The US Supreme Court has issued a 2-day pause on a lower ruling that would revoke the decades-old approval of mifepristone, a key component of the abortion pill. The stay would end at midnight this Friday, April 21st. The ruling has drawn substantial criticism, not the least of which is that allowing a judge to overturn approval by the US Food and Drug Administration (FDA) would undermine the agency’s authority to regulate medications.
Following calls to act on a ruling from a Texas federal judge that would overturn the US Food and Drug Administration’s (FDA’s) approval of the abortion drug mifepristone, the Supreme Court has stepped in and placed a 5-day hold on the lower court’s decision. The temporary stay will last until Wednesday, April 19th.
Both the US Department of Justice (DOJ) and the mifepristone distributor Danco Laboratories have called upon the US Supreme Court to act quickly to hold back the effects of dueling federal court cases regarding the drug. The Fifth Circuit Court of Appeals temporarily paused last week’s ruling that mifepristone, a key drug used in the abortion pill, was inappropriately approved. Although mifepristone can stay on the market for now, expanded access to the drug would be cut, putting manufacturers and the FDA in conflict with another ruling last Friday.
The US Fifth Circuit of Appeals issued a ruling that temporarily blocks last week’s federal court ruling overturning the approval of mifepristone, a key component for the abortion pill. The pause is temporary, and it may require the US Food and Drug Administration (FDA) to revert to previous rules regarding its distribution.
The US Food and Drug Administration’s authority to approve medications is on the line, following a Texas judge shooting down the decades-old approval of the abortion medication mifepristone. With this development, the agency is looking for ways to preserve its powers while keeping mifepristone on the market. The strategy will depend on an appeal at the Fifth Circuit tomorrow.
In an amicus brief filed by a group of organizations, industry groups, and several biotech executives, writers argue that last week’s ruling overturning the US Food and Drug Administration’s (FDA’s) approval of mifepristone, a key component of the abortion pill, will “upend” the agency’s approval process for new drugs. This change, the authors warn, would harm patients and cut back research investments into drug development, as any drug may be pulled from market based on a judge’s whims.
Last week’s ruling in a US federal court that struck down the decades-old approval of mifepristone, a key drug in the abortion pill, has the US Food and Drug Administration (FDA) and the entire pharma industry on edge. The ruling, according to some legal experts, would undermine the agency’s ability to independently approve drugs based on scientific evidence. Another ruling last Friday ordered the FDA to continue providing the drug to 17 states.
Following a ruling invalidating the approval of mifepristone, a key component of the abortion pill, US Health and Human Services Secretary Xavier Beccera noted that such a decision undermines the Food and Drug Administration’s authority to approve therapeutics. Beccera said that the decision could let judges make the final call on whether drugs are approved, which may be weaponized against politically polarized drugs like COVID vaccines or new Alzheimer’s drugs.
The same day that a Texas judge issued a ruling invalidating the US Food and Drug Administration’s (FDA’s) decades long approval of mifepristone, a key component of the abortion pill, a federal judge in Washington state ruled that the FDA may not roll back access to the drug in 17 states. The ruling , delivered by US District Court Judge Thomas Rice, is in direct opposition by the nationwide ruling issued in Texas.
In response to a ruling by US District Court Judge Matthew Kacsmaryk that invalidated the 20-year-old approval of mifepristone, a key component of the abortion pill, US House Democrats have begun preparing a bill that would codify the agency’s right to approve the drug. The bill, which will likely face stiff resistance from the Republican House majority, was announced by representatives Pat Ryan (D-NY) and Lizzie Fletcher (D-Texas).
US District Court Judge Matthew Kacsmaryk issued a ruling invalidating the decades-old approval of a key component of the most common form of abortion pill in the US, mifepristone. The ruling, which fell in favor of anti-abortion activists, ends not only the initial approval by the US Food and Drug Administration (FDA) but also recent policies meant to expand access to the drug. The move, some lawmakers, abortion rights advocates, and legal experts content, would undermine the agency’s independence.
A court case that will determine the fate of nationwide access to the a pill used to induce abortions and treating miscarriage may trigger a sea change in the pharmaceutical industry in the US. If the far right-wing judge presiding over the case, a Donald Trump appointee, rules in favor of rescinding the approval of mifepristone, it will set a precedent that court cases can overrule drug approvals by the Food and Drug Administration (FDA).
A District Court judge in Texas will decide the fate of access to abortion pills in the US. Judge Matthew Kacsmaryk, appointed to his office by Donald Trump, could decide to overrule the Food and Drug Administration’s long-standing approval of one of two drugs used for pharmaceutical abortions or limit access – even outside of the Lone Star State.
A group of conservatives called the Alliance for Hippocratic Medicine challenging the approval of mifepristone, a pill used for safe abortions, has met resistance from the US Food and Drug Administration (FDA). The group and other far-right activists claim the agency rushed the drug’s approval and claim that the agency declared pregnancy an illness in the decision.
In response to crackdowns on abortion rights in the US after Roe v. Wade was overturned, the Food and Drug Administration has changed risk evaluation and mitigation strategy (REMS) policies regarding Mifeprex, an abortion pill, that will increase patient access. The drug was formerly only available at registered clinics, but can now be dispensed at a pharmacy or by mail. It still requires a prescription, however, a potential barrier in many states.
The cancer care for many US patients is in peril due to the legal consequences of the wave of abortion bans following the repeal of Roe v. Wade. States like Georgia have adopted laws that have legal ambiguity in definitions of medically-necessary abortion. As a result some patients will likely be denied care or have it delayed due to fears of legal repercussions.
Only weeks after the US Supreme Court reversed the right to safe abortions by overturning Roe V. Wade, Senator Lindsey Graham (R-SC) has introduced a bill that would ban abortions after 15 weeks into pregnancy. The bill, which is doomed to fail with Democrats controlling Congress and the presidency, is in contradiction with Graham’s statement a month ago that abortion laws should be decided at the state level.