A person holds a box of mifepristone tablets on March 26, 2024.
Court Lets US Abortion Pill Access Continue—Until Trump FDA Finishes Review Condemned as 'Sham'
A federal judge opted not to rule on a lawsuit seeking to overturn FDA approval of mifepristone until the FDA completes a review that has been described as a political pretext to restrict abortion.
Access to the abortion drug mifepristone will remain unchanged in the US for now after a federal district judge on Sunday paused a lawsuit aimed at overturning the Food and Drug Administration's approval of the medication. But he left the door open for the Trump administration to restrict access to the drug.
US District Judge Reed O'Connor of the Northern District of Texas refused the manufacturer's motion to dismiss a lawsuit brought by Texas and Florida seeking to overturn FDA approval of mifepristone altogether. But the judge accepted the US Department of Justice's (DOJ) motion to stay the case until December 1, or until the FDA completes a "review" of the drug that it will use to determine whether access to it should be tightened.
That FDA review, spearheaded by Health and Human Services Secretary Robert F. Kennedy Jr., has been criticized as a politicized effort to create a pretext for the anti-abortion Trump administration to restrict abortion pill access, including in states where the procedure is legal.
Nearly 700,000 people use mifepristone per year, according to the Guttmacher Institute, which has found it to be the method for the majority of US abortions in recent years.
Receiving it through the mail via out-of-state telehealth providers has become a go-to method for those in states with bans on terminating a pregnancy. The drug has been used by around 7.5 million people since it was first approved in 2000.
The FDA's own current webpage states that its periodic reviews of mifepristone have “not identified any new safety concerns” and that the drug is safe when used as directed. Prior FDA reviews have found that hospitalization occurs in only 0.04-0.6% of all medication abortions.
Despite the lack of any clearly identified risk, the Trump FDA has said that the ongoing review could lead to “substantive changes" to the Risk Evaluation and Mitigation Strategy for the drug, leading some to argue that it is a "sham" meant to create a scientific justification for the administration's goal of restricting abortion.
"Ensuring legal access to mifepristone in the long term is vital to women’s healthcare and reproductive freedom," said Evan Masingill, the CEO of GenBioPro, which manufactures generic mifepristone and sued to defend the FDA's approval of its product.
"We expect the FDA’s review of mifepristone to not contradict the decision they made in 2023 that reaffirmed our product is safe and effective," Masingill said.
The US Supreme Court ruled earlier this year that lower courts could not block the FDA's 2023 decision, under the Biden administration, to lift in-person dispensing requirements for mifepristone following the overturning of Roe v. Wade the previous year. The in-person requirement was lifted following a 2021 FDA review that deemed the rules unnecessary.
The Supreme Court has previously blocked individual anti-abortion doctors from bringing lawsuits against the FDA, ruling that they did not have standing to claim personal injury.
But Texas and Florida have sought to get around this by suing as states, and so far, courts have allowed them to do so. The conservative 5th Circuit accepted a similar argument from Louisiana earlier this year.
However, O'Connor—an appointee of former President George W. Bush—did not rule on the merits of whether the states' claims against the FDA were correct.
But even if that lawsuit fails, the Trump administration could dramatically curtail access to mifepristone by reinstating in-person dispensing requirements, placing new limits on which pharmacies can dispense the drug, and adding new requirements for prescribers and patients.
“The FDA has affirmed time and again that mifepristone is safe and effective,” said Skye Perryman, President and CEO of Democracy Forward, which is representing the drugmaker. “Far-right, anti-science extremists may be pressuring the Trump-Vance administration to reach a different, ideologically-driven outcome, but we will continue to represent our clients to hold the FDA to the same science-based standards it has long applied to protect people’s ability to access effective, evidence-based healthcare, including protecting access to medication abortion.”
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Access to the abortion drug mifepristone will remain unchanged in the US for now after a federal district judge on Sunday paused a lawsuit aimed at overturning the Food and Drug Administration's approval of the medication. But he left the door open for the Trump administration to restrict access to the drug.
US District Judge Reed O'Connor of the Northern District of Texas refused the manufacturer's motion to dismiss a lawsuit brought by Texas and Florida seeking to overturn FDA approval of mifepristone altogether. But the judge accepted the US Department of Justice's (DOJ) motion to stay the case until December 1, or until the FDA completes a "review" of the drug that it will use to determine whether access to it should be tightened.
That FDA review, spearheaded by Health and Human Services Secretary Robert F. Kennedy Jr., has been criticized as a politicized effort to create a pretext for the anti-abortion Trump administration to restrict abortion pill access, including in states where the procedure is legal.
Nearly 700,000 people use mifepristone per year, according to the Guttmacher Institute, which has found it to be the method for the majority of US abortions in recent years.
Receiving it through the mail via out-of-state telehealth providers has become a go-to method for those in states with bans on terminating a pregnancy. The drug has been used by around 7.5 million people since it was first approved in 2000.
The FDA's own current webpage states that its periodic reviews of mifepristone have “not identified any new safety concerns” and that the drug is safe when used as directed. Prior FDA reviews have found that hospitalization occurs in only 0.04-0.6% of all medication abortions.
Despite the lack of any clearly identified risk, the Trump FDA has said that the ongoing review could lead to “substantive changes" to the Risk Evaluation and Mitigation Strategy for the drug, leading some to argue that it is a "sham" meant to create a scientific justification for the administration's goal of restricting abortion.
