Texas Judge Mulls Revoking FDA Approval for Abortion Pills In USA - medtigo



Texas Judge Mulls Revoking FDA Approval for Abortion Pills In USA

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A Texas judge heard arguments on whether a commonly used abortion pill should be sold in the United States, and his decision could limit access to the treatment nationwide.  

As per BBC, The pill, mifepristone, can be taken at home and is utilized in over fifty percent of pregnancy terminations in the United States. A lawsuit filed in Texas by an anti-abortion group asserts that the drug’s safety was never adequately evaluated. Mifepristone has been authorized for use for more than two decades.  

The case, which will be handled by Judge Matthew Kacsmaryk, an appointee of US President Donald Trump, follows the historic overturning of the constitutional right to abortion by the US Supreme Court last year. During the four-hour hearing on Wednesday, he stated that he will issue his decision as soon as possible.  

The Association for Hippocratic Medicine, an anti-abortion organization, believes that the drug should be pulled off shelves for three reasons in a lawsuit filed in Texas. First, the lawsuit alleges that the US Food and Drug Administration (FDA) erred by allowing the pill under a provision designed to expedite the approval of medications used to treat life-threatening diseases.  

The second argument is that the FDA approved mifepristone without sufficient testing.  

The third argument is that shipping the medicine is prohibited under the Comstock Act of 1873, which prohibited the mailing of abortion drugs. In December of last year, however, the Office of Legal Counsel of the United States Department of Justice published an opinion that the Comstock Act does not prohibit the distribution of abortion drugs intended for legal use.  

According to the Washington Post, in court, Judge Kacsmaryk called the FDA’s approval procedure as rushed.  The FDA reviewed the medicine for four years prior to its approval in 2000.  

The administration of President Joe Biden has replied to the lawsuit by saying that the approval of mifepristone was fully backed by research. Since its approval in 2000, the FDA has reported a total of 26 deaths related with the medicine, or around 0.65 deaths per 100,000 abortions via pill.  


Comparatively, the death risk associated with chronic aspirin use is approximately 15.3 per 100,000 aspirin users. If Judge Kacsmaryk determines that the FDA made an error in approving the medicine, sales of one of just two tablets used to induce an abortion might be blocked.  

According to I. Glenn Cohen, a Harvard law expert, such an unusual judgement would fundamentally undermine the entire independent drug regulatory system in the United States. Prof. Cohen stated that this could affect not only access to the treatment for millions of women, but also the development of new drugs by pharmaceutical corporations.  

He stated that it was feasible for the matter to reach the Supreme Court. If the pill were taken off the market, women may still utilize misoprostol, the other licensed abortion medication. Misoprostol is typically the sole alternative in nations where mifepristone is prohibited for abortions. Several clinics and providers in the United States solely offer misoprostol.  

However, the treatment is somewhat less effective than a two-drug regimen with mifepristone. Judge Kacsmaryk instructed attorneys not to disclose the date of Wednesday’s session, citing death threats and threatening phone calls. Numerous media sites criticized the unusual request, citing worries about openness, and wrote to the court. A tiny group of anti-lawsuit demonstrators gathered in front of the federal court in Amarillo.  

Julie Marie Blake, senior counsel for the Alliance Defending Freedom, a conservative organization that supports the lawsuit, told the BBC’s US partner CBS that the organization is “confident that when any court examines the law and the science, it will realize that the FDA has completely failed its responsibility to protect women and girls.”  

However, twelve states run by Democrats, including Washington, Arizona, Colorado, Delaware, and Connecticut, have launched a second case against the FDA in an effort to expand access to mifepristone. This lawsuit contends that the FDA’s present medication restrictions are “burdensome, detrimental, and unneeded.” 


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