Judge had a basis for his attack on FDA, but not regarding mifepristone
The chiefs of more than 400 pharmaceutical companies signed a scathing letter this week blasting federal Judge Matthew Kacsmaryk’s ruling that the Food and Drug Administration had overstepped its authority in approving the abortion-inducing drug mifepristone. The letter was more than justified and, while harshly worded, accurately recounted Kacsmaryk’s abysmal lack of scientific qualification to rule on mifepristone’s safety.
What the pharmaceutical leaders didn’t mention, however, was their industry’s own abysmal record of prioritizing profits over science and pressuring the FDA to fast-track the approval of products that aren’t proven safe. The nation’s opioid epidemic is rooted in the FDA’s failure to stand up to Big Pharma — a record that could come back to haunt the agency as the appeals process plays out regarding mifepristone.
ADVERTISING
Ultimately, however, the FDA’s record remains intact as the world leader in setting the highest scientific standards to review and test medicines and medical products. Its authority to do so comes from Congress, and Kacsmaryk’s ruling — clearly influenced not by law or science but by his personal religious beliefs — appears to massively overstep his authority.
The pharmaceutical chiefs used blunt and direct language to dissect Kacsmaryk’s ruling and qualifications, labeling him a “federal judge with no scientific training” who ignored “decades of scientific evidence and legal precedent” to declare mifepristone unsafe even though its safety record surpasses that of “Tylenol, nearly all antibiotics and insulin.”
The danger if this ruling is allowed to stand, they wrote, is that “courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs,” making any medicine vulnerable to the same outcome as mifepristone.
All valid points. But where were these leaders when companies like Purdue Pharma were engaging in high-pressure tactics to manipulate the scientific process and win fast-track approval of oxycodone when the company knew about its highly addictive potential?
The FDA shirked its regulatory duties when it knew Purdue and other companies were misrepresenting the scientific facts, Dr. Andrew Kolodny wrote in the Journal of Medical Ethics in 2020. “As Purdue earned billions of dollars from sales of oxycodone, other drug companies took note. They introduced their own opioids and joined Purdue in funding a brilliant, multifaceted campaign that changed the culture of opioid prescribing in the United States.” Millions of people wound up being addicted, with the aftermath still playing out on American streets today.
Like most issues these days in American politics and jurisprudence, this one is murky — in large part because of the FDA’s own history. But mifepristone bears no comparison to opioids. The record of safety is clear after decades of use by millions of women exercising their right to biological autonomy. Kacsmaryk disregarded science and hard data while allowing his religious views to skew his judicial judgment.
—St. Louis Post-Dispatch
