Day: April 14, 2023

The Biden administration and a drug manufacturer asked the Supreme Court on Friday to preserve access to an abortion drug free from restrictions imposed by lower court rulings, while a legal fight continues. 

The Justice Department and Danco Laboratories both warned of “regulatory chaos” and harm to women if the high court doesn’t block an appeals court ruling in a case from Texas that had the effect of tightening Food and Drug Administration rules under which the drug, mifepristone, can be prescribed and dispensed. 

The new limits would take effect Saturday unless the court acts before then. 

“This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling. 

A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the justices should reject the drugmaker’s and the administration’s pleas and allow the appeals court-ordered changes to take effect. 

The fight over mifepristone lands at the Supreme Court less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright. 

The justices are being asked for a temporary order to keep in place Food and Drug Administration regulations governing mifepristone. Such an order would give them time to more fully consider each side’s arguments without the pressure of a deadline. 

The Biden administration and Danco, which is based in New York, also want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year. 

The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved. 

A ruling from the 5th U.S. Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor. It also would withdraw the Food and Drug Administration’s approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe through 10 weeks. 

Still, the appeals court did not entirely withdraw FDA approval of mifepristone while the fight over it continues. The 5th Circuit narrowed an April 7 ruling by U.S. District Judge Matthew Kacsmaryk, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal. 

“To the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years,” Prelogar wrote. 

Erin Hawley, a lawyer for the challengers, said in a statement that the FDA has put politics ahead of health concerns in its actions on medication abortion. 

“The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place,” said Hawley said, a senior counsel with Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade. 

Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol. 

Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market. 

It’s unclear how the FDA can comply with court orders in both cases, a situation that Prelogar described Friday as untenable. 

The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely for now to allow oral arguments in the case. 

The appeals court judges in the majority in Wednesday’s decision noted that the Biden administration and mifepristone’s manufacturer “warn us of significant public consequences” that would result if mifepristone were withdrawn entirely from the market under the lower court ruling. 

But the judges suggested FDA changes making mifepristone easier to obtain since 2016 were less consequential than its initial approval of the drug in 2000. It would be difficult to argue the changes were “so critical to the public given that the nation operated — and mifepristone was administered to millions of women — without them for sixteen years” the judges wrote. 

Use of medication abortion jumped significantly after the 2016 rule expansion, according to data gathered by the Guttmacher Institute, a research group that supports abortion rights. In 2017, medication abortion accounted for 39% of abortions but by 2020 had increased to become the most common method, accounting for 53% of all abortions. 

Experts have said the use of medication abortion has increased since the court overturned Roe. 

When the drug was initially approved, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences of the drug. 

If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now. At the core of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks. 

Mifepristone has been used by millions of women in the past 23 years. While less drastic than completely overturning the drug’s approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the U.S. The panel overturned multiple decisions made by FDA regulators after years of scientific review. 

Common side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhea. In rare cases, women can experience excess bleeding that requires surgery to stop. 

Still, in loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.” More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one-tenth of 1% of women who took the drug. 
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Taifa 1, Kenya’s first operational 3U nanosatellite, was set to launch aboard the SpaceX Falcon 9 rocket from the Vandenberg Space Force Base in the U.S. state of California on Friday after being delayed twice. But the launch was scrubbed at the last minute because of unfavorable weather.  

Teddy Warria, with Africa’s Talking Limited, a high-tech company, traveled to the University of Nairobi in Kenya from Kisumu, 563 kilometers west of Nairobi. He said he’ll stay as long it takes to witness the historic day.  

“It shows us through science, technology, engineering and mathematics, and if we apply the lessons learned from STEM, we can go as far as our minds and imagination can take us,” Warria said. 

Regardless of the delay, Charles Mwangi, the acting director of space sector and technology development at the Kenya Space Agency, said the satellite is quite significant. 

“… [I]t’s initiating conversations we’ve not been having in terms of what our role within the space sector should be,” Mwangi said. “How do we leverage the potential space to address our societal need. More importantly, how do we catalyze research and activities of developing systems within our region.”  

Mwangi told VOA that launching the satellite will have some major benefits “that will help us in monitoring our forests, doing crop prediction, determine where the yield for our crops, disaster management, planning.” 

The satellite was developed by nine Kenyan engineers and cost $385,000 to build. The engineers collaborated with Bulgarian aerospace manufacturer Endurosat AD for testing and parts.  

Pattern Odhiambo, an electrical and electronics engineer at the Kenyan Space Agency, who worked on the Taifa 1 mission, said, “I took part in deciding what kind of a camera we are supposed to have on this mission, so that we can meet the mission’s objectives, which is to take images over the Kenyan territory for agricultural use, for urban planning, monitoring of natural resources and the likes.”  

And, as the communication subsystem lead, he also had other tasks. 

