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What We're Reading: FDA Says Novartis Hid Data; Judge Halts Ark. Abortion Rules; New Phase in Opioid Suits

AJMC Staff
Novartis hid manipulated data about its $2 million gene therapy Zolgensma from the FDA; US District Judge Kristine Baker granted a preliminary injunction preventing Arkansas from enforcing 3 abortion restrictions; a federal judge in Ohio expressed support for a plan by attorneys representing cities and counties suing US opioid manufacturers and distributors that would bring every US community into their settlement talks despite objections from most states.

Novartis Concealed Manipulated Data About Zolgensma Gene Therapy, FDA Says

Novartis hid manipulated data about its $2 million gene therapy Zolgensma from the FDA, the agency reported. The concealment occurred while the company was applying for approval for the treatment for spinal muscular atrophy, then delayed reporting the issue, the agency said. The inaccurate data involved testing in mice of 2 different strengths of the treatment and did not affect the safety or efficacy of the treatment, but had the agency known about the issue, it would have delayed approval.

 

Arkansas’ 3 Abortion Restrictions Temporarily Blocked by Federal Judge

US District Judge Kristine Baker granted a preliminary injunction preventing Arkansas from enforcing 3 abortion restrictions, The Associated Press reported. They include a measure prohibiting abortion at 18 weeks, a requirement that physicians performing abortions be board-certified or board-eligible in obstetrics and gynecology, and the third prohibits doctors from performing an abortion if it’s being sought because the fetus was diagnosed with Down syndrome.

 

Proposal in Opioid Lawsuits Envisions Adding US Counties, Municipalities to Plaintiff List 

A federal judge in Ohio expressed support for a plan by attorneys representing cities and counties suing US opioid manufacturers and distributors that would bring every community nationally into their settlement talks despite objections from most states. US District Judge Dan Polster said the idea could allow the defendants accused of fueling the opioid crisis in nearly 2000 lawsuits before him the ability to obtain “global peace.” Reuters said the proposal calls for creating a class of up to 3000 counties and 30,000 municipalities that could vote on whether to accept any settlement the plaintiffs reach with defendants. Bloomberg reported that 3 of the companies—McKesson, Cardinal Health, and AmerisourceBergen—have offered $10 billion to settle claims; the National Association of Attorneys General, on behalf of 35 states, want $45 billion.

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