TIME Foreign Policy

The 5 Keys to a Final Nuclear Deal With Iran

The details of the agreement are only part of it. Here's what else matters.

The U.S., Iran, the European Union, Russia and China announced that they had “reached solutions on key parameters” to a nuclear deal April 2 after more than a week of tough negotiations in Lausanne, Switzerland.

Speaking at the White House, President Obama called the deal “historic” but also said that it was only a “framework” that depended on a final written agreement being set to paper in coming weeks.

In principle, the deal traded limits on the Iranian nuclear program and broad but unspecified international inspections in exchange for the lifting of U.S. and E.U. sanctions and conditional removal of United Nations sanctions. Obama said that until the written agreement was signed, “our work is not yet done” and that if Iran backslid, “there will be no deal.”

Five things will determine whether the U.S. and Iran can ultimately reach a signed, sealed agreement.

  1. What the deal says. Iranian acceptance of intrusive international monitoring of its nuclear program, and the ability of the U.S. and others to reimpose penalties if Iran cheats on a deal are the most important parts of any agreement for the Obama administration. The April 2 statement includes some specifics of the inspections, but leaves others open. Iran has apparently agreed to inspections of all parts of the Iranian nuclear program from mining and milling uranium to suspected nuclear weapons research facilities, and is “required to grant access” to suspicious sites. But the details of that access, its frequency and any limits Iran might try to impose are unclear. If the inspectors, or Western spies, turn up evidence of cheating, the U.S. wants to be able to reimpose the tough economic sanctions that forced Iran to the negotiating table without engaging in lengthy diplomatic wrangling at the U.N. The April 2 agreement speaks of removing some UN sanctions, maintaining others and says a “dispute resolution process” will be put in place.
  1. How Obama handles Congress. The March 31 deadline that drove the current round of talks was actually just a way for the administration to get the U.S. Congress off its back. The real deadline is the June 30 expiration of the Nov. 2013 interim agreement which froze Iran’s nuclear program in return for freezing Western sanctions. Many in Congress believe, rightly, that tough U.S. sanctions helped force Iran to sign that interim agreement to begin with, and now Republicans and some Democrats want a say in whether those sanctions get lifted. Some want to take action to force Iran to agree to concessions in writing. Congressional action could backfire and undermine the April 2 statement before a final deal is written down and signed. The administration is negotiating the terms of any Congressional action, and the outcome of those discussions is unclear.
  1. How Obama handles the international coalition. The greatest downside to the recent talks in Lausanne, from the U.S. perspective, was the appearance of fractures in the international sanctions coalition. Russia and China’s agreement to squeeze Iran through U.N. sanctions was another key to Iranian concessions over the last few years. At one point in the lengthy talks in Switzerland, Russia seemed to side with Iran over whether a deal had been agreed even as the U.S. and France said one hadn’t, raising the danger of a split. If Iran can divide the U.S. and the E.U. from Russia before signing a final deal June 30, it could escape sanctions without having to follow through on the April 2 concessions it provisionally agreed to.
  1. What happens in Iran and Saudi Arabia’s proxy war. Our magazine story this week details the region-wide proxy war between Saudi Arabia and Iran that is the urgent regional context for the nuclear issue. The Obama Administration is struggling to reassure allies in the Middle East that a deal with Iran doesn’t mean Washington is looking to help Iran’s ascendancy in the new, post-Arab Spring Middle East order. In his White House statement April 2, Obama said he would convene a conference with Saudi Arabia and other Gulf Arab powers this spring as part of that effort. But the worsening violence in Yemen, Syria and Iraq, where Iranian and Saudi proxies are battling it out, could have an unexpected effect on the effort to reach a final written agreement.
  1. How long everyone talks. If the U.S. and Iran can’t get a final written deal by June 30, an ultimate agreement would depend on whether the two sides agree to keep talking, and writing, anyway. Some administration officials have argued it would be better to keep the talks going than to see a complete collapse. Under the terms of the Nov. 2013 temporary agreement, Iran’s program is frozen and the sanctions are in place. But keeping Congress onside, the sanctions coalition together and the Iranians at the table may be impossible after the next deadline.
TIME Foreign Policy

