Crawford’s Choice: Deflect, Delay, Deny

By Amy Allina

The Food and Drug Administration (FDA) announced at the end of August that it was not approving Barr Laboratory’s application to make Plan B emergency contraception available over-the-counter (OTC). The FDA cloaked its denial in bureaucratic language, claiming that it needed public input on the implications of making Plan B available OTC for some while maintaining prescription status for younger women. The FDA cloaked it’s denial in bureaucratic language, claiming that it needed public input on the implications of making Plan B available OTC for some while maintaining prescription status for younger women.

In fact, this is just the latest in a series of delay tactics that the agency has used to block this effort to improve women’s access to EC. Since the first OTC application was filed in April 2003, the FDA has repeatedly responded with delays and denials, despite the overwhelming scientific and medical agreement both inside and outside the agency that women can use the product safely without a prescription.

The FDA has sent mixed signals about a possible age restriction on OTC access to Plan B, first suggesting that it might consider lifting the prescription requirement for women 16 and older, and later asserting that the evidence supports safe use for women 17 and older. There’s no scientific evidence to support establishing such a restriction at either age, however. Experience in the U.S. and Europe shows that young women can use Plan B safely, and that expanded access does not have negative effects on their behavior or health. The FDA’s own expert Advisory Committees discussed adolescent EC use, debated the idea of placing an age limit on the OTC availability of Plan B, and firmly rejected it. Medical experts outside the FDA agree, including the Society of Adolescent Medicine, which has issued a position paper stating that it: ‘strongly supports efforts to [make EC available] over-the-counter without an age restriction’ (Journal of Adolescent Health 2004; 35:66-70).

Although the FDA made the announcement at the end of a Friday afternoon late in August, when it might have hoped the media attention would be low, the public and media reaction was strong. Editorials condemning the FDA’s failure to act based on science appeared in dozens of newspapers across the country within days.

And, media attention flared again less than a week later when Dr. Susan Wood resigned from her position as Director of the FDA Office of Women’s Health in protest of the agency’s handling of the Plan B application. (Dr. Wood was also the keynote speaker at the NWHN’s 30th anniversary event in October, see page X.) In explaining her resignation, Dr. Wood said that the FDA’s actions were “contrary to my core commitment to improving and advancing women's health.” In a letter to her colleagues, she wrote, “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff [at the FDA], has been overruled.”

What Happens Next?
The FDA has asked the public to submit comments on the implications of making Plan B available OTC to one group of women while maintaining a prescription requirement for younger women. Comments were due by November 1, but FDA Commissioner, Dr. Lester Crawford, told reporters that it was impossible to say how long it would take the FDA to finish considering this issue after comments were received. While Crawford’s unexpected resignation in September won’t have a direct effect on the OTC application, his successor’s actions on this issue will be seen as an early indicator of whether the new Commissioner will restore scientific integrity to the FDA.

EC advocates are continuing to work on several fronts to improve women’s access to this safe and effective, after-the-fact contraceptive. Our efforts include:

• Filing comments with the FDA endorsing the scientifically-supported position that OTC access to EC is safe and should be established for women in the United States .
• Advocating that the Senate hold hearings about the FDA and Plan B to investigate why the agency didn’t stick to the science and do its job.
• Reducing barriers to EC access by establishing pharmacy access options in states where that is possible.
• Pursuing litigation against the FDA for denying women access to EC over-the-counter.
• Maintaining a vocal and visible critique of the FDA’s politicization of the Plan B application at the expense of women’s health.