During his first term in office, President Trump’s FDA approved abortion pill maker GenBioPro Brief New Drug ApplicationOfficially bringing the first generic mifepristone to market. Six years later, their FDA has made the same mistake, approving another generic By Avita Solutions.
If they believe the pro-life movement is not paying attention, they are sorely mistaken.
The approval of Avita Solutions’ abbreviated new drug application comes swiftly after Department of Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary promised to review the safety of name-brand Mifeprex. reply to a letter Expressing the concerns of Republican attorneys general. This raises the question of how approving a second generic mifepristone accelerates the administration’s “Make America Healthy Again.”
Kennedy, champion of the MAHA agenda, went to x for rescue Agency’s bad decision amid pro-life response. They argued that the FDA “only approved the second generic mifepristone tablet because federal law requires approval when an application proves that the generic is substantially identical to the brand-name drug.”
While Kennedy may be right regarding the statutory requirements, this justification falls short and fails to take responsibility for what he acknowledges is forcing the agency’s hand – keeping Mifeprex on the market.
Medicines approved under the abbreviated application protocol depend on 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 right to suspend or withdraw altogether In the case of approval of a new medicine application or abbreviated application new information shows that “the medicine has not been shown to be safe for use under the conditions of use on the basis of which the application or abbreviated application was approved.”
Simply put, Kennedy and Makri had no legal obligation to keep mifepristone on the market while they reviewed the serious safety concerns brought forward by the Attorney General.
As noted by the Attorney General, a Analysis of health claims data Released this year, strong evidence was found that chemical abortion using mifepristone resulted in 22 times the number of adverse events claimed by the clinical trials supporting the original approval of Mifeprex.
Based on these concerns alone, Kennedy could have acted well within the powers of his office to suspend the approval of Mifeprex until an official review took place. This suspension would have clearly voided the statutory requirements he cited that oblige the FDA to approve Evita Solutions’ abbreviated application.
This reckless approval of a second generic mifepristone is not the “gold standard science” Secretary Kennedy wants 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 on the market will only increase competition, lower prices and increase access – the original goal of the abortion lobby.
Those who continue to argue that the promised review is unnecessary and nothing more than politically motivated drama ignore that even after highly favorable original approval and clinical trials, approval was only given with a full risk assessment and mitigation strategy.
Although the Kennedy-Makari FDA has not explicitly announced that the drug will remain on the market, the message appears to suggest that any action on their part would be a resumption of risk assessment and mitigation strategies, including requiring individual distribution. However, due to the prevalence of interstate distributors protected (for now) by abortion shield laws, as well as international distributors unaffected by federal law, resumption of risk assessment and mitigation strategies will not suffice. The only way to protect women from its dangers is to completely revoke the approval for the use of mifepristone for chemical abortion.
The Trump administration will undoubtedly face lawsuits from all sides of the abortion lobby. But when before was Trump’s team afraid of the threat of a lawsuit? It is not only within the authority, but also the duty, of the FDA to immediately remove mifepristone from the market while it completes its official review.
Gavin Oxley is the Media Relations Manager for Americans United for Life.
