Bound by science, bent by politics: Inside the FDA's reversals and walk-backs as it grapples with the coronavirus pandemic – CNN

The FDA had already put out a stark 1,000-word warning about the risks of hydroxychloroquine, a malaria drug some hoped would be an effective treatment for Covid-19. But this week, Trump suddenly announced he was taking the drug and falsely claimed there was no FDA warning.

Such is the life of a Food and Drug Commissioner in the Trump Era, in the year of the worst pandemic since 1918, with 1.5 million sick Americans and more than 95,000 lives lost.

Whether due to political pressure — a charge Hahn denies — or the natural burden of dealing with a global pandemic, the FDA has had to issue a number of high-profile walk-backs and revisions to its efforts to tackle Covid-19.

The agency’s initially strict regulations for diagnostic test developers were removed after complaints. Its emergency authorization for hydroxychloroquine was followed by a sharp warning about deadly side effects. It issued a pullback after letting faulty antibody tests flood the market. In April it changed its guidance to allow the use of Chinese-made KN95 masks in healthcare settings, only to reverse course in May and ban many of them. There were even issues with the FDA-authorized test the White House used to screen visitors.

“Some of the science and data aren’t perfect in emergency situations,” Hahn told CNN in an interview this week. “You make the best with the information you have at hand.”

To be sure, the coronavirus pandemic poses an unprecedented challenge to the nation’s foremost health regulator. The agency has to walk a tightrope between speed and safety, responding quickly to a fast-moving crisis yet maintaining its job of thoroughly vetting tests, drugs and devices that could save lives. The FDA, Hahn acknowledged, is adapting as more is learned about the virus.

But former FDA officials and drug safety experts worry that, in some cases, the FDA might be more devoted to placating Trump — and giving him quick wins to tout on television — than sticking to the science.

“The political engagement here is magnitudes above anything I experienced over my public health career,” said Dr. Stephen Ostroff, the FDA’s former chief scientist who twice served as acting commissioner. “You want to separate out those political dimensions so you can make data-driven decisions. It has been incredibly challenging. Some of the things that have ended up happening, like the enthusiasm for hydroxychloroquine, have been exceptionally unfortunate.”

Hydroxychloroquine rollercoaster

The tug-of-war between Trump and his public health agencies — including the FDA — has played out most publicly in the still-ongoing battle over hydroxychloroquine.

The anti-malaria drug has been on the market for decades, and was seen early on as a potential coronavirus treatment.

In March, Trump and Hahn were publicly out of sync: Trump promoted the drug and cited anecdotal success stories, while Hahn stressed the need for a “large, pragmatic clinical trial.”

According to a whistleblower complaint from Dr. Rick Bright, the former head of vaccine development at the Department of Health and Human Services, federal health officials were pressured to greenlight the widespread, unsupervised use of hydroxychloroquine to score a “short-term political victory” for Trump, even though FDA scientists weren’t satisfied by the data.

The White House, HHS and the FDA deny Bright’s allegations.

Nevertheless, the FDA granted an emergency use authorization (EUA) for the drug on March 28. This allowed a large donation from drug manufacturers to be used in the US, but only in hospitals or clinical trials — far short of what Trump wanted. While the EUA cited “anecdotal reports” that the drugs “may” work, that note of caution was often lost amid the President’s public promotions of the drug.

“It’s an impossible political situation,” one former top FDA official told CNN on the condition of anonymity. “They were fairly artful with their wording to make it clear they thought this was BS.”

Also of concern to health experts who spoke to CNN, the FDA quietly lifted bans on previously censured drugmakers in India, to hasten the flow of hydroxychloroquine and other drugs into the US. Some of these manufacturers had been flagged for repeatedly misleading the FDA about the quality of their products, with one inspection finding a “cascade of failure” as last summer.

“So, does the FDA believe these companies, that were trying to fool them in the past, suddenly became good manufacturers?” said Dinesh Thakur, a former pharmaceutical executive who became a drug safety whistleblower, leading to a $500 million settlement by his ex-company.

With the EUA in hand, Trump praised Hahn for moving quickly on hydroxychloroquine and other approvals. But within weeks, more studies came out suggesting the drug had no meaningful impact and could even lead to cardiac arrest. Finally on April 30, the FDA issued a science-heavy warning on hydroxychloroquine, stating unequivocally that the drug hasn’t been proven safe for Covid-19 patients and that it should only be used be used under direct supervision of doctors.

