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How Will Pricing Be Set for a COVID-19 Vaccine

The unprecedented challenge of pricing a coronavirus vaccine

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This article was originally published by PharmaPhorum.

  The optimal pricing strategy for a new vaccine involves setting a fair and sustainable price that enables the eligible population in need across the world to gain access, while also rewarding innovation and supporting further research and development. The need for a SARS-CoV-2 vaccine is arguably more urgent, and more global, than ever before for a vaccine. As the 130+ vaccine candidates currently in development progress through clinical testing, a key question for their manufacturers is how COVID-19 might be changing the equation when it comes to what a responsible pricing strategy might look like. At the same time, payers are also faced with needing to prepare and plan for how to react and manage this situation. Payers’ expectations regarding the pricing of SARS-CoV-2 vaccines was one of a number of areas we explored in the first wave of our latest syndicated study, in which we set out to assess the impact of COVID-19 on biopharmaceutical market access through interviews conducted with payers and advisors in the US, Europe, Brazil, and China during April and May 2020. This article shares selected insights from our study that are relevant to this topic, bringing the perspectives of the experts we interviewed together with a review of the recent commentary and discourse around fair pricing strategies for COVID-19 technologies more generally. Learnings from drugs and therapies Vaccine development – even at the accelerated speeds developers are currently working towards – takes significantly longer than repurposing existing or legacy treatments that have already been developed or entered the clinical development process for other indications. Therefore much of the debate around the pricing of COVID-19 technologies to date has focused on drugs and therapies.

“Gilead remains under close public scrutiny. Feedback from experts in our study suggests a ‘hangover effect’ from their approach to pricing in HCV, particularly in the US”

In particular, Gilead has been fast off the mark with its antiviral remdesivir, which was originally developed to treat hepatitis C, and later tested against ebola and marburg – but not found effective for any of these. On 29 April, an early data read out from a placebo-controlled trial of patients with advanced COVID-19 showed patients receiving remdesivir recovered in a median of 11 days after beginning treatment, compared with 15 days for patients in the placebo arm. The data also hinted at a survival benefit for remdesivir-treated patients (although death rate was – quietly and controversially – switched from a primary to a secondary endpoint mid-trial in order to secure a positive outcome with regulators). Based on this data, the Institute for Clinical and Economic Review (ICER), an independent US price watchdog, proposed two different approaches to estimate a potential price for the drug. The first approach, which they termed ‘cost recovery’, uses a marginal cost model in which the price set would compensate Gilead for the cost of production without factoring in the cost of R&D or allowing for any additional profit. They worked this out to be $10 per patient. Such a model is virtually unheard of for innovative pharmaceuticals in ‘normal’ circumstances, given the high cost of R&D and the need to reward risk and innovation. However in the context of COVID-19, consumer advocacy groups such as Public Citizen have been quick to endorse this proposal. ICER’s second proposed approach, a value-based pricing model, reflects the more common approach to pricing pharmaceuticals. This involves setting a price that considers the perceived value of the product, customers’ willingness to pay and affordability. Here they conducted a cost-effectiveness analysis to calculate the quality-adjusted life years (QALYs) saved by using the treatment, and used a cost per QALY willingness-to-pay threshold of $50,000. With this approach (assuming the survival benefit can be further substantiated), a course of treatment would cost $4,460. While such a price would result in a huge (and in many countries simply unmanageable) budget impact for payers given the expected burden of COVID-19 disease, the $50,000 cost per QALY threshold used to calculate this price actually represents a lower valuation than ICER’s typical willingness-to-pay threshold of $150,000 per QALY. The QALY calculation also excludes any broader societal benefits, which are usually factored in to ICER’s calculations – and are particularly far reaching in this case given the widespread effects of lockdown on the economy. The cost-effectiveness analysis will certainly evolve further; on 1 June, Gilead announced results from a phase 3 trial involving patients with moderate pneumonia resulting from COVID-19. While overall favourable for remdesivir, Gilead’s share prices dropped as investors were underwhelmed by the lack of significant improvement. digital-vaccine-microscope For the Gilead executives in the unenviable position of being tasked to set a price, there’s no easy win – keeping investors happy while avoiding widespread consumer backlash is a delicate balance. Gilead has been in this situation before, when it came under fire for setting the price for its hepatitis C treatment Sovaldi at $84,000 per patient back in 2013. As we are finding with remdesivir today, for a drug with such high demand, cost-effectiveness analysis broke down in the real world: Sovaldi was highly cost effective at this price – but unfortunately not affordable for most payers given the high budget impact. Despite a recent announcement that their investment in remdesivir for 2020 could be “up to $1 billion or more”, despite having pledged to donate 1.5 million doses of remdesivir globally and despite asking the FDA to rescind the orphan drug designation it granted for the drug earlier this year (which would have given it additional years of market exclusivity), Gilead remains under close public scrutiny. Feedback from experts in our study suggests a ‘hangover effect’ from their approach to pricing in HCV, particularly in the US.

