The Supreme Court on Friday issued an order that would keep the status quo of access to mifepristone, the abortion and miscarriage drug, as the FDA’s legal battle over the drug’s approval and regulation continues. The court did not explain its reasoning, but noted that Judges Clarence Thomas and Samuel Alito disagreed.

The decision overturns a New Orleans 5th Circuit Court of Appeals ruling that would have restricted access to the drug as the federal government considers an appeal of the district court’s decision. That decision, handed down on April 7 by Conservative District Judge Matthew Kaczmarik, should have denied access to the drug entirely, as the FDA’s approval of mifepristone in 2000 was illegal, as was the agency’s subsequent actions.

However, a three-judge panel of the appeals court determined that the plaintiff in the case — a group of anti-abortion organizations and individuals led by the Hippocratic Medicine Alliance — had exceeded the statute of limitations in which they could legally challenge the FDA approval in 2000. But the judges ruled 2-1 to allow the rest of Kaczmarik’s ruling, overturning FDA actions in 2016 and 2021 that eased restrictions and access to the drug.

If restrictions were reinstated, this would mean that mifepristone would only be available during seven weeks of pregnancy, not 10; that women would have to visit the doctor three times, and not just once, perhaps with the help of telemedicine; the medicine will not be allowed to be sold by mail; and that doctors again had to report all non-fatal side effects.

In an appeal to the Supreme Court, Danco Laboratories, the maker of mifepristone (brand name Mifeprex), said the appeals court’s decision created “debilitating uncertainty” and “regulatory turmoil.” In his address, he wrote:

To distribute Mifeprex under something other than REMS 2023. [the FDA’s latest regulations], Danco should: review labels, packaging and promotional materials; re-certify suppliers; and amend their contracts with suppliers and distributors and policies (among other things). All are currently based on the 2023 REMS. This is Danco’s current distribution model. However, before Danco can make any changes, it must have a new REMS in place that will require Danco to submit and approve an additional non-disclosure agreement (sNDA) from the FDA. This process usually takes months. It is not clear if Danco can continue to distribute mifeprex while this sNDA is pending with the FDA, even if it is technically misbranded, or if it could expose Danco to civil and criminal penalties. And then Danco may need to go through all those hoops again if the injunction is eventually changed or sent in response to an appeal.

Further complicating matters is a ruling by a district judge in Washington blocking the FDA from changing access to mifepristone in 17 states and the District of Columbia. And on Wednesday, GenBioPro, the maker of a generic mifepristone that was approved by the FDA in 2019, sued the FDA to prevent the agency from complying with any order to remove the generic from the market.

Overall, this case is the first time that an inexperienced district judge has ruled to revoke an FDA approval, based in part on the argument that the FDA was wrong in its expert scientific analysis. If anti-abortion groups ultimately win on appeal, it would set a dangerous precedent, opening the floodgates for litigation to override the FDA’s authority in regulatory actions and approvals and plunge drug development into chaos, according to legal experts, the former federal officials and numerous representatives of the pharmaceutical and biotech industries.

The Court of Appeal moved the case to an accelerated timetable and plans to hear the first oral presentations on May 17.

We become biologically older when our bodies are under stress, but younger again when we recover, according to a study that analyzed the DNA of people who had emergency hip surgery, severe Covid-19, or who were pregnant.

“This recovery shows that we have a mechanism that allows us to turn back time at least a little,” he says. James White at Duke University in North Carolina, who led the study with Vadim Gladyshev at Harvard University.

We usually measure age by the number of birthdays – the so-called chronological age. But people can be biologically older or younger than their chronological age depending on factors such as smoking or smoking habits. get enough sleep.

To measure biological age, researchers have developed an “epigenetic clock” that analyzes patterns of DNA markers called methyl groups that correlate with age.

White, Gladyshev, and colleagues used these clocks to assess the impact of three types of stressful events on biological age. In each case, they analyzed DNA from blood samples that were collected at different time points from participants in previous studies.

In the first analysis, the team found that the biological age of nine people, with a mean age of 81, increased rapidly when they had emergency surgery to repair a broken hip, but returned to preoperative levels over the next week.

The team then measured the biological age of 29 people, with a mean age of 60, when they were hospitalized with severe Covid-19 and after they were discharged. The biological age of the female participants decreased after discharge, but the age of the male participants did not, possibly due to men on average take longer to fully recover from illness.

Finally, the team collected data from four studies that included more than 200 pregnant women known to put the body under stress. Their biological age increased during pregnancy, but by six weeks after birth, it was again below the level observed in early pregnancy.

The researchers also used the epigenetic clock to measure the biological age of mice before, during, and after pregnancy and found the same pattern.

In another experiment, the team showed that young mice had a sudden increase in biological age after they were surgically paired with older mice to allow blood from the old mice to enter their own circulation. This changed after they were surgically separated from older mice.

The idea that biological aging speeds up during stressful events but then slows down is consistent with previous research that found that people’s gray hair sometimes regains its original color after it recovers from psychologically stressful events such as marital separation. .

However, Luigi Fontana at the University of Sydney in Australia says that while there may be short-term fluctuations in biological age, the overall trend towards aging still persists. “Your gray hair may bring back some color, but it won’t go back to what it was when you were 10,” he says.

However, we now know that biological aging can be at least slightly reversed, and this raises the possibility of developing therapeutics to further accelerate this reversal, White says.