I still remember how I felt when I saw the sign warning of potential traffic jams due to a special event at the Food and Drug Administration (FDA). It was early morning on July 19, 1996, and four NWHN colleagues and I were on the way to attend the FDA Advisory Committee meeting about mifepristone (known as “RU 486” or the “French abortion pill”). I was representing the NWHN and testifying in favor of approving this abortion care approach. We hoped to witness history being made when the Advisory Committee recommended the FDA approve the first-ever abortion pill.
Two more NWHN women were already on-site – they served as Advisory Committee members. Through them, and other conversations with various FDA staffers, we knew that senior officials feared anti-abortionists would disrupt the meeting. As a precaution, it was moved to an isolated building, where everyone in attendance could be searched.
I got into my car that morning thinking we were ready for whatever happened. But, when I saw that traffic alert, I realized the FDA was profoundly afraid about what might happen that day. I feared that the overwhelming evidence about mifepristone’s safety and effectiveness might not be enough to win FDA approval, and that the FDA might block approval in order to mitigate anti-abortion opposition.
My worst fears weren’t realized — mifepristone was eventually approved in 2000. But, the FDA’s fear about political opposition led it to impose unprecedented restrictions on mifepristone — restrictions that had nothing to do with mifepristone’s safe use, and everything to do with the FDA’s fears.
Under FDA restrictions, the manufacturer wasn’t allowed to supply mifepristone to pharmacies; instead, it had to ship it only to physicians who registered with the company. The physicians then had to pre-order mifepristone and keep it on hand for future use. The FDA label also included explicit instructions for clinical practice, including requiring women to take the follow-up medication on-site, rather than at home. This forced women to make another, unnecessary, appointment, compounding costs and challenges in using mifepristone. The FDA label also specified the exact drug dose, route of administration, and gestational limits — clinical parameters that were already outdated at the time of the FDA’s approval.
The FDA was wrong to restrict mifepristone in this way. The NWHN and other women’s health advocates protested these restrictions, pointing out that there was no scientific justification for restricting abortion care in this fashion.
Privately, we heard from FDA staff that they sought to prevent any complications that could justify anti-abortionists’ claim that mifepristone was too dangerous. They felt that the strict label led to the pill being used by relatively few, highly experienced physicians, to women’s long-term benefit. Simply put, the FDA was afraid of what would happen if mifepristone was approved for unrestricted use, as it should have been.
Tragically, the unusually strict label — which was intended to protect access to mifepristone — became a mechanism for anti-abortionists to further restrict access to abortion care.
Anti-abortion activists seized on the FDA label to stop providers from using the safer, more convenient, evidence-based protocol. They helped pass state laws mandating the FDA label be followed exactly. (This is unusual: doctors usually have the professional right to use medications “off label,” to benefit patients.) Courts have prevented the laws from taking effect in some states, but women in North Dakota, Ohio, and Texas who want a medication-induced abortion had to make an extra clinic visit for the second medication dose, often driving long distances, taking time off work, and struggling to find child care. Women whose doctors were forced to use the higher dose required by the FDA label experienced more side effects, including dizziness and nausea.
Now, almost 16 years later, the FDA’s close to fixing most of what it got wrong before. On March 30th, the FDA announced three changes to the Mifeprex label, effective immediately. First, the recommended dose was lowered from 600 to 200 mg. Second, the gestational age limit was increased from 49 to 70 days. Third, the label no longer requires an in-person visit for follow-up medication. These changes were supported by solid safety and effectiveness evidence.
Many clinics in states with “FDA label” laws changed practices the very next day. Now, women who choose mifepristone for abortion care can get a procedure that’s just as effective as that mandated by the old label, but with fewer (unnecessary) clinic visits and side effects. That’s good news for women.
But, the FDA didn’t fix all of the problems it introduced in 2000. We’re frustrated that the FDA left the distribution restrictions in place. Doctors must still register with the company and pre-order mifepristone for later use. This is completely unnecessary and creates barriers to clinicians who want to provide abortion care but don’t use the drug often enough to justify keeping a supply on hand.
When I was driving to the FDA in 1996, I didn’t realize that the road to women’s access to evidence-based effective care would be so long, and beset with so many challenges and barriers. Anti-abortion forces are dedicated to creating as many roadblocks as possible to women’s access to abortion care, and providers’ ability to deliver needed care. Sometimes there are detours created by even well-intentioned stakeholders. But, we are getting closer to the destination. FDA…help us get the rest of the way!