“Pricing at these levels will risk the prospect of governments taking extraordinary actions. Several have already made moves to enact compulsory licenses or invoke Crown Use – generally viewed as a last resort”

Some consider it unethical for drugmakers to profit at all from this crisis given the potential for broader reputational benefits, while others suggest that relying on the altruism of private companies is not sustainable. Commentators in the latter camp argue that delivering Gilead with a return on investment for the drug is important to set a precedent that will encourage more widespread investment from manufacturers. On 3rd June, financial analyst Geoffrey Porges of SVB Leerink predicted that remdesivir would deliver revenues approaching $2 billion in 2020, rising to $7.7 billion by 2022. These figures are based on his estimation that Gilead set a tiered pricing per treatment course of $5,000 in the US, $4,000 in Europe and $2,000 elsewhere – a lower profit contribution than from the rest of its portfolio, but still very much assuming a commercial strategy that Gilead has been trying to distance itself from taking. Pricing at these levels will risk the prospect of governments taking extraordinary actions. Several countries, including France, Germany, Canada and Australia have already made moves to enact compulsory licenses or invoke Crown Use, giving them the flexibility to revoke patents should the need arise. This is generally viewed as a last resort, especially in high income countries, as it dis-incentivises investment in development. In low and middle income countries, exclusivity is even less likely. Gilead has already struck deals with five generic drugmakers in India and Pakistan, allowing them to manufacture and distribute remdesivir to 127 countries, free to set their own prices without needing to pay royalties to Gilead until the public health emergency is declared over or another drug or vaccine is approved to treat or prevent COVID-19. In May, Bangladesh drugmaker Beximco Pharmaceuticals started selling an unlicensed generic version of remdesivir under the provisions of a World Trade Organization agreement for ‘Least-Developed Countries’ for approximately $65 per vial (meaning a full course could cost around $300-$800 per patient). Under this agreement, Beximco is allowed to export its generic to other Least-Developed Countries, but other countries, including those in Europe, have reportedly contacted the company to explore potential to import the drug. To satisfy global demand and ensure widespread access, perhaps an entirely new model will be needed during this time of pandemic, involving ‘lump sum’ advance purchase commitment payments from governments, patent buyouts or other innovative contracting approaches.

“‘In-pandemic’ pricing will likely look very different to ‘out-of-pandemic’ pricing… this reinforces the element of risk the manufacturers are taking on in pursuing development”

