- Ohana says coalition could set up ‘constitutional court’ to bypass judicial oversight The Times of Israel
- Israel’s Supreme Court: How it became so controversial, explained Vox.com
- Israel’s judicial reform: A country on the brink of a constitutional crisis? • FRANCE 24 English FRANCE 24 English
- ‘Jewish and democratic’ were never in question for state’s founders, scholar says The Times of Israel
- Israel: 15-judge bench Supreme Court bench hearing petitions against reforms | WION WION
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Tag Archives: oversight
Central Florida Oversight District reconsiders its plans to eliminate Walt Disney World Annual Pass benefits for its employees – wdwmagic.com
- Central Florida Oversight District reconsiders its plans to eliminate Walt Disney World Annual Pass benefits for its employees wdwmagic.com
- Central Florida Tourism Oversight District employees push for Disney pass benefits WESH 2 News
- Central Florida Tourism Oversight District Propose $3.1 Million Cut to Roadway Repair and Maintenance Around Walt Disney World WDW News Today
- DeSantis’ tourism board seeks ‘satisfactory alternative’ to Disney perks Orlando Sentinel
- DeSantis’ CFTOD is cutting more than $3 million from road maintenance at Walt Disney World to pay for its legal fights wdwmagic.com
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Phil Mickelson’s alleged gambling habit could contribute to more oversight of all sports – NBC Sports
- Phil Mickelson’s alleged gambling habit could contribute to more oversight of all sports NBC Sports
- “This Is an Illness” – Rich Eisen on the Allegations of Phil Mickelson’s $1 Billion Gambling Habit The Rich Eisen Show
- Phil Mickelson has wagered more than $1 billion, according to book by renowned gambler Billy Walters The Associated Press
- Phil Mickelson wagered over $1 billion, tried to bet on Ryder Cup, book alleges – ESPN ESPN
- Jordan Spieth Stopped Himself From Commenting on Wild Phil Mickelson Betting Allegations Mid-Answer Sports Illustrated
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Comer Releases Third Bank Memo Detailing Payments to the Bidens from Russia, Kazakhstan, and Ukraine – United States House Committee on Oversight and Accountability – House Committee on Oversight and Reform |
- Comer Releases Third Bank Memo Detailing Payments to the Bidens from Russia, Kazakhstan, and Ukraine – United States House Committee on Oversight and Accountability House Committee on Oversight and Reform |
- House GOP release bank records on Hunter Biden payments from Russian, Kazakh oligarchs, total clears $20M Fox News
- Biden Family Received Millions from Foreign Oligarchs Who Had Dinners with Then-VP Joe Biden National Review
- Hunter Biden-linked foreign haul at $20M with Russia, Ukraine, Kazakh bank transfers, Comer says New York Post
- More Biden Family Bank Records Reveal Suspicious Wires, James Comer Says Newsweek
Hunter Biden business associate Devon Archer to testify at House Oversight hearing – Fox News
- Hunter Biden business associate Devon Archer to testify at House Oversight hearing Fox News
- High Profile Witnesses Testify Before U.S. Congress On Hunter Biden Probe | Hunter Biden News LIVE CNN-News18
- July 31: Hunter Biden’s business partner to testify. Group buying American land sues farmers. NewsNation Now
- Hunter’s ex-business partner, Devon Archer, could blow the lid off Joe Biden’s phony claims of innocence Fox News
- Hunter Biden’s partner testifies: Congress must not skip one crucial question Fox News
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Facebook Parent’s Oversight Board Criticizes ‘Cross Check’ Program That Protects VIP Users
Meta Platforms Inc. has long given unfair deference to VIP users of its Facebook and Instagram services under a program called “cross check” and has misled the public about the program, the company’s oversight board concluded in a report issued Tuesday.
The report offers the most detailed review to date of cross check, which Meta has billed as a quality-control effort to prevent moderation errors on content of heightened public interest. The oversight board took up the issue more than a year ago in the wake of a Wall Street Journal article based on internal documents that showed that cross check was plagued by favoritism, mismanagement and understaffing.
