Guest Commentary

Guest Commentary: Speak out against burdensome restrictions on abortion medication or get ready for limits on other technologies

Mary Pendergast says failure to demand removal of unscientific restrictions on abortion medication will only invite more politics into drug development

Failure to demand removal of unscientific restrictions on abortion medication will only invite more politics into drug development, writes Mary Pendergast. 

Unneeded, unscientific restrictions around access to abortion medication remain in place, perpetuating a two decade-long intrusion of politics where it does not belong.  The incoming Biden-Harris Administration now has an opportunity to fix that. 

The biotech industry should worry about politics being put ahead of public health — similar restrictions could be imposed on any technology or individual medicine that is feared because of its innovation, or because it is unpopular with a small, albeit vocal, group.

More than 20 years ago, FDA approved the first abortion medication, mifepristone followed by misoprostol, which promised easier access, more privacy and less expense than a surgical abortion. But the political debate surrounding abortion has kept the FDA from fixing burdensome restrictions on the medication that may have made sense 20 years ago but are no longer sensible or helpful to the pregnant woman or society in general.

Specifically, FDA still requires a pregnant woman to go to a clinic to obtain the medication, even when she plans on taking the pills later at home. Even in the pandemic when in-person requirements for other medications have been suspended, there has been resistance to doing this for these drugs.

Modern healthcare permits women to pick up their medicines at their local pharmacies, chat with their healthcare providers using telemedicine, and save money and time using medications that are sent through the mail.

Yet these are not allowed for pregnant women. Why? Are women stupid once pregnant? Can they not remember to take one pill, then the other, just as countless non-prescription and prescription drug labels explain? Have they forgotten there are emergency rooms if problems arise? Or is there some sense of shame, fear and punishment involved? Is there a goal to make the pregnant woman expose herself to anti-abortionists? Is the Scarlett Letter still alive?

We know FDA staff are fearful. Unlike for all other meetings, FDA staff discussing abortion-related therapies do not sign in to the meeting for fear that some anti-abortionist will find out that they have even dared to talk about abortion. Memoranda go unsigned, to keep the FDA staff from bearing the acknowledgement that they helped women in their reproductive needs.

Scientific study after study has shown that the current restrictions are unneeded, professional societies have called for change, and there is litigation trying to change the restrictions during the COVID-19 pandemic when visiting the clinic may not be possible.

But so far, FDA has not loosened the restrictions.

The biopharma industry should not remain silent on this topic.

Doing so leaves the industry vulnerable to all kinds of restraints on other types of products or research — stem cells, regenerative therapies, genetic testing and genetically modified cellular treatments, to name only the most obvious.

We can no longer neglect the sociological, political and economic dimensions of pandemics and other global health problems. We will have to have hard, uncomfortable conversations about how our health systems tilt towards benefiting rich white people at the expense of others, as do the restrictions on abortion medication. To do this, we have to come to terms with groups we are already treating shabbily — such as pregnant women — and to help others understand that no one should restrict another’s access to needed healthcare.

Mary Pendergast is founder and president of Pendergast Consulting and former FDA Deputy Commissioner.

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