“I took part in the design of the radio frequency link between the satellite and the ground station, the decision-making process on the kind of modulation schemes you can have on the satellite, the kind of transmitter power, the kind of antenna you are supposed to have,” he said.

Samuel Nyangi, a University of Nairobi graduate in astronomy and Astro physics, was also at the university to witness his country’s history making. 

“If you look at the African countries that are economically strong — Nigeria, South Africa, Egypt — they all have very strong space industries. We are so proud of the Kenya Space Agency, having taken this initiative, because the satellite data that we use [is] from foreign nations, specifically NASA in the United States. For us having our own data, tailoring it to our own needs as Kenyans, it’s a very big step,” Nyangi said.

This sentiment is echoed by Paul Baki, professor of Physics at the Technical University of Kenya, who participated in a panel discussion on education and research to help answer students’ questions. Baki told VOA this is a big leap for Kenya. 

“We have walked this journey, I think, for over 20 years when the first draft space policy was done in 1994,” Baki said. “We’ve decided that we are going to walk the talk and build something domestically. It has happened in approximately three years, which to me is no mean feat, and this is quite inspiring to our students because they have something to look up to.” 

Student James Achesa, who is in his fourth year studying mechanical engineering at Nairobi University, explained his understanding of the Taifa 1 mission.

“It’ll help the small-scale farmer, as well as just general people in Kenya to see and understand where our country is going to. So, they might not enjoy the science of putting a spacecraft into space, but the science that does will come and disseminate to them at grassroots levels and will help them plan for their future,” Achesa said.

Ivy Kut, who has a bachelor’s degree in applied sciences and geoinformatics from the Technical University of Kenya, said, “It’s going to benefit Kenyans in that we are going to get our own satellite data with better resolution and that is going to inform a lot of decisions in all sectors, especially in the analysis of earth data.”

The next launch attempt is scheduled for Saturday.  
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A European spacecraft rocketed away Friday on a decadelong quest to explore Jupiter and three of its icy moons that could have buried oceans.

The journey began with a morning liftoff by Europe’s Ariane rocket from French Guiana in South America. Arianespace’s chief executive Stephane Israel called it “an absolutely perfect launch.”

But there were some tense minutes later as controllers waited for signals from the spacecraft nearly an hour into the flight.

When contact was confirmed, European Space Agency’s Bruno Sousa declared from Mission Control in Germany: “The spacecraft is alive!”

It will take the robotic explorer, dubbed Juice, eight years to reach Jupiter, where it will scope out not only the solar system’s biggest planet but also Europa, Callisto and Ganymede. The three ice-encrusted moons are believed to harbor underground oceans, where sea life could exist.

Then in perhaps the most impressive feat of all, Juice will attempt to go into orbit around Ganymede: No spacecraft has ever orbited a moon other than our own.

With so many moons,— at last count 95 — astronomers consider Jupiter a mini solar system of its own, with missions like Juice long overdue.

“We are not going to detect life with Juice,” stressed the European Space Agency’s project scientist, Olivier Witasse.

But learning more about the moons and their potential seas will bring scientists closer to answering the is-there-life-elsewhere question. “That will be really the most interesting aspect of the mission,” he said.

Juice is taking a long, roundabout route to Jupiter, covering 6.6 billion kilometers (4 billion miles).

It will swoop within 200 kilometers (125 miles) of Callisto and 400 kilometers (250 miles) of Europa and Ganymede, completing 35 flybys while circling Jupiter. Then it will hit the brakes to orbit Ganymede, the primary target of the 1.6 billion-euro mission (nearly $1.8 billion).

Ganymede is not only the solar system’s largest moon — it surpasses Mercury — but has its own magnetic field with dazzling auroras at the poles.

Even more enticing, it’s thought to have an underground ocean holding more water than Earth. Ditto for Europa and its reported geysers, and heavily cratered Callisto, a potential destination for humans given its distance from Jupiter’s debilitating radiation belts, according to Carnegie Institution’s Scott Sheppard, who’s not involved with the Juice mission.

“The ocean worlds in our solar system are the most likely to have possible life, so these large moons of Jupiter are prime candidates to search,” said Sheppard, a moon hunter who’s helped discover well over 100 in the outer solar system.

The spacecraft, about the size of a small bus, won’t reach Jupiter until 2031, relying on gravity-assist flybys of Earth and our moon, as well as Venus.

“These things take time — and they change our world,” said the Planetary Society’s chief executive, Bill Nye. The California-based space advocacy group organized a virtual watch party for the launch.

Belgium’s King Philippe and Prince Gabriel, and a pair of astronauts — France’s Thomas Pesquet and Germany’s Matthias Maurer — were among the spectators in French Guiana. Thursday’s launch attempt was nixed by the threat of lightning.

