In the days since Texas federal judge Matthew J. Kacsmaryk invalidated the approval by the US Food and Drug Administration (FDA) of mifepristone, a medication used to terminate pregnancy, a shock wave of concern has swept through many people, organizations, and companies that work closely with the agency. The strong opposition reflects the high stakes not only for pregnant persons and for the FDA, but also for the scientific process of drug development and public access to safe and effective medications. Twists and turns in the case are already happening. A federal appeals court stayed the full suspension of mifepristone, but permitted multiple restrictions on its availability. Then the Supreme Court, which recently overturned the constitutional right to abortion, kept the status quo in place for a few days while considering the government’s appeal. The results of the legal battle will be enormously consequential for reproductive health care—and far beyond, for innovation, science, and health.
The FDA plays such an important role in the health of Americans that it is easy to take its functions for granted. More than 15,000 agency employees regulate an estimated $2.7 trillion in consumer goods, including all medical products. Over more than a century, the FDA has developed extensive processes that govern the collection and review of preclinical and clinical data on biologics and drugs with defined scientific and legal-regulatory standards, earning high levels of trust from the public in the process.
The agency’s review of mifepristone in 2000 was thorough and fair. The drug’s manufacturer submitted a large dataset for the agency’s experts to review. An external advisory panel supported its approval. After a 6-month review, FDA’s scientific staff concluded that mifepristone is safe and effective. Over the past two decades, the medication’s safety record has grown stronger, with major medical professional associations in full support of access. Over time, the FDA, after thorough safety reviews, loosened restrictions on distribution.
The FDA’s expertise and diligence, however, barely seemed to matter to Kacsmaryk in his unprecedented decision last week. The judge’s use of extreme rhetoric, reliance on noncredible sources, and tendentious reasoning may have raised the hopes of the plaintiffs, who have a strong ideological opposition to abortion, but the decision also shredded any pretense of judicial objectivity and lowered the bar for efforts to overturn well-considered and justified determinations by the FDA......The FDA is a unique institution, bringing together intellectual resources from inside and outside government to make decisions on thousands of products each year. Once courts dismiss core scientific judgments by the agency, there is no reason to believe they will limit themselves to this one medication. There is already political pressure against vaccines, antidepressants and other psychotropic medication, and certain cell-derived therapies. If judges begin to dictate the terms of medication access, then others will seek to use ideology and influence to advance their agendas.
Respect for the integrity of the FDA underlies decades of progress in using science to save lives. Cracks in this foundation are as dangerous as they are unwarranted.
CNN—The federal district judge who first suspended the US Food and Drug Administration’s approval of the so-called abortion pill mifepristone failed to disclose during his Senate confirmation process two interviews on Christian talk radio where he discussed social issues such as contraception and gay rights.
In undisclosed radio interviews, Matthew Kacsmaryk referred to being gay as “a lifestyle” and expressed concerns that new norms for “people who experience same-sex attraction” would lead to clashes with religious institutions, calling it the latest in a change in sexual norms that began with “no-fault divorce” and “permissive policies on contraception.”
Kacsmaryk, a Trump-appointed federal district judge, made the unreported comments in two appearances in 2014 on Chosen Generation, a radio show that offers “a biblical constitutional worldview.” At the time, Kacsmaryk was deputy general counsel at First Liberty Institute, a nonprofit religious liberty advocacy group known before 2016 as the Liberty Institute, and was brought on to the radio show to discuss “the homosexual agenda” to silence churches and religious liberty, according to the show’s host…
(WaPo)—As a lawyer for a conservative legal group, Matthew Kacsmaryk in early 2017 submitted an article to a Texas law review criticizing Obama-era protections for transgender people and those seeking abortions.
The Obama administration, the draft article argued, had discounted religious physicians who “cannot use their scalpels to make female what God created male” and “cannot use their pens to prescribe or dispense abortifacient drugs designed to kill unborn children.”
But a few months after the piece arrived, an editor at the law journal who had been working with Kacsmaryk received an unusual email: Citing “reasons I may discuss at a later date,” Kacsmaryk, who had originally been listed as the article’s sole author, said he would be removing his name and replacing it with those of two colleagues at his legal group, First Liberty Institute, according to emails and early drafts obtained by The Washington Post.
What Kacsmaryk did not say in the email was that he had already been interviewed for a judgeship by his state’s two senators and was awaiting an interview at the White House.
As part of that process, he was required to list all of his published work on a questionnaire submitted to the Senate Judiciary Committee, including “books, articles, reports, letters to the editor, editorial pieces, or other published material you have written or edited.”
The article, titled “The Jurisprudence of the Body,” was published in September 2017 by the Texas Review of Law and Politics, a right-leaning journal that Kacsmaryk had led as a law student at the University of Texas. But Kacsmaryk’s role in the article was not disclosed, nor did he list the article on the paperwork he submitted to the Senate in advance of confirmation hearings in which Kacsmaryk’s past statements on LGBT issues became a point of contention…
UPDATE
"We just saw a fetal heartbeat bill signed in the dead of night recently in Florida. In my home state of South Carolina, there was a very small group of state legislators that filed a bill that would execute women who have abortions and gave more rights to rapists than women who've been raped."—Rep Nancy Mace, R-SC
"...I would deny the stay applications. Contrary to the impression that may be held by many, that disposition would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone. Rather, it would simply refuse to take a step that has not been shown as necessary to avoid the threat of any real harm during the presumably short period at issue."
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