Amazon Studios Jennifer Salke Adds MGM Oversight, Chris Brearton Upped – Deadline
It’s official – Jennifer Salke, Head of Amazon Studios, will also oversee MGM, the venerable film and TV studio, which was acquired by Amazon earlier this year for $8.5 billion. Additionally, MGM’s COO Chris Brearton will take on a new role, VP, PVS Corporate Strategy, MGM+ and MGM Alternative Television. Mike Hopkins, SVP, Prime Video and Amazon Studios, just made the announcement internally in a memo. (You can read it under the post.)
“Jen’s outstanding reputation in the creative community has earned her the respect of Hollywood’s top talent throughout the industry,” Hopkins wrote. “With Jen now having oversight of both studios – along with distribution and all creative marketing – creatives will have a single point of entry for the opportunity to showcase their content across all our platforms.”
In his new role, Chris Brearton, who has been shepherding MGM’s integration into Prime Video and Amazon Studios, will lead business planning and corporate strategy for Prime Video and Studios. He will also oversee MGM+ and MGM Alternative.
The expansion of Salke’s responsibilities was expected, and it was indirectly signaled earlier today when one of her direct reports, Head of Television Vernon Sanders, unveiled the MGM scripted TV leadership which reports into him.
In her staff memo, Salke laid out the executive structure of the combined operation she is overseeing. Still TBD is a new film head for MGM who will be reporting to her.
As previously reported, Sanders will continue to run Amazon television and will now have oversight of scripted MGM television, led by Lindsay Sloane and Rola Bauer on the scripted side. Julie Rapaport will continue to run the AOM team as well as oversee the MGM film team. Dan Scharf will add oversight of MGM’s BA and business operations as well as casting, music and production. Amazon Studios’ newly appointed marketing head Sue Kroll will add MGM to her purview, and MGM’s chief marketing officer Stephen Bruno will now report to her. Brad Beale’s content licensing remit will now include MGM, with Chris Ottinger, MGM’s head of worldwide distribution and acquisition, now reporting to Beale. And Erik Lomis, head of theatrical distribution at United Artists Releasing, will report directly to Salke.
Separately, Brearton unveiled his senior executive team which includes Michael Wright as Head Of MGM+ as well as Brian Edwards and Barry Poznick as Heads Of MGM Unscripted TV.
Prime Video is coming off the Season 1 run of its biggest Amazon Studios series to date, LOTR: The Rings of Power. Other hit scripted series on the platform include The Boys, which has spawned a franchise; Jack Ryan; and The Marvelous Mrs. Maisel. The streamer also just won the Reality Competition Emmy Award for Lizzo’s Watch Out for the Big Grrrls. On the film side, notable ratings performers include the Borat and Welcome to America sequels as well as The Tomorrow War. The studio has a couple of Oscar contenders on the documentary side, Good Night Oppy and Wildcat.
Salke has been Head of Amazon Studios since February 2018. Before that, she was President of NBC Entertainment. Some of the hits she has shepherded included This Is Us and the Chicago franchise.
Prior to joining NBC, Salke served as EVP Creative Affairs at 20th Century Fox TV, where she oversaw the development of such popular series as Glee and Modern Family. As SVP of Drama Development at the studio, she shepherded the development of hits Bones and Prison Break, among others.
Salke began her career at Aaron Spelling Productions in the early 1990s where she worked on the original Beverly Hills, 90210 and Melrose Place.
Here is Hopkins’ memo:
Hi team,
Nearly nine months ago when we acquired MGM, we said we would take a thoughtful and measured approach to the integration process. It was important to take the time to ensure the right people were in the right jobs for maximum collaboration, creativity, and innovation. We have made many important decisions during this time, and now have completed the essential work of setting up our organizational structure. I am pleased to share that effective immediately, Jennifer Salke will become head of Amazon and MGM Studios, adding oversight of MGM scripted television and film, distribution, and creative marketing. Additionally, I’d like to welcome Chris Brearton, who will take on a new role, VP, PVS Corporate Strategy, MGM+ and MGM Alternative Television.
Jen’s outstanding reputation in the creative community has earned her the respect of Hollywood’s top talent throughout the industry. With Jen now having oversight of both studios – along with distribution and all creative marketing – creatives will have a single point of entry for the opportunity to showcase their content across all our platforms. Serving the creative community in this way will streamline and enhance the creative process, expand our growing stable of content, and strongly reinforce Jen’s commitment to being the home for talent.
