'Pregnancy Isn't an Illness': Judge to Decide 'Soon' if FDA Violated Safety Rules on Abortion Drug
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A federal judge pressed both sides in a hearing on Wednesday questioning FDA approval of an abortion drug.
The case comes after the FDA recently expanded access to the drug regimen, allowing doctors to prescribe it via telehealth appointments for women to receive the abortion-inducing pills through the mail.
The lawsuit takes aim at the FDA's decisions to loosen safety rules around prescribing the pill. It also contends that mifepristone, the first of the two drugs taken to cause an abortion, is not as safe as advertised and should not have even received FDA approval back in 2000.
The Alliance Defending Freedom is part of the case, arguing that mifepristone did not undergo proper vetting.
In the four-hour hearing, Judge Matthew Kacsmaryk questioned whether the process to approve the drug rose to federal standards needed for approval.
FDA's 'Accelerated Approval'
The FDA had approved the pill under its so-called Accelerated Approval Program, which was created to expedite access to the first HIV drugs. Since then, it has been used to rush drugs for cancer and other “serious or life-threatening diseases."
“The plain text is clear – it applies to illnesses,” argued Erik Baptist, ADF's lead attorney. “Mifepristone is used to end pregnancies, and pregnancy isn’t an illness.”
Dr. Ingrid Skop, senior fellow and director of Medical Affairs for the Charlotte Lozier Institute, told CBN News earlier this month, "From approval and then every time the FDA has loosened its restrictions, it has gone against its own rules to do so."
"Studies since that time have shown us that women have four times as many complications after chemical abortions, so they added a drug that was subpar compared to what was already available," Dr. Skop said.
Skop notes a third of women who have chemical abortions are under 18, but she contends the FDA didn't conduct a study on pediatric populations during the approval process.
Does a Judge Have the Power to Overturn the FDA?
Meanwhile, during the hearing Kacsmaryk also questioned whether a judge has the authority to withdraw the FDA's approval of the drug.
“Explain to me why this court has that sweeping authority?” Kacsmaryk asked, in reference to the request for a preliminary order pulling mifepristone from the market.
Kacsmaryk is a Christian who is known for his pro-life views. He did not indicate how he might rule, but did say he would make a decision "as soon as possible."
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