Vaccine pricing specificities As we wait to see what compromise will be found for a price for remdesivir, let’s turn our attention to the specific issues that vaccine manufacturers will have to consider as they start thinking about setting a price for SARS-CoV-2 vaccines. As vaccines are usually procured through tenders on a much broader scale, pricing strategies already tend to take into account the total budget rather than cost-effectiveness analysis or value-based pricing approaches taken for drugs. Experts in our study assumed the standard payment models would hold true for vaccines that are developed against SARS-CoV-2, with limited enthusiasm for innovative contracting approaches – at least at this early stage. However the question of how payers would value different potential candidates remains a pertinent one. A key consideration is of course the quality of the evidence: a consistent finding that emerged from our study was experts’ strong desire for human disease prevention efficacy data over immunogenicity alone. A vaccine demonstrating the former would command a higher price, although the final price would also depend on so many other factors:
  • What other clinical endpoints have been investigated? (the more the better, especially if they can demonstrate reduction in severe cases, hospitalisations and healthcare resource utilisation)
  • Will the manufacturer be able to supply all needed doses within a rapid timeframe? (Security of supply – and proven demonstration of supply capabilities via other vaccines – has the potential to increase willingness to pay, given this is a key concern)
  • What alternatives are there and over what timescale will these become available? (The fewer the alternative options, the further away they are, the higher the willingness to pay for the first available option, and the greater the willingness to enter into an exclusive contract with the manufacturer in order to secure supply)
  • Are effective treatments already available at this point? (If so, this could potentially reduce willingness to pay)
  • Will the vaccine offer cross-protection against any other respiratory viruses? (Again, this would increase willingness to pay)
Potentially, given the vast, global scale of demand, payers will need to draw up contracts with multiple manufacturers to cover the entirety of their eligible population. With current resources and capacity constraints, implementation of an immunisation programme covering the whole population is not considered to be feasible, meaning a staggered approach in which the most exposed and/or vulnerable population groups are prioritised is expected to be necessary. All of this of course assumes the perceived need remains high at the time of launch, as ‘in-pandemic’ pricing will likely look very different to ‘out-of-pandemic’ pricing. This is an issue manufacturers have faced for vaccines developed for previous pandemics such as H1N1, where infection rates plummeted to negligible levels prior to launch. The potential for something similar to happen again here reinforces the element of risk the manufacturers are taking on in pursuing development, a risk that arguably deserves rewarding with the potential to make profit. There are also nuances around duration of protection and number of doses required – both aspects that would impact not only the logistics of implementation of a vaccination programme but also the price of the vaccine. vaccine In our study, we saw that experts thought a vaccine given as a one-off could potentially command a price multiple times higher than one that needed to be given every season. Duration of trial data comes into play when setting an initial price in this situation. Given the eagerness to get a vaccine, experts expect data from a single season will be sufficient, but this means uncertainty regarding duration of protection over the long term. Vaccine technology and approach is yet another consideration, with experts recognising that live-attenuated vaccines take longer to develop and are more expensive to produce compared to other approaches; efficacy will also vary from one approach to another. However these kinds of technical considerations could potentially be dwarfed by the major national and political interests at play. Our study shows that payers in some countries will more readily engage in discussions with a local manufacturer, or at least one that includes trial data from their local population. Then there is the matter of government funding and global equity of access. French drugmaker Sanofi faced controversy in May with a (quickly back-pedalled) suggestion from its CEO that the US would be the first country to benefit from access to its vaccine, once available, given that it had financially supported its research. BARDA, the Biomedical Advanced Research and Development Authority, a department of the US Health and Human Services office, has channelled funding into a number of vaccine candidates, as have other national governments. The level of upfront public investment has been higher than for any other vaccine. How this investment will be recognised in pricing discussions and country dose allocations will surely be the source of much discussion as these vaccines move closer to launch. Especially when considered alongside the work of other non-profit organisations and public health actors such as CEPI (the Coalition for Epidemic Preparedness Innovation), and Gavi, the Vaccine Alliance, which focuses on increasing access to immunisation in the world’s poorest countries. On 9 June, Gavi launched a $2 billion financing initiative to help secure access to SARS-CoV-2 vaccines for these countries, while Médecins Sans Frontières (MSF) has already released a statement urging world leaders to demand pharmaceutical companies to make the vaccines available at cost, and China’s President Xi Jinping has vowed to make vaccines developed in China available as a ‘global public good’. Given the multiple variables above, establishing a price corridor for SARS-CoV-2 vaccines seems challenging at this point. Experts participating in our study suggested they would look to a number of potential analogues, from seasonal influenza to shingles, when trying to conceptualise how they would start to rationalise the pricing. Each has pros and cons but no benchmark from history is perfectly suited to the extraordinary situation we find ourselves in today. We could draw some parallels with antibiotics, another area in which there is a widespread global public health need, in this case to combat antimicrobial resistance. As with COVID-19, governments and non-profits have channelled large amounts of funding into R&D to counteract limited investment by the private sector due to low potential returns relative to other areas. Targeted economic incentives such as ‘market entry rewards’ for bringing a novel antibiotic to market have been called for to offset the low potential selling price of these drugs. Perhaps similar policy levers could be considered here. Despite experts’ limited enthusiasm for new payment models in our study, in the unlikely event that SARS-CoV-2 vaccines are to be sold at or close to cost price, creative solutions that go beyond a simple price per dose and are designed to mitigate against failure or evaporating demand, may be essential to ensure the market is sustainable. These could include spreading risk between all parties involved (including governments / commercial payers, suppliers and distributors, as well as manufacturers), or recognising manufacturers’ investment in this area by committing to support pipeline candidates from their broader vaccine portfolios in areas that are likely to have more predictable markets and thus offer potential for them to realise profits in the future. Conclusion While our study showed lots of factors will be taken into account for the pricing of future SARS-CoV-2 vaccines, with variable impact depending on timing, the evolution of the virus itself and other external factors, and varying weight by country, the one thing that is certain is that manufacturers will need to keep up to date as the situation develops. As we have seen in the remdesivir pricing debate, and our understanding of COVID-19 more generally, pricing expectations will continue to evolve rapidly. For the manufacturers, setting the wrong price will have potentially ruinous reputational ramifications. Public relations always need to be considered when pricing any new biopharmaceutical asset, but now more than ever, with the glare of the world watching, it will be ever so important to be conscious of setting a price that minimises consumer criticism and maintains public relations. Especially since early indications suggest biopharma’s rapid response to the COVID-19 crisis has helped the industry to start rebuilding its reputation among payers and the public. Click here to find out more about the first wave of our syndicated report, which is available now and includes detailed information on a range of topics, including national immunisation groups’ and payers’ price estimates by country. Click here for more information on our pricing research capabilities.
About the authors Rachel Howard – director, market access at Research Partnership Brett Gardiner – director, market access at Research Partnership Suzan Serip – consultant, market access at Research Partnership About Research Partnership Research Partnership Research Partnership is the largest independent healthcare market research and consulting agency in the world. We collaborate with clients from the global pharmaceutical, medtech and biotech industries, providing research intelligence and strategic recommendations that elevate healthcare brands and power their success. Our specialist market access service supports the world’s leading manufacturers in market access, pricing, and reimbursement. www.researchpartnership.com
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President Biden Delivers The “Darkest, Most Un-American Speech Given By A President”

