Not much is known about a new manufacturer expected to start selling a generic version of the abortion pill in January.
Evita Solutions has received FDA approval as of September, despite earlier assurances from government officials that a review of the abortion pill was ongoing.
“While Evita Solutions has openly stated its mission is to ‘de-stigmatize abortion’ and make it available to ‘all,’ not a lot of information is available publicly about the company that has been authorized to manufacture and distribute generic mifepristone,” commented Katie Glenn Daniel, general counsel and policy advisor for the Small Business Administration. “This application was submitted in October 2021, just months after the Biden FDA relaxed requirements for in-person physician visits for abortion pills due to the coronavirus. It languished for over 1,200 days during the Biden administration, but got approval less than a year into the current administration.”
The company is led by Robert Patane and is located in Glen Allen, Virginia. According to the Dun & Bradstreet Business Directory, their registered agent is CT Corporation System as per their record.
Evita Solutions is now the third FDA-approved manufacturer of mifepristone, joining Danco Laboratories and GenBioPro. Their website doesn’t offer much more detail, but mentions that they aim to “de-stigmatize abortion care.”
“At Evita Solutions, we believe that everyone should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of race, sex, gender, age, sexuality, income, or where they live,” the website states. “We trust individuals to make the best choices for their bodies.”
The company did not respond to inquiries from DCNF regarding its founding, ownership, and future plans.
Andrew Nixon, the communications director for HHS, mentioned in October that the FDA has limited discretion when it comes to approving generic drugs. Republican Missouri State Senator Josh Hawley expressed skepticism about the FDA’s integrity following the approval of this new generic drug.
HHS Secretary Robert F. Kennedy Jr. stated in a Senate hearing in September that the Biden administration “manipulated data to obscure one of the safety signals” associated with mifepristone.
“To be clear, this authorization does not reduce risks for women and does not protect them from being compelled to use the drug,” said Republican Louisiana Sen. Bill Cassidy, along with 16 others in a formal statement. In an October letter to the FDA, he added: “This also goes against President Trump’s assertion that he is the ‘most pro-life president in history’ committed to safeguarding unborn children and ensuring women’s safety.”
FDA Commissioner Marty McCulley recently said that the FDA is in the “data collection stage” of their review process. (Related: Concerns about forced abortion and new reports about mail-order pills continue to grow)
“We are conducting ongoing research but are also focused on extensive studies that might either validate or dispute other claims published in the literature,” McCulley explained.
A study from the Charlotte Rozier Institute indicated that between 2016 and 2021, around 83.5% of emergency room visits related to mifepristone were mistakenly listed as miscarriages. According to a separate review by the Ethics and Public Policy Center (EPPC), one in ten women taking abortion pills faces a “serious adverse event.”
A DCNF investigation in June discovered that five online abortion providers sent abortion pills for “future use” without physicians verifying essential eligibility criteria. Aid Access, one of the organizations that distributed pills to DCNF, is involved in a lawsuit over alleged forced abortions.
“It’s concerning that companies, clearly politically motivated, are stepping into a market that represents over 60% of abortions in the U.S. and do not undergo thorough scrutiny,” Daniel said. “Unregulated abortion drugs pose a public health risk, with reports of serious harm and documented instances of coercion and abuse. The lack of information surrounding Evita Solutions is unsettling. The FDA’s approval of this generic abortion drug seems reckless, and the public deserves more transparency.”
