(C) Minnesota Reformer This story was originally published by Minnesota Reformer and is unaltered. . . . . . . . . . . Texas judge’s attack on medication abortion is an attack on the rule of law [1] ['More From Author', 'April', 'Laura Hermer'] Date: 2023-04-13 The ruling by the federal judge in Texas last week to stay the Food and Drug Administration’s 23-year-old approval of a critical abortion drug is, to be charitable, the work of a partisan. But far worse, Judge Matthew Kacsmaryk’s opinion on mifepristone — one of two drugs used in most medication abortions — disregards legal standards and further destabilizes the rule of law in America. If the higher courts reviewing the decision care more about fidelity to the law and our social contract than they do about restricting abortion at any cost, they will swiftly reverse the decision. The 5th Circuit’s Wednesday order, however, does not inspire confidence in this regard, even though it temporarily maintains mifepristone’s availability with restrictions. Kacsmaryk made no secret of his allegiances in his opinion. To the judge, products of conception at any stage of gestation are “unborn children.” Physicians who prescribe mifepristone to terminate a pregnancy are “abortionists.” Planned Parenthood doesn’t provide reproductive health care; rather, it is run by “eugenicists.” This certainly isn’t the worst part of the opinion, but it shows the reader from the very outset where it’s going. The role of the FDA is to determine whether a proposed drug is both safe and effective for its proposed purpose: here, pregnancy termination. All drugs have risks and benefits. The question is whether the risks are reasonable concerning any benefit the drug confers. These risks and benefits are evaluated through a series of trials — first for safety, and then for effectiveness — which the FDA evaluates in determining whether to grant approval to an entity to market the drug. FDA didn’t review mifepristone under the normal protocols. Rather, it used an accelerated process to approve risky drugs for “serious” or “life-threatening” conditions like HIV and cancer that allows FDA to impose “Risk Evaluation and Mitigation Strategies,” or REMS, on the drug. The FDA says it can require REMS for certain medications with safety concerns to help ensure the benefits of the medication outweigh its risks. Very few drugs are subject to REMS. Presently, only about 61 drugs out of over 19,000 have active REMS in place. History suggests that FDA used this approval pathway not because it found mifepristone to be dangerous to its user, but because a substance that makes it easier and safer to abort a pregnancy was far too controversial in the 1990s to not impose obstacles to its use. But this accelerated approval process made the drug more vulnerable to a host of incorrect claims like the very ones made in this case. If FDA had used its normal process, this case would not have been possible. Since its approval in 2000, over 5 million people have safely used mifepristone to terminate their pregnancies. The drug has a better safety record than penicillin or Viagra. Despite this, Kacsmaryk — a judge, not an FDA scientist — used a handful of studies that authors affiliated with the plaintiffs and amici helped write to reject FDA’s conclusions about mifepristone’s safety. These studies purported to find, despite copious research to the contrary, that medication abortion is dangerous and that many women who take mifepristone allegedly suffer “intense psychological trauma and post-traumatic stress.” The judge didn’t reach this conclusion by reasonably construing relevant law and applying that law to the facts. Rather, he substituted his own opinion for the FDA’s, staying mifepristone’s approval in order, he said, “to protect women and girls.” This is not about protecting women and girls. It is also not about protecting fetuses. This is about delegitimizing an institution necessary for our safety – the FDA – in the service of forcing both unwanted parenthood with all its duties and costs and subordinate status onto women and others who can get pregnant. Nowhere else in American law do we force anyone to provide any part of themselves to keep someone else alive. Minnesota can take two steps now: First, it can join Washington, California and Massachusetts in stockpiling mifepristone. Second, the Legislature needs to pass the bill (HF91/SF70) that would repeal antiquated, unconstitutional laws sitting dormant on our books. In his decision, Kacsmaryk used the Comstock Act — a federal law originally enacted in 1873 to criminalize the mailing of “lewd” and “obscene” materials, abortifacients, and contraceptives — to declare that FDA likely acted illegally in permitting mifepristone to be dispensed by mail. It sat unenforced for the last half century. But now, this zombie law lurches among us again. Minnesota, too, has a state “Comstock” law, waiting either to be repealed this legislative session through HF91 … or to be brought back to life again, perhaps soon. This is no joke. It’s happening now. We cannot sleep on our rights. We must act now. [END] --- [1] Url: https://minnesotareformer.com/2023/04/13/texas-judges-attack-on-medication-abortion-is-an-attack-on-the-rule-of-law/ Published and (C) by Minnesota Reformer Content appears here under this condition or license: Creative Commons License CC BY-NC-ND 4.0. via Magical.Fish Gopher News Feeds: gopher://magical.fish/1/feeds/news/MnReformer/