- Pharmaceutical leaders and drugmakers criticize a Texas judge's abortion pill ruling
- Judge Matthew Kacsmaryk ruled to suspend the FDA approval of mifepristone despite being in the market for more than two decades
- More than 400 companies are now calling for the reversal of the decision
Drugmakers and pharmaceutical leaders, including Pfizer's CEO, have criticized a Texas judge's abortion pill ruling that could make the drug unavailable by Friday.
More than 400 pharmaceutical and biotech companies weighed in on Monday regarding Texas Judge Matthew Kacsmaryk's decision to suspend the Food and Drug Administration's (FDA) approval of mifepristone.
Criticizing Texas Abortion Pill Ruling
The decision came despite the abortion pill being on the market for over two decades. Pharmaceutical leaders and drugmakers are calling for lawmakers to reverse the ruling.
In a statement, the chief executive of Pfizer, Albert Bourla, and the president of Biogen, Alisha Alaimo, said that the Texas judge's decision ignored decades of scientific evidence and legal precedent. They argued that these were signed by leaders of some of the most prominent companies in the industry, as per the New York Times.
The joint letter argued that Kacsmaryk's decision set a precedent of diminishing the FDA's authority over the approval of drugs. It added that the situation creates uncertainty for the whole biopharma industry.
The Department of Justice on Monday afternoon filed a motion requesting the United States Court of Appeals for the Fifth Circuit to stay the Texas ruling until the appeal for the case can be heard. However, Judge Kacsmaryk of the U.S. District Court for the Northern District of Texas stayed his ruling for only seven days.
Furthermore, the letter from pharmaceutical company leaders argued that their establishments relied on the FDA's autonomy to provide products to the market under what they called a "reliable regulatory process for drug evaluation and approval."
The Justice Department's lawyers argued that if the Texas judge's ruling took effect, it could result in a significant risk to women's health, particularly for those that require the abortion pill as a medical or practical necessity, according to CNN.
Undermining Regulatory Process of Pharmaceutical Industry
In the filing, the DOJ noted that the decision harms the entire country because mifepristone has several lawful uses in every state. It adds that the judge's order would undermine various healthcare systems and the reliance interests of several businesses and medical providers.
The department added that plaintiffs present no evidence that they faced risks of getting injured, much less irreparably harmed by the abortion pill. Danco, a manufacturer of mifepristone, also said that Kacsmaryk's decision would harm women who rely on the drug for their regimen.
The Texas judge's reasoning for his order was that the FDA "acquiesced on its legitimate safety concerns - in violation of its statutory duty - based on plainly unsound reasoning and studies that did not support its conclusions."
On the other hand, PhRMA, the primary lobbying arm of the pharmaceutical industry, stated on Monday, arguing that Kacsmaryk's ruling undermines the regulatory process. The organization noted that the FDA is considered the gold standard when determining whether or not a medicine is safe and effective for people to use, said NBC News.
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