency contraception, period. They have decided – wrongly – that access to Plan B will encourage promiscuity among women, but they couch these views in concerns over whether the drug is safe for adolescents, despite evidence to the contrary. Last year FDA reported that scientific data shows that Plan B is safe for 17-year-olds. Monday, FDA's announcement suddenly changed the approval age it would discuss with Barr to 18, a shift clearly based on little more than the administration's preference that adolescents not have access to the drug.

Senator Clinton was right to say that FDA is "slow-walking" this process. The delays over the last three years have not been caused by real concerns over public health, as FDA is charged with addressing, but by politics run amok. This latest attempt to manipulate the Senate and the American people into believing that FDA is moving closer to making a non-political, science-based decision on Plan B simply isn't going to work. The audience has seen through the smoke and mirrors, and just isn't buying it anymore. It's time for the show to close and for FDA to make a final decision on Plan B. In the words of Senator Murray, "Fool me once. We're not going to go there again."

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