Exclusive: Netanyahu Canceled Intel Briefing for U.S. Senators on Iran Dangers

Israel's Prime Minister Netanyahu attends cabinet meeting in Jerusalem
Gali Tibbon—Reuters Israel's Prime Minister Benjamin Netanyahu attends the weekly cabinet meeting at his office in Jerusalem March 8, 2015.

Israeli spy chief warned Congress might blow up talks on Iranian nuke program

Israeli Prime Minister Benjamin Netanyahu tried to cancel a January briefing for U.S. Senators by his nation’s intelligence service that warned Congress could damage talks aimed at constraining Iran’s nuclear program, according to sources familiar with the events.

Tennessee Republican Bob Corker, the head of the Senate Foreign Relations Committee, had requested the Jan. 19 briefing for six of his colleagues traveling to Israel so that the intelligence agency, Mossad, could warn them that a Senate proposal might inadvertently collapse the talks. After Netanyahu’s office stripped the meeting from the trip schedule, Corker threatened to cut his own Israel trip short in protest.

Netanyahu relented after the personal intervention of Israeli ambassador to the U.S., Ron Dermer, and allowed the briefing to go forward, sources say. Attending were Corker, Republican Senators John McCain, Lindsey Graham and John Barrasso, Democratic Senators Tim Kaine and Joe Donnelly, and Independent Senator Angus King.

At issue was the fate of a Nov. 2013 agreement between Iran, the U.S. and five other international powers. That temporary agreement promised no new economic sanctions on Iran in exchange for a freeze of Iran’s nuclear program, new international inspections of Iran’s nuclear sites and the removal of nearly all medium-enriched uranium from Iran’s possession. Both sides have stuck to the interim deal while talks on a long-term deal to constrain the Iranian nuclear program have dragged out.

The controversial but popular bill proposed by Republican Mark Kirk and Democrat Robert Menendez would have imposed new sanctions on Iran if it didn’t agree by June 30 to a long-term deal. U.S. intelligence officials had concluded that the Kirk-Menendez bill risked collapsing the talks and taking with it the 16-month-old agreement, according to a report by Eli Lake and Josh Rogin of Bloomberg View. Corker wanted the Mossad briefing to bolster the U.S. assessment.

During the Mossad briefing, the agency’s chief, Tamir Pardo, warned that the Kirk-Menendez bill would be like “throwing a grenade” into the U.S.-Iran diplomatic process. After some of the contents of the briefing were first reported by Bloomberg View, Pardo released a statement saying he had used the phrase not to oppose new sanctions, but “as a metaphor” to describe the effect derailing current talks might have.

A spokesman for Netanyahu declined to say why the Prime Minister acted to prevent the Senators from receiving the briefing from Pardo. Since the Mossad briefing, Corker has rallied support for an alternative measure to replace the Kirk-Menendez proposal, support for which has faded. Corker’s bill, which has broad support and potentially could receive enough votes for a veto-proof majority, would only impose new sanctions if Iran walked away from the Nov. 2013 agreement.

U.S. and Iranian officials are entering a tense phase of negotiations in Switzerland this week as they attempt to reach a political deal to extend and expand the Nov. 2013 agreement for at least 10 years. As the challenges of reaching the longer-term deal have increased, some in the U.S. are trying to ensure the interim agreement that has frozen the Iranian program isn’t undermined in the process.

Some members of the Senate oppose the ongoing talks with Iran. Freshman Republican Senator Tom Cotton last week issued an open letter with 46 other GOP Senators warning the Iranian leadership that Congress could reverse parts of any deal the talks produce. Corker did not sign that letter; his bill provides for partial Congressional approval of a deal.