President Biden Delivers The "Darkest, Most Un-American Speech Given By A President"

Having successfully raged, ranted, lied, and yelled through…

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President Biden Delivers The "Darkest, Most Un-American Speech Given By A President"

Having successfully raged, ranted, lied, and yelled through the State of The Union, President Biden can go back to his crypt now.

Whatever 'they' gave Biden, every American man, woman, and the other should be allowed to take it - though it seems the cocktail brings out 'dark Brandon'?

Tl;dw: Biden's Speech tonight ...

  • Fund Ukraine.

  • Trump is threat to democracy and America itself.

  • Abortion is good.

  • American Economy is stronger than ever.

  • Inflation wasn't Biden's fault.

  • Illegals are Americans too.

  • Republicans are responsible for the border crisis.

  • Trump is bad.

  • Biden stands with trans-children.

  • J6 was the worst insurrection since the Civil War.

(h/t @TCDMS99)

Tucker Carlson's response sums it all up perfectly:

"that was possibly the darkest, most un-American speech given by an American president. It wasn't a speech, it was a rant..."

Carlson continued: "The true measure of a nation's greatness lies within its capacity to control borders, yet Bid refuses to do it."

"In a fair election, Joe Biden cannot win"

And concluded:

“There was not a meaningful word for the entire duration about the things that actually matter to people who live here.”

Victor Davis Hanson added some excellent color, but this was probably the best line on Biden:

"he doesn't care... he lives in an alternative reality."

*  *  *

Watch SOTU Live here...

*   *   *

Mises' Connor O'Keeffe, warns: "Be on the Lookout for These Lies in Biden's State of the Union Address." 

On Thursday evening, President Joe Biden is set to give his third State of the Union address. The political press has been buzzing with speculation over what the president will say. That speculation, however, is focused more on how Biden will perform, and which issues he will prioritize. Much of the speech is expected to be familiar.

