Around 300 top-level biotech CEOs and other business officials are protesting a Texas federal judge’s ruling to halt the FDA’s approval of the abortion pill mifepristone. The executives claim that the agency’s power would be weakened and that new innovations would be at risk as a result of this judicial meddling.
Controversy over Judicial Intervention on Abortion Pill Approval
- Executives publish open letter expressing concern over judicial intervention by Judge Kacsmaryk in the FDA drug approval process
- Judge Kacsmaryk’s decision sets precedent for reducing FDA’s authority over drug approval
- 299 signatures collected so far in support of the open letter
- Mifepristone has been demonstrated to be safe and effective over the 23 years since its approval
- Mifepristone is the primary medication for inducing medical abortions in the US
- U.S. District Judge Thomas Rice delivers a second judgment in Washington ordering FDA to maintain the drug’s status in 17 states and Washington, D.C.
- Confusion arises across the country due to conflicting judgments
The White House and the Department of Health and Human Services (HHS) announced that they would challenge Kacsmaryk’s verdict. At the same time, the House Democrats submitted legislation to defend the power of the FDA as the agency that is responsible for approving pharmaceuticals.
The Department of Justice lodged an appeal in the Texas case, and Xavier Becerra, the Secretary of HHS, criticized the ruling as being backward and stated that it paves the way for courts to overturn evidence-based decisions made by the FDA for purely ideological or political motives.
Leaders from Atlas Ventures, Absci, Bayer, 89bio, and many other prominent healthcare companies signed the biotech industry letter.
The leaders wrote in the letter, “As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”
According to the leaders, the safety of any treatment may be jeopardized if judges were granted the authority to unilaterally reverse medicinal approvals without giving any consideration to science or evidence.
They further remarked that even if the drug development, approval, and monitoring processes are not flawless, the agency’s structure has resulted in decades of unrivaled medical innovation and in legislative procedures to remove medications from the marketplace if, among other causes, they fail to preserve the projected safety and effectiveness profile.
The leaders have asked for the FDA’s power to be restored and the decision to be rescinded. The letter ended with the leaders claiming that they’ll not remain silent on the issue and work together to find a way to fight rulings that are not in the best interests of everyone involved.
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