On Friday, The Lancet medical journal published the results of an observational study of 96,000 Covid-19 patients, which found that the drugs were linked to greater risk of often deadly heart problems. The study concluded that seriously ill patients who got Trump’s much-touted treatment plan of hydroxychloroquine combined with an antibiotic were more likely to die than people who got neither drug.

In an interview this week, Hahn defended his agency’s handling of hydroxychloroquine. He acknowledged the political climate surrounding the drug, but said, “I stand by our decisions because I think they are rooted in science and data, and we’ll continue to reevaluate.”

But some experts say it’s time for the FDA to pull the authorization.

“I just didn’t see it, and I still don’t see it,” said Ostroff, the FDA’s former chief scientist, referring to the efficacy of the drugs. “At this point, I’m not sure there remains a very strong rationale for keeping that EUA in place.”

Ostroff was one of a handful of former officials who shared this view in recent interviews, even though pulling the authorization won’t prevent doctors from prescribing the drugs off-label.

The FDA warning was a brave stand in the eyes of some Republican health experts, like former HHS Secretary Tommy Thompson, who served for four years under President George W. Bush.

“Politically, they’re getting pushed pretty hard on hydroxychloroquine, but they’re standing up and saying that it’s not a clear-cut decision,” Thompson told CNN in an interview. “You’ve got to applaud them for that. The desperation is there, but they’re saying it still needs to be discussed.”

Paging Dr. Hahn

Food and Drug Administration Commissioner Stephen Hahn testifies before the House Energy and Commerce Committee's Health Subcommittee in the Rayburn House Office Building on Capitol Hill February 26, 2020 in Washington, DC.

When China reported a cluster of unknown respiratory illnesses in December — soon to be identified as Covid-19 — Hahn had been on the job just two weeks.

His nomination had sailed through the Senate in bipartisan fashion after a hearing focused heavily on the risks of flavored e-cigarettes, the most prominent public health challenge the administration faced at the time. The word “pandemic” was mentioned only twice at the hearing.

A radiation oncologist, Hahn worked as the chief medical executive at the University of Texas MD Anderson Cancer Center before joining the FDA. He acknowledged that he has been learning on the job, both about the novel coronavirus — as all health officials are — and about the ins and outs of the FDA.

That’s included learning how to guide the agency from his home while self-quarantining for 14 days earlier this month after coming into contact with someone infected with coronavirus.

Hahn says he has continued his usual routine of waking up at 4 a.m. and doing P90X — an at-home plyometrics and resistance workout — and brushed up on his reading in Italian when he needed a few minutes to unwind.

“I’m not going to argue that I’m happy that it happened,” Hahn said of his recent move to self-quarantine, but he said it served as a reminder that Americans still face great risk from the virus.

‘Open and honest counsel’

Hahn has managed mostly to fly under the radar, even amid waves of speculation about whether Trump is on good terms with many of the medical experts around him. The President has clashed with infectious disease expert Dr. Anthony Fauci; reportedly been on the brink of firing HHS Secretary Alex Azar; or been at odds with Dr. Robert Redfield, director of the Centers for Disease Control and Prevention.

Personable and unassuming, Hahn’s style couldn’t be further from Trump’s brash showboating. Still, the two men get along well, sources tell CNN.

“He’s fantastic,” Trump said of Hahn at a March briefing. “He has been working 24 hours a day. He’s been — he’s worked like, probably as hard or harder than anybody in this — in the group, other than maybe Mike Pence or me.”

Hahn has repeatedly and publicly denied that the President has pressured him to make decisions, such as authorizing hydroxychloroquine.

“I enjoy a very good relationship with the President. He asks for and he receives my open and honest counsel,” Hahn said.

Whether the President takes that counsel to heart is another question. Just this week, Trump publicly usurped FDA guidance with his own medical wisdom when he unexpectedly announced he was taking hydroxychloroquine to prevent coronavirus, even though there’s no proof it works, and the FDA is urging Americans against this course of action.

“Doctors are free to write prescriptions for unapproved indications of approved drugs, and that includes hydroxychloroquine,” Hahn said, declining to comment on Trump’s medical decisions, citing the fact that Trump said he consulted with and is being watched by the White House physician.

The testing tightrope

A lab technician dips a sample into the Abbott Laboratories ID Now testing machine at the Detroit Health Center.

The FDA’s struggle to hit the right balance between speed and efficacy was perhaps clearest when it came to testing.

As the CDC struggled to get its coronavirus test up and running in February, the FDA was proactive in troubleshooting. The agency sent an official to visit the CDC labs in Atlanta and determined contamination at the lab was likely causing the tests to malfunction.

