by crissly | Apr 21, 2023 | Uncategorized
The US Supreme Court on Friday temporarily blocked a lower court’s order that would have banned the abortion pill mifepristone. The action means that the drug will remain available and legal under status quo regulations until the case works its way through the appeals process, which could take months.
The court’s ultimate ruling could be the most consequential decision on reproductive rights since its overturning of Roe v. Wade in June 2022.
Mifepristone has been available in the United States since 2000, when the US Food and Drug Administration approved its use. It’s the first dose of a two-drug series used in a medication abortion, which now accounts for over half of all abortions across the country. Access to medication abortion is already limited in 15 states.
But on April 7, Judge Matthew Kacsmaryk of the Northern District of Texas ruled to rescind the approval of the pill nationwide. The plaintiffs in the case, antiabortion doctors, argued that the drug is unsafe and the FDA’s authorization was improper because pregnancy is not an illness. However, the drug has a decades-long track record of safety, and a comprehensive review conducted by the National Academies of Sciences confirmed that it has a very low rate of serious complications.
The following week, the Fifth Circuit Court of Appeals partially blocked Kacsmaryk’s decision, allowing the pill to retain its FDA approval but rolling back several changes the agency has made in recent years to expand access to it. Among them: pandemic-era provisions that made mifepristone easier to prescribe online and distribute by mail and a 2016 change that allowed the pill to be taken up to the 10th week of pregnancy.
The US Department of Justice, acting on behalf of the FDA, and New York-based Danco Laboratories, which makes mifepristone, asked the justices to intervene. Over the past week, the Supreme Court issued two separate short-term holds as it considered the matter. The court had given itself a deadline of Wednesday by midnight to decide whether the pill would face tighter rules while an appeal moves forward, but it extended that deadline to today.
GenBioPro, the manufacturer of a generic form of mifepristone, entered the fray this week with a lawsuit against the FDA. If mifepristone’s approval is revoked, GenBioPro’s generic version would also be suspended. The company alleges that if the FDA complies with Kacsmaryk’s ruling, it would violate the established legal process for withdrawing a previously approved drug from use.
“There is a very detailed procedure of removing drugs from the market,” says Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School. Kacsmaryk’s ruling circumvents that established process, Sarpatwari says. Manufacturers and the FDA have removed drugs from the market before, either because of low demand or dangers to patients, but a court has never stepped in to pull a long-approved drug from use.
Pharmaceutical companies and drug manufacturers say the lower courts’ rulings represent an unprecedented intrusion into the authority of the FDA. The agency is tasked with reviewing, approving, and regulating drugs for their safety and efficacy. They say if mifepristone is banned or restricted, it puts other drugs in danger, particularly ones vulnerable to political pushback, such as hormonal birth control, preventive HIV drugs, and vaccines.
More than 600 executives from biotech and pharmaceutical companies have signed a letter warning that pulling mifepristone off the market would have a chilling effect on innovation. Companies often spend billions of dollars to get a drug through the development pipeline, and they would hate to have their investment quashed by the courts. “You could see decreased investment because of uncertainty as to whether or not courts are going to take action on decades-old drugs,” Sarpatwari says.
by crissly | Apr 19, 2023 | Uncategorized
The legal saga over the abortion pill mifepristone isn’t over yet. On Wednesday, the US Supreme Court extended its own deadline to decide on the fate of the drug until Friday by just before midnight Eastern Time.
The pill will remain on the market for at least the next few days. The Supreme Court’s decision on access to the pill will likely be the most important ruling on reproductive rights since the court overturned Roe v. Wade in June 2022.
Approved by the US Food and Drug Administration in 2000, mifepristone is the first dose in a two-pill regimen to induce an abortion in the first trimester. In recent years, the FDA has taken measures to make it more accessible, including making it available by mail and allowing patients to take the drug up until 10 weeks of pregnancy. Medication abortion now accounts for a little over half of all abortions in the US.
On April 7, US District Judge Matthew Kacsmaryk of Texas ruled to revoke the FDA’s approval of mifepristone and make it illegal throughout the country, writing that the drug is unsafe and its authorization in 2000 was rushed. However, more than 100 studies over several decades show that the pill is safe and effective at ending pregnancies in the first trimester.
Last week, the Fifth Circuit Court of Appeals blocked Kacsmaryk’s ban but upheld restrictions on the drug that haven’t been in place since 2016, when the FDA started loosening access to mifepristone. The three-judge panel said the pill could remain available but must be dispensed in person and can only be taken through the first seven weeks of pregnancy. The rulings threaten the FDA’s authority to assess and approve drugs, especially ones that are considered politically controversial.
The Justice Department, acting on behalf of the FDA, asked the Supreme Court to keep the pill available. On April 14, Justice Samuel Alito put a hold on the rulings until the high court could consider the issue.
GenBioPro, which makes a generic form of mifepristone, filed a lawsuit against the FDA on Wednesday in an effort to keep the drug available. In the suit, the company argues that if the FDA complies with court orders to restrict the pill’s access, it would be violating laws that dictate the process of withdrawing an already-approved drug.
