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      in US Politics

      To protect abortion access, the FDA should decline to enforce a mifepristone ban | David S Cohen, Greer Donley and Rachel Rebouché

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      On Friday, the nation faced dueling decisions from federal judges regarding the first drug in a medication abortion: mifepristone. A judge in Texas ruled that the Food and Drug Administration (FDA) likely improperly approved the drug, putting mifepristone’s approval on hold while the case plays out (though this order won’t take effect until late Friday this week). Minutes later, a judge in Washington state ruled that the FDA could not change the status quo regarding mifepristone’s availability.In response to these two cases and two other less-publicized cases involving the FDA and medication abortion, the agency needs to chart a course consistent with its mission to protect patient health and to follow the evidence. As the Biden administration has stated, protecting medication abortion is a public health imperative now that states can ban all abortion outright. If the agency does not respond to these conflicting rulings in a manner tailored to provide the greatest access possible to medication abortion, it will be telling of Biden’s commitment to reproductive justice.Though the case in Texas has garnered enormous attention, it is not the only case thrusting the FDA into the center of the abortion debate. The others have the opposite goal of improving access to the drug. The litigation in Washington state, not widely discussed until Friday, centered around the FDA’s special and onerous regulation of medication abortion. Eighteen state attorneys general sued the FDA arguing that the agency’s overregulation is not justified by the statute or the drug’s safety and must be lifted. If successful on appeal, this would ensure mifepristone is treated like other prescription drugs – prescribed through any provider and accessible at any pharmacy.Plaintiffs in two other cases are pushing even further, trying to use the FDA’s special regulation of mifepristone to argue that a state cannot ban or overregulate the drug. These lawsuits, filed respectively by the generic manufacturer of mifepristone in West Virginia and a physician in North Carolina, might restore access to medication abortion across the country. The plaintiffs argue that federal approval of mifepristone trumps state abortion laws, essentially forcing all states to allow medication abortion as regulated by the FDA.The FDA is caught in the crosshairs. Though the agency prides itself on scientific independence and seeks to avoid the appearance of partisanship, any reaction the agency has to these cases – even a decision not to act – will appear political to one side. Nonetheless, the FDA must push forward to ensure access to this critical drug.Starting with the two cases just decided, the agency can comply with both by announcing that it will exercise enforcement discretion. Enforcement discretion allows the agency to provide safe harbor for technical violations of law. So even if mifepristone becomes an unapproved drug per the Texas order, the agency could announce that it would not pursue action against the entities that market or dispense the drug to maintain the status quo as required by the Washington case.This would not require the agency to “ignore” the Texas order, as some have suggested. Rather, enforcement discretion is a normal part of the FDA’s operation and only relevant if the drug becomes unapproved as ordered. The FDA could exercise this discretion without being ordered to by the Washington court, but the Washington case provides enormous political cover for the agency to use this discretion.Repercussions for patient and public health could result from the FDA failing to clearly exercise its enforcement discretion. Clinicians may turn to a different medication abortion regimen that does not include mifepristone and is outside of current FDA regulation. Though alternative regimens will be vital to maintaining abortion access if mifepristone becomes inaccessible, they are slightly less effective and, more importantly, will upend what has been the uniform, established protocol for a medication abortion in the United States for over two decades. Relatedly, confusion is sure to reign after the Texas decision unless the FDA speaks in a clear and timely voice. Already, certain abortion providers have indicated that they will continue to dispense mifepristone regardless of the order in Texas unless the FDA tells them they cannot.As requested by plaintiffs in the Washington case, the FDA could also start the process to remove the unnecessary barriers to accessing mifepristone, which every relevant medical organization agrees are not medically necessary. These barriers make abortion less accessible without any benefit for patient safety. Though the FDA has repealed parts of these unduly restrictive rules over the last decade, the FDA should abandon the remaining restrictions, which are also contradicted by the best evidence. These policies do not make the agency seem evenhanded; they make it seem unscientific. The agency should not wait for the Washington court to order this – it should start the process now.In the pre-emption cases, the FDA could help the effort to restore access to early abortion in states with abortion bans by embracing the theory that the federal agency’s regulation of medication abortion trumps state law. The Department of Justice has already signaled its agreement, but the FDA has been silent. The FDA has spent decades assessing the risks and benefits of medication abortion, examining and re-examining the evidence even decades after its approval in 2000. States should not be able to override that authority and create a public health crisis by banning a safe and effective medication.The agency, however, has appeared unwilling to remove the remaining unnecessary barriers to mifepristone or support pre-emption at this juncture. Indeed, it has said nothing about pre-emption and is opposing the attorneys general in the Washington case – a fact that may surprise people who think the Biden administration is doing all it can to support abortion access. Given the current public health crisis, the FDA must be bolder in its support of reproductive healthcare.Try as it might, the FDA cannot escape the abortion debate. Instead of trying to play both sides, the agency must act now by following the science and protecting the public’s health to the best of its ability. Protecting access to safe abortion is the way to do that.
      David S Cohen, a law professor at Drexel University, is a co-author of Obstacle Course: The Everyday Struggle to Get an Abortion in America, a board member of the Abortion Care Network and a consulting attorney with the Women’s Law Project
      Greer Donley is a law professor at the University of Pittsburgh and a board member of the Women’s Law Project
      Rachel Rebouché is the dean of the Temple University Beasley School of Law and a faculty fellow at the Center for Public Health Law Research More