Cotton has said that rather than negotiate with Iran, the U.S. should adopt a policy of regime change and should arm Israel with bombers and bunker busting bombs with which it could attack Iranian nuclear sites. Authorities in both parties, including Obama’s first Defense Secretary Robert Gates, have worried that an Israeli attack could draw the U.S. into a military confrontation with Iran on unfavorable terms.

Supporters of Kirk-Menendez argue it would increase pressure on Iran to make concessions that would more effectively limit its ability to get a nuclear weapon. Republicans are concerned that the Obama administration is too eager to do a long-term deal with Iran and is making too many concessions in the current talks. Secretary of State John Kerry arrives for talks in Geneva Sunday ahead of a self-imposed Mar. 24 deadline for the political framework for a long-term deal. Final terms of a comprehensive agreement would not be worked out before June.

Netanyahu is seeking re-election in a tough vote Tuesday, with his Likud Party trailing his strongest competitor, Zionist Union, by four points in recent polls.

TIME Foreign Policy

Why Republicans Wrote to the Ayatollahs

Senator Tom Cotton speaks during a news conference with members of the Senate Armed Services Committee about arming Ukraine in the fight against Russia in Washington, D.C. on Feb. 5, 2015.
Samuel Corum—Anadolu Agency/Getty Images Senator Tom Cotton speaks during a news conference with members of the Senate Armed Services Committee about arming Ukraine in the fight against Russia in Washington, D.C. on Feb. 5, 2015.

Two words: Regime change

The 47 Republican Senators who wrote to the leaders of the Islamic Republic of Iran yesterday did so, they said, “to bring to your attention two features of our Constitution” which the Senators said limit how much President Obama can commit to in nuclear negotiations between Tehran, the U.S. and its five allies.

But to judge by his past statements about those negotiations, the letter’s primary author intended it not so much to edify the Iranians about the American system of government as to completely undermine the talks themselves.

Freshman Sen. Tom Cotton of Arkansas strongly opposes the nuclear talks and believes they should stop immediately. In January, he told the Heritage Foundation “the ongoing nuclear negotiations with Iran … started out as an unwise policy [and have] now descended into a dangerous farce.”

In his Heritage speech, Cotton suggested that Obama might have cut a quiet deal to push off Iranian nuclear weapons capability until after the end of his second term. Cotton said that the President, in writing to Iran’s supreme leader over the last several years in pursuit of a diplomatic solution to the nuclear impasse, had behaved “like a love-struck teenager.”

By contrast, Cotton informed the Iranian leaders in his letter Monday that any deal Obama cut with them might not last. “We will consider any agreement regarding your nuclear weapons program that is not approved by the Congress as nothing more than an executive agreement,” Cotton and his fellow Senators wrote. “The next president could revoke such an executive agreement with the stroke of a pen and future Congresses could modify the terms of the agreement at any time,” the Republican Senators added.

Cotton has thoughts on what an alternative policy should be. In his Heritage speech, he said the U.S. should focus first and foremost on bringing down the regime in Tehran. “The goal of our policy must be clear: regime change in Iran,” Cotton said. To that end, Cotton said, the U.S. Congress should offer to transfer bombers and 30,000 pound bunker busting bombs to Israel for use should Israel decide to attack Iranian nuclear sites.

Not all the Republicans agree with that policy. Seven Republican Senators did not sign the letter, although they have not all stated their reasons. Former Defense Secretary Robert Gates has previously argued that Israeli military strikes against Iran could draw the U.S. unprepared into war. Cotton served in Iraq and Afghanistan, but after two long and costly wars few politicians are willing publicly to embrace policies that could drag the U.S. into another Middle East conflict.

Which may explain why Cotton and his fellow signatories ended their letter to the Iranians by saying only that, “We hope this letter enriches your knowledge of our constitutional system and promotes mutual understanding and clarity as nuclear negotiations progress.”

