He should be one of the most glorified men in America – a leading cardiologist who married his childhood sweetheart and now runs one of the biggest health agencies in the world.
But Robert Califf has rocketed to public enemy number one with parents across the country due to his role in the baby formula crisis.
The 71-year-old doctor was brought back into the fold as FDA commissioner in February and immediately shut down Abbott Laboratories in Michigan.
It has contributed to one of the worst shortages of baby formula the US has ever seen – and it looks set to last for months more.
It is not the first time Califf has courted controversy, with him being slammed for ‘turned a blind eye’ to the opioid crisis and making millions out of Big Pharma.
He has also found enemies on either side of politics, with both Democrats and Republicans loathing him for ditching public service to cash in in the private sector.
Califf was returned as FDA commissioner by Joe Biden in February having previously held the role between 2015 and 2017 under Barack Obama.
Since then he has become a household name across the country over the agency’s failings during the baby formula crisis.
He claimed yesterday Abbott’s key site in Michigan would be reopened within the next few weeks but the firm said it had yet to be given the green light.
Robert Califf has rocketed to public enemy number one with parents across the country due to his role in the baby formula crisis
The Califfs live in a $700,000 home in Durham, North Carolina – close to the research institute he ran
This chart shows how quickly the nationwide crisis has escalated. The scale of the crisis is revealed in the new analysis, which shows that only 43 percent of the usual national supply of baby formula is available
The latest row swirling around the health chief kicked off after the FDA probed Abbott’s facility in Sturgis, Michigan, amid reports the baby formula produced there could be contaminated.
Consumers reported four infants who were sick, including three with cronobacter sakazakii infections and one with salmonella newport, and had been fed formula products made at the Sturgis plant.
A fourth infant with cronobacter sakazakii was later added to the investigation by the U.S. Centers for Disease and Control Prevention.
Cronobacter sakazakii can cause life threatening sepsis infections or meningitis and may have contributed to the death of two of the infants, the FDA has said.
The plant’s owners, Abbott Laboratories, recalled their products, and in February took the decision to shut the plant down, pending further inspections.
They have since stressed that no link was found between the two deaths and their plant. But the company needed FDA approval to restart production.
As the shortage of baby formula escalated nationwide – in August it passed 10 percent, and it is now at 43 percent, exacerbated by the Sturgis shutdown – calls mounted for the shuttered Sturgis plant to resume operations.
The company said they were ready, but are awaiting FDA approval. Approval was not granted until Monday, and must now be authorized by the courts.
When the green light is given, it will be at least ten weeks until the products are back on the shelves.
The Abbott Laboratories factory has reached a deal with the FDA that could see it reopen in as few as two weeks. The plant closed down in February after the FDA found multiple violations at the facility
The formula shortage is the result of supply chain disruptions and workforce issues, but it was amplified by a safety recall of formulas by the factory
Califf is in the spotlight for the delay, with many asking whether it was necessary to be dragged out for so long.
Before rejoining the FDA, the health expert was already seen as controversial in some circles.
He was first appointed FDA chief by Barack Obama – a role he held from February 2016 until the end of the Obama administration.
Questions were quickly asked about his industry ties – his predecessor, Dr Margaret A. Hamburg, a former top health official in New York City, came from the field of public health.
Efforts were made to reassure people, and the Obama administration stressed Califf had been donating all his consulting fees to nonprofits since the mid-2000s.
According to data accessed by The New York Times from PharmaShine, a database of payments to health care professionals, and the federal government’s Open Payments database, Califf received about $215,000 in consulting fees from 2009 to early 2015.
A political appointee, he left when the outgoing president stepped down before heading to Google’s parent company Alphabet to earn his millions.
He was paid $2.7 million by Verily Life Sciences, the biomedical research organization operated by Alphabet, and between $1 million and $5 million in stock from his role as head of clinical policy and strategy.
He also sat on the boards of two pharmaceutical companies, AmyriAD and Centessa Pharmaceuticals PLC.
Robert Califf is seen in May 2016, shortly after his first appointment as FDA commissioner
The South Carolina-born medic reported ties to 16 other research organizations and biotech companies, ethics and financial disclosure documents show.
‘For people like Robert Califf every time they spin through the revolving door they can demand higher salaries from the private sector,’ said Craig Holman, a lobbyist with consumer advocacy group Public Citizen.
‘This is a money making operation for revolvers.’
When Biden nominated Califf for a second stint at the helm of the FDA, his lucrative work for big pharma turned many against him.
Ed Markey, the Democrat senator for Massachusetts, was unimpressed by Califf’s failure to do more to stop the opioid epidemic.
Markey said ‘the FDA repeatedly rubberstamped new prescription opioids that increased the risk of misuse and dependence and failed to limit the broad availability of these drugs, acted too slowly to remove them from the market or place restrictions on their labels, and continued to approve powerful new opioids either over the express objections of its advisory committees or without convening an advisory committee at all.’
Robert and Lydia Califf – who met at high school in South Carolina
He met with Califf in December 2021, to discuss his concerns about why more was not done.
But he came away unsatisfied, and refused to confirm his president’s nominee – having also refused to confirm him in 2016.
‘During our meeting, Dr Califf did not commit to the decisive and comprehensive action necessary to ensure reforms that the FDA, under his leadership, would implement on opioid regulation,’ said Markey, in a letter to Acting FDA Commissioner Janet Woodcock.
‘After years of agency failures and in the midst of a worsening opioid epidemic, we need FDA leadership that is fully committed to utilizing the agency’s full oversight authority to protect public health.
‘We continue to live with the consequences of the FDA’s failure to effectively regulate opioids.
‘I remain alarmed that the agency has not done enough to account for or reform its processes for reviewing these supercharged painkillers.’
Another to vote against him, for the same reasons, was Joe Manchin, Democrat senator for West Virginia.
‘I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,’ said Manchin, shortly after Califf was nominated.
Califf is seen with Joe Manchin, in August 2016. Manchin refused to vote for him as Biden’s FDA chief
‘Instead, Dr Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward.’
A third Democrat, Senator Richard Blumenthal, representing Connecticut, also opposed Califf’s nomination based on his industry ties.
And Bernie Sanders became one of the most vocal opponents to Califf’s candidacy, saying he feared he was too soft on big pharma.
‘I am disappointed that Dr Califf has been confirmed to be the new FDA commissioner,’ he said in February this year, after Califf squeaked through his confirmation with a 50-46 vote.
‘I opposed his nomination because I was not convinced that he would stand up to the greed of the pharmaceutical industry, one of the most powerful special interests in Washington.
‘In my view, it is unacceptable that the American people pay, by far, the highest prices in the world for prescription drugs.
‘At a time when one in five Americans cannot afford to pay for the medications that have been prescribed to them, we have got to do everything we can to lower the skyrocketing price of prescription drugs.
‘A life-saving drug does no good if a sick patient cannot afford it.’
Between his stints at the FDA, Califf worked at Duke University in North Carolina before retiring in November 2019.
He had been a tenured professor and founding director of the Duke Clinical Research Institute – part of the Duke University School of Medicine, and the world’s largest academic clinical research organization.
The Institute received more than 60 percent of its funding from industry.
Califf is believed to live in Durham in the state in a $700,000 four-bedroom home with his wife Lydia – who he met at high school, in Columbia, South Carolina.
The couple have three children: Sharon, Sam, and Tom.