But in the meantime, clinical labs were sitting on the sidelines, frustrated that the FDA’s regulations made it hard for them to get tests approved. More than a month after the first known US coronavirus case, the FDA finally loosened its rules and large commercial test-makers began bringing their diagnostic tests to market, allowing the US to — belatedly — scale up testing.

Since then, the FDA has issued a warning that one of the prominent tests it authorized — the Abbott ID Now test used by the White House — sometimes falsely indicates individuals are negative for the virus. The FDA is looking into the issue. Abbott has defended its test.

When it came to antibody tests — designed to check for prior Covid-19 infection — some former FDA officials said the agency went too fast in granting approvals.

In March, the FDA announced companies could sell antibody tests without providing evidence they actually worked. Since then, some tests on the market have proven to be inaccurate or fraudulent — a serious risk since people who get a false positive result may wrongly believe they have already had the virus, and potentially developed some immunity.

In May, the FDA pulled an about-face, updating its guidance to require companies to promptly submit antibody tests for approval. It arranged for the US government to independently validate the tests available.

If the FDA regrets the initial free-for-all of allowing unproven antibody tests on the market, Hahn isn’t letting on. The agency needed to get some tests out quickly, FDA officials said, and once a dozen or so had emergency use authorizations, the FDA tightened the rules.

“One of the lessons learned here is that this real-world evidence becomes very important in urgent situations,” Hahn said. “What we have to find is the right balance so that we can ensure that the right tests are on the market.”

Scott Whitaker, president and chief executive of medical technology association AdvaMed and a former Health and Human Services official during the Bush administration, defended the FDA’s leadership on testing.

“If they had not moved quickly to get more serology tests to market, they would have been criticized for being too slow,” said Whitaker, who has worked closely with Hahn on testing and capacity issues for his group’s members. “Before this crisis, they were dealing with a normal world and a normal FDA and their job of making sure products are safe and effective before they get to market. When the world changed then they changed, as they should have.”

Politics versus science

The whiplash at the FDA is symptomatic of a larger issue. What happens when a notorious science skeptic is President during a once-in-a-century pandemic?

Long before he entered the White House, Trump made a name for himself denying climate change and linking vaccines to autism. As President, he has claimed that windmills cause cancer and even suggested that ingesting disinfectant may help treat coronavirus.

With this backdrop, it’s no surprise that Trump has repeatedly clashed with the federal health officials and agencies that are charged with following science — not polls or public pressure.

“He chooses convenience over science,” said Michael Gerrard, a Columbia Law School professor who tracks what he says are anti-science actions by the Trump administration. “What we saw with hydroxychloroquine and the FDA is all quite consistent. It’s tragically not surprising.”

In some cases, Trump has even turned to celebrity doctors for advice.

Dr. Mehmet Oz, the highly controversial TV personality, has been informally advising Trump, according to The New York Times. And Trump even summoned Hahn to the White House to listen to a pro-hydroxychloroquine presentation in April from Fox News host Laura Ingraham and two physicians who regularly appear on her program, according to the Washington Post.

Exasperated by the idea of Fox News personalities lecturing the FDA chief, the former top FDA official who spoke to CNN on the condition of anonymity said, “I would have quit on the spot.”

Hahn’s colleagues, current and former, dismiss the notion that Hahn is carrying out Trump’s bidding, describing him as honest and transparent.

“Every position comes with some political realities to it,” said Dr. Ramesh Rengan, who has known Hahn for 15 years and is chair of the radiation oncology department at the University of Washington. But, he added, “He’s never taken the easier road. He’s taken the right road.”

This is not the first White House to lean on the FDA. There were high-profile partisan fights over the approval of emergency contraception during the Bush and Obama years, and dealing with pressure, both political and from industry, comes with the job.

But some experts say Trump has gone farther than his predecessors, and that some of the recent reversals and missteps under Hahn have tarnished the agency’s hard-won reputation.

“We took 100 years to build this reputation as a science-based, impartial regulator. That’s why everyone around the world trusts the FDA,” said Thakur, the pharmaceutical whistleblower who now focuses on global drug safety issues. “I get this is an emergency, and you need to respond to the public need, but we aren’t using science.”

Politics

First on CNN: Key government agency acknowledges Biden's win and begins formal transition – CNN

Published

41 mins ago

November 23, 2020

READ: GSA letter to Biden stating that transition can formally begin

The letter is the first step the administration has taken to acknowledge President Donald Trump’s defeat, more than two weeks after Biden was declared the winner in the election.

Murphy said she had not been pressured by the White House to delay the formal transition and did not make a decision “out of fear or favoritism.”

