A judge on Wednesday is being asked to clear the way for local governments and individual victims to vote on it.

Government entities, emergency room doctors, insurers, families of children born into withdrawal from the powerful prescription painkiller, individual victims and their families and others would have until Sept. 30 to vote on whether to accept the deal, which calls for members of the Sackler family who own the company to pay up to $7 billion over 15 years.

If approved, the settlement would be among the largest in a wave of lawsuits over the past decade as governments and others sought to hold drugmakers, wholesalers and pharmacies accountable for the opioid epidemic that started rising in the years after OxyContin hit the market in 1996. The other settlements together are worth about $50 billion, and most of the money is to be used to combat the crisis.

In the early 2000s, most opioid deaths were linked to prescription drugs, including OxyContin. Since then, heroin and then illicitly produced fentanyl became the biggest killers. In some years, the class of drugs was linked to more than 80,000 deaths, but that number dropped sharply last year.

The request of U.S. Bankruptcy Court Judge Sean Lane comes about a year after the U.S. Supreme Court rejected a previous version of Purdue’s proposed settlement. The court found it was improper that the earlier iteration would have protected members of the Sackler family from lawsuits over opioids, even though they themselves were not filing for bankruptcy protection.

Under the reworked plan hammered out with lawyers for state and local governments and others, groups that don’t opt in to the settlement would still have the right to sue members of the wealthy family whose name once adorned museum galleries around the world and programs at several prestigious U.S. universities.

Under the plan, the Sackler family members would give up ownership of Purdue. They resigned from the company’s board and stopped receiving distributions from its funds before the company’s initial bankruptcy filing in 2019. The remaining entity would get a new name and its profits would be dedicated to battling the epidemic.

Most of the money would go to state and local governments to address the nation’s addiction and overdose crisis, but potentially more than $850 million would go directly to individual victims. That makes it different from the other major settlements.

The payouts would not begin until after a hearing scheduled for Nov. 10, during which Lane is to be asked to approve the entire plan if enough of the affected parties agree.

The report, produced by the nonpartisan CBO and the Joint Committee on Taxation, factors in expected debt service costs and finds that the bill would increase interest rates and boost interest payments on the baseline projection of federal debt by $441 billion.

The analysis comes at a crucial moment as Trump is pushing the GOP-led Congress to act on what he calls his “big, beautiful bill.” It passed the House last month on a party-line vote, and now faces revisions in the Senate. Vice President JD Vance urged Senate Republicans during a private lunch meeting Tuesday to send the final package to the president’s desk.

“We’re excited to get this bill out,” said Senate Majority Leader John Thune afterward.

Tuesday’s report uses dynamic analysis by estimating the budgetary impact of the tax bill by considering how changes in the economy might affect revenues and spending. This is in contrast to static scoring, which presumes all other economic factors stay constant.

The CBO released its static scoring analysis earlier this month, estimating that Trump’s bill would unleash trillions in tax cuts and slash spending, but also increase deficits by $2.4 trillion over the decade and leave some 10.9 million more people without health insurance.

Republicans have repeatedly argued that a more dynamic scoring model would more accurately show how cutting taxes would spur economic growth — essentially overcoming any lost revenue to the federal government.

But the larger deficit numbers in the new analysis gave Democrats, who are unified against the big bill, fresh arguments for challenging the GOP position that the tax cuts would essentially pay for themselves.

“The Republican claim that this bill does not add to the debt or deficit is laughable, and the proof is in the numbers,” said Sen. Jeff Merkley of Oregon, the top Democrat on the Senate Budget Committee.

“The cost of these tax giveaways for billionaires, even when considering economic growth, will add even more to the debt than we previously expected,” he said.

Marc Goldwein, senior vice president and senior policy director for the Committee for a Responsible Federal Budget, said Tuesday on social media that considering the new dynamic analysis, “It’s not only not paying for all of itself, it’s not paying for any of itself.”

Treasury Secretary Scott Bessent and other Republicans have sought to discredit the CBO, saying the organization isn’t giving enough credit to the economic growth the bill will create.

