Sex and Science at the Food and Drug Administration

By Amy Allina

On August 13th, the Food and Drug Administration (FDA) announced the approval of ulipristal acetate – to be known by the brand name ella — giving couples another safe and effective method of preventing unintended pregnancy.  Ulipristal allows a woman to back up her birth control for 120 hours after unprotected or under-protected sex or contraceptive failure (in comparison, emergency contraception can be used for up to 72 hours). As a new drug, ella will be available by prescription only, unlike other emergency contraceptive (EC) products that are available without prescription to women 17 and older. The National Women’s Health Network had advocated for the approval of ulipristal, and we celebrated the news of its approval not only because it gives women a new contraceptive option, but also as a welcome sign that  the FDA’s willingness to evaluate reproductive health drugs based on science, without political interference, is finally returning.

On guard against a repeat of the FDA’s shameful history

When the FDA’s Reproductive Health Drugs Advisory Committee met in June to consider the ulipristal application, the NWHN spoke strongly in favor of approval and urged the FDA not to impose any medically unjustified conditions on the distribution of this drug.  We reminded the agency of the recent court ruling which found that the FDA acted “arbitrarily” and “capriciously” when it refused to allow women under age18 access to a levonorgestrel EC without a prescription. We noted that the agency lost considerable credibility in the eyes of women, clinicians, and regulators because its leadership at the time was seen to override the conclusions and recommendations of scientific staff and expert advisors in order to satisfy political aims.

Although the FDA has new leadership now — leadership appointed by an administration that has spoken out in support of family planning — some doubts lingered about the agency’s commitment to a science-based process for this product.  The FDA has taken active steps to bring its handling of the levonorgerstrel emergency contraceptive in line with the science, but it has not removed the age restriction despite the medical communities’ consensus that it is inappropriate and serves only to block young women’s timely access to EC.
As we prepared for the advisory committee meeting, the continued existence of the restrictive EC policy kept us from feeling confident about how the FDA would handle ella. And we noticed, with concern, that the questions that the FDA staff posed to the advisory committee included some that could open the door to unwarranted restrictions and unnecessary medicalization of ulipristal, as well. With that in mind, in our comments, the NHWN urged the FDA not to dig itself a deeper hole by pursuing a similar path with this application as it had taken with the earlier EC approval.

An anti-choice agenda, masquerading as drug safety concerns

One of the issues the FDA staff asked its advisors to discuss at the meeting was whether product labeling and health care provider education would be adequate to address potential off-label use of ulipristal.  This question arose because anti-choice activists had raised questions about the possible off-label use of ella to cause an abortion. When the NWHN spoke, we noted that these questions were not based on scientific or medical concerns about ella that would justify taking measures to address off-label use beyond those routinely and commonly taken for other drugs. 

We used our credibility as long-time drug safety advocates, to point out that there are hundreds, even thousands, of drugs approved by the FDA and prescribed by clinicians whose effect on pregnancy is unknown. Yet, the critics who were raising questions about ulipristal’s possible effect on pregnancy don’t raise this question about other drugs that come before the FDA, because their true goal is not drug safety, but rather to hamper women’s access to another contraceptive option. These anti-choice activists raised questions about ella’s possible use to cause an abortion in order to confuse the issue under discussion.

The facts are that ulipristal has been well-studied as a contraceptive and data on its use at the recommended dose do not support fears that it could cause an abortion. While we don’t know what effect a higher dose would have on pregnancy, we do know that there is already a safe, effective, FDA-approved drug available in the U.S. for medical abortion.  FDA approval of a drug for a specific use does not prevent off-label use, but there’s no reason to believe that this product will be more likely than any other to be used for a different purpose. In light of all those facts, the NWHN argued that there was neither a practical need nor any medical justification for the FDA to take additional measures to address ulipristal’s off-label use.

The good news, the bad news and the news we’re still waiting for…

The advisory committee agreed with the NWHN and other reproductive health advocates who spoke that day, and voted against putting any unusual distribution restrictions on the drug. And, the FDA followed its advisors’ recommendation. (This is a marked contrast to the EC debate, when the FDA ignored advisory committee recommendation to make levonorgestrel EC available without a prescription to women of all ages.)

As a result, women will soon have access to a new contraceptive that works at a time when no other product has been proven to be effective.  That is, of course, the good news. The bad news is that the company that will sell ella in the U.S. has already informed advocates that the drug will cost more than currently available EC products, which typically go for $35-60 per dose. If the price is that high, the economic barriers to access for ella may turn out to be more significant than the age restriction on its predecessors.

Still, the NWHN was pleased to be able to commend the FDA for a thorough, science-based review of ulipristal acetate.  This approval process demonstrated that the agency is no longer allowing a political agenda to override its scientific decision-making capacity.  We look forward to the day when the FDA will complete the job by eliminating the medically unjustified age restriction on over-the-counter distribution of levonorgestrel EC that continues to undermine public trust in the agency.

Amy Allina is the NWHN Program and Policy Director