“Please know that I came to my decision independently, based on the law and available facts,” Murphy wrote. “I was never directly or indirectly pressured by any Executive Branch official — including those who work at the White House or GSA — with regard to the substance or timing of my decision. To be clear, I did not receive any direction to delay my determination.”

The letter marks Murphy’s formal sign off on Biden’s victory, a normally perfunctory process known as ascertainment. The move will allow the transition to officially begin, permitting current administration agency officials to coordinate with the incoming Biden team, and providing millions in government funding for the transition.

The Biden team has not waited for the formal transition process to begin preparing for the presidency, as Biden announced several Cabinet picks on Monday. But the delay in ascertainment meant that Biden’s team was locked out from government data and could not make contact with federal agencies, nor could it spend $6.3 million in government funding now available for the transition. A Biden official said the most urgent need was for the transition to be given access to Covid-19 data and the vaccine distribution plans.

The Biden team will now have access to additional office space inside the agencies and the ability to use federal resources for background checks on Biden’s White House staff appointments and Cabinet picks.

Yohannes Abraham, executive director of Biden’s transition, said the start of the transition was a “needed step to begin tackling the challenges facing our nation, including getting the pandemic under control and our economy back on track.”

“This final decision is a definitive administrative action to formally begin the transition process with federal agencies,” Abraham said. “In the days ahead, transition officials will begin meeting with federal officials to discuss the pandemic response, have a full accounting of our national security interests and gain complete understanding of the Trump administration’s efforts to hollow out government agencies.”

The ascertainment letter was sent Monday after Michigan formally certified its election results earlier in the day and more Trump lawsuits were dismissed. Georgia certified its razor-thin presidential results on Friday, and Pennsylvania is nearing certification of its election results, too.

It’s the latest sign that Trump’s conspiracy-laden legal bid, led by Rudy Giuliani, to circumvent the outcome of the election is nearing an end. The Trump campaign’s lawsuits to delay certification of the election have been dismissed in multiple states, as his legal team has failed to provide any evidence of widespread voter fraud.

But until now, Murphy had refused to move forward with the ascertainment process, despite Biden’s clear victory. Murphy, a Trump political appointee, has faced intense scrutiny and political pressure from Democrats and, in recent days, Republicans calling for the start of a smooth transition. In a statement Monday, Sen. Rob Portman, an Ohio Republican, said that “there is no evidence as of now of any widespread fraud or irregularities that would change the result in any state” and called on the transition process to begin.

In the letter, Murphy suggested that the ascertainment rules were vague and should be updated.

“GSA does not dictate the outcome of legal disputes and recounts, nor does it determine whether such proceedings are reasonable or justified,” she wrote. “These are issues that the Constitution, federal laws, and state laws leave to the election certification process and decisions by courts of competent jurisdiction. I do not think that an agency charged with improving federal procurement and property management should place itself above the constitutionally-based election process. I strongly urge Congress to consider amendments to the Act.”

Trump tweeted moments after the letter was reported, thanking Murphy for her work and affirming the decision to start the transition.

“I want to thank Emily Murphy at GSA for her steadfast dedication and loyalty to our Country. She has been harassed, threatened, and abused — and I do not want to see this happen to her, her family, or employees of GSA. Our case STRONGLY continues, we will keep up the good fight, and I believe we will prevail!” Trump tweeted. “Nevertheless, in the best interest of our Country, I am recommending that Emily and her team do what needs to be done with regard to initial protocols, and have told my team to do the same.”

Two Trump advisers said the President’s tweets are being read by people in his orbit as essentially a concession.

“A veiled attempt to justify continued fundraising solicitations,” the second adviser said.

The General Services Administration informed federal departments on Monday night that it has ascertained Biden to be the winner of the presidential election, according to an email obtained by CNN.

“In accordance with the Presidential Transition Act of 1963, as amended, today, November 23, 2020, the GSA Administrator has ascertained Joseph R. Biden and Senator Kamala Harris the apparent successful candidates for the offices of President and Vice President, respectively,” Mary Gibert, the federal transition coordinator, wrote in an email to federal department contacts.

A senior White House official said some staffers were initially caught off guard by the GSA letter, learning about it first from CNN. But the official said staffers will begin to cooperate with the Biden transition team, adding that they were seeking more information on next steps.

For two weeks after the election was called for Biden, Murphy was silent as the ascertainment delay dragged on, sparking public pressure from congressional Democrats and Biden himself, who warned that the delay could cost lives due to the Covid-19 pandemic.