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      in US Politics

      If you have a miscarriage in Republican America, your health is now at risk | Moira Donegan

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      If you have a miscarriage in Republican America, your health is now at riskMoira DoneganThe supreme court’s decision to overturn Roe has created a vast new public health crisis, as abortion bans complicate once-standard care for pregnant women The worst-case scenarios arrived with alarming speed. In the weeks since the US supreme court’s decision in Dobbs v Jackson Women’s Health, the case that overturned Roe v Wade and eliminated the constitutional right to an abortion, American women have faced a radical reordering of their lives. A right essential to their dignity and self-determination has been stripped away after nearly 50 years – and with it, the gains women have made in professional, political and social life are newly and gravely endangered. But in addition to this moral and civic crisis, the supreme court’s decision has also created a vast and acute new public health crisis, as abortion bans complicate once-standard care for pregnant women – and place the health of even those who are not pregnant into new and arbitrary danger.From natural birth to caesarean: women must be given unbiased information | Kara ThompsonRead moreTopicsUS politicsOpinionAbortionWomen’s healthHealthHealth policyRepublicanscommentReuse this content More

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      in Elections

      Joe Biden challenges Americans to 'mask up' for first 100 days – video

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      Joe Biden has urged Americans to wear face masks for 99 days as part of a challenge for his first 100 days in office during a speech on Thursday in which he unveiled his administrations’s national Covid strategy.
      Biden signed an executive order to mandate face coverings during interstate travel and within federal buildings as he noted the US coronavirus death toll is higher than that from the second world war. More

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      in US Politics

      PM channels his inner John Wayne in vaccine metaphor meltdown | John Crace

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      Shortly before 5pm in the UK, president-elect Joe Biden gave a press conference. The results of the trials were very promising, he said, but there was still a long way to go before a vaccination programme could be rolled out nationwide. So it was now more important than ever not to let your guard down and to carry on wearing masks. It was coherent, informative and in less than five minutes Biden had told Americans just about everything they needed to know.
      Boris Johnson likes to do things rather differently. Almost to the second after Biden had finished speaking, the prime minister stepped out into the Downing Street briefing room, flanked by the deputy chief medical officer, Jonathan Van-Tam, and Brigadier Joe Fossey, dressed in full camo gear that had the reverse effect of drawing attention to himself. A new form of anti-camo perhaps.
      After a few introductions, Boris went on one of his long rambles. He didn’t really have anything to say that couldn’t have been wrapped up in minutes but he considers a press conference not to have taken place unless he’s wasted the best part of an hour of everyone’s time.
      Perhaps it was the excitement of having a real life soldier standing next to him, but Johnson’s explanation of the new vaccination was relayed in a series of metaphors straight out of the movie Stagecoach. The arrows were in the quiver! The cavalry was on its way, the toot of the bugle – Michael Gove’s presumably – was getting louder but still some way off. Having a prime minister who manages to trivialise something really important is getting extremely draining and it’s hard not to zone out within moments of him starting a sentence. So much for the great communicator.
      Next up was the brigadier who is in charge of the mass testing in Liverpool and looked uncomfortable throughout. “Two thousand troops have answered the call,” he said, making it sound as if the soldiers had had some say in their deployment rather than been told they were off to Liverpool for the next four weeks.
      He then pulled out a piece of plastic from his pocket. “You know what a swab is,” he continued. “Well this is the lateral flow that gives you a result within an hour.” And that was all he had to say. He didn’t seem at all sure what the lateral flow actually was or how it worked but then he was only following orders. If he’d had his way, he’d have saved the taxpayer a return train ticket from Liverpool to London.
      There was no slideshow this time – obviously No 10 has started to wonder if they are more trouble than they are worth after recent events – so Van-Tam was left to ad lib on the vaccine trial. Even though he had no more information than Boris, so all he could do was repeat the fact that it was exciting but we shouldn’t get carried away just yet. Try to think of it as a penalty shootout, he said – Boris’s crap analogies are as contagious as the coronavirus. We’ve scored the first goal, so we know the keeper can be beaten, but there was a long way to go before the match was won. No one seemed to have told Van-Tam that the expectation in a shootout was that the penalty-taker would score.
      Things carried on in much the same vein when questions came in from the media. The brigadier tried to make himself as inconspicuous as possible – merging into the background was part of his SAS training – and so the only other thing he had to offer was that he was just on day four of his deployment so it was hard to tell whether things were going well or badly. Van-Tam desperately hunted around for new ways of saying the vaccination trials were still at an early stage, but things were looking more hopeful for next year.
      Try to think of yourself as being on a railway station on a wet and windy night, he said, doing his best to channel his inner Fat Controller. You could see the lights of the train two miles away. Then the train pulled into the station and you didn’t know if the door was going to open. Next you couldn’t even be sure of whether there would be enough seats for everyone. The UK had only ordered enough vaccine for about a third of the population, so unless more doses came online most people were going to miss out. It didn’t sound quite as hopeful as he had suggested. But maybe that’s just the way he tells them.
      Boris, meanwhile, just looked relieved to only get one question on the US presidential election. And that wasn’t even on if he had spoken to the president-elect – he hadn’t as Biden has been too busy taking calls from Micronesia – or if he had any reaction to being called a “shape-shifting creep” by a former adviser to Barack Obama. The Democrats still haven’t forgiven Boris for his remarks about Obama’s part-Kenyan ancestry giving him a dislike of the British empire.
      “I congratulate the president-elect,” said Johnson, sidestepping a suggestion he give Donald Trump a call to persuade him to throw in the towel. The US and the UK had had a close relationship in the past and no doubt would do so in the future. He had nothing to say on Brexit. Rather he chose to accentuate the shared climate change objectives of Cop27. Or Cop26 as the rest of the world knows it. More

