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Pharma CEOs say US abortion pill ruling threatens drug development

Hundreds of pharmaceutical executives on Monday condemned a US judicial ruling outlawing a leading abortion pill, saying it threatens the development of needed medications in the United States.

Some 400 executives, including Pfizer CEO Albert Bourla and top management at Novartis, Biogen and Merck, signed a letter criticizing Friday’s ruling by Texas federal judge Matthew Kacsmaryk that could block access to mifepristone nationwide.

“The decision ignores decades of scientific evidence and legal precedent,” said the letter slamming Kacsmaryk’s move to bar the drug 23 years after it was approved by the US Food and Drug Administration (FDA).

“Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” it added.

The letter described a reliable FDA as essential to high-risk investments on new treatments.

“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,” the letter said.

Mifepristone has been used as part of a two-drug regimen by 5.6 million women since 2000.

But the drug’s future has become the latest uncertainty in the wake of the US Supreme Court’s June 2022 ruling outlawing national abortion rights.

Kacsmaryk, a conservative appointee of former president Donald Trump, said in his order that the FDA had used “unsound” reasoning at a time when it “faced significant political pressure” to greenlight the medication.

The US Justice Department on Monday asked a federal appeals court to freeze the ruling, writing that Kacsmaryk’s action “would thwart FDA’s scientific judgment and severely harm women.”

At a briefing Monday, White House Press Secretary Karine Jean-Pierre called the ruling an “attack” on FDA authority that could “open the floodgates for other medications to be targeted and denied to people who need them.”

© 2023 AFP

Pharma CEOs say US abortion pill ruling threatens drug development (2023, April 10)
retrieved 10 April 2023
from https://medicalxpress.com/news/2023-04-pharma-ceos-abortion-pill-threatens.html

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