Democrats were demanding a briefing from Murphy on Tuesday to explain her decision-making, rejecting the GSA’s proposal earlier Monday for her deputy to brief Congress next week. Democratic committee chairmen sent a slew of new letters to Murphy on Tuesday demanding she allow the transition to begin and warning of the consequences for failing to do so.

This story has been updated with additional reporting on Monday.

CORRECTION: An earlier version of this story misspelled Mary Gibert’s name.

CNN’s Jeff Zeleny, Jeremy Diamond, Jim Acosta and Arlette Saenz contributed to this report.

Politics

How Trump's fundraising could benefit his post-White House political life – CNN

Published

3 hours ago

November 23, 2020

All these missives from President Donald Trump’s political operation landed in supporters’ inboxes Monday morning claiming to solicit funds to help Trump fund recounts and legal challenges to overturn the election results.

But the legal fine print on each shows that a new Trump fundraising arm, Save America, actually will get the first cut of any money that comes in. And because spending rules for leadership PACs are so loose, campaign-finance experts warn that Save America could easily become a political slush fund for Trump and those close to him.

Here’s a closer look at the President’s recent fundraising efforts and his new fundraising vehicle Save America:

What’s Save America?

Save America is a leadership PAC that Trump launched less than a week after the election.

In an email to CNN earlier this month, Trump campaign spokesman Tim Murtaugh said Trump “always planned” to create a leadership PAC “win or lose, so he can support candidates and issues he cares about, such as combating voter fraud.”

Team Trump has been on a fundraising spree in recent weeks, sending more than 330 fundraising emails and 92 text messages to supporters since 11 p.m. ET on Election Night.

The current solicitations direct the first 75% of each contribution up to $5,000 to Save America. Only after that threshold is met does money go into the campaign’s recount account.

Additionally, 25% of the funds go to the Republican National Committee’s operating account.

What’s a leadership PAC?

Leadership PACs are political action committees generally established by current and former politicians to raise money and to curry influence with others.

Political figures use these PACs donate to other candidates, helping maintain their profiles and build leverage within their own party. But they also have become vehicles for a campaigns-in-waiting, funding polling, staff and travel. Save America could become an avenue for Trump to continue funding political operations as he weighs a future presidential bid in 2024.

Are there fundraising limits on leadership PACs?

Yes, but fundraising limits are higher for leadership PACs than candidate committees.

An individual donor can contribute up to $5,000 a year to a leadership PAC — allowing a politician to collect up to $20,000 over a four-year period from a single contributor. By contrast, that same donor could only give a maximum of $2,800 at this point for a 2024 presidential campaign.

Does Trump have to spend the money in the leadership PAC on election challenges?

No. The rules on spending by leadership PACs also are far more relaxed than those for campaign committees and do not restrict politicians from using donors’ funds for personal expenses — a use forbidden in a presidential campaign account.

It’s one reason campaign-finance experts say donors should be leery of what they view as a Trump campaign bait-and-switch tactic: soliciting funds for legal challenges and instead first routing the money to his leadership PAC.

“The typical donor doesn’t read the legal fine print,” Paul Ryan, vice president of vice president of policy and litigation at Common Cause, told CNN.

Ryan said few restrictions apply on the PAC’s spending. Should they choose to do so, Trump and his family members could draw salaries from Save America funds or direct its donors’ money to his businesses by hosting PAC events at a Trump-owned properties.

“This money could easily — and legally — end up in his own pocket in the coming years,” Ryan said. And even after the long-shot legal challenges to the 2020 election end, Trump “could tease a 2024 run for years and continue milking his supporters for contributions to this slush fund,” he added.

Under federal election rules, Save America will have to file its first public report detailing fundraising and spending Dec. 3, but it will only cover the first fews weeks of its operations.

CNN’s Betsy Klein contributed to this report

Politics

The fraught politics facing Biden’s foreign policy – Brookings Institution

Published

8 hours ago

November 23, 2020

For 18 months, Joe Biden was able to contrast his foreign policy with Donald Trump’s by painting in broad brushstrokes. He was in favor of alliances; Trump was opposed to them. He believed in American leadership in the world; Trump thought countries were taking advantage of the United States. Biden championed human rights; Trump sided with the autocrats.

Now that he is president-elect, Biden will need to be more specific about his foreign-policy stance. In many ways, Biden is a known quantity. He has a track record dating back almost five decades. But he will begin his term in a very different world than when he was vice president or a senator. He will face new, substantive challenges, including COVID-19 and a more assertive China. To meet this particularly difficult moment, he will need to master the politics of foreign policy — among different factions within his team, with a potentially obstructionist Republican Senate, and with skeptical American allies.