The story Biden will tell about what he has done as president and where the country finds itself as a result will be the same dishonest story he's been telling since at least the summer.

He'll cite government statistics to say the economy is growing, unemployment is low, and inflation is down.

Something that has been frustrating Biden, his team, and his allies in the media is that the American people do not feel as economically well off as the official data says they are. Despite what the White House and establishment-friendly journalists say, the problem lies with the data, not the American people's ability to perceive their own well-being.

As I wrote back in January, the reason for the discrepancy is the lack of distinction made between private economic activity and government spending in the most frequently cited economic indicators. There is an important difference between the two:

  • Government, unlike any other entity in the economy, can simply take money and resources from others to spend on things and hire people. Whether or not the spending brings people value is irrelevant

  • It's the private sector that's responsible for producing goods and services that actually meet people's needs and wants. So, the private components of the economy have the most significant effect on people's economic well-being.

Recently, government spending and hiring has accounted for a larger than normal share of both economic activity and employment. This means the government is propping up these traditional measures, making the economy appear better than it actually is. Also, many of the jobs Biden and his allies take credit for creating will quickly go away once it becomes clear that consumers don't actually want whatever the government encouraged these companies to produce.

On top of all that, the administration is dealing with the consequences of their chosen inflation rhetoric.

Since its peak in the summer of 2022, the president's team has talked about inflation "coming back down," which can easily give the impression that it's prices that will eventually come back down.

But that's not what that phrase means. It would be more honest to say that price increases are slowing down.

Americans are finally waking up to the fact that the cost of living will not return to prepandemic levels, and they're not happy about it.

The president has made some clumsy attempts at damage control, such as a Super Bowl Sunday video attacking food companies for "shrinkflation"—selling smaller portions at the same price instead of simply raising prices.

In his speech Thursday, Biden is expected to play up his desire to crack down on the "corporate greed" he's blaming for high prices.

In the name of "bringing down costs for Americans," the administration wants to implement targeted price ceilings - something anyone who has taken even a single economics class could tell you does more harm than good. Biden would never place the blame for the dramatic price increases we've experienced during his term where it actually belongs—on all the government spending that he and President Donald Trump oversaw during the pandemic, funded by the creation of $6 trillion out of thin air - because that kind of spending is precisely what he hopes to kick back up in a second term.

If reelected, the president wants to "revive" parts of his so-called Build Back Better agenda, which he tried and failed to pass in his first year. That would bring a significant expansion of domestic spending. And Biden remains committed to the idea that Americans must be forced to continue funding the war in Ukraine. That's another topic Biden is expected to highlight in the State of the Union, likely accompanied by the lie that Ukraine spending is good for the American economy. It isn't.

It's not possible to predict all the ways President Biden will exaggerate, mislead, and outright lie in his speech on Thursday. But we can be sure of two things. The "state of the Union" is not as strong as Biden will say it is. And his policy ambitions risk making it much worse.

*  *  *

The American people will be tuning in on their smartphones, laptops, and televisions on Thursday evening to see if 'sloppy joe' 81-year-old President Joe Biden can coherently put together more than two sentences (even with a teleprompter) as he gives his third State of the Union in front of a divided Congress. 

President Biden will speak on various topics to convince voters why he shouldn't be sent to a retirement home.

According to CNN sources, here are some of the topics Biden will discuss tonight:

  • Economic issues: Biden and his team have been drafting a speech heavy on economic populism, aides said, with calls for higher taxes on corporations and the wealthy – an attempt to draw a sharp contrast with Republicans and their likely presidential nominee, Donald Trump.

  • Health care expenses: Biden will also push for lowering health care costs and discuss his efforts to go after drug manufacturers to lower the cost of prescription medications — all issues his advisers believe can help buoy what have been sagging economic approval ratings.

  • Israel's war with Hamas: Also looming large over Biden's primetime address is the ongoing Israel-Hamas war, which has consumed much of the president's time and attention over the past few months. The president's top national security advisers have been working around the clock to try to finalize a ceasefire-hostages release deal by Ramadan, the Muslim holy month that begins next week.