TIME justice

U.S. Faults Ferguson Police for Racial Bias

Protesters drop a mirrored casket in front of a line of police officers in front of the Ferguson Police Department in Ferguson, Mo. on Oct. 10, 2014.
Robert Cohen—St. Louis Post-Dispatch/Getty Images Protesters drop a mirrored casket in front of a line of police officers in front of the Ferguson Police Department in Ferguson, Mo., on Oct. 10, 2014

The report is scathing, but the big question is what comes next

The violent protests in Ferguson last August were driven by the indelible image of an unarmed black teenager, Michael Brown, lying in the street after a white police officer, Darren Wilson, shot him dead. But the outrage in Ferguson, and the national debate that accompanied it, were also about something harder to see: racism, and the allegation that Ferguson’s largely white cops were deeply, systematically and violently prejudiced against black residents.

Now, as one of his last acts as U.S. Attorney General, Eric Holder has painted a picture of Ferguson’s entrenched racism that is clear and unmistakable. A Justice Department investigation opened after Brown’s shooting has found routine patterns and practices of racism in Ferguson, including the excessive use of force and unjustified arrests, officials said Tuesday. The findings are scathing in their detail:

In 88 percent of the cases in which the department used force, it was against African Americans. In all of the 14 canine-bite incidents for which racial information was available, the person bitten was African American.

In Ferguson court cases, African Americans are 68 percent less likely than others to have their cases dismissed by a municipal judge, according to the Justice review. In 2013, African Americans accounted for 92 percent of cases in which an arrest warrant was issued.

The investigation also turned up bigoted emails, like one from November 2008 that reportedly said President Obama wouldn’t complete his first term as President because “what black man holds a steady job for four years.” The St. Louis Post-Dispatch reported another racist message, from May 2011, reading: “An African-American woman in New Orleans was admitted into the hospital for a pregnancy termination. Two weeks later she received a check for $5,000. She phoned the hospital to ask who it was from. The hospital said, ‘Crimestoppers.'”

The Justice Department spent 100 days in Ferguson collecting such details, and the report is an end in itself, putting an official stamp on the town’s problems that some had found easy to dismiss. But when it comes to fixing the harsh reality of racism in Ferguson, it’s not clear transparency will be enough.

The question now is whether the report will deliver reform in the beleaguered St. Louis suburb. The Justice Department under Holder has significantly increased the number of pattern or practice investigations, and some past settlements with police departments have led to dramatic improvements. But others say the department’s lack of enforcement powers mean reform depends on local politicians, and worry Ferguson’s leaders won’t bring change.

Under the 1994 law authorizing such “pattern or practice” investigations, the Justice Department has little enforcement power to fix the problems it finds. As a rule, it enters into contracts with the offending force, which agrees to increase transparency and data collection and to provide better training and supervision.

Police officials and their unions often resist reform, several studies have shown. The Justice Department has “very few sticks they can use,” to get past such obstacles, says Elliot Harvey Schatmeier, a lawyer at the New York City office of Kirkland & Ellis and the author of one such study.

Others say that in many cases, the attention brought by the investigations is enough. In Pittsburgh, New Jersey and Los Angeles, Justice Department investigations led to successful reforms, says Chris Stone, president of the Open Society Foundations and a criminal-justice scholar. More important, Stone says, “They’ve established a national standard for what good policing looks like.”

Holder’s Ferguson findings, Stone says, have the potential to lead to a similar blueprint for smaller, suburban police forces around the country, which have typically been hard to reform.

By the same token, though, a failure in the high-profile Ferguson case could set back the effort to reform small police departments. Holder has established with clarity the problem in Ferguson. But without local political buy-in, the town that came to symbolize 21st century police racism in America could end up symbolizing its resistance to reform too.

TIME Foreign Policy

Why Bibi and Barack Can’t Get Along

It would be easy but for the deep differences in policy, politics and personality.