Juice — short for Jupiter Icy Moons Explorer — will spend three years buzzing Callisto, Europa and Ganymede. The spacecraft will attempt to enter orbit around Ganymede in late 2034, circling the moon for nearly a year before flight controllers send it crashing down in 2035, later if enough fuel remains.

Europa is especially attractive to scientists hunting for signs of life beyond Earth. Juice will keep its Europa encounters to a minimum, however, because of the intense radiation there so close to Jupiter.

Juice’s sensitive electronics are encased in lead to protect against radiation. The 6,350-kilogram (14,000-pound) spacecraft also is wrapped with thermal blankets — temperatures near Jupiter hover around minus 230 degrees Celsius (minus 380 degrees Fahrenheit). And its solar panels stretch 27 meters (88 feet) tip to tip to soak in as much sunlight that far from the sun.

Late next year, NASA will send an even more heavily shielded spacecraft to Jupiter, the long-awaited Europa Clipper, which will beat Juice to Jupiter by more than a year because it will launch on SpaceX’s mightier rocket. The two spacecraft will team up to study Europa like never before.

NASA has long dominated exploration at Jupiter, beginning with flybys in the 1970s by the twin Pioneers and then Voyagers. Only one spacecraft remains humming at Jupiter: NASA’s Juno, which just logged its 50th orbit since 2016.

Europe provided nine of Juice’s science instruments, with NASA supplying just one.

If Juice confirms underground oceans conducive to past or present life, Witasse said the next step will be to send drills to penetrate the icy crusts and maybe even a submarine.

“We have to be creative,” he said. “We can still think it’s science fiction, but sometimes the science fiction can join the reality.”
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The World Health Organization says that the focus of this year’s World Chagas Disease Day observation is expanding awareness of Chagas and on “providing access to crucial care and implementing disease surveillance, at the primary health care level.”

The Centers for Disease Control says Chagas is caused by the parasite Trypanosoma cruzi, which is transmitted to animals and people by insects.

It is often referred to as a silent killer because if it is not detected early, it can cause serious heart and digestive problems and can be fatal.

It is found mainly in Latin America, but according to WHO, it has been detected elsewhere, including the United States, Canada, some European countries and some African, Eastern Mediterranean and Western Pacific countries.

WHO reports 6 million to 7 million people worldwide are infected with Chagas and 30,000 to 40,000 new cases are detected yearly.   Approximately 12,000 Chagas-related deaths are reported annually.

The disease is named after Carlos Justiniano Chagas, a Brazilian doctor who discovered the disease in 1909.
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A Zimbabwean actress battling cancer has asked wealthy citizens to buy a radiotherapy machine for government hospitals because she says the country’s only unit has stopped working. As Columbus Mavhunga reports from Harare, many blame Zimbabwe’s high mortality rate among cancer patients on the country’s poor state of health care.]
Camera: Blessing Chigwenhembe
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The Republican-dominated Florida Legislature on Thursday approved a ban on abortions after six weeks of pregnancy, a proposal supported by the Republican Gov. Ron DeSantis as he prepares for an expected presidential run.

DeSantis is expected to sign the bill into law. Florida currently prohibits abortions after 15 weeks.

A six-week ban would give DeSantis a key political victory among Republican primary voters as he prepares to launch a presidential candidacy built on his national brand as a conservative standard-bearer.

The policy would also have wider implications for abortion access throughout the South in the wake of the U.S. Supreme Court’s decision last year overturning Roe v. Wade and leaving decisions about abortion access to states. Alabama, Louisiana and Mississippi have banned abortion at all stages of pregnancy, while Georgia forbids the procedure after cardiac activity can be detected, which is around six weeks.

“We have the opportunity to lead the national debate about the importance of protecting life and giving every child the opportunity to be born and find his or her purpose,” said Republican Rep. Jenna Persons-Mulicka.

Democrats and abortion-rights groups have criticized Florida’s proposal as extreme.

“This ban would prevent 4 million Florida women of reproductive age from accessing abortion care after six weeks — before many women even know they’re pregnant,” White House press secretary Karine Jean-Pierre said in a statement issued after Thursday’s vote. “This ban would also impact the nearly 15 million women of reproductive age who live in abortion-banning states throughout the South, many of whom have previously relied on travel to Florida as an option to access care.”

The bill contains some exceptions, including to save the woman’s life. Abortions for pregnancies involving rape or incest would be allowed until 15 weeks of pregnancy, provided a woman has documentation such as a restraining order or police report. DeSantis has called the rape and incest provisions sensible.

Drugs used in medication-induced abortions — which make up the majority of those provided nationally — could be dispensed only in person or by a physician under the Florida bill. Separately, nationwide access to the abortion pill mifepristone is being challenged in court.

Florida’s six-week ban would take effect only if the state’s current 15-week ban is upheld in an ongoing legal challenge that is before the state Supreme Court, which is controlled by conservatives.

