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Search resuls for: "Glenn Cohen"


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If the Supreme Court agrees with the appeals court, the approval of mifepristone could be reset to where it stood before 2016, limiting telehealth access to medication abortion and reimplementing other restrictions. “Nevertheless, drug developers invest in new medicines because, if their investments succeed, FDA’s rigorous drug approvals and subsequent regulatory actions are sturdy enough to facilitate reliable returns. “And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.”Of course, if the Supreme Court upholds the appeals court decision, the most immediate impact would be to mifepristone itself. “It is both my hope and my ‘bet’ that the court doesn’t uphold the 5th Circuit on the standing argument,” Cohen wrote. “But I have learned the Supreme Court is hard to predict much of the time.”
Persons: thalidomide, mifepristone that’s, , Daniel Grossman, ” Grossman, ” PhRMA, Glenn Cohen, Dr, Sanjay Gupta, Cohen, ” Cohen Organizations: CNN, Food and Drug, Federal Food, FDA, US, University of California San, Reproductive, Guttmacher Institute, Circuit, Appeals, Pharmaceutical Research, Manufacturers of America, Harvard Law School, CNN Health Locations: Massengill, University of California San Francisco, Texas
Evelyn Hockstein | ReutersA federal appeals court will hear arguments Wednesday afternoon in a closely watched lawsuit that seeks to pull the abortion pill mifepristone from the U.S. market. The hearing at the U.S. 5th Circuit Court of Appeals in New Orleans comes 11 months after the Supreme Court ruled there was no longer a federal constitutional right to abortion. But if it refuses to hear an appeal, the 5th Circuit decision will be the final word on the drug's fate. Days later, the DOJ appealed Kacsmaryk's decision to the 5th Circuit, which handles cases arising from the Northern District of Texas. He said the Supreme Court will likely agree to take the case if the 5th Circuit panel decides to pull mifepristone from the U.S. market.
Two federal judges are poised to issue rulings soon in dueling cases that could dramatically impact access to the abortion pill mifepristone. In Washington state, U.S. Judge Thomas Rice is weighing whether to scrap federal regulations on mifepristone that complicate access even where abortion is legal. In the case of Texas, medical associations that oppose abortion are asking the judge to pull the abortion pill from the U.S. market nationwide. Ferguson and the 17 other attorneys general are asking the judge in Washington state to drop these restrictions. The states include Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania and Washington State.
Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process. Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said. The FDA said the pill was deemed safe after extensive studies and use, and that the challenge comes much too late. Under FDA statutes and regulations, drug approval withdrawal generally begins with an informal hearing, which can entail extensive document preparation and the convening of an advisory committee. Overseas provider Aid Access, an Austria-based service that ships abortion medication to U.S. patients, said it would continue providing the pill no matter how the FDA responds.
The Alliance For Hippocratic Medicine wants Judge Kacsmaryk to nullify the FDA's medical approval of mifepristone, which would effectively ban the abortion pill across the US. Senate Judiciary Committee | YouTubeA Texas judge will soon issue a pivotal ruling in a closely watched case challenging the Food and Drug Administration's approval of the abortion pill mifepristone. It's also possible that Kacsmaryk could order the agency to impose tighter restrictions on access to mifepristone but stop short of completely halting sales. Abortion rights groups and legal experts expect the judge will rule against the FDA in some form. Possible injunctionIf Kacsmaryk issues an order to withdraw mifepristone from the market, there are several ways such a ruling could be drafted.
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