Tero
Philosopher
https://slate.com/news-and-politics...rtion-case-actually-limited-mifepristone.htmlBut we would like to offer some clarification here. Because despite the barrage of predictions that this case could ban mifepristone and take it off the market, there are several basic legal principles suggesting that Judge Kacsmaryk’s power is limited and that a ruling for the plaintiffs will not necessarily change much at all with medication abortion.
Judge Kacsmaryk cannot force the FDA to adopt another process to do the same—doing so would violate federal law. At best, he should only be able to order the agency to start the congressionally mandated process, which involves public hearings and new agency deliberations. This could take months or years, with no guarantee of the result.
....settled law, decided in a unanimous 1985 Supreme Court decision, that the agency has broad enforcement discretion, meaning the agency, not courts, gets to decide if and when to enforce the statute. The FDA has historically used a risk-based approach to prioritize its enforcement actions, focusing on the products with demonstrated safety concerns. Occasionally, the FDA will issue a guidance document giving some drug manufacturers safe harbor to violate the relevant statute in certain contexts, such as when the safety risk is low, which it has done with products as wide-ranging as infant formula and fecal transplants. It should decide to take a similar approach with mifepristone if the drug’s approval is removed, given the drug’s exemplary safety profile.
The type of situation the judge is dealing with would be more appropriate for cases against a drug company. Many drugs were taken off market only after a clear risk became apparent after the drug was launched. The 1 in 10 000 deaths and the cases where long term use caused harm for the patients. Those a judge could alert the FDA on if they had not noticed the problem.
. Elections in the USA are FUBAR. There is no voting these wingnuts in, because the American vote doesn't matter.