Many drugs have been taken off the market, either because of risks to patients or due to commercial reasons, such as low demand. But no court has ever suspended the FDA approval of a drug before.
Even if the Supreme Court sides with Kacsmaryk’s ruling and rolls back the drug’s approval, there’s a scenario in which mifepristone could remain on the market. The FDA could continue to allow access to the drug by exercising a policy known as “enforcement discretion,” which means it wouldn’t prosecute manufacturers or distributors, according to Allison Whelan, assistant professor of law at Georgia State University.
But while the current FDA leadership may choose to use its enforcement discretion, a future presidential administration could always reverse course. “I don’t see any real stability for medication abortion in the short term, potentially even the long term,” Whelan says.
by crissly | Apr 14, 2023 | Uncategorized
US Supreme Court Justice Samuel Alito on Friday stepped in to temporarily block lower courts’ decisions to impose restrictions on mifepristone, a pill used for medication abortion. The measure is essentially a pause on a Texas judge’s ruling last week to void the drug’s approval by the Food and Drug Administration. It also overrides the Fifth Circuit Court of Appeals’ attempt late Wednesday to curb access to the drug.
It means mifepristone remains legal to use, and can continue to be distributed by mail and taken up until the 10th week of pregnancy—at least until midnight on Wednesday, April 19, when the temporary hold expires.
The Department of Justice is appealing the Fifth Circuit decision, and the Supreme Court has given all parties until noon on Tuesday, April 18, to submit their responses.
The legal firestorm over mifepristone erupted on April 7, when Judge Matthew Kacsmaryk of the Northern District of Texas ruled to revoke its FDA approval, overriding decades of scientific consensus on the drug’s safety. Kacsmaryk’s ruling claimed that the pill was unsafe and the FDA didn’t do its due diligence when approving it in 2000. It was the first time a court had stepped in to pull a long-approved medication from the market, and the most significant ruling on reproductive rights since the Supreme Court overturned Roe v. Wade.
On the same day as Kacsmaryk’s ruling, a judge in Washington state issued a conflicting order, saying that the FDA must keep mifepristone available in 17 states and the District of Columbia.
Mifepristone has been available in France since 1988, and was approved by the FDA in 2000 after the agency carefully weighed its safety and efficacy. It’s also approved in the United Kingdom, Sweden, and dozens of other countries. The first pill in a two-step regimen, it blocks the hormone progesterone, which is necessary for pregnancy. A second drug, misoprostol, is taken 24 to 48 hours after mifepristone to complete the abortion. The two-pill combination can be used up to the first 10 weeks of pregnancy. As of 2020, medication abortion accounted for just over half of all abortions in the US.
Late Wednesday, a federal appeals court partially blocked Kacsmaryk’s order, keeping mifepristone on the market but imposing certain key restrictions on its access. The ruling, which came from the conservative US Fifth Circuit Court of Appeals, would prevent dispensing the pill by mail and shorten the window in which it can be obtained, from 10 weeks to seven. These new restrictions would roll back changes the FDA made in recent years to expand the pill’s availability, particularly during the pandemic, when telehealth became a necessity for some patients.
On Thursday, April 13, US Attorney General Merrick Garland said the Justice Department sought “emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.” The department filed its appeal with the Supreme Court Friday morning.
Legal experts and those in the pharmaceutical industry worry that the courts’ meddling in the FDA’s authority could put access to other medications at risk, especially ones considered politically sensitive, such as hormonal birth control, drugs to prevent HIV infection, or even vaccines.
by crissly | Apr 13, 2023 | Uncategorized
After conflicting legal rulings triggered widespread uncertainty about the future of abortion pill access in the United States, both US-based telehealth providers and overseas pill-by-mail sellers want to make one thing clear: They’re here to stay.
Since the Supreme Court overturned Roe v. Wade, virtual abortion clinics have taken a more prominent role in reproductive healthcare. Before that decision, virtual abortion clinics accounted for 4 percent of abortions in the US; after the decision, the number rose to 11 percent, according to a study from the Society of Family Planning.
The ground shifted for abortion pill providers on April 8, when a ruling from Judge Matthew Kacsmaryk of the Northern District of Texas invalidated the US Food and Drug Administration’s approval of mifepristone, one of the two drugs commonly used in a two-step medication abortion. The ruling ignored decades of scientific consensus about mifepristone’s safety, and undermined the FDA’s decades-old approval of the medication. It also directly conflicted with a ruling made the same day by Judge Thomas Rice of the Eastern District of Washington, directing US authorities to preserve access to the medication.
Wednesday, the Fifth Circuit Court of Appeals partly overruled Kacsmaryk, ordering that mifepristone remain legally available—but it also overturned mifepristone dispensation by mail in states where it was previously legal. The ruling states the drug must now be dispensed in person, undoing recent changes the FDA made to ensure people can access healthcare.