Biden cannot simply rely on competent technocratic management in foreign policy. His presidency may be the establishment’s last best chance to demonstrate that liberal internationalism is a superior strategy to populist nationalism. He must consider the strategic options generated by an ideologically diverse team, and he has to make big choices that are attuned to the politics of the moment, in the United States and around the world. Such a bold path is not one that a newly elected president with no foreign-policy experience could take. But he can.

To understand how Biden might approach his foreign policy, I spoke with half a dozen Biden advisers and people who worked closely with him in the Obama administration, as well as current and former congressional staff, Trump administration officials, and allied diplomats. I agreed not to identify them by name, to ensure their candor.

Within Biden’s team, an ongoing, but largely overlooked, debate has been brewing among Democratic centrists about the future of U.S. foreign policy. One group, which I call “restorationist,” favors a foreign policy broadly consistent with that of President Barack Obama. They believe in careful management of the post-Cold War order. They are cautious and incrementalist. They will stand up to China but will not want to define their strategy as a great power competition. They maintain high hopes for bilateral cooperation with Beijing on climate change, global public health, and other issues. They support Biden’s idea for a summit of democracies, aimed at repairing democracy and encouraging cooperation, but are wary of an ideological competition between democracy and authoritarianism. They favor a return to the Iran nuclear deal and intend to continue to play America’s traditional role in the Middle East. They generally support free-trade deals and embrace globalization.

A second group, which I call “reformist,” challenges key orthodoxies from the Obama era. Philosophically, these advisers believe that U.S. foreign policy needs to fundamentally change if it is to deal with the underlying forces of Trumpism and nationalist populism. They are more willing than restorationists to take calculated risks and more comfortable tolerating friction with rivals and problematic allies. They see China as the administration’s defining challenge and favor a more competitive approach than Obama’s. They view cooperation with other free societies as a central component of U.S. foreign policy, even if those partnerships result in clashes with authoritarian allies that are not particularly vital. They want less Middle East involvement overall and are more willing to use leverage against Iran and Gulf Arab states in the hopes of securing an agreement to replace the Iran nuclear deal. They favor significant changes to foreign economic policy, focusing on international tax, cybersecurity and data sharing, industrial policy, and technology, rather than traditional free-trade agreements.

Biden’s worldview is broad enough to be compatible with the restorationist and reformist schools of thought. He obviously trusts many of Obama’s senior officials and is proud of the administration’s record. At the same time, he chafed against Obama’s caution and incrementalism — for example, Biden wanted to send lethal assistance to Ukraine, when Obama did not. Biden has spoken more explicitly than Obama about competition with China and Russia, and he favors a foreign policy that works for the middle class. It is important to note that the legitimate and substantive disagreements between restorationists and reformists are between people who get along with each other. Restorationist sounds pejorative in the sense that the term looks backward, but it is not intended to be. Obama’s foreign policy was successful in many respects, and the case for restoring it is reasonable, as is the case for significant departures from it. Some officials are also restorationist on particular issues and reformist on others.

The progressives who staked out new ground on foreign policy during the primary campaign will be a significant force inside the Democratic Party in a Biden administration. Progressives believe foreign policy should primarily serve domestic economic and political goals. They are skeptical of high defense spending and want to demilitarize U.S. foreign policy, but they are also alarmed by the rise of autocracy globally and want to push back against it. Several Biden advisers, in particular Jake Sullivan and Tony Blinken, made a special effort to engage progressives from the Elizabeth Warren and Bernie Sanders campaigns after the primary. Now that the election is over, progressives mainly focused on domestic politics are very much inside the tent shaping Biden’s economic agenda, but some foreign-policy progressives have adopted a more confrontational approach toward the Biden team, hoping to pressure it from the outside on China, Iran, and defense spending.

Biden should see these contrasting perspectives as assets, and proactively create a team that reflects the broader foreign-policy debate and avoids groupthink. But he will need to actively manage the different views. He should start by learning lessons from Obama. In late 2012, Obama chose John Kerry to be his second secretary of state because he was the chair of the Senate Foreign Relations Committee, was an old political ally, and was widely perceived to be the most logical candidate. Obama’s signature foreign-policy accomplishment in his first term was the pivot to Asia away from the Middle East, but Kerry wanted to pivot back. Obama returned to a Middle East-centric State Department, seemingly without intending to do so. Blinken, then Kerry’s deputy, was left to manage America’s alliances in Asia—something that he did effectively and that might fall to him now.

