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The pharmaceutical company that produces mifespristone asks the Supreme Court to intervene to guarantee access

2023-04-14T15:43:00.706Z


The Department of Justice had already requested an "emergency" measure from the country's highest court in light of the recent ruling against the drug used for medical abortions.


The pharmaceutical company that produces and markets mifepristone, a drug used in abortion pills, joined this Friday the Justice Department's request that the Supreme Court intervene to guarantee access to the drug, which is used in more than half of the interruptions of pregnancies in the country and has been shown to be safe and effective.

Danco Laboratories asked the highest court, which has a 6-3 majority and struck down federal abortion protections last year, to permanently stay a decision by a Texas federal judge against the drug, challenging its authorization of the drug. Food and Drug Administration (FDA) more than 20 years ago and orders that it be withdrawn from the market.

The company makes Mifeprex, the brand-name version of the drug, which was licensed in 2000.  

U.S. District Judge Matthew Kacsmaryk also struck down updates made by the FDA in 2016 and 2021 that expanded access, such as allowing them to be used until the 10th week of gestation, requiring only one person visit to obtain them instead of three as was originally;

and also authorize the mailing of the medication.

Danco said the court should immediately block Kacsmaryk's ruling in its entirety while it considers what steps to take, and should consider whether to quickly hear oral arguments and issue a full ruling in an expedited manner.

The company argued in its Supreme Court filing that it would be "irreparably harmed" if the decision goes into effect because it "will not be able to conduct its business nationwide and comply with its legal obligations," according to NBC News.

Cecilia, an abortion rights protester, holds an American flag during the Women's March in front of the Supreme Court in Washington, Sunday, Jan. 22, 2023. Amanda Andrade-Rhoades / AP

The Government of Joe Biden had appealed the decision of Judge Kacsmaryk, who was appointed by former President Donald Trump, warning that suspending the FDA's authorization of the pill "would seriously harm women" in the country, beyond the commercial consequences or how the ruling cast doubt on the agency's scientific judgment.

The New Orleans-based US Court of Appeals for the 5th Circuit responded to this request late Wednesday and did not uphold the Texas judge's suspension of mifepristone, which may continue to be sold while the legal challenge in against him, but he did agree to remove the 2016 and 2021 rules that expand access. 

The Justice Department then asked the Supreme Court on Thursday to intervene in the court battle with an "emergency" measure to strike down these restrictions, in defense of the FDA and to "protect access to safe and effective reproductive care." Attorney General Merrick Garland said in a statement.

Mifepristone was approved in 2000 by the FDA along with another drug, misoprostol, for medical abortion in the United States.

Multiple studies have shown that it is safe.

The new restrictions imposed in the latest appeals court ruling mean that those who need the drug would have to go in person multiple times to get it, which can limit access, particularly when there are more than a dozen states that do not allow it. medical abortion so its residents have to travel to other states to get the care they need. 

The time in which they may require it is also shortened, since it can only be used up to the seventh week of pregnancy. 

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The White House had anticipated that it would fight to the bitter end to guarantee access to mifepristone since the coalition of anti-abortion groups with the Alliance for Hippocratic Medicine launched the case against the drug.

Clinics in different parts of the country have also anticipated that they are preparing for a possible scenario in which the drug is not available on the market, by providing more services for surgical procedures or by prescribing the other drug, misoprostol, as an alternative for perform an abortion.

Some states have also purchased large quantities of abortion pill doses or hoarded stocks.

Defenders of reproductive rights have also recalled that abortion is not prohibited in a good part of the country, and that options can be sought in different states, although the restrictions have varied since the Supreme Court annulled Roe v

.

Wade

.

Medical abortion is legal in some form in 37 states: it is authorized in 22 states and Washington DC, but in 15 states it must be prescribed by a specialized doctor.

Some have more restrictions like requiring an in-person visit.

Source: telemundo

All news articles on 2023-04-14

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