Miscarriages are common. But a medication for it is practically inaccessible in Kentucky because it’s also used for abortion.
Kentuckians can't get mifepristone to treat miscarriages because of state anti-abortion law, FDA regulation and confusion ...
It also failed to consider whether it needed to continue to collect data of non-fatal adverse events in light of the major changes to the mifepristone REMS (risk evaluation and mitigation strategy).
The REMS program is required by the FDA for any drug that has serious safety concerns and is meant to ensure that the benefits outweigh the risk. Some critics have argued mifepristone’s ...
They argue that the REMS used for mifepristone is a particularly burdensome form known as Elements to Assure Safe Use (ETASU), which strictly limit who can prescribe and dispense the drug.
Since its approval in France in 1988, the abortifacient mifepristone (RU486) has proven to be a safe, effective, acceptable option for millions of women seeking abortion during the first several ...
In a split decision, it also rejected restrictions on mifepristone implemented by a lower court, essentially maintaining the status quo. The future of the drug was called into question after a ...
Joshua Cohen is a Boston-based writer who covers health policy. Louisiana is criminalizing the abortion pills mifepristone and misoprostol, just two years after the Supreme Court ruling to ...
The article discussed the implications of Judge Kacsmaryk’s opinion in Alliance for Hippocratic Medicine v US Food and Drug Administration, which questioned the FDA’s approval and subsequent Risk ...