400 Drug Company CEOs Stand Up for Mifepristone

Businesses benefit from the orderly pursuit of legal precedent in a democratic society, because precedent helps to create a level playing field and a predictable regulatory environment. When that order is upended, chaos ensues. That is exactly what happened in April when a federal judge in Texas ruled that the drug mifepristone should be pulled from the market. Now it’s up to stakeholders in the pharmaceutical and biotech industries to unravel the mess — if they can. 

400 CEOs finally wake up

The judge in question is U.S. District Court Judge Matthew Kacsmaryk of Amarillo, Texas, who has become widely known for his association with religious extremists. On April 7, Judge Kacsmaryk issued his ruling on a case that challenged the authority of the Food and Drug Administration to approve mifepristone for abortions. The FDA initially approved mifepristone 23 years ago and has reaffirmed its findings in recent regulatory updates. 

Despite that history of science-based approval, Judge Kacsmaryk accepted the plaintiffs’ argument that the FDA was wrong. In doing so, he exposed the entire drug and biotech industries to the threat of having their products suddenly pulled off the market for any reason, regardless of the FDA’s science-based determinations.

The reaction from the pharmaceutical and biotech industries was forceful and united. More than 400 CEOs signed an open letter that warned against “judicial activism” and “judicial interference,” while underscoring the bottom-line risks of pulling FDA-approved products off the market without a basis in science or evidence.

The letter also emphasized that Kacsmaryk placed the whole future of modern U.S. medicine and biotechnology at risk because his decision disincentivizes researching, developing and bringing new products to market.

Mifepristone is not an isolated case

As framed by the mifepristone letter, it is difficult to imagine a more far-reaching and destructive anti-business decision rendered by a federal judge. Adding to the irony is the fact that Kacsmaryk is among the many federal judges appointed by former President Donald Trump. When Trump won his office in 2016, he carried a pro-business reputation with him, consistent with the pro-business mantle cultivated by Republican Party leadership over generations.

That pro-business reputation now seems to have evaporated. The Kacsmaryk ruling is just one manifestation of a broader attack on businesses large and small, including book bans against publishers and drag show bans that target entertainers and their host venues. The "woke capitalism” canard against corporate diversity, equity and inclusion programs is another manifestation, as are the state-based legal actions aimed at thwarting corporate and investor principles that follow science-based environmental, social and governance (ESG) guidelines.

The Kacsmaryk decision was itself enabled by the three Trump appointees to the U.S. Supreme Court. As half of a six-judge supermajority on the court, all three demonstrated an antipathy toward science when they voted to overturn 50 years of precedent on abortion rights in the 2022 Dobbs v. Jackson case. The ostensible aim of the Dobbs ruling was to empower states to set their own abortion standards. Apparently Kacsmaryk did not get the memo.

What CEOs can do

If drug and biotech CEOs are serious about tamping down the existential risks posed by individual judges with a religion-based agenda, they can start by taking accountability.

David Dayan, executive editor of American Prospect, rendered just such a verdict on the open letter. "The industry’s lament about judicial activism feels a bit like Dr. Frankenstein expressing outrage over the destruction carried out by his monster," he wrote in a long-form article published on April 12. "The pharmaceutical industry as a whole, and many of the individual officials who signed the letter, financially supported the Senate Republicans who confirmed Kacsmaryk to the federal bench.” 

The industry gives generously on both sides of the aisle. However, this policy-blind approach to corporate political giving is clearly out of step with the radical anti-business, anti-science activism practiced by many in today’s Republican leadership.

In addition, as Dayan notes, there is no accounting for the partisan flow of dark money. If the activities of industry trade groups are any indication, though, the aura of policy-blind giving starts to crumble. Dayan cites the example of the leading trade group PhRMA, which has steered 81 percent of its donations to Republican officials over the past 15 years. Among the chief recipients of that largesse is Sen. Mitch McConnell, who is widely credited with engineering Trump’s three Supreme Court appointments.

Money is a good place to start, but not the only place

In advance of the all-important 2024 presidential election cycle, the U.S. pharmaceutical and biotech industries could help counterbalance anti-business radicalism by halting the flow of both public and dark monies to Republican candidates who look to restrict business activities and civil rights.

Beyond that, industry groups can help increase public support for reforming the U.S. Supreme Court. Opinion polls indicate that the public knows something is wrong, but they may not necessarily realize just how far below the ethical bar some of the Supreme Court justices have slid.

The lavish, undisclosed gifts endowed upon Associate Justice Clarence Thomas by a Republican mega-donor placed him in the media spotlight earlier this year. Since then, other instances of partisan influence-peddling have come to light, including magnanimous teaching assignments at the conservative George Mason University for Associate Justices Thomas, Neil Gorsuch and Brett Kavanaugh. The role of Chief Justice John Roberts’ wife as a top recruiter for law firms with cases before the court is another red flag.

The mifepristone case is heading to the Supreme Court on appeal. Pharmaceutical and biotech stakeholders will breathe a sigh of relief if it is overturned, but the fight to restore a pro-business, rational, science-based approach to public policy has only just begun.    

Image credit: Gayatri Malhotra/Unsplash