  • An argument for reelection: Aides view Thursday's speech as a critical opportunity for the president to tout his accomplishments in office and lay out his plans for another four years in the nation's top job. Even though viewership has declined over the years, the yearly speech reliably draws tens of millions of households.

Sources provided more color on Biden's SOTU address: 

The speech is expected to be heavy on economic populism. The president will talk about raising taxes on corporations and the wealthy. He'll highlight efforts to cut costs for the American people, including pushing Congress to help make prescription drugs more affordable.

Biden will talk about the need to preserve democracy and freedom, a cornerstone of his re-election bid. That includes protecting and bolstering reproductive rights, an issue Democrats believe will energize voters in November. Biden is also expected to promote his unity agenda, a key feature of each of his addresses to Congress while in office.

Biden is also expected to give remarks on border security while the invasion of illegals has become one of the most heated topics among American voters. A majority of voters are frustrated with radical progressives in the White House facilitating the illegal migrant invasion. 

It is probable that the president will attribute the failure of the Senate border bill to the Republicans, a claim many voters view as unfounded. This is because the White House has the option to issue an executive order to restore border security, yet opts not to do so

Maybe this is why? 

While Biden addresses the nation, the Biden administration will be armed with a social media team to pump propaganda to at least 100 million Americans. 

"The White House hosted about 70 creators, digital publishers, and influencers across three separate events" on Wednesday and Thursday, a White House official told CNN. 

Not a very capable social media team... 

The administration's move to ramp up social media operations comes as users on X are mostly free from government censorship with Elon Musk at the helm. This infuriates Democrats, who can no longer censor their political enemies on X. 

Meanwhile, Democratic lawmakers tell Axios that the president's SOTU performance will be critical as he tries to dispel voter concerns about his elderly age. The address reached as many as 27 million people in 2023. 

"We are all nervous," said one House Democrat, citing concerns about the president's "ability to speak without blowing things."

The SOTU address comes as Biden's polling data is in the dumps

BetOnline has created several money-making opportunities for gamblers tonight, such as betting on what word Biden mentions the most. 

As well as...

We will update you when Tucker Carlson's live feed of SOTU is published. 

Tyler Durden Fri, 03/08/2024 - 07:44

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What is intersectionality and why does it make feminism more effective?

The social categories that we belong to shape our understanding of the world in different ways.

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Mary Long/Shutterstock

The way we talk about society and the people and structures in it is constantly changing. One term you may come across this International Women’s Day is “intersectionality”. And specifically, the concept of “intersectional feminism”.

Intersectionality refers to the fact that everyone is part of multiple social categories. These include gender, social class, sexuality, (dis)ability and racialisation (when people are divided into “racial” groups often based on skin colour or features).

These categories are not independent of each other, they intersect. This looks different for every person. For example, a black woman without a disability will have a different experience of society than a white woman without a disability – or a black woman with a disability.

An intersectional approach makes social policy more inclusive and just. Its value was evident in research during the pandemic, when it became clear that women from various groups, those who worked in caring jobs and who lived in crowded circumstances were much more likely to die from COVID.

A long-fought battle

American civil rights leader and scholar Kimberlé Crenshaw first introduced the term intersectionality in a 1989 paper. She argued that focusing on a single form of oppression (such as gender or race) perpetuated discrimination against black women, who are simultaneously subjected to both racism and sexism.

Crenshaw gave a name to ways of thinking and theorising that black and Latina feminists, as well as working-class and lesbian feminists, had argued for decades. The Combahee River Collective of black lesbians was groundbreaking in this work.

They called for strategic alliances with black men to oppose racism, white women to oppose sexism and lesbians to oppose homophobia. This was an example of how an intersectional understanding of identity and social power relations can create more opportunities for action.

These ideas have, through political struggle, come to be accepted in feminist thinking and women’s studies scholarship. An increasing number of feminists now use the term “intersectional feminism”.

The term has moved from academia to feminist activist and social justice circles and beyond in recent years. Its popularity and widespread use means it is subjected to much scrutiny and debate about how and when it should be employed. For example, some argue that it should always include attention to racism and racialisation.