“I can’t think of any bill that’s going to provide more protections to more people who are more vulnerable than this piece of legislation,” said Republican Rep. Mike Beltran, who said the bill’s exceptions and six-week timeframe represented a compromise.

Abortion bans are popular among some religious conservatives who are part of the GOP voting base, but the issue has motivated many others to vote for Democrats. Republicans in recent weeks and months have suffered defeats in elections centered on abortion access in states such as Kentucky, Michigan and Wisconsin.

“Have we learned nothing?” House Democratic Minority Leader Fentrice Driskell said of recent elections in other states. “Do we not listen to our constituents and to the people of Florida and what they are asking for?”

DeSantis, who often places himself on the front lines of culture war issues, has said he backs the six-week ban but has appeared uncharacteristically tepid on the bill. He has often said, “We welcome pro-life legislation,” when asked about the policy.

DeSantis is expected to announce his presidential candidacy after the session ends in May, with his potential White House run in part buoyed by the conservative policies approved by the Republican supermajority in the Statehouse this year.

Democrats, without power at any level of state government, have mostly turned to stall tactics and protests to oppose the bill, which easily passed both chambers on largely party-line votes. The Senate approved it last week, and the House did so Thursday.

A Democratic senator and chairwoman of the Florida Democratic Party were arrested and charged with trespassing during a protest in Tallahassee against the six-week ban. In a last ditch move to delay the bill’s passage in the House on Thursday, Democrats filed dozens of amendments to the proposal, all of which were rejected by Republicans.

“Women’s health and their personal right to choose is being stolen,” said Democratic Rep. Felicia Simone Robinson. “So I ask: Is Florida truly a free state?”
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The U.S. Department of Justice responded Thursday to a ruling that limits access to the abortion pill mifepristone and said it would ask the Supreme Court for an emergency order to put any restrictions on hold.

After conflicting rulings by various courts on mifepristone, a pill that induces abortion and is the most commonly used method in the United States, a federal appeals court ruled Wednesday that it could be used for now but with some restrictions. They include reducing the period of time when the drug can be taken and prohibiting it from being mailed.

Mifepristone has been approved by the Food and Drug Administration for 23 years. Last week, Matthew Kacsmaryk, a U.S. district judge in Texas, reversed approval of the pill’s use following a lawsuit by opponents of abortion.

Less than an hour later, a judge in Washington state ordered the FDA to preserve access to the drug in 17 states and the District of Columbia.

In response, the New Orleans-based U.S. Court of Appeals for the Fifth Circuit voted late Wednesday to temporarily narrow the ruling by Kacsmaryk.

In a 2-1 vote, the judges on the appeals court put on hold changes made by the FDA in 2016 and 2021 that relaxed the rules for prescribing and dispensing mifepristone. The relaxed rules included allowing the pill to be sent through the mail, lifting a requirement for three in-person doctor visits, and approving the drug’s use for up to 10 weeks into a pregnancy, rather than seven weeks.

Preventing the pill from being sent by mail reduces abortion access. The reversal of Roe vs. Wade less than a year ago has resulted in more than a dozen states banning abortion outright. Roe vs. Wade was the case that recognized a constitutional right to abortion.

Reactions to rulings

Attorney General Merrick Garland said in a statement, “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.” Without the granting of an emergency order, the Court of Appeals’ ruling will go into effect on Saturday.

Vice President Kamala Harris issued a statement as well.

“There is a reproductive health care crisis in America. Our administration will continue fighting to protect women’s health and the right to make decisions about one’s own body,” she wrote.

Erin Hawley, a lead lawyer for the plaintiffs in the case, expressed satisfaction with the latest ruling.

“The 5th Circuit’s decision is a significant victory for the doctors we represent, women’s health, and every American who deserves an accountable federal government acting within the bounds of the law,” said Hawley, senior counsel for the conservative legal advocacy group Alliance Defending Freedom.

Abortion rights supporters or opponents could take the case to the Supreme Court. Opponents of the drug could try to keep the full Court of Appeals ruling in effect. Or, the Biden administration could ask the Supreme Court to allow all the FDA changes to remain in place while the case makes its way through the legal system.

Ruling alleges inadequate review

At the core of the Texas ruling is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.

Common side effects include cramping, bleeding, nausea, headache and diarrhea. In rare cases, women can experience excess bleeding that requires a surgical intervention.

More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications, which represented less than one-tenth of 1% of women who took the drug.

In loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.”

More than 250 pharmaceutical executives criticized the Texas judge’s decision in a public letter. They said it ignored decades of scientific evidence and legal precedent.

In the letter, they wrote, “We call for the reversal of this decision to disregard science, and the appropriate restitution of the mandate for the safety and efficacy of medicines for all with the FDA, the agency entrusted to do so in the first place.”

Some information for this report came from The Associated Press, Agence France Presse and Reuters.
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