This is a tectonic shift in the national fight over reproductive rights.
of scientific review; now a lone judge has undermined its authority, abolishing the agency’s longtime role as the final arbiter of which drugs are safe and effective.To see why Friday’s decision imperils the entire biopharma field, start with Kacsmaryk’s attempt to establish standing for the plaintiffs, a group of anti-abortion doctors. To sue in federal court, the Constitution
plaintiffs to establish a “concrete and particularized” injury that is “actual or imminent.” To meet these requirements, the doctors in Kacsmaryk’s case said they. That’s a totally speculative and generalized injury—the opposite of “concrete” and “imminent.” Incredibly, Kacsmaryk still embraced this theory of standing,By doing so, he set off alarm bells for every drug manufacturer in the country.
who suffered side effects from the vaccine. They need only claim that they may one day have to do so. And that, per Kacsmaryk, is enough to establish standing. The exact same scenario could play out with any other drug, but controversial treatments would be most vulnerable. For example, Republicansat PrEP, an extremely effective HIV prevention drug that’s commonly prescribed to gay and bisexual men, longtime targets of the GOP’s ire. Under Kacsmaryk’s theory, an anti-gay doctor could stroll into federal court and ask a judge to revoke the FDA’s approval of PrEP because, at some point in the future, they might treat a PrEP user who suffers side effects.
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