The federal officials have approved another general version of the abortion pill Mifepristone, a regulatory format that quickly triggered push bags from politicians linked to the abortion group and the Trump administration.
Pharmaceuticals, EVITA SOLUTIONS, announced on the website that the food pharmacy has signed a low cost pill, which has been approved for 10 weeks of pregnancy. EVITA SOLUTIONS is the second company with the approved general version of Mifepristone. The first came from the pharmaceutical company Genbiopro approved 2019.
This movement caused some conservatives’ backlash.
Senator Josh Hawley, a Republican Senator of Missouri, criticized the director in X’s universe.
“Anyone who says that his hand is tied did not pay attention.” “This drug is dangerous and this is a stain of full management.”
Marjorie Dannenfelser, chairman of Susan B. Anthony Pro-Life America, said in a Thursday statement that “this reckless decision of the FDA to expand the availability of abortion drugs is impossible.”
The criticism has been approved by President Trump’s chief health officials, including Robert F. Kennedy Jr. Health, and is increasing pressure from abortions who have to re -evaluate the US PyPristone, which is considered repeatedly safe and effective by FDA scientists.
In the statement, HHS spokesman Andrew Nixon said in the CBS news, “The discretion is very limited in determining whether to approve the general medicine, and according to the law,” “The law and the Minister of Human Service must approve the application if the generic drug is the same as the brand name drug.” Said.
A A letter to Republican lawyer last monthKennedy and FDA commissioner Mati Macari promised to complete the drug’s safety.
Kennedy and Makary wrote in the letter that “HHS (HHS) through FDA is conducting self -review on evidence, including the actual results and evidence associated with the safety and efficacy of the drug.”
CBS News Medical Conservative Dr. Celine Gounder I said last month The FDA is unlikely to withdraw its approval, and it is a rare movement that can cause litigation, but it can be restricted by narrowing people who can limit remote health or mail delivery or narrow people who can prescribe drugs according to safety review.
In the campaign trail last year, President Trump was to CBS News’s Caitlin Huey-Burns It does not interfere with access to MIFEPRISTONE.
In 2021, the FDA of the Democratic Democratic Party’s FDA expanded the approach by allowing online prescriptions and mail orders to mail order of drugs. Abortion opponents have been fighting the change since then.
The approval of generic drugs is generally a ROTE process in the FDA, and after the patent for the original drug is generally approved, several copy cat versions are generally approved. In most cases, the generic drug producer only needs to show that his drug is consistent with the formula with the ingredients developed by the original drug producer.
The FDA usually approves these applications within 10 months. However, according to the documents published on the FDA website, Evita Solutions shows that four years ago submitted an application to MIFEPRISTONE Market.
The company did not immediately respond to the request of the Associated Press.
EVITA said on the website, “I think everyone should be able to approach safe, inexpensive, high quality effective, effective and merciful abortion.”
The second generic approval will not generally affect the approach to the pills taken with other drugs, Misoprostol. that multitude This is through drug abortion among women who end pregnancy. MIFEPRISTONE extends the cervix and blocks hormonal progesterone, while Misoprostol causes the uterus to cramps and contraction.
Mini Timmaraju, the president and CEO of reproductive freedom, said in a statement, “This is about how our system works, and has been working in this way for decades.
Access to MIFEPRISTONE is limited to large areas of the country due to the state law that prohibits abortion, including drug abortion, or imposes a separate restriction on drug use. This law applies a lot of progress suits that are on their way through the legal system.
Restrictions on pills are not supported by most major medical societies, including the American Medical Association.