At the Capitol, Mehmet Oz, who heads up the Centers for Medicaid and Medicare Services and joined Vance at the GOP Senate lunch, challenged CBO’s findings when asked about its estimate that the bill would leave 10.9 million more people without health care, largely from new work requirements.

“What will an American do if they’re given the option of trying to get a job or an education or volunteering their community — having some engagement — or losing their Medicaid insurance coverage?” Oz asked. “I have more confidence in the American people than has been given to them by some of these analyzing organizations.”

Republicans on the Senate Finance Committee unveiled their proposal Monday for deeper Medicaid cuts, including new work requirements for parents of teens, as a way to offset the costs of making Trump’s tax breaks more permanent in their draft for the big bill.

The Senate’s version of the package also enhances Trump’s proposed new tax break for seniors, with a bigger $6,000 deduction for low- to moderate-income senior households earning no more than $75,000 a year for singles, $150,000 for couples.

The proposals from Senate Republicans keep in place the current $10,000 deduction of state and local taxes, called SALT, drawing quick blowback from GOP lawmakers from New York and other high-tax states, who fought for a $40,000 cap in the House-passed bill. Senators insisted negotiations continue.

Bessent said Tuesday that the Senate Republican proposal for the tax cuts bill “will deliver the permanence and certainty both individual taxpayers and businesses alike are looking for, driving growth and unleashing the American economy.”

“We look forward to continuing to work with the Senate and the House to further refine this bill and get it to President Trump’s desk,” he said in a news release.

While the House-passed bill exempted parents with dependents from the new Medicaid work requirements, the Senate’s version broadened the requirement to include parents of children older than 14, as part of their effort to combat waste in the program and push personal responsibility.

The work requirements “demonstrate that you are trying your hardest to help this country be greater,” Oz said. “By doing that, you earn the right to be on Medicaid.”

The CBO separately released another analysis on the tax bill last week, including a look at how the measure would affect households based on income distribution. It estimates the bill would cost the poorest Americans roughly $1,600 a year while increasing the income of the wealthiest households by an average of $12,000 annually.

Under pressure from corporate lobbyists, the EC has been discussing reshaping rules that govern how companies monitor and report their activity. Last month, both French President Emmanuel Macron and German Chancellor Friedrich Merz escalated their campaign against the EU’s Corporate Sustainability Due Diligence Directive (CSDDD), which covers firms’ supply chains, claiming that the regulations threatened to make European businesses uncompetitive. In a speech, Macron told business executives the CSDDD should be “put off the table” entirely, expressing support for an EC “Omnibus Simplification Package” that would eliminate requirements for companies to monitor their supply chains for violations, remove mandatory climate transition plans, and significantly weaken enforcement mechanisms including civil liability provisions.

But legal and economics scholars, environmental organizations and businesses, along with countries such as Sweden and Denmark, have united to defend the regulations.

“The members of the European Parliament shouldn’t be fooled into thinking that if they remove this article that that’s going to somehow amount to a reduction in regulatory burden,” said Thom Wetzer, associate professor of law and finance at the University of Oxford, and the founding director of the Oxford Sustainable Law Programme. “What will come in its place is a very litigious landscape and differential implementation of national requirements. You will have replaced a nicely uniform obligation with a patchwork of a variety of different and uncertain obligations.”

In May, Wetzer and more than 30 other legal scholars sent a letter to the EC warning that, far from reducing costs, scrapping the regulations would create a range of new financial and legal risks for companies, as well as making it harder for them to achieve their sustainability and climate goals. The scholars warn that, “Without guiding regulations, corporate climate transitions will be more disorderly and costly.”

Furthermore, Wetzer notes, many European companies have already taken steps to comply with the regulations. Indeed, towards the beginning of the year, 11 major brands, including the likes of IKEA [F500E #85, as Ingka], Maersk [F500E #70] and Unilever [F500E #49] came out in support of the CSDDD, signing and open letter that stated: “Investment and competitiveness are founded on policy certainty and legal predictability. The announcement that the European Commission will bring forward an ‘omnibus’ initiative that could include revisiting existing legislation risks undermining both of these.”

