Biden admin sued over failure to release abortion pill records

The Biden administration is being sued for information about the effectiveness of an abortion drug after the Department of Health and Human Services refused to release details about its test results.

Judicial Watch first filed Freedom of Information Act requests with HHS on the drug mifepristone in February, but when HHS refused to respond, the group filed a lawsuit last week. Judicial Watch believes the Food and Drug Administration may not have properly reviewed the drug for public use.

“Our experience is that this chemical abortion pill did not and will not receive appropriate review from the politicized FDA,” said Judicial Watch President Tom Fitton. “It is outrageous that Judicial Watch has had to sue in federal court for basic safety information about the abortion pill, which is being pushed on women by a desperate pro-abortion movement.”

The group is seeking correspondence between FDA and the manufacturers of Mifeprex, the brand name for the drug, about the drug’s stability, along with company tests on stability, which relates in part to how long the drug remains effective after its manufacture. The drug is made by DANCO and GenBio.

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President Biden waves to the crowd as he departs from a Democratic National Committee event at the Howard Theatre on Oct. 18, 2022 in Washington, D.C.
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Mifepristone is commonly referred to as “medication abortion” or “Plan C,” and is taken to terminate a pregnancy through the first 10 weeks. Studies show the drug, which is often taken privately without medical supervision, has four times the complication rate of surgical abortions.

The lawsuit comes as the Biden administration continues to promote the use of abortion pills as a way to maximize abortion access after the Supreme Court overturned Roe v. Wade. Health and Human Services said it will fight against future restrictions against abortion pills at the state level and warned that a refusal from pharmacies to provide access could be a violation of civil law.

In December, the FDA made permanent a pandemic-era decision to allow women to receive abortion pills via mail and allowed doctor visits to obtain prescriptions to be done virtually.

Fitton said he is concerned the FDA “is playing politics with the safety of this drug.”

“The Biden administration wants the pill to have wide access, so anything that threatens that agenda will be kept secret,” Fitton told Fox News Digital. “If this pill is as important as the Biden administration suggests, then American women have the right to as much information as possible on its safety and efficacy.”

Abortion pills have steadily increased in popularity over the past two decades. They accounted for more than half of U.S. abortions for the first time in 2020, which is expected to increase after the Roe decision. Meanwhile, the rate of emergency room visits after the use of abortion pills increased more than 500% between 2002 and 2015, according to data collected by the Charlotte Lozier Institute.

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People rally in support of abortion rights at the state Capitol in Sacramento, California, in May 2019. A proposed amendment to the state constitution that would protect the right to an abortion and contraceptives was approved by the state Senate Monday.
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Mifepristone has been the subject of wider complaints that it is much more dangerous than abortion activists are willing to admit. The FDA approved mifepristone to be prescribed and sold in the U.S. in 2000, and the agency continues to monitor its use through its Risk Evaluation and Mitigation Strategies, which require reports of adverse events for drugs deemed to have serious health risks.

However, the Obama administration in 2016 ended requirements to report adverse events after taking the drug, such as hemorrhages and ectopic pregnancies, so long as they do not result in death.

Dr. Ingrid Skop, a senior fellow at the Charlotte Lozier Institute with more than 25 years of experience as an OB-GYN, said the federal government owes its citizens answers on abortion pills, especially considering its documented risks.

“Judicial Watch’s action shines light on the FDA’s lack of transparency regarding the dangerous drug mifepristone,” Skop told Fox News Digital. “After 22 years, and progressively diminished supervision, the American public still has no reassurance regarding the quality of the manufacturing process or the quantity of complications because the FDA does not mandate complication reporting unless it results in a woman’s death.”

The FDA and HHS did not respond to a request for comment.

Mifepristone terminates a pregnancy by stopping the woman’s production of progesterone, which is the hormone that develops the fetus. The pill is usually followed by another drug, misoprostol, which causes cramping and bleeding to empty the uterus of the no-longer-living fetus.

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President Biden tugs at shirt collar while in White House.
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The U.S. struggled to receive approval to distribute abortion pills as they grew in popularity in the 1990s, but President Clinton eventually convinced the European manufacturer of mifepristone, Hoechst-Roussel, to donate its patent rights to the Population Council — a left-wing population control group. The Population Council was then tasked to find a pharmaceutical company through Danco Laboratories to manufacture the drug and eventually settled with a Chinese company after a European one backed out in fear of protest from pro-life activists.

The agency claimed earlier this year that U.S sold mifepristone manufacturing site switched from China to Europe, but declined to provide information on if, when, and how it changed pharmaceutical companies.

GenBio was approved to distribute the first genetic version of mifepristone in 2019, which had previously only been sold by Danco Laboratories under the label Mifeprex.

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Meredith Di Liberto, an attorney for Judicial Watch, said the health risks of abortion pills makes this information essential to the wellbeing of the public.

“The question is simply what is going on — and if there’s nothing nefarious, then let us know,” Di Liberto told Fox News Digital. “It’s so ludicrous that you can have something as simple as Tylenol saying where it’s from, then something the complete opposite with no answers.”