The messy relationship between Benjamin Netanyahu and Barack Obama began, appropriately enough, in a janitor’s office at Reagan National Airport in March 2007. U.S. and Israeli diplomats have been cleaning up ever since, as the two men have left a path littered with personal slights and policy differences.

But their confrontation over Netanyahu’s politically tinged speech to Congress Tuesday could end up being their messiest yet, affecting the outcome of U.S.-Iran nuclear talks, the upcoming election in Israel and the future of the Middle East.

Bibi and Barack’s hastily arranged first meeting was, in fact, cordial and respectful, according to those who were there. Obama was returning to Washington from the primary campaign trail. Netanyahu was headed back to Israel where he was the opposition leader in the Knesset. Both knew they might soon be in power, and both recognized it would be work to reconcile their differences.

For starters, they came from very different backgrounds. As TIME wrote in 2010, Netanyahu’s father, Benzion, was among the intellectual leaders of what is known as revisionist Zionism while his older brother became a national hero after leading, and dying in, the 1976 raid on Entebbe.

Obama for his part is the Christian son of an atheist father who had been raised a Muslim. The future president spent formative childhood years in a Jakarta house that had no refrigerator and no flushing toilet, and he still bears on his arm a scar from a playing-field cut perfunctorily stitched up in a Jakarta hospital.

But the real challenge the two have faced is their different policies in the Middle East. Obama came to office reaching out to Iran and pushing for Israeli-Palestinian peace. Netanyahu opposed warming ties with the militantly anti-Israel theocrats in Tehran and refused in early meetings with Obama publicly to embrace the possibility of a Palestinian state.

The two men have endeavored to put a positive face on their differences, and at times it wasn’t hard since they and their countries often had common interests. The two countries have collaborated on anti-Iran measures, and senior officials say the security relationship between the two countries has never been closer.

But as often as not, the combination of personal and policy differences, fueled by distrustful staffers, gave way to friction between the two men. There was the time Israel announced a massive expansion of settlements in East Jerusalem just as Vice President Joe Biden arrived there for talks—a traditional Israeli greeting for peace-process pushing U.S. diplomats that dates back at least to Secretary of State James Baker. Then there was “the Snub” —Obama’s 2010 decision to leave Netanyahu negotiating with aides in the West Wing while he went for dinner with his family.

The outcome of their latest confrontation remains to be seen. Netanyahu faces a tough election this month and the White House’s increasingly public criticism may well show their desire for a change in leadership. Netanyahu’s effort to encourage anti-Obama members of Congress to push new sanctions could help scupper the already tenuous U.S.-Iranian talks.

But even if nothing much comes of their latest confrontation, few imagine the men will ever be inclined to patch up their differences. As Netanyahu’s sometime political nemesis Avram Burg told TIME in 2010, the two men may simply be irreconcilable. “You cannot stitch together the world visions of Obama and Netanyahu,” Burg said. “This is a clash of the psychological infrastructure.”

Read next: Netanyahu Speech Becomes Applause Line for 2016 Republicans

Listen to the most important stories of the day.

TIME Terrorism

Why Terrorism Works: Jihadi John and the Fear Premium

Alan Henning
AP This frame from a video released by Islamic State militants purports to show 'Jihadi John' before the alleged killing of taxi driver Alan Henning, released on Oct. 3, 2014.

It costs a lot to identify future threats

What’s it worth it to keep the world safe from “Jihadi John”? In theory, the vast economic resources and intelligence power of the West should make identifying, tracking and detaining a single, brutal terrorist worth the cost.

But ease of travel, availability of low-tech weapons and our inability to identify future threats from the vast pool of potential terrorists make neutralizing bad guys before they become high-profile killers difficult. The calculation becomes even harder when you realize the enormous cost of counterterrorism investments and how many lives can be saved in other areas of life for the same money.