“Businesses have already started to put in place reporting frameworks to be able to align with the regulatory package,” Wetzer told Fortune. “There has been a lot of investment in the regulatory architecture on the assumption that this would stay in place for a long time. If you change this regulation and you go beyond simplification, you run the risk that all of those investments go down the drain.”

Legal scholars aren’t the only experts to have sounded the alarm on the EC’s plans. Also in May, more than 90 prominent economists criticized Omnibus proposals, strongly refuting claims that the sustainability regulations harm European competitiveness. Instead, they point to other factors behind Europe’s economic challenges, including the energy price crisis following Russia’s invasion of Ukraine, declining global demand, wage stagnation, and chronic underinvestment in public infrastructure.

The economists’ statement emphasizes that implementation costs for sustainability regulations are minimal, citing a London School of Economics study that estimated compliance costs for large companies at just 0.009% of revenue. They argue that the benefits of the regulations far outweigh such modest expenses, and further note that, with an estimated €750 billion investment gap in sustainable initiatives, the weakening of sustainability reporting requirements could undermine crucial programs like the Clean Industrial Deal and discourage private investment in sustainable projects.

“Economic choices are political choices,” said Johannes Jäger, a professor at the University of Applied Sciences BFi Vienna. “With the Omnibus proposal, the European Commission is choosing to reward short-sighted corporate lobbying at the expense of people, planet, and long-term economic resilience.”

To this point, many critics of the Omnibus package have framed it as opportunistic, saying it is an attempt to both mimic and placate U.S. President Donald Trump who, whilst threatening Europe with tariffs, is carrying out a program of sweeping deregulation across America. U.S. companies have been at the forefront of lobbying efforts to undermine the CSDDD, with watchdogs claiming that investment giant BlackRock helped carve out exemptions from the directive for large financial firms. 

Such actions have motivated other European finance leaders to rally around the CSDDD. In February, more than 200 financial institutions, representing $7.6 trillion in assets under management, urged the EC to maintain strong sustainability standards. Aleksandra Palinska, executive director at the European Sustainable Investment Forum, warned that the Omnibus would “limit investor access to comparable and reliable sustainability data and impair their ability to scale-up investments for industrial decarbonisation.”

Rather than following Trump and doubling down on deregulation, European finance experts have urged the EU to maintain its resolve, along with its reputation for probity. In January, François Gemenne, a professor at HEC Paris and a lead author of the Intergovernmental Panel on Climate Change’s sixth assessment report, said that “the best response to the policies implemented in the U.S. is to beef up the EU green agenda, not to weaken it. Rather than follow Trump’s way, we should design our own path.”

Wetzer agreed, saying that the Omnibus proposals harm the European Union’s standing as a rational actor. “The European Union is proving itself not to be a reliable regulator because they’re flip-flopping in the face of changing political winds,” he said. In turbulent times, he suggested, a strong stabilizing influence is required. “We should chart our own course based on our assessment of the fundamentals.”

But beyond the legal and economic impacts, it is the environmental and human rights implications of the EC’s proposed changes that have drawn the most fire. In March, more than 360 global NGOs and civil society groups issued a joint statement against the Omnibus, stating that EC President Ursula von der Leyen was “deprioritizing human rights, workers’ rights and environmental protections for the sake of dangerous deregulation.” 

In comments accompanying the letter, Marion Lupin, policy officer for the European Coalition for Corporate Justice, said: “The message from Brussels couldn’t be clearer: industry interests come first, while people and the planet are left behind … hundreds of civil society organisations around the world are standing up—no to deregulation, no to greenwashing, and no to this reckless rollback of corporate accountability.”

As the Omnibus proposal moves through the European Parliament, the key question is whether EU institutions will preserve their original ambition to guide Europe through its sustainability transition, or acquiesce to corporate lobbying power. The outcome will likely have far-reaching implications for corporate accountability, human rights, and the fight against climate change.