Similarly, Biden could unintentionally create a uniformly Obamian worldview in his national-security team, unless he purposefully decides to go another route. Biden’s governing goal should be a genuinely intellectually honest process in which fundamental assumptions and policies of restorationist, reformist, and progressive ideas are constantly stress-tested and assessed with an open mind. This process needs to be outcome-oriented and not devolve into the “more meetings” mindset that creates gridlock and trends toward the lowest common denominator. Biden needs a variety of strategic choices. As a seasoned foreign-policy leader, he is ideally positioned to adjudicate this debate and to choose among the options that it will present.

Biden should certainly entrust senior positions to people who tend toward the Obamian worldview, but he should also find roles for people who might advocate for a new direction, including Pete Buttigieg, Senators Chris Coons and Chris Murphy, and former officials Jake Sullivan, Toria Nuland, Kurt Campbell, and others who have written or spoken in favor of major policy changes since 2016. Sullivan is likely to take a domestic-policy job, but given his role in developing reformist ideas over the past four years, it is important that he also remain an influential voice on national security, and he is well positioned to help connect the domestic to the foreign. Given the substantive nature of the debate thus far and that it has generally been amicable, an ideologically diverse Cabinet should bring out the best in all factions, sharpening thinking and policy options.

Biden will need a variety of ideas because he faces significant political challenges at home. By any metric, Biden certainly has a mandate. He won 306 electoral votes and more popular votes than any president in history. However, the election was not the sweeping repudiation of Trump that Democrats craved. Trumpism has not gone away and instead appears to have transformed the Republican Party into a force for populist nationalism, including hostility toward international cooperation and skepticism about alliances.

The Republicans are well positioned to retain control of the Senate following the two runoffs in Georgia in January. If Mitch McConnell reprises the obstructionist role he played in the Obama administration, he could kill Biden’s domestic agenda on arrival. Many Biden Democrats believe that a successful foreign policy requires rejuvenation at home, so McConnell’s tactics may be a big problem. Republicans will likely put Biden’s nominees through intensive hearings, and they may be willing to reject appointees, particularly at the subcabinet level.

All Democrats and many Republicans agree on the need to repair and strengthen America’s alliances and partnerships, but this is more complicated than the campaign rhetoric made it appear. The year 2021 will not be like 2009, when Obama was widely greeted as a conquering hero, winning the Nobel Prize after less than a year in office, simply because of what his election signified. The world is a less cooperative and liberal place today. Just consider the rise of nationalist-populist governments in Brazil and India and the erosion of democracy in Turkey and Hungary.

America’s closest allies will all work with Biden and welcome the end of Trump’s erraticism, but they have lingering doubts about where things are headed. The Australian and Japanese governments, for example, are quietly concerned about Biden’s approach to China and are watching his early appointments very closely. The French worry that Democrats will leave Europe high and dry as they try to withdraw from the Middle East and from the war on terrorism more broadly so that they can pivot to the China challenge. The British are wondering whether Biden will invest in their special relationship, given that he opposed Brexit. Several officials I spoke with from America’s allies in Europe and Asia have reservations about the planned summit of democracies that Biden made a centerpiece of his election. They worry that the meeting could become an end in itself and be too inwardly focused and beset by problems about which countries qualify as democracies.

So how should Biden navigate this complicated landscape? Although he is absolutely right to claim a mandate and to convey optimism about the future, Biden must also be cognizant of the precariousness of his liberal-internationalist worldview. Liberalism is under siege at home and abroad. It will not automatically endure.

In COVID-19, Biden will inherit the greatest international challenge facing the United States since the height of the Cold War. The pandemic is a moment of global reordering — not to deal only with the coronavirus but also the underlying issues it revealed, including an uncooperative China and the vulnerabilities of interdependence. Biden must be ambitious at home and abroad, because these realms are inextricably linked. The tricky part is that he must construct a bold policy within the political constraints of Washington, where Democrats may not carry the Senate.

Biden should use competition with China as a bridge to Senate Republicans. Their instinct may be obstructionist, particularly because Trump is pressuring them not to recognize Biden’s win as legitimate, but many of them also know that the U.S. cannot afford four years of legislative gridlock if it is to compete with China. A number of Republican foreign-policy experts pointed out to me that some senators, including Tom Cotton and Ted Cruz, may be out for scalps, but that others, including Susan Collins, Joni Ernst, Mitt Romney, Marco Rubio, and Dan Sullivan, are mainly interested in the substance of Biden’s foreign policy, especially toward China. Biden, then, can use competition with the country to gain support for other political measures.

He can create goodwill with some of these Republicans by, in the first few weeks of his term, supporting pending legislation on investments in the semiconductor industry and 5G infrastructure, appointing assistant secretaries for Asia at the State Department and the Pentagon who can easily win bipartisan support, and showing that he is serious about using the Treasury and Commerce Departments to compete with China.