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      in US Politics

      If the poorest Americans are selling their blood, the US is in serious trouble | Arwa Mahdawi

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      Looking to make extra cash? Don’t want to retrain in “cyber” but need a new gig? Good news! All you need to do is contract Covid-19, try not to die, then sell your antibody-rich blood plasma. Blood centres in the US are currently paying Covid-19 survivors a premium for their plasma, the yellowish liquid that makes up about 55% of blood. Apparently, you can get $100-$200 (£75-£155) a pop.It would seem some enterprising students have cottoned on to this money-making scheme. Administrators at Brigham Young University’s campus in Idaho recently announced that they are “deeply troubled” by accounts of students who have “intentionally” exposed themselves to coronavirus in order to get that sweet, sweet blood money. “There is never a need to resort to behaviour that endangers health or safety in order to make ends meet,” the school said.A noble sentiment. However, the US would not have a booming blood plasma industry in the first place if it weren’t for the fact that so many people have to resort to potentially endangering their own health in order to make ends meet. Even before the coronavirus hit, low-income Americans were selling blood plasma to get by.“Selling plasma is so common among America’s extremely poor that it can be thought of as their lifeblood,” a 2015 Atlantic article noted. The US is an outlier in this regard: you’re not allowed to sell your blood plasma in the UK or in many other developed countries. In the US, however, you can donate up to twice a week; the procedure typically takes about 90 minutes, and you will get somewhere between $30 (£23) and $50 (£38) a time. Which is more than the $7.25 (£5.50) per hour federal minimum wage. The companies bleeding you dry, of course, will be earning a whole lot more: blood plasma is a multibillion dollar business in the US. Indeed, blood products are the US’s 12th most valuable export; in 2016, they made up a greater percentage of all American exports than soya beans or computers. Industry people joke that the US, which produces 70% of all plasma worldwide, is “the Opec of plasma collections.”Giving blood plasma now and again won’t hurt you. Indeed, it is something we should all do if we can: plasma is desperately needed for life-saving therapies. In Britain, the NHS is urging Covid-19 survivors to donate plasma to treat those who fall ill during a second wave. But selling your blood plasma 104 times a year, as some desperate Americans do, may be another matter. Someexperts and research have queried whether it is healthy, and even in the US if you donate plasma rather than sell, there are limits on how many times you can do it. Some people who sell their plasma frequently have also complained about things like migraines, numbness, and fainting.I am not necessarily against the idea of allowing people to sell blood plasma: as long it is strictly regulated, the number of donations safely capped, and the pay fair. However, I am definitely against people having to resort to selling plasma because the lack of a meaningful welfare state, along with a stagnant minimum wage, means it’s the only way they can scrape by. Even if there were zero health consequences involved there is something fundamentally sickening about the blood plasma industry. According to one study, plasma donation centres are disproportionately located in low-income areas and the most frequent use of money earned from donating was paying for food and basic necessities. And this is happening in the richest country in the world. It should make your blood boil.• Arwa Mahdawi is a Guardian columnist More

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      in World Politics

      Global Health Policy Is World Politics

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      Border closures, lockdowns, competition for medical equipment, export bans — at the beginning of the health crisis, states in Europe and around the world were primarily concerned with implementing national measures and interests to contain COVID-19, the disease caused by the novel coronavirus. This discernible lack of solidarity and commitment to international cooperation among key […] More

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      in US Politics

      Don't let free speech be a casualty of coronavirus. We need it more than ever | Cas Mudde

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      Don’t let free speech be a casualty of coronavirus. We need it more than ever Cas Mudde Despots like Hungary’s Viktor Orbán are banning speech to ‘fight’ Covid-19. But more democratic countries are too Coronavirus – latest US updates Coronavirus – latest global updates See all our coronavirus coverage Ccoronavirus has given autocratic populists an […] More