Reproductive plights: The industry’s mission to keep drugs accessible has become very visible

March 13, 2023
There is no rest for reproductive health drugs in post-Roe America

We need to talk about abortion — and there is no subtle way to start this conversation. 

The discussion actually starts before the birth of Roe v. Wade, at a time when any contraception was considered ‘lascivious’ and ‘immoral.’

In the early 20th century, oral contraceptives began battling their way through development, embroiled in religious and legal persecution. When the pill finally got approval for use as contraception, more than half of U.S. states still had anti-birth control laws on the books. It took two Supreme Court rulings, the second of which came 12 years post-FDA approval, to legalize birth control for all. 

But surely as society evolved and we stopped viewing women as baby-making machines, the environment for reproductive health drugs became more hospitable, right? Consider that, in 2003, the manufacturer of the emergency contraceptive, Plan B One Step, submitted an application to the FDA seeking to switch the drug from prescription to OTC. The drug got tangled in regulatory delays, staff resignations, legal action against the FDA and political interference that went as high as the White House before finally getting full approval — ten years later.

Fortunately, along with their gritty histories, reproductive health drugs also have decades of documented safe and effective use. And generally speaking, drugs that have been on the market for 20+ years get a reprieve from controversy. 

But as you will read in this month’s cover story, it seems there is no rest for reproductive health drugs in post-Roe America. While the Dobbs v. Jackson ruling was viewed by many as the worst blow to reproductive rights in fifty years, it is quickly proving to be the harbinger of ongoing attacks. And on the industry side, drugmakers and the FDA are fending off blows.

With the power to regulate abortion shifted back to states, mifepristone, a medical abortion drug approved back in 2000, is currently bearing the brunt. There are only two drugmakers selling mifepristone on the U.S. market, and both are currently involved in high profile, high stakes lawsuits. Danco Labs, the brand owner, has joined the FDA in a Texas lawsuit that seeks to overturn the agency’s approval of the drug. Meanwhile, the generic drugmaker, GenBioPro, has gone on the offensive, suing West Virginia over its statewide abortion bans.

As the fate of abortion drugs plays out in the courts, pressure on the FDA and the rest of the reproductive health space to keep all drugs accessible is mounting. Last year, the FDA finally approved a request from the maker of Plan B to update the drug’s label clarifying that it does not cause an abortion. In an effort to break down as many barriers to access as possible, two drugmakers are currently working with the FDA to bring their oral contraceptives over the counter.

While politicians paint abortion in black or white, for most people, reproductive freedom comes in many shades of grey. Throughout history, drugmakers navigating this space have always met with resistance, but the new legal instability created by the Dobbs ruling could have severe and reverberating consequences. Like many of you, I am watching the precarious situation unfold in real time. And with sorrow — for the millions of Americans who rely on these drugs for reproductive health — I dissent.

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'