On the surface, it seems like a simple thing. Mohammed Emwazi, who was identified by the Washington Post Thursday as the ISIS executioner “Jihadi John”, had been questioned and released by British authorities long before he went to Syria to join the group, according to the BBC. Not surprisingly, some are already asking how such a notorious killer could have slipped through authorities’ hands.

For starters, it’s hard to know whom to watch. Investigations into the July 7, 2005 terrorist bombings in London that killed 52 people and injured 700 confirmed that the UK’s domestic security service, MI5, had previously come across some of the members of the plot. But the investigations [pdf] concluded that the huge amount of threat information before MI5 and the lack of evidence of an imminent threat meant “it would not be right or fair to criticise the Security Service for the fact they did not pay greater attention” to the plotters.

Similarly, after the Paris attack at the satirical weekly magazine, Charlie Hebdo, French authorities were criticized for not doing a better job tracking the killers beforehand. Both men had been on U.S. terrorist watch lists, and the French Prime Minister admitted “failings” by intelligence services after the attack. But some estimates say it costs millions to monitor just one terrorism suspect, let alone the hundreds that French authorities say they would have to track to foil every possible future attacker, assuming one could even create a reliable and useful list of suspects.

Some have tried to calculate the total cost of such an effort. A 2014 study by John Mueller of Ohio University and the CATO Institute and Mark Stewart of the University of Newcastle in Australia, did a “back of the envelope” estimate to compare the cost of attacks to the cost of prevention. The authors assumed what they say is a common valuation of a human life of $6 million-$7 million and factored in their calculations the consequences of an attack, its likelihood of success, the risk reduction of terrorism measures and their costs.

Their conclusion: based on an estimated $75 billion increase in annual counterterrorism spending in the wake of 9/11 by the U.S. government, authorities would have to stop “150 Boston-type attacks per year, 15 London-type attacks each year, or one 9/11-type attack every three years” to justify the expense.

Such numbers are more polemical than scientific, of course: dollar costs aren’t the only consequences to factor into the equation. We may decide to pay extra to feel safe from foreign threats, or to fight back against those who directly challenge our political and social structures. We may value humanitarian intervention against terrorists who embrace genocide. Or we may think that the costs of current terrorist attacks could rise dramatically if, for example, bad guys got nuclear, biological or chemical weapons.

National security hawks argue that we should pay with diminished privacy to leverage America’s technical superiority in electronic surveillance, which gives a lot of coverage for relatively little money. Mueller points out that the “Transportation Security Administration’s Federal Air Marshal Service and its full body scanner technology together are nearly as costly as the entire FBI counterterrorism budget,” which delivers a regular stream of arrested potential future jihadis.

Ultimately, if all we’re doing is paying extra because we’re afraid, though, Mueller’s numbers highlight the premium that fear factor represents. It costs a lot more to protect you from a terrorist attack that is statistically extremely unlikely to kill you than to minimize many other daily dangers, like auto accidents, gun deaths and falls by seniors.

That of course is the asymmetric idea as far as terrorists are concerned–use cheap but scary methods to trick opponents into costly, ineffectual countermeasures. In other words, terrorism works.

See our cover story this week, “The ISIS Trap” for more on the current calculation before the Obama administration.

TIME Food and Drug Administration

Candidate to Lead FDA Has Close Ties to Big Pharma

Dr. Robert Califf
Jared Lazarus—Duke Photography Dr. Robert Califf

Duke's Dr. Robert Califf sees closer collaboration between government and industry

Last May, Duke University’s Vice Chancellor for clinical research, Dr. Robert Califf, told an audience of executives that the American system for developing drugs and medical devices was in crisis. Using slides [pdf] developed by Duke’s business school, he said the system was too slow and too expensive, and required disruption and transformation. Towards the end of his talk, he put up a slide that identified a key barrier to change: regulation.

