- Source: www.cbsnews.com
The Food and Drug Administration (FDA) has approved another generic version of the generic abortion pill mifepristone, expanding the list of authorized manufacturers. Drugmaker Evita Solutions announced on its website that the agency signed off on its lower-cost version of the medication, which is approved for use through 10 weeks of pregnancy.
Evita Solutions becomes the second company to offer a generic version of generic abortion pill mifepristone . The first, developed by GenBioPro, received FDA approval in 2019. Mifepristone, used in combination with misoprostol, is the most common method of medication abortion in the United States.
Conservative backlash follows approval
The approval quickly drew criticism from anti-abortion groups and Republican lawmakers. Sen. Josh Hawley of Missouri wrote on X that he had “lost confidence in the leadership at FDA.”
Kristan Hawkins, president of Students for Life of America and Students for Life Action, said in an interview, “These drugs are dangerous, and this is a stain on the entire administration.”
Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said in a statement that the FDA’s decision to expand the availability of abortion drugs was “unconscionable.”
The opposition comes as Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary face pressure from abortion opponents to revisit the drug’s approval. Generic Abortion Pill Mifepristone has been on the market for 25 years and has consistently been found safe and effective by FDA scientists.
HHS cites limited discretion
In response to criticism, HHS spokesperson Andrew Nixon said federal law gives the agency little room to reject generic drug applications if they meet requirements. “By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” Nixon said.
Last month, Kennedy and Makary wrote to Republican attorneys general, pledging to conduct a full review of the drug’s safety. Their letter stated that HHS, through the FDA, was evaluating “real-world outcomes and evidence” on abortion pill mifepristone’s safety and effectiveness.
Medical experts have noted that while the FDA rarely withdraws approval of a drug, it could impose restrictions depending on the results of its review. Dr. Celine Gounder, a medical contributor, said potential measures could include limiting mail-order delivery or telehealth access, or narrowing the group of providers allowed to prescribe the drug.
Broader context on abortion access
Medication abortion accounts for the majority of abortions in the U.S. Mifepristone works by blocking the hormone progesterone and dilating the cervix, while misoprostol causes uterine contractions. Together, the drugs are considered the standard protocol for terminating early pregnancies.
Although the FDA’s approval of a second generic is unlikely to significantly expand access, Evita Solutions said on its website that it aims to provide “safe, affordable, high-quality, effective, and compassionate abortion care.”
Mini Timmaraju, president and CEO of Reproductive Freedom for All, said the process was routine. “The only reason this approval is making headlines is because anti-abortion politicians have turned health care into a political battlefield,” she said.
Access to mifepristone remains restricted in several states due to abortion bans and specific regulations on medication abortion. Many of those laws are subject to ongoing legal challenges. National medical organizations, including the American Medical Association, do not support restrictions on the drug.
Generic drug approval process
Approval of generic abortion pill drugs generally follows a standardized process at the FDA. Once the patent on a brand-name medication expires, multiple companies typically seek authorization to market generic equivalents. These applications must show that the generic version matches the brand-name formula and ingredients.
Most applications are processed within 10 months, though filings can take longer. Records show Evita Solutions submitted its application four years ago. The company has not publicly commented beyond its website statement.
The FDA’s decision adds another manufacturer to the supply of mifepristone but does not override state-level abortion restrictions. Legal battles over access to medication abortion remain ongoing in courts across the country.
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