Texas ruling could spell trouble for the FDA

Texas ruling could spell trouble for the FDA
# 08 April 2023 09:51 (UTC +04:00)

In the US, drugs are approved by the Food and Drug Administration (FDA). Review teams are made up of medical experts, who are tasked with determining if a drug is safe, APA reports citing BBC.

In his ruling, Judge Kacsmaryk - who does not have a medical degree - found that allowing the drug to remain on the market meant that plaintiffs "are likely to suffer irreparable harm".

Legal scholars say this ruling is a direct challenge to the authority of the FDA - if he can decide that a review panel of experts erred, than another judge could do the same for other controversial drugs.

This could make drug makers wary about developing new drugs, experts caution, because they will not be able to rely on FDA approval.

Conversely in Washington, Judge Rice specifically said he could not weigh in on mifepristone safety: “It is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks."

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THE OPERATION IS BEING PERFORMED