Chris Brearton has been running the business of MGM and leading its integration into Prime Video and Amazon Studios. In his new role, he will lead business planning and corporate strategy for PVS. He will also oversee MGM+ and MGM Alternative, where he will be responsible for accelerating the rebrand and spearheading the growth of the MGM + premium service, while also working closely with the seasoned MGM unscripted television team to continue their legacy of megahits, such as Survivor, Shark Tank and The Voice. Brearton will report to me and join my senior leadership team, effective immediately.
I appreciate all of the work on this integration and believe we are now better positioned to deliver on our ambitious vision with very best leaders at the helm. Throughout this process you have continued to deliver great entertainment to customers around the world. We released three MGM film titles to direct-to-streaming (DTS) releases on PV including Thirteen Lives, Anything Is Possible, and Samaritan, and the critically lauded theatrical releases of Till and Bones & All. We partnered on celebrating the 60th anniversary of the 007 franchise in October 2022.
We have new quality storytelling to bring to our customers in the coming weeks with Women Talking, Boys in the Boat, and Creed III, with even more in development for Prime Video. In addition to launches, we greenlit Road House with Jake Gyllenhaal and The Underdoggs with Snoop Dogg. In partnership with MGM Television, we greenlit and commenced production on Shelter (based on the bestselling thriller novel by Harlan Coben), The Consultant (starring Christoph Waltz), and A Road to a Million (a reality competition series featuring locales from 007 movies).
I am so appreciative of all the work you’ve collectively done this year, and look forward to all we can do together as we build the next phase of this rich legacy of amazing content. You will be hearing from Jen and Chris soon about their visions and goals for their respective organizations. Thank you all for your patience and commitment throughout this process.
Mike
Here’s Salke’s email:
Team,
Mike just shared some news about our organizational structure, and I wanted to say how proud I am to be named the head of Amazon and MGM Studios. It is a privilege to lead a team of such immensely talented people. We have such an exciting opportunity ahead of us as we continue to build out our best-in-class studios and entertain even more people all over the world.
With my added oversight of MGM’s scripted television and film, distribution, and creative marketing, I have some news to share on my leadership team. Vernon Sanders will continue to run Amazon television and will now have oversight of scripted MGM television with Lindsay Sloane and Rola Bauer. Julie Rapaport will continue to run the AOM team as well as oversee the MGM film team as we continue to integrate. Dan Scharf will add oversight of MGM’s BA and business operations as well as casting, music, and production. Amazon Studios newly appointed marketing head Sue Kroll will add MGM to her purview, and MGM’s chief marketing officer Stephen Bruno will now report to Sue. Brad Beale’s content licensing remit will now include MGM, with Chris Ottinger, MGM’s head of worldwide distribution and acquisition, now reporting to Brad. And Erik Lomis, head of theatrical distribution at United Artists Releasing, will report directly to me. I’d like to thank all of you for your patience as we integrate the talented teams at MGM. And we will have more announcements to share over the next few months.
These are dynamic times for all of us in the entertainment industry. And here at Amazon and MGM Studios, we have the best leaders, creatives, and talent in the business. I am proud to be a part of this amazing organization and look forward to all that we can – and will – do together.
Jen
Americans Take Ketamine at Home for Depression With Little Oversight
Startups are prescribing ketamine online to treat serious mental-health conditions, raising concern among psychiatrists about the safety of taking the mind-altering anesthetic without medical supervision, sometimes at high doses that raise risks of side effects.
Ketamine is approved by the Food and Drug Administration to anesthetize people and animals and has been used safely in hospitals for decades. The out-of-body, hallucinogenic sensations it produces made it popular as a party drug known as Special K. Some doctors prescribe ketamine off-label to treat patients with conditions including severe depression, suicidal thoughts and post-traumatic stress disorder.
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Is there enough support available for people taking ketamine at home because of mental-health concerns? Join the conversation below.
Generic ketamine isn’t approved for those conditions. Studies have shown it can rapidly alleviate symptoms of severe depression when other treatments have failed.
