During his first term in office, President Trump’s FDA approved abortion pill manufacturer GenBioPro’s abbreviated new drug application, officially bringing the first generic mifepristone to the market. Six years later, his FDA has made the same mistake, approving a second generic by Evita Solutions.
If they believe the pro-life movement is not watching, they are sorely mistaken.
The approval of the Evita Solutions abbreviated new drug application comes swiftly on the heels of a promise by Department of Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to review the safety of the name-brand Mifeprex, responding to a letter voicing the concerns of Republican attorneys general. This raises questions about just how approving a second generic mifepristone accelerates the administration’s “Make America Healthy Again.”
Kennedy, a champion of the MAHA agenda, took to X to defend the agency’s ill-conceived decision amidst pro-life backlash. He argued that the FDA “only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”
Although Kennedy may be correct regarding statutory requirements, this justification falls short and fails to take responsibility for the very thing he acknowledges is forcing the agency’s hand — keeping Mifeprex on the market.
Drugs approved under the abbreviated application protocol rely upon the clinical trials and safety record of the original name-brand approval — in this case, Mifeprex. Under the Code of Federal Regulations, the secretary of HHS has authority to suspend or completely withdraw approval of a new drug application or abbreviated application in the case new information reveals that “the drug is not shown to be safe for use under the conditions of use upon the basis of which the application or abbreviated application was approved.”
Simply put, Kennedy and Makary were under no legal obligation to keep mifepristone on the market while reviewing the serious safety concerns brought forth by the attorneys general.
As noted by the attorneys general, an analysis of health claims data released this year demonstrated strong evidence that chemical abortions using mifepristone resulted in 22 times the number of adverse events claimed by clinical trials supporting the original approval of Mifeprex.
Based on these concerns alone, Kennedy would have been well within the powers of his office to suspend approval of Mifeprex until an official review is conducted. This suspension would have plainly nullified the statutory requirements he referenced that bound the FDA to approve the Evita Solutions abbreviated application.
This negligent approval of a second generic mifepristone is not the “Gold Standard Science” Secretary Kennedy wishes to be the legacy of his office.
Due to the nature of our free market economy, the approval and introduction of a second generic mifepristone to the market will only increase competition, driving prices down and increasing accessibility — the very goal of the abortion lobby.
Those who continue to argue the promised review is unnecessary and nothing more than a politically motivated charade ignore that even after the highly favorable original approval and clinical trials, approval was given only with a full Risk Evaluation and Mitigation Strategy.
Although the Kennedy-Makary FDA has not unequivocally announced that the drug will stay on the market, is messaging seems to imply that any action on their part will be, at most, the restoration of the Risk Evaluation and Mitigation Strategy, including the in-person dispensing requirement. However, due to the prevalence of interstate distributors protected (for now) by abortion shield laws, as well as international distributors undeterred by federal law, restorations of the Risk Evaluation and Mitigation Strategy will not be enough. Complete revocation of mifepristone’s approval to be used for chemical abortions is the only path to protecting women from its dangers.
The Trump administration will unquestionably face lawsuits from all parties within the abortion lobby. But when before has Trump’s team been deterred by the threat of litigation? It is not only within the power but also part of the the duty of the FDA to immediately remove mifepristone from the market while completing its official review.
Gavin Oxley is the Media Relations Manager for Americans United for Life.
