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FDA Defends Abortion Pill Approval in Response to Texas Lawsuit
FDA Defends Abortion Pill Approval in Response to Texas Lawsuit
Jan. 18, 2023, 11:58 AM
• Challenge threatens pill access, HHS says
• Pharmacies can now get certified to dispense
A Texas judge should reject an attempt by abortion opponents to halt access to a pill that induces abortions, the FDA said in response to a lawsuit challenging the agency’s decades-old approval of the drug.
An order granting the motion from conservative legal group Alliance Defending Freedom to stop the distribution of mifepristone would improperly undo a “longstanding scientific determination based on speculative allegations of harm,” attorneys for the Department of Health and Human Services and the Food and Drug Administration wrote in a Jan. 13 court filing. ... They added that a decision in favor of ADF would also “upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”
The Biden administration’s response comes as it seeks to maintain abortion access after the Supreme Court’s ruling overturning Roe v. Wade. Legal observers have said that ADF’s challenge, which sits before a Trump-appointed Texas judge, poses the greatest legal threat in years to access to abortion pills in America.
ADF, known for Supreme Court victories such as its protection of a Christian baker who refused to make a wedding cake for an LGBTQ couple, argued in its November legal filing against the FDA that the agency used accelerated approval regulations to improperly characterize pregnancy as an illness. The provisions are supposed to apply to drugs that “are intended to treat serious or life-threatening illnesses” and provide a substantial benefit over existing treatments.
{snip}
Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 2:22-cv-00223, Response in Opposition 1/13/23
To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com
To contact the editor responsible for this story: Cheryl Saenz at csaenz@bloombergindustry.com
Jan. 18, 2023, 11:58 AM
• Challenge threatens pill access, HHS says
• Pharmacies can now get certified to dispense
A Texas judge should reject an attempt by abortion opponents to halt access to a pill that induces abortions, the FDA said in response to a lawsuit challenging the agency’s decades-old approval of the drug.
An order granting the motion from conservative legal group Alliance Defending Freedom to stop the distribution of mifepristone would improperly undo a “longstanding scientific determination based on speculative allegations of harm,” attorneys for the Department of Health and Human Services and the Food and Drug Administration wrote in a Jan. 13 court filing. ... They added that a decision in favor of ADF would also “upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”
The Biden administration’s response comes as it seeks to maintain abortion access after the Supreme Court’s ruling overturning Roe v. Wade. Legal observers have said that ADF’s challenge, which sits before a Trump-appointed Texas judge, poses the greatest legal threat in years to access to abortion pills in America.
ADF, known for Supreme Court victories such as its protection of a Christian baker who refused to make a wedding cake for an LGBTQ couple, argued in its November legal filing against the FDA that the agency used accelerated approval regulations to improperly characterize pregnancy as an illness. The provisions are supposed to apply to drugs that “are intended to treat serious or life-threatening illnesses” and provide a substantial benefit over existing treatments.
{snip}
Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 2:22-cv-00223, Response in Opposition 1/13/23
To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com
To contact the editor responsible for this story: Cheryl Saenz at csaenz@bloombergindustry.com