There is less data on ketamine’s effectiveness for other conditions including anxiety and PTSD, and little data on its long-term use.
The FDA has approved a chemically related version of the drug, called esketamine, from
Johnson & Johnson
for treatment-resistant depression with suicidal thoughts.
Clinics that are certified to administer J&J’s nasal spray must monitor patients for two hours afterward.
People taking generic ketamine at home aren’t subject to the same oversight.
Mindbloom Inc., Nue Life Health PBC and Wondermed LLC are among around a dozen companies now selling ketamine tablets or lozenges online, making use of relaxed restrictions on the prescription of controlled substances during the pandemic.
The companies work with clinicians who prescribe ketamine to patients based on a questionnaire and virtual evaluation. The generic ketamine pills or lozenges are mailed to patients’ homes. The companies say they instruct people to take the medication with someone nearby, among other safety measures.
Taking ketamine at home without medical supervision increases risks of patients falling and hurting themselves or taking more of the drug than prescribed, doctors said. Ketamine can be addictive, and patients might not get the help they need if they have a distressing experience while taking the drug, psychiatrists said.
“Places that are doing virtual ketamine are negotiating a compromise between accessibility and safety,” said Dr.
Benjamin Yudkoff,
medical director of the ketamine and esketamine program at Brigham and Women’s Faulkner Hospital in Boston.
Ketamine increases heart rate and blood pressure, raising the risk of rare complications including stroke or heart attack at the higher doses that some telehealth patients have been prescribed, medical experts said.
“Giving any drug like that has the potential to cause general anesthesia at home in a completely unmonitored environment,” said Dr.
Michael Champeau,
president of the American Society of Anesthesiologists.
The companies said prescribing ketamine-assisted therapy at home can help fill a need for people who don’t respond to existing medications or can’t reach or afford treatment in person. Ketamine blocks a receptor in brain cells important for brain adaptability, which researchers say might help facilitate changes in mood and mind-set.
Ketamine was prescribed for Leon New Valentine, who said it alleviated symptoms of treatment-resistant depression and PTSD.
Photo:
Tara Pixley for The Wall Street Journal
Mindbloom and Nue Life cited peer-reviewed research they published suggesting that many patients reported feeling better after taking ketamine and that few reported problems related to taking the drug.
Mindbloom, Nue Life and Wondermed said they decline to treat people who have symptoms that are too severe or histories of conditions such as substance-use disorder, psychosis or uncontrolled hypertension. Nue Life said it sometimes consults with a patient’s doctor before prescribing ketamine, and Mindbloom said it often asks for medical records. Wondermed said patients can choose to have their doctors work with the company during treatment.
“‘Places that are doing virtual ketamine are negotiating a compromise between accessibility and safety.’”
Nue Life said it starts patients at around 125 milligrams and prescribes at most 750 milligrams for a dose. Wondermed said it prescribes patients between 100 milligrams and 400 milligrams for a dose. Mindbloom said that it starts patients at around 400 milligrams and that some patients graduate to doses of around 1,000 milligrams.
Doses of around 1,000 milligrams heighten risks for severe side effects including rare seizures, hemorrhages or strokes, said
Ari Aal,
a psychiatrist in Boulder, Colo., who prescribes ketamine at lower doses to patients who take it under supervision at his clinic.
“That’s way too much of a dose to be doing at home and probably at all, and way too much without a practitioner watching you,” Dr. Aal said.
Mindbloom and Wondermed said they provide blood-pressure monitors for patients to use before and during treatment. Nue Life said it instructs patients with controlled hypertension to monitor their blood pressure.
A ketamine kit provided by Mindbloom for Courtney Gable.
Photo:
Courtney Gable
Timothy Mitchell,
a 40-year-old patient advocate from Ballston Lake, N.Y., said Mindbloom started him on an 800-milligram dose last year. He said he is undergoing his third course of a six-dose regimen with Mindbloom at 1,200 milligrams a dose. The treatment helped quiet suicidal thoughts, he said.
Wondermed said it charges $399 for a month of ketamine tablets or lozenges and telemedicine treatment. Mindbloom said it charges around $1,000 for around three months of ketamine and telemedicine care. Nue Life said it charges as much as $2,999 for ketamine tablets and telemedicine treatment over four months. Health insurers usually don’t reimburse people for the off-label treatments.