Recognising more issues makes feminism more effective

In writing about intersectionality, Crenshaw argued that singular approaches to social categories made black women’s oppression invisible. Many black feminists have pointed out that white feminists frequently overlook how racial categories shape different women’s experiences.

One example is hair discrimination. It is only in the 2020s that many organisations in South Africa, the UK and US have recognised that it is discriminatory to regulate black women’s hairstyles in ways that render their natural hair unacceptable.

This is an intersectional approach. White women and most black men do not face the same discrimination and pressures to straighten their hair.

View from behind of a young, black woman speaking to female colleagues in an office
Intersectionality can lead to more inclusive organisations, activism and social movements. Rawpixel.com/Shutterstock

“Abortion on demand” in the 1970s and 1980s in the UK and USA took no account of the fact that black women in these and many other countries needed to campaign against being given abortions against their will. The fight for reproductive justice does not look the same for all women.

Similarly, the experiences of working-class women have frequently been rendered invisible in white, middle class feminist campaigns and writings. Intersectionality means that these issues are recognised and fought for in an inclusive and more powerful way.

In the 35 years since Crenshaw coined the term, feminist scholars have analysed how women are positioned in society, for example, as black, working-class, lesbian or colonial subjects. Intersectionality reminds us that fruitful discussions about discrimination and justice must acknowledge how these different categories affect each other and their associated power relations.

This does not mean that research and policy cannot focus predominantly on one social category, such as race, gender or social class. But it does mean that we cannot, and should not, understand those categories in isolation of each other.

Ann Phoenix does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Biden defends immigration policy during State of the Union, blaming Republicans in Congress for refusing to act

A rising number of Americans say that immigration is the country’s biggest problem. Biden called for Congress to pass a bipartisan border and immigration…

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President Joe Biden delivers his State of the Union address on March 7, 2024. Alex Brandon-Pool/Getty Images

President Joe Biden delivered the annual State of the Union address on March 7, 2024, casting a wide net on a range of major themes – the economy, abortion rights, threats to democracy, the wars in Gaza and Ukraine – that are preoccupying many Americans heading into the November presidential election.

The president also addressed massive increases in immigration at the southern border and the political battle in Congress over how to manage it. “We can fight about the border, or we can fix it. I’m ready to fix it,” Biden said.

But while Biden stressed that he wants to overcome political division and take action on immigration and the border, he cautioned that he will not “demonize immigrants,” as he said his predecessor, former President Donald Trump, does.

“I will not separate families. I will not ban people from America because of their faith,” Biden said.

Biden’s speech comes as a rising number of American voters say that immigration is the country’s biggest problem.

Immigration law scholar Jean Lantz Reisz answers four questions about why immigration has become a top issue for Americans, and the limits of presidential power when it comes to immigration and border security.

President Joe Biden stands surrounded by people in formal clothing and smiles. One man holds a cell phone camera close up to his face.
President Joe Biden arrives to deliver the State of the Union address at the US Capitol on March 7, 2024. Chip Somodevilla/Getty Images

1. What is driving all of the attention and concern immigration is receiving?

The unprecedented number of undocumented migrants crossing the U.S.-Mexico border right now has drawn national concern to the U.S. immigration system and the president’s enforcement policies at the border.

Border security has always been part of the immigration debate about how to stop unlawful immigration.

But in this election, the immigration debate is also fueled by images of large groups of migrants crossing a river and crawling through barbed wire fences. There is also news of standoffs between Texas law enforcement and U.S. Border Patrol agents and cities like New York and Chicago struggling to handle the influx of arriving migrants.

Republicans blame Biden for not taking action on what they say is an “invasion” at the U.S. border. Democrats blame Republicans for refusing to pass laws that would give the president the power to stop the flow of migration at the border.

2. Are Biden’s immigration policies effective?

Confusion about immigration laws may be the reason people believe that Biden is not implementing effective policies at the border.

The U.S. passed a law in 1952 that gives any person arriving at the border or inside the U.S. the right to apply for asylum and the right to legally stay in the country, even if that person crossed the border illegally. That law has not changed.

Courts struck down many of former President Donald Trump’s policies that tried to limit immigration. Trump was able to lawfully deport migrants at the border without processing their asylum claims during the COVID-19 pandemic under a public health law called Title 42. Biden continued that policy until the legal justification for Title 42 – meaning the public health emergency – ended in 2023.

