The ruling by three judges on the 5th U.S. Circuit Court of Appeals in New Orleans overturned part of a lower court ruling that revoked the Food and Drug Administration's approval - more than two decades ago - of. But it left intact part of the ruling that would end the availability of the drug by mail and require that the drug be administered in the presence of a physician.
Those restrictions won't take effect, at least right away, because the Supreme Court previously intervened to keep the drug available during the legal fight. At issue is a Texas-based federal judge's April ruling revoking the drug's approval, which was granted more than 20 years ago by the Food and Drug Administration.
There is no precedent for a U.S. court overturning the approval of a drug that the FDA has deemed safe and effective. While new drug safety issues often emerge after FDA approval, the agency is required to monitor medicines on the market, evaluate emerging issues and take action to protect U.S. patients. Congress delegated that responsibility to the FDA - not the courts- more than a century ago.
But during a May 17 hearing, the 5th Circuit panel - Judges Jennifer Walker Elrod, James Ho and Cory Wilson - pushed back frequently against assertions that