Amanda Itzkoff,
a psychiatrist and chief executive of Curated Mental Health, which administers ketamine in clinics, said she declined to be on Mindbloom’s advisory board in part because she was concerned that at-home use might not include enough patient supervision.
Making a comparison with a crackdown on psychedelic-drug research decades ago, she said that if companies recklessly prescribe ketamine for home use, they could set back adoption of a valuable treatment. “We could blow it again,” Dr. Itzkoff said.
A spokesman said that Mindbloom ended its relationship with Dr. Itzkoff and that she didn’t raise safety concerns. Mindbloom’s medical director, Dr.
Leonardo Vando,
said striking the right balance between expanding access to ketamine and safe prescribing practices is critical to Mindbloom.
Courtney Gable,
47, said her husband checked on her when she took ketamine that Mindbloom prescribed for her this year to treat chronic pain and depression. The 400-milligram dose was higher than initial doses prescribed at a clinic where she works in Philadelphia, she said.
“There’s a safety net, but the spaces between the net are a little wider,” Ms. Gable said.
Leon New Valentine,
a 32-year-old actor and videogame model in Los Angeles, was prescribed 100 milligrams of ketamine online last year by Peak Health Global Inc., and took the medication with someone nearby. Mx. Valentine, who uses they as a pronoun, said they graduated to 150-milligram doses and took that alone. Ketamine alleviated symptoms of treatment-resistant depression and PTSD, Mx. Valentine said.
“Things are joyful again even though I’m in pain,” Mx. Valentine said. Peak said it would close in November because it expects rules allowing controlled substances to be prescribed remotely to be tightened soon.
Write to Brianna Abbott at brianna.abbott@wsj.com and Daniela Hernandez at daniela.hernandez@wsj.com
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SEC’s Gensler Signals Support for Commodities Regulator Having Bitcoin Oversight
WASHINGTON—Securities and Exchange Commission Chairman
Gary Gensler
signaled that he would support Congress handing more authority to the SEC’s sister markets regulator to oversee certain cryptocurrencies such as bitcoin.
Mr. Gensler, speaking at an industry conference, said Thursday he looked forward to working with Congress to give the Commodity Futures Trading Commission added power, to the extent the agency needs greater authority to oversee and regulate “nonsecurity tokens…and the related intermediaries.”
The remarks come amid an intensifying battle among federal agencies and congressional committees that oversee them over who will regulate crypto.
Cryptocurrencies remain largely unregulated by the federal government, leaving investors without protections from fraud and market manipulation that come with many other types of investments. The competition for jurisdiction heated up in recent months as a meltdown in crypto markets underscored the need for guardrails in the eyes of many policy makers.
The competition also reflects the industry’s ramped-up lobbying presence in Washington and its push to reach more mainstream investors through Super Bowl ads and other high-profile marketing initiatives.
Mr. Gensler, who headed the CFTC from 2009 to 2014, qualified his remarks by saying he welcomed working with lawmakers as long as it doesn’t take away power from the SEC.
“Let’s ensure that we don’t inadvertently undermine securities laws,” he said. “We’ve got a $100 trillion capital market. Crypto is less than $1 trillion worldwide. But we don’t want that to somehow undermine what we do elsewhere.”
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Leaders of the Senate Agriculture Committee, which oversees the CFTC, are pitching legislation that would assign oversight of the two largest cryptocurrencies—bitcoin and ether—to that agency. At present, the CFTC generally has the power to regulate derivatives—such as futures and swaps—as opposed to cash or spot markets where the underlying assets are bought and sold for immediate delivery.
The SEC has declined for years to assert jurisdiction over bitcoin and ether, which proponents say are more “decentralized” than other cryptocurrencies. Mr. Gensler noted Thursday that bitcoin is often likened to a digital form of gold, and that it doesn’t bear all of the characteristics of a security.
The bill from the leaders of the agriculture panel is one of several that lawmakers have offered to more tightly oversee cryptocurrencies. In his remarks, Mr. Gensler didn’t express support for any particular bill.