This reversal impacts a wide network of telehealth providers. During the pandemic, when the FDA eased restrictions around virtual abortion care, abortion pills became available by mail in 25 states and Washington, DC. Many of these pills were provided by services specifically devoted to reproductive telehealth, including the virtual clinics like Hey Jane and Choix.
These companies have been preparing for increased restrictions, and are now moving quickly to ensure they’re still able to legally operate without pause. As of now, both Hey Jane and Choix are continuing to offer mifepristone pills by mail in the states they were previously servicing.
It’s unclear what might happen long-term if the mifepristone-by-mail ban stays, though. Even if virtual clinics want to keep dispensing the pills, they may run into an issue with the two major US manufacturers, Danco Laboratories and GenBioPro. “They would not give the pills to mail-order pharmacies to mail, unless the Biden administration issues an enforcement discretion notice, telling them that they’re allowed to do that,” says Drexel University law professor David Cohen, referring to an FDA policy in which the agency does not take action against the dissemination of unapproved drugs if there are extenuating circumstances.
The FDA declined to comment on whether it would exercise enforcement discretion in regards to mifepristone-by-mail distribution.
There are back-up plans in place if mifepristone becomes unavailable for US telehealth providers. Medication abortions typically consist of two pills: mifepristone and misoprostol. Mifepristone works by blocking the hormone progesterone, which is necessary for pregnancies to continue. While mifepristone is often referred to colloquially as “the abortion pill,” it’s actually misoprostol that causes the uterine contractions that expel fetal tissue from the body. And as misoprostol is not subject to the recent rulings, there is a possibility that these companies will begin offering misoprostol on its own if manufacturers cut off access to mifepristone. This is not ideal, as the combination of pills produces the best results; misoprostol on its own can cause additional cramping and nausea. But for providers determined to keep helping patients, it’s better than nothing.
by crissly | Apr 9, 2023 | Uncategorized
Nearly 400,000 years after the Big Bang, the primordial plasma of the infant universe cooled enough for the first atoms to coalesce, making space for the embedded radiation to soar free. That light—the cosmic microwave background (CMB)—continues to stream through the sky in all directions, broadcasting a snapshot of the early universe that’s picked up by dedicated telescopes and even revealed in the static on old cathode-ray televisions.
After scientists discovered the CMB radiation in 1965, they meticulously mapped its tiny temperature variations, which displayed the exact state of the cosmos when it was a mere frothing plasma. Now they’re repurposing CMB data to catalog the large-scale structures that developed over billions of years as the universe matured.
“That light experienced a bulk of the history of the universe, and by seeing how it’s changed, we can learn about different epochs,” said Kimmy Wu, a cosmologist at SLAC National Accelerator Laboratory.
Over the course of its nearly 14-billion-year journey, the light from the CMB has been stretched, squeezed, and warped by all the matter in its way. Cosmologists are beginning to look beyond the primary fluctuations in the CMB light to the secondary imprints left by interactions with galaxies and other cosmic structures. From these signals, they’re gaining a crisper view of the distribution of both ordinary matter—everything that’s composed of atomic parts—and the mysterious dark matter. In turn, those insights are helping to settle some long-standing cosmological mysteries and pose some new ones.
“We’re realizing that the CMB does not only tell us about the initial conditions of the universe. It also tells us about the galaxies themselves,” said Emmanuel Schaan, also a cosmologist at SLAC. “And that turns out to be really powerful.”
A Universe of Shadows
Standard optical surveys, which track the light emitted by stars, overlook most of the galaxies’ underlying mass. That’s because the vast majority of the universe’s total matter content is invisible to telescopes—tucked out of sight either as clumps of dark matter or as the diffuse ionized gas that bridges galaxies. But both the dark matter and the strewn gas leave detectable imprints on the magnification and color of the incoming CMB light.
“The universe is really a shadow theater in which the galaxies are the protagonists and the CMB is the backlight,” Schaan said.
Many of the shadow players are now coming into relief.
When light particles, or photons, from the CMB scatter off electrons in the gas between galaxies, they get bumped to higher energies. In addition, if those galaxies are in motion with respect to the expanding universe, the CMB photons get a second energy shift, either up or down, depending on the relative motion of the cluster.
This pair of effects, known respectively as the thermal and kinematic Sunyaev-Zel’dovich (SZ) effects, were first theorized in the late 1960s and have been detected with increasing precision in the past decade. Together, the SZ effects leave a characteristic signature that can be teased out of CMB images, allowing scientists to map the location and temperature of all the ordinary matter in the universe.
Finally, a third effect known as weak gravitational lensing warps the path of CMB light as it travels near massive objects, distorting the CMB as though it were viewed through the base of a wineglass. Unlike the SZ effects, lensing is sensitive to all matter—dark or otherwise.
Taken together, these effects allow cosmologists to separate the ordinary matter from the dark matter. Then scientists can overlay these maps with images from galaxy surveys to gauge cosmic distances and even trace star formation.