These efforts would lay the groundwork for crucial elements of Biden’s Build Back Better domestic program: targeted infrastructure investments, including clean technology; an industrial policy to compete with China on 5G, quantum computing, and artificial intelligence; a limited and strategic decoupling from China in certain areas; and bolstering the resilience of the U.S. economy to external shocks, which would include making supply chains more secure.

Although some in Biden Land support this bipartisan give-and-take, others, including many of the restorationists, are very skeptical of using competition with China as a framework for U.S. foreign and domestic policy. Some also have substantive reservations about any decoupling from China. They expect China to reach out for a reset early in 2021—probably regarding the pandemic and climate change—and would like to explore opportunities for cooperation. Foreign-policy progressives are also generally opposed to building Biden’s foreign policy around competition with China, believing that the strategy risks creating a Cold War.

These restorationist and progressive fears are overblown. Almost all of these early measures are about enhancing domestic competitiveness, not engaging in an arms race or a clash of civilizations. Indeed, Elizabeth Warren advocated for domestic reforms to compete with China during her presidential campaign. Domestic progressives are much more inclined than their foreign-policy counterparts to support this conceptual framework if it unlocks the politics of an ambitious domestic agenda, which will include new jobs through investments in clean technology—a vital part of a climate policy.

Getting serious about competing with China is also justified on the merits. Xi Jinping’s China has become more dictatorial and aggressive. Even the European Union, which is about as benign a geopolitical actor as China could hope for, has all but given up hope that engagement and cooperation will change China or fundamentally moderate its behavior, even on shared interests such as global public health. Cooperation with China on shared interests should occur, but we need to be realistic about the limits. To prevent competition with China from spiraling into outright confrontation, Biden should situate the strategy as part of a larger affirmative vision for strengthening the free world. This policy would include making free societies more resilient to external shocks such as pandemics and economic crises, fighting corruption and kleptocracy, standing up to autocratic countries that try to bully or coerce democracies, and combatting democratic backsliding. This approach would be more effective than organizing a global summit of democracies.

The inescapable political reality in Washington is that competition with China is the only way to persuade a Trumpian Republican Party of the benefits of international cooperation—whether through alliances providing a counterweight to Chinese power, through vying with China for influence inside international institutions, or through relying on international law to prevent Chinese revisionism in the South China Sea. Without the China component, Biden has no hope of creating any kind of domestic consensus around internationalism.

After addressing the China issue, Biden should shockproof U.S. foreign policy against the return of Trumpism in 2025. Republican senators may hope to harness populism for future elections, but they are, for now at least, committed to America’s alliances. Why not codify their support by introducing legislation that requires congressional approval if the United States is to leave NATO? Biden could proactively build redundancy into the alliance system by supporting EU security and defense cooperation, even if the action risks a duplication with NATO. Biden should also press Congress to enact new commonsense restraints on presidents—for instance on their ability to circumvent the confirmation and security-clearance procedures for appointees—to prevent a recurrence of Trump’s abuses of power. On climate change, he must prioritize carbon-emission cuts at the state and city levels, which are less likely to be stopped or reversed by Congress.

In managing relationships with allies, Biden cannot rely only on shared problems to bring them closer. He must also engage these leaders on their terms, paying special interest to their political situation and priorities. It would be a disaster if France were to fall into the hands of Marine Le Pen’s National Rally in 2022, so Biden should bolster President Emmanuel Macron, including by showing solidarity with France in the face of a domestic terrorism threat. He should make a genuine effort to help Britain succeed after leaving the EU, as long as it respects its obligations under the Good Friday Agreement. And finally, a bipartisan consensus on China will reassure Japan and Australia.

Managing nondemocratic allies—including Saudi Arabia, Turkey, Hungary, and the Philippines—is more difficult. They will try to put him in a vise by flirting with Russia and China. Biden won’t succeed by appealing to the better angels of their nature, and he cannot be tricked into thinking that America needs these regimes more than they need America. Biden must be feared by the so-called strongmen before he can be respected by them. He must show that he is willing to push back and that he can wield power and generate leverage more effectively than Obama. He must introduce red lines that cannot be crossed. Only then can transactional cooperation on matters of mutual interest really occur.

Biden’s election is a reprieve from Trumpism. Whether that break is permanent or temporary depends very much on the choices that Biden makes. Biden must act with a degree of urgency and boldness to demonstrate that his brand of liberal internationalism effectively addresses the real concerns and anxieties Americans have about the world.