It seems like we’ll never see the end of the fight for reproductive health. In fact, recent court rulings threaten the existence of the U.S. drug industry, believe it or not! These rulings strictly limit access to abortion pills and could derail the regulatory foundations of the industry. But let’s dive in and see what the hubbub is all about.
Last April 7th, District Court Judge Matthew Kacsmaryk had a public freak-out, noting that the FDA should not have approved the abortion pill mifepristone in 2000, claiming that the FDA didn’t give the process a fair shake and that the pill’s unsafe. On April 14th, the Justice Department asked the Supreme Court to allow full access to a critical abortion medication. It’s like watching an episode of Law and Order but without Olivia Benson to keep it together!
The drug industry is up in arms and throwing a fit about how these court rulings could nullify years of science-based regulations by the FDA. Then what’s the point of all that hard work, really? Should we even invest in cutting-edge biotechnology fields at all? These are just a few of the industry’s concerns laid out in recent amicus curiae briefs. It’s like watching overly dramatic teenagers in a high school play!
The Biden administration, pro-reproductive rights groups, doctors, former government officials from the FDA and the Department of Justice, and industry interests are begging the Supreme Court to stop these lower-court rulings as they technically meddle with FDA approvals. But this kind of meddling could lead to catastrophic consequences. How far are people willing to go? This is like watching a suspenseful thriller!
WARNING: Millions of dollars are at stake! Suspend disbeliefs, and let’s explore these dire warnings that illustrate the extent to which the U.S. health care industry relies on federal rules to survive. The industry has invested years lobbying the White House and Congress to shape the FDA’s approval regulations. Now, if people can’t trust that the FDA’s actions will withstand challenges, tens of billions of dollars invested every year are in jeopardy, says the industry. Yikes!
Say, some good news! PhRMA and leading industry trade groups filed a brief before the Supreme Court, and they called Kacsmaryk’s ruling that invalidated the FDA’s 2000 approval of mifepristone an “unprecedented assault on FDA’s approval decisions.” The energy and emotion of the briefs they filed were a thing of beauty, let me tell you. It was high drama like Shakespeare up in here!
Now the Supreme Court has the unenviable task of deciding if they will temporarily halt the 5th Circuit Court of Appeals’ decision. Danco, the brand name manufacturer of mifepristone, urged the Supreme Court to stay the lower court’s decision, so they could update the packaging for their drug reflecting the new, court-imposed restrictions. But can they use the Comstock Act to do so?
And the twists keep coming. While attacking the FDA’s actions, anti-abortion advocates cited the Comstock Act, an 1873 law that legalized shipment in the mail of obscene materials as well as birth control products and items that could induce abortions. After lengthy deliberations, interpretations, and analyses by the courts, Congress, and the executive branch, former officials from the Department of Justice are crying foul. But then, the American Center for Law and Justice jumps in and argues that the Office of Legal Council was wrong, and the Comstock Act should only ban the shipment of abortion pills if the abortion would be illegal. (Phwew! Try saying that out loud without coming up for air!)
It all comes back to the Supreme Court, who has the responsibility to decide how this ends. Will it be a tragi-comedy, a drama, or a classic suspense flick? Whatever it is, it’s been an emotional rollercoaster.
Serious News: washingtonpost