"Ensuring legal access to mifepristone in the long term is vital to women’s healthcare and reproductive freedom," said Evan Masingill, the CEO of GenBioPro, which manufactures generic mifepristone and sued to defend the FDA's approval of its product.
"We expect the FDA’s review of mifepristone to not contradict the decision they made in 2023 that reaffirmed our product is safe and effective," Masingill said.
The US Supreme Court ruled earlier this year that lower courts could not block the FDA's 2023 decision, under the Biden administration, to lift in-person dispensing requirements for mifepristone following the overturning of Roe v. Wade the previous year. The in-person requirement was lifted following a 2021 FDA review that deemed the rules unnecessary.
The Supreme Court has previously blocked individual anti-abortion doctors from bringing lawsuits against the FDA, ruling that they did not have standing to claim personal injury.
But Texas and Florida have sought to get around this by suing as states, and so far, courts have allowed them to do so. The conservative 5th Circuit accepted a similar argument from Louisiana earlier this year.
However, O'Connor—an appointee of former President George W. Bush—did not rule on the merits of whether the states' claims against the FDA were correct.
But even if that lawsuit fails, the Trump administration could dramatically curtail access to mifepristone by reinstating in-person dispensing requirements, placing new limits on which pharmacies can dispense the drug, and adding new requirements for prescribers and patients.
“The FDA has affirmed time and again that mifepristone is safe and effective,” said Skye Perryman, President and CEO of Democracy Forward, which is representing the drugmaker. “Far-right, anti-science extremists may be pressuring the Trump-Vance administration to reach a different, ideologically-driven outcome, but we will continue to represent our clients to hold the FDA to the same science-based standards it has long applied to protect people’s ability to access effective, evidence-based healthcare, including protecting access to medication abortion.”
Access to the abortion drug mifepristone will remain unchanged in the US for now after a federal district judge on Sunday paused a lawsuit aimed at overturning the Food and Drug Administration's approval of the medication. But he left the door open for the Trump administration to restrict access to the drug.
US District Judge Reed O'Connor of the Northern District of Texas refused the manufacturer's motion to dismiss a lawsuit brought by Texas and Florida seeking to overturn FDA approval of mifepristone altogether. But the judge accepted the US Department of Justice's (DOJ) motion to stay the case until December 1, or until the FDA completes a "review" of the drug that it will use to determine whether access to it should be tightened.
That FDA review, spearheaded by Health and Human Services Secretary Robert F. Kennedy Jr., has been criticized as a politicized effort to create a pretext for the anti-abortion Trump administration to restrict abortion pill access, including in states where the procedure is legal.
Nearly 700,000 people use mifepristone per year, according to the Guttmacher Institute, which has found it to be the method for the majority of US abortions in recent years.
Receiving it through the mail via out-of-state telehealth providers has become a go-to method for those in states with bans on terminating a pregnancy. The drug has been used by around 7.5 million people since it was first approved in 2000.
The FDA's own current webpage states that its periodic reviews of mifepristone have “not identified any new safety concerns” and that the drug is safe when used as directed. Prior FDA reviews have found that hospitalization occurs in only 0.04-0.6% of all medication abortions.
Despite the lack of any clearly identified risk, the Trump FDA has said that the ongoing review could lead to “substantive changes" to the Risk Evaluation and Mitigation Strategy for the drug, leading some to argue that it is a "sham" meant to create a scientific justification for the administration's goal of restricting abortion.
"Ensuring legal access to mifepristone in the long term is vital to women’s healthcare and reproductive freedom," said Evan Masingill, the CEO of GenBioPro, which manufactures generic mifepristone and sued to defend the FDA's approval of its product.
"We expect the FDA’s review of mifepristone to not contradict the decision they made in 2023 that reaffirmed our product is safe and effective," Masingill said.
The US Supreme Court ruled earlier this year that lower courts could not block the FDA's 2023 decision, under the Biden administration, to lift in-person dispensing requirements for mifepristone following the overturning of Roe v. Wade the previous year. The in-person requirement was lifted following a 2021 FDA review that deemed the rules unnecessary.
The Supreme Court has previously blocked individual anti-abortion doctors from bringing lawsuits against the FDA, ruling that they did not have standing to claim personal injury.
But Texas and Florida have sought to get around this by suing as states, and so far, courts have allowed them to do so. The conservative 5th Circuit accepted a similar argument from Louisiana earlier this year.
However, O'Connor—an appointee of former President George W. Bush—did not rule on the merits of whether the states' claims against the FDA were correct.
But even if that lawsuit fails, the Trump administration could dramatically curtail access to mifepristone by reinstating in-person dispensing requirements, placing new limits on which pharmacies can dispense the drug, and adding new requirements for prescribers and patients.
“The FDA has affirmed time and again that mifepristone is safe and effective,” said Skye Perryman, President and CEO of Democracy Forward, which is representing the drugmaker. “Far-right, anti-science extremists may be pressuring the Trump-Vance administration to reach a different, ideologically-driven outcome, but we will continue to represent our clients to hold the FDA to the same science-based standards it has long applied to protect people’s ability to access effective, evidence-based healthcare, including protecting access to medication abortion.”