Republicans falsely attribute the surge in undocumented migration to the U.S. over the past three years to something they call Biden’s “open border” policy. There is no such policy.

Multiple factors are driving increased migration to the U.S.

More people are leaving dangerous or difficult situations in their countries, and some people have waited to migrate until after the COVID-19 pandemic ended. People who smuggle migrants are also spreading misinformation to migrants about the ability to enter and stay in the U.S.

Joe Biden wears a black blazer and a black hat as he stands next to a bald white man wearing a green uniform and a white truck that says 'Border Patrol' in green
President Joe Biden walks with Jason Owens, the chief of the U.S. Border Patrol, as he visits the U.S.-Mexico border in Brownsville, Texas, on Feb. 29, 2024. Jim Watson/AFP via Getty Images

3. How much power does the president have over immigration?

The president’s power regarding immigration is limited to enforcing existing immigration laws. But the president has broad authority over how to enforce those laws.

For example, the president can place every single immigrant unlawfully present in the U.S. in deportation proceedings. Because there is not enough money or employees at federal agencies and courts to accomplish that, the president will usually choose to prioritize the deportation of certain immigrants, like those who have committed serious and violent crimes in the U.S.

The federal agency Immigration and Customs Enforcement deported more than 142,000 immigrants from October 2022 through September 2023, double the number of people it deported the previous fiscal year.

But under current law, the president does not have the power to summarily expel migrants who say they are afraid of returning to their country. The law requires the president to process their claims for asylum.

Biden’s ability to enforce immigration law also depends on a budget approved by Congress. Without congressional approval, the president cannot spend money to build a wall, increase immigration detention facilities’ capacity or send more Border Patrol agents to process undocumented migrants entering the country.

A large group of people are seen sitting and standing along a tall brown fence in an empty area of brown dirt.
Migrants arrive at the border between El Paso, Texas, and Ciudad Juarez, Mexico, to surrender to American Border Patrol agents on March 5, 2024. Lokman Vural Elibol/Anadolu via Getty Images

4. How could Biden address the current immigration problems in this country?

In early 2024, Republicans in the Senate refused to pass a bill – developed by a bipartisan team of legislators – that would have made it harder to get asylum and given Biden the power to stop taking asylum applications when migrant crossings reached a certain number.

During his speech, Biden called this bill the “toughest set of border security reforms we’ve ever seen in this country.”

That bill would have also provided more federal money to help immigration agencies and courts quickly review more asylum claims and expedite the asylum process, which remains backlogged with millions of cases, Biden said. Biden said the bipartisan deal would also hire 1,500 more border security agents and officers, as well as 4,300 more asylum officers.

Removing this backlog in immigration courts could mean that some undocumented migrants, who now might wait six to eight years for an asylum hearing, would instead only wait six weeks, Biden said. That means it would be “highly unlikely” migrants would pay a large amount to be smuggled into the country, only to be “kicked out quickly,” Biden said.

“My Republican friends, you owe it to the American people to get this bill done. We need to act,” Biden said.

Biden’s remarks calling for Congress to pass the bill drew jeers from some in the audience. Biden quickly responded, saying that it was a bipartisan effort: “What are you against?” he asked.

Biden is now considering using section 212(f) of the Immigration and Nationality Act to get more control over immigration. This sweeping law allows the president to temporarily suspend or restrict the entry of all foreigners if their arrival is detrimental to the U.S.

This obscure law gained attention when Trump used it in January 2017 to implement a travel ban on foreigners from mainly Muslim countries. The Supreme Court upheld the travel ban in 2018.

Trump again also signed an executive order in April 2020 that blocked foreigners who were seeking lawful permanent residency from entering the country for 60 days, citing this same section of the Immigration and Nationality Act.

Biden did not mention any possible use of section 212(f) during his State of the Union speech. If the president uses this, it would likely be challenged in court. It is not clear that 212(f) would apply to people already in the U.S., and it conflicts with existing asylum law that gives people within the U.S. the right to seek asylum.

Jean Lantz Reisz does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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