The Office for Products and Medicines on Tuesday quietly approved the overall form of mifepristone, one of two drugs used in most US abortions.
This makes the drug from Evita Solutions, the second common version that enters the market. The first from the pharmaceutical company Genbiopro was approved in 2019.
Mifepristone is usually used in combination with another tablet, a mizrodrostol to cause abortion. Abortion of drugs make up almost two thirds of abortions in the USA
FDA wrote in Letter to the decision Evita On Tuesday, the day before the closure of the government began, his pills of Mifepriston were “therapeutically equivalent” for the branded version of Mifeprex, which has been available in the United States since 2000.
On His web siteEvita Solutions describes its mission as assisting the “medical community in recognizing usefulness and freedom that medical abortion provides to patients.”
“We strive to normalize abortion care, and we strive to be accessible to everyone,” he adds.
The company did not immediately answer a request about the comment.
The approval of the FDA comes less than two weeks after the Minister of Health and Social Services Robert F. Kennedy, Jr., told the Prosecutors of the Republicans in a letter that the FDA will consider the security of MifePristone.
In a letter to Kennedy and FDA commissar, Marty Makari wrote that the FDA's past decisions to refuse certain restrictions on the access of Mifepriston at that time were not “adequate consideration”.
Andrew Nixon, a representative of the Department of Health and Social Services, said that the FDA does not support medicines and directs appointments to comply with the entire marking.
“FDA has a very limited discretion when deciding on whether the general drug should be approved. According to the law, the Minister of Health and Social Services must approve the statement if it demonstrates that the common drug is identical to the corporate drug, ”Nixon said in a statement.
“Common applicants are not required to present independent evidence proving security and effectiveness,” he added. “HHS is studying the communicated side effects of mifepristone to ensure that the FDA risk reduction program for the drug is sufficient to protect women from unidentified risks.”
FDA often produces a press release after new or significant permits for medicines, but in this case there was no.
The approval was caused by a fierce response from Marjorie Dunnenfelser, the president of the SBA Pro-Life America abortion group.
“The secretary of Kennedy and the FDA Commissioner Makari assured Congress and the American people, who will conduct a thorough review, taking into account reliable evidence of the harm caused by these drugs,” she said. “The former completion of the review has become more urgent, given this permission to flood the market with a cheap drug for abortion.”
Reviewed studies have long shown that serious adverse reactions from abortion tablets are rare. In combination, Mifepriston and the Misoprostol can be used up to 70 days after the start of the last menstrual period. The first blocks the hormone progesterone, which supports pregnancy, and the latter causes abbreviations.
Brittani Fontaino, General Director of the National Abortion Federation, the professional association of abortion suppliers, said in her statement that the approval of the second common drug for mifepristone “emphasizes that the studies have shown for decades: the abortion of drugs is safe, effective and significant medical care used by millions with effectiveness”.
Activists to combat abortion urged FDA to cancel the approval of the first general drug for mifepristone, as well as two specific changes in the rules for the use of the drug. (The first, in 2016, said that Mifepriston could be used up to 10 weeks of pregnancy instead of seven, and the second, in 2021, excluded the requirement that Mifepriston be personally mined, which allowed him to appoint by mail through the country).
In his letter last month, Kennedy and Makari quoted April report From the conservative analytical center, the center of ethics and state policy, which claimed to have discovered a higher level of serious complications from Mifepristone than FDA reports. But this report was not reviewed and not published in a medical journal, and researchers of reproductive health said this is an unwanted scienceField
Over the past few months, many conservatives have called the report as the reason why the FDA should carefully look at the safety of Mifepristone. In July, 22 General Lawyer Republicans sent a letter to Kennedy and Makari To this; The letter, which two, sent last month, was a response to this request.
Groups against abortions in the past were skeptical of Kennedy, a former Democrat, who in 2023 ran for the presidency as a supporter of abortion rights. He later said that he supported restrictions after a certain moment of pregnancy. Kennedy's position in an abortion was a source of horror for some conservatives during his hearing in the Senate.
