FDA Approves Second Generic Abortion Pill

Abortion opponents are outraged regarding the Food and Drug Administration’s decision to approve a generic version of the abortion pill mifepristone, expanding the supply of the medication and likely lowering its price. 

The approval was quietly issued on Tuesday via a letter to Evita Solutions ahead of the government shutdown.

“It means that three American companies can now produce mifepristone for abortion,” according to The New York Times. “The decision comes at a time when anti-abortion advocates have been urging the FDA and the department of Health and Human Services to take action to curtail access, especially by rolling back steps the agency took in recent years to allow the pills to be prescribed without an in-person doctor visit and sent to patients by mail.”

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The FDA approved the original pill 25 years ago and gave approval in 2019 for another company to produce a generic version.

“The FDA approval comes less than two weeks after Health and Human Services Secretary Robert F. Kennedy Jr. told Republican state attorneys general in a letter that the FDA would review mifepristone’s safety,” according to NBC News. “In the letter, Kennedy and FDA Commissioner Marty Makary wrote that the FDA’s past decisions to roll back certain restrictions on mifepristone access had not been given ‘adequate consideration’ at the time.”

Antiabortion activists “are questioning the administration’s commitment to their cause, marking the first significant pushback Trump has received from his otherwise loyal base of socially conservative activists,” according to The Washington Post

In a statement, the Health and Human Services agency said it “has very limited discretion in deciding whether to approve a generic drug,” and that by law the department must approve a generic drug application if the manufacturer demonstrates it’s identical to the branded product, according to Politico

In other prescription drug news, President Donald Trump on Tuesday announced TrumpRx, an effort aimed at lowering drug costs in the United States, including the creation of a direct-to-consumer website where Americans can buy medicine at discounted prices. The plan also includes a deal with Pfizer to reduce prices.

“Pfizer is the first drugmaker to voluntarily agree to all the demands Trump laid out in a July letter to pharmaceutical company CEOs,” according to CNN Politics. “Pfizer will sell drugs to Medicaid and set prices of new drugs at ‘Most Favored Nation’ levels, the lowest price made available in peer countries. It will sell many of its primary care medicines and some specialty brand-name drugs at a 50% savings, on average, at TrumpRx, the company said. And it will expand its domestic manufacturing, while receiving a three-year reprieve on certain tariffs on pharmaceutical imports.”

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