The common abortion pill mifepristone will remain available to patients, but with restrictions, a federal appeals court ruled on Wednesday. However, the decision from the U.S. Court of Appeals for …
The appeals court ruled that the abortion pill mifepristone can remain available but with restrictions. However, access remains unchanged until the Supreme Court decides whether to take the case. The case marks a major legal battle since Roe was overturned. While the ruling allows the drug to stay on the market, it turns back changes by the FDA easing access. Any effects of the ruling are delayed as the case will likely return to the Supreme Court. The judges were appointed by Republican presidents and indicated a willingness to restrict the drug during arguments. Overall the ruling was a partial victory for both sides but access remains unsettled as the legal fight continues.
As I understand the regulations, the FDA did a roundabout way of approving the drug for general use (it was originally approved under a pathway for drugs that were dangerous and had to be closely monitored by a doctor. This really was a weak spot for the FDA’s case. So I think the main critique from the court being that the decision-making of the FDA was abitrary and capricious in relaxing rules to prescribe (if it was dangerous, why did they relax the rules for use during covid? If COVID necessitated an easier way to obtain it, was it dangerous enough to need the Subpart H approval in the first place?). So the way the FDA approved the drug opened them up to administrative challenge.
Do you know if that means that the FDA could just backup and do the approval process again and conclude that it does not need to follow the pathway of a dangerous drug? If it aligned with other drugs that way, then legal arguments might be moot?
They might have to depending on the final court opinion. It’s important to know that that’s a long process, it takes about 10 years. I’m not sure about the specifics of what that would look like for a drug getting re-approved.
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As I understand the regulations, the FDA did a roundabout way of approving the drug for general use (it was originally approved under a pathway for drugs that were dangerous and had to be closely monitored by a doctor. This really was a weak spot for the FDA’s case. So I think the main critique from the court being that the decision-making of the FDA was abitrary and capricious in relaxing rules to prescribe (if it was dangerous, why did they relax the rules for use during covid? If COVID necessitated an easier way to obtain it, was it dangerous enough to need the Subpart H approval in the first place?). So the way the FDA approved the drug opened them up to administrative challenge.
Do you know if that means that the FDA could just backup and do the approval process again and conclude that it does not need to follow the pathway of a dangerous drug? If it aligned with other drugs that way, then legal arguments might be moot?
They might have to depending on the final court opinion. It’s important to know that that’s a long process, it takes about 10 years. I’m not sure about the specifics of what that would look like for a drug getting re-approved.