Tag: Robert Califf

US Infant formula crisis increases scrutiny of the FDA

Volume 399, Issue 10347
11 June 2022 

 

WORLD REPORT Both Republican and Democrat legislators have called for changes following a shortage of breastmilk substitute. Susan Jaffe reports from Washington, DC..  

The leading US producer of infant formula resumed partial operations on June 4 following a 4-month shutdown, but it may take several more weeks before supplies return to normal, along with the shortage-induced panic and desperation of American parents. When the US Food and Drug Administration (FDA) can regain trust in its ability to police the nation’s food manufacturers is another matter.

The agency’s failure to respond quickly to health hazards at the Abbott Nutrition facility in Sturgis, MI, that released potentially contaminated formula across the country has provoked rare bipartisan outrage in Congress and equally rare apologies from the manufacturer. The shutdown and resulting shortage have also prompted calls for major changes in the FDA’s food safety division, along with questions about why one supplier dominates the market. [Continued here.]  

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Califf takes the helm at the US FDA, again

Volume 399, Issue 10330
19 March 2022 

WORLD REPORT   Robert Califf will have to face several controversial health issues in his second tenure as commissioner. Susan Jaffe reports from Washington, DC.  

Califf takes over amid a lull in the COVID-19 pandemic and an array of hotly debated issues 9 months before a congressional election. The
election results could shrink, if not eliminate, the Democratic majority President Joe Biden needs to propel his health agenda, including the relaunched cancer moonshot and the Advanced Research Projects Agency for Health that would accelerate the development of medical treatments. [Plus new COVID-19 tests and treatments, opioid misuse, accelerated approval process, abortion pill conflict, continued here.] 
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Will Trump snuff out e-cigarettes?

Volume 394       Number 10213     30 November 2019   
WORLD REPORT President Trump promised to ban flavoured e-cigarettes, but 11 weeks later, they are still on the shelves. Susan Jaffe reports from Washington. 
When US President Donald Trump announced a plan on Sept 11 to prohibit the sale of most flavoured electronic cigarettes, more than 450 people in the USA had a mysterious lung disease associated with vaping, and six had died, according to the Centers for Disease Control and Prevention (CDC). The ban would be finalised within 30 days, said Health and Human Services Secretary Alex Azar.
The number of cases of the lung disease has since soared to 2290, as of Nov 20, in 49 states, Washington, DC, and the US Virgin Islands. 47 e-cigarette smokers (vapers) have died, according to the CDC. However, as this report went to press, officials from the Trump administration would not disclose when the promised ban would be issued.
…The decision [to implement] a nationwide ban is up to President Trump. “It is a chain of command”, said Robert Califf, a professor of cardiology at Duke University School of Medicine and the FDA commissioner under Trump and former President Barack Obama. “The commissioner reports to the Secretary of Health and Human Services [HHS]and the secretary reports to the president. FDA policies are de facto policies of the Executive Branch, so if the HHS secretary or president chooses to do so, they can intercede.”  [Continued here]  
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Scott Gottlieb steps down from US FDA leadership

 Volume 393, Number 10176      

 16 March 2019       

 

WORLD REPORT   The announcement came as a surprise, prompting many to ask: Can the US FDA commissioner’s policies continue without him? Susan Jaffe reports.

Unlike some government agencies that can toil peaceably in relative obscurity, the FDA is frequently in the headlines. It is responsible for ensuring the safety of products that account for about 20 cents of every dollar US consumers spend—or US$2·5 trillion annually.  …When Gottlieb became commissioner in 2017, the agency had an estimated 1000 vacancies which has now risen to 1400.[Continued here.]
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US FDA: the Margaret Hamburg years

lancet cover 2

Volume 385, Issue 9970, 28 February 2015

WORLD REPORT US Food and Drug Administration commissioner Margaret Hamburg is stepping down after nearly 6 years in office. The Lancet‘s Washington correspondent, Susan Jaffe, reports on her achievements.

Margaret Hamburg

At the end of March, Margaret Hamburg is leaving what has got to be one of the toughest unelected US Government jobs outside of the Pentagon—commissioner of the US Food and Drug Administration (FDA).

A champion of science-based regulation and streamlined approvals for breakthrough drugs, the Harvard-trained physician is one of the two longest-serving FDA commissioners in five decades.

The FDA is responsible for the safety of 20% of the products Americans buy, including more than US$1 trillion dollars worth of goods that might seem to have little in common, such as artificial hips, dietary supplements, gene therapy, surgical lasers, prescription drugs for human beings and animals, nanotechnology products, cosmetics, blood and biologics products, tobacco, and—last but not least—most of the food we eat (excluding meat and poultry, which are the domain of the agriculture department). The agency has 16 000 employees. [article continued in full text or PDF]

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