CFTC Chairman
Rostin Behnam
has asked Congress to pass a law that would allow the CFTC to regulate cash markets for certain types of cryptocurrencies and provide it with funding to conduct additional oversight.
After objecting for years to meaningful federal oversight, cryptocurrency lobbyists have recently shifted their focus to convincing lawmakers and regulators that the CFTC should have primary jurisdiction over their industry. They say the SEC’s rules for traditional securities like stocks and bonds don’t fit because cryptocurrencies aren’t organized as traditional corporations with stockholders.
Jake Chervinsky, head of policy at the Blockchain Association, a crypto lobbying group, said in a statement that “decades of legal precedent shows that most digital assets” are commodities.” He said lawmakers should address the issue.
“This is a matter for Congress rather than regulators, and we’re glad to see consensus in Congress that the CFTC, not the SEC, should regulate spot markets,” he said.
While Mr. Gensler’s comments suggest that his agency shouldn’t oversee bitcoin, he said the majority of crypto tokens are securities that fall under his agency’s jurisdiction and should comply with investor-protection laws. Mr. Gensler also said it is possible some crypto intermediaries would need to be dually registered with both his agency and the CFTC, similar to the way some brokers and mutual-fund firms are overseen by both agencies.
Mr. Gensler has also repeatedly demanded that cryptocurrency-trading platforms such as Coinbase Global Inc. register with the agency as securities exchanges akin to the New York Stock Exchange or Nasdaq. In May, the SEC nearly doubled the staff of an enforcement unit focused on cryptocurrencies.
—Paul Kiernan contributed to this article.
Write to Andrew Ackerman at andrew.ackerman@wsj.com
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
FDA weighs oversight changes after formula, Juul troubles
WASHINGTON (AP) — The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.
Tuesday’s announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including the delayed response to contamination problems at the country’s largest infant formula plant.
“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s food program, Califf said in a statement. The agency’s tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health,” he said.
Califf said the Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations. The experts are expected to consult with FDA staff along with outside groups to gather a broad range of opinions. Califf and his team have already begun meeting with outside stakeholders, the FDA noted.
The review announcement comes one day before Califf is scheduled to testify before the Senate agriculture committee about FDA’s oversight of food safety.
More than two dozen consumer groups have called on Califf to appoint one official to oversee all FDA food operations, which are dispersed across multiple centers responsible for nutrition standards, plant inspections and animal food. But Califf told The Associated Press in an interview that he believes more fundamental changes are needed.
“I don’t think structure alone is really the fix, or that leadership alone is the fix,” Califf said. “There’s a consistent concern out there that we need to really fix the fundamentals, which includes all those elements.”
Califf said he agreed with critiques that the food program has been underfunded compared with FDA’s drug program, which receives more than $1 billion annually in industry user fees. The agency recently sought more food funding and authority to help track supply chains in order to head off future shortages.
Parents and politicians also have expressed frustration over the agency’s handling of a recent decision to ban all e-cigarettes from Juul, the leading U.S. vaping company. A federal court quickly blocked the agency’s order. FDA then backtracked further in court, saying it needed more time to review Juul’s application due to its “unique scientific issues.”
The FDA has also struggled to review millions of other applications from vaping companies, prompting multiple missed regulatory deadlines over the last two years.
Califf again cited funding challenges, pointing out that the FDA cannot collect user fees from vaping companies who submit their products. The agency has asked Congress for that authority.
“I don’t think anyone anticipated that there would be 6.7 million vaping product applications that came rolling in during a pandemic that was stressing the entire agency,” Califf said.
Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over those products, which had used a legal loophole to skirt regulation.
Sen. Dick Durbin, an Illinois Democrat, suggested Califf should resign if the agency can’t swiftly remove such products.
President Joe Biden tapped Califf for the FDA job largely because of his prior experience at the agency, which he briefly led during the Obama administration. A cardiologist and respected researcher, Califf planned to focus his time at FDA on fighting medical misinformation and streamlining the agency’s data systems.
But those efforts have been eclipsed by newer controversies, including political outrage over the formula shortage, which has forced the U.S. to airlift millions of containers of formula from Europe. Recently, the FDA said it would