Such views are not uncommon in industry, academic research and on Capitol Hill, but they are noteworthy coming from Califf because he could soon be America’s top regulator overseeing the safety and efficacy of the country’s drugs and medical devices. Califf is already set to become deputy commissioner at the Food and Drug Administration (FDA) next month. Now sources familiar with the process tell TIME he is on President Barack Obama’s short list to run the agency following this month’s announcement that its long-serving commissioner, Margaret Hamburg, will step down in March.

The White House declined to comment on pending personnel decisions, but word that Califf is in contention for the top spot at the FDA comes at a key moment. The agency faces potentially dramatic changes this year as Congress prepares to rewrite many of the rules for how drugs and medical devices are reviewed and tested for safety and efficacy. Califf is widely respected in the public and private sectors, but his candidacy is seen by some as a threat to the independence and authority of the FDA, thanks to his views on the need to accelerate change and his deep financial and intellectual ties to the pharmaceutical and medical device industries.

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. He says he is divesting his holdings in two privately-held pharmaceutical companies he helped get off the ground.

Califf says such collaboration, not just between industry and academia, but with government, too, is the way of the future. “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” Califf says. He says there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.” He says it would be “useful to have someone [leading the FDA] who understands how companies operate because you’re interacting with them all the time.”

Diana Zuckerman, President of the National Center for Health Research, which advocates for FDA regulatory authority, says such ties “should be of great concern.” Dr. Califf is “a very accomplished, smart physician who’s been an important name in the field,” Zuckerman says, but his “interdependent relationships” raise questions about his “objectivity and distance.” She cites several studies suggesting the medical products industry uses such ties to influence the behavior and decision making of doctors and researchers, even when the scientists don’t realize it.

The tension over Califf’s collaboration with industry gets to the heart of the future of the FDA at a pivotal moment. While FDA defenders see the collaboration as a threat to its independence, others see close relationships between government, industry and academia as the model for the future. Califf heads a successful and powerful clinical research program, the Duke Translational Medicine Institute, which brings together industry drug researchers, academic scientists and federal regulators to speed drug development and approval. Califf estimates 50-60% of its $320 million in annual research funding comes from industry.

Capitol Hill is considering codifying parts of that collaborative model for the FDA. The powerful Energy and Commerce Committee in the U.S. House of Representatives recently introduced a draft bill called 21st Century Cures, which would loosen the drug approval and post-market oversight process. Califf says because the bill is still in draft it is too early to pass an overall judgment on it but he says, “I support a lot of the concepts in the bill.”

In the Senate, the Health, Education, Labor and Pensions (HELP) committee has begun work on its own bill, with committee chairman Lamar Alexander declaring, “It takes too long and costs too much to develop medical products.” In a report paving the way for his legislation, Alexander concluded the FDA has grown too large, has fallen behind scientific innovation and threatens American leadership in biomedical innovation. Reform efforts in the Senate may be aided by the support of liberals like Elizabeth Warren who back looser regulations on the medical device industry.

The FDA uses a model for drug testing and oversight largely developed in the early 1960s, with phased trials before drugs and devices are approved for sale to ensure they are safe and effective, and “post-market” studies afterwards to monitor them. Over time, the agency has come to rely on the medical product industry for more than 60% of its budget for post-market monitoring. Accused of regulatory capture by those who see undue industry influence, the FDA has faced attacks from both sides.

That means the FDA has few defenders and will rely heavily on its next commissioner to stand up for it in public and on Capitol Hill. “This is a very dangerous time for the agency,” says Zuckerman of the National Center for Health Research, “It’s under fire in a way that is unprecedented in the last 20 years.”

Califf’s supporters point out that he is among the ten most cited medical authors in America, and that he has spent his career as a clinician helping patients. Regarding the danger of regulators being “captured” by their interactions with industry, Califf says, “The difference between capture and collaboration towards improving human health is a pretty big difference.”

The White House has set no time frame for its decision on Hamburg’s replacement. It has announced the acting commissioner will be Dr. Stephen Ostroff, a scientist and long-time official at the Health and Human Services department, when she steps down in March.

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