A Texas judge recently decided that the Food and Drug Administration (FDA) approval of a drug that has been used for 23 years safely was wrongly made and that the drug should not be allowed to be used.
It doesn’t matter what drug it is and it doesn’t matter that the judge’s decision was riddled with inaccuracies, loaded phrasing, and partisan wording.
What matters is who decides what drug is safe and effective to use. And who do you think is trained to make those decisions? Who has a process in place for evaluation? And, who is the leading organization in the world for doing so?
One federal judge or the FDA?
I’ve loaded the questions above in favor of the FDA, of course. I’m a member of the FDA Advisory Committee for Drug Safety and Risk Management. I participate in a few of the drug approval and disapproval decisions that the FDA makes each year. (For some of the ways in which I suggest the FDA improve the process of the Advisory Committees to be even better, see my article here.)
The FDA is the leading and best drug review board in the world. Other countries follow the United States’ lead, and it is a point of pride for the U.S. medical community. No review process is perfect, but for the most part, the FDA gets it right. And they get it right because the review process that pharmaceutical manufacturers must undergo is multi-leveled, with drug trials that start in the laboratory, move on to animal testing, then to limited human trials and then larger human trials. The failure rate is astronomical, 90% of drugs fail in clinical trials.
For a judge to override the FDA’s decision is inconceivable to me. In a – so far never happened – scenario, in which the FDA approved a drug that was subsequently clearly causing immediate danger to the public but the FDA chose not to take it off the market, then yes, the judicial system would be one option. This is not that scenario.
The drug that is at the center of this controversy is one of the two-pill regimen prescribed to women who need or request a medical abortion. U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas ruled that the approval of mifepristone by the FDA should be suspended, and that the drug should not be allowed to be used in the U.S. His ruling was not to take effect for seven days.
Just a few minutes later, U.S. District Judge Thomas O. Rice, chief judge of the United States District Court for the Eastern District of Washington, ordered the FDA to not enforce any restrictions on mifepristone.
The drug was approved 23 years ago after an FDA review that included an Advisory Committee of independent doctors. The FDA required ongoing studies and restrictions on the distribution of mifepristone. Since then the FDA has met two times to go over the ongoing research which showed convincing data that confirmed the safety of mifepristone and led to the lowering of the barriers at first required: in 2019 to approve generics and in 2021 to allow telemedicine prescribing. These decisions were made because it was clear the drug was safe enough to be more accessible.
Let me be clear, no drug is perfectly safe. All drugs can and do harm to a small percent of those it is intended to help. That’s because the human body has unlimited variables, both in its unique makeup and to what it is exposed – pollution, stress, poor food, etc. Many people would be shocked to learn that Viagra is the cause of 49 deaths per one million users. The leading cause of acute liver failure is the overuse of Tylenol and products containing Tylenol. In comparison, mifepristone causes only five deaths per million users, and only 280 hospitalizations in the decade of 2012 to 2022, fewer than .01%.
If the drug has a 23-year history of wide use, proving it is safe and effective, then why are we in a judicial battle over its legal use?