Few details are known about the new manufacturer expected to start selling its generic version of the abortion pill in January.
Evita Solutions’ application was approved by the Food and Drug Administration (FDA) in September, despite earlier promises from administration officials that a review of the abortion pill was underway.
“Evita Solutions openly says its mission is to ‘destigmatize abortion’ and make abortions accessible ‘for all,’ yet very little is publicly known about the company now approved to manufacture and sell generic mifepristone,” Small Business Administration Director of Legal Affairs and Policy Counsel Katie Glenn Daniel told the Daily Caller News Foundation. “Its application was filed in October 2021, just months after the Biden FDA used COVID to eliminate the in-person doctor visit requirement for abortion drugs. It sat unapproved for more than 1,200 days under the Biden administration, yet was greenlit less than a year into the current administration.”
The company’s key principal is Robert Patane, and it is based in Glen Allen, Virginia, according to the Dun & Bradstreet business directory. Its registered agent is CT Corporation System, according to Virginia business records.
Evita Solutions is now the third FDA-approved manufacturer of mifepristone, alongside the brand-name producer Danco Laboratories and the other generic manufacturer GenBioPro. Its website offers little additional information but states that the company aims to “seek to destigmatize abortion care.”
“Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live,” the website states. “We know that you can make the best choice for your body.”
The company did not respond to the DCNF’s questions seeking more details about its founding, owners and plans.
HHS Communications Director Andrew Nixon said in October that the FDA has “very limited discretion in deciding whether to approve a generic drug.” Republican Missouri Sen. Josh Hawley said he “lost confidence in the leadership at FDA” after the new generic pill’s approval.
HHS Secretary Robert F. Kennedy Jr. said during a Senate hearing in September that the Biden administration “twisted the data to bury one of the safety signals” for mifepristone.
“To be clear: this approval fails to mitigate the risks to women that have been identified and fails to protect women from the coercive use of the drug,” Republican Louisiana Sen. Bill Cassidy and 16 other senators wrote in an October letter to the FDA. “It also flies in the face of President Trump’s strong statement that he is ‘the most pro-life president’ in history and his dedication to protecting the lives of unborn children and keeping women safe.”
FDA Commissioner Marty Makary told The Daily Signal in December that the FDA is in the “data acquisition phase” of its review.
“We do an ongoing review, but we’re also engaging in a robust study that can serve to validate or not validate other numbers that have been put out there in the literature,” Makary said.
Nearly 83.5% of abortion-related emergency room visits resulting from mifepristone were incorrectly coded as miscarriages between 2016 and 2021, according to a study of Medicaid data by the Charlotte Lozier Institute. An April study of insurance data by the Ethics and Public Policy Center (EPPC) likewise found that one in ten women who take the abortion pill will experience a “serious adverse event.”
Five online abortion providers sent abortion pills via mail for “future use” without a doctor verifying key eligibility requirements during a DCNF investigation in June. One of the organizations that supplied pills to the DCNF, Aid Access, is named in a lawsuit over alleged abortion coercion.
“A clearly politically driven company entering a market that now accounts for more than 60% of U.S. abortions warrants greater scrutiny, not less,” Daniel told the DCNF. “Unregulated abortion drugs have already created a public health crisis, with women reporting serious harm and documented cases of coercion and abuse. There is a troubling lack of information surrounding Evita Solutions. The FDA’s approval of this generic abortion drug was reckless, and the public deserves answers.”
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