Amid Review Of Deadly Abortion Drug, FDA Greenlights Copycat

The U.S. Food and Drug Administration (FDA) has approved a generic version of mifepristone, a medication widely used for abortions, manufactured by Evita Solutions. This decision comes after the agency announced plans to re-evaluate the safety and efficacy of mifepristone amid ongoing scrutiny.

Explainer Amid Review Of Deadly Abortion Drug, FDA Greenlights Copycat

Health and Human Services Secretary Robert F. Kennedy Jr. confirmed on September 4 that the FDA was reviewing new data on mifepristone. He stated that the Biden administration had previously manipulated data to downplay safety concerns associated with the drug.

In a letter to 22 Republican attorneys general on September 19, Kennedy and FDA Commissioner Marty Makary reiterated that the agency would conduct its own review of evidence related to mifepristone's safety and efficacy.

Despite these ongoing evaluations, the FDA granted Evita Solutions permission to sell and distribute its off-brand version of the abortion pill. Mifepristone, originally branded as Mifeprex by Danco Laboratories, has been the leading abortion medication in the U.S. for over two decades. It works by blocking hormones necessary for fetal development, followed by the use of misoprostol to induce contractions and expel the fetus.

The approval of Evita's generic version is expected to make the drug more affordable and accessible. Both the Danco and Evita products will carry the same labeling, in accordance with FDA policy for generics.

Susan B. Anthony Pro-Life America criticized the FDA's decision, stating that it expands access to drugs that they argue endanger unborn children and women's health. Marjorie Dannenfelser, president of the organization, called the approval "reckless" and highlighted the potential risks to women and minors.

Evita Solutions has described mifepristone as a "safe" method for terminating early pregnancy, although critics argue that evidence contradicts this claim. HHS Communications Director Andrew Nixon defended the FDA's approval process, stating that the agency has limited discretion and must approve a generic drug if it is shown to be identical to the brand-name version.

The FDA's history with mifepristone has been contentious. Pro-life advocates have long argued that the agency failed to address safety concerns raised about the drug. Changes made during the Obama administration expanded access to mifepristone, including allowing non-doctors to prescribe it and reducing the required number of doctor visits.

The Biden administration further relaxed regulations, permitting at-home abortions via mail order. Critics have pointed to a rise in complications and adverse effects associated with the drug, with some studies suggesting that serious complications occur at rates significantly higher than reported.

The Supreme Court has previously declined to rule on the legality of mifepristone's approval, leaving the door open for future challenges. The Trump administration had initiated a review of the drug's status, which has continued under the current administration.

As the debate over mifepristone continues, the FDA's recent approval of a generic version adds another layer to the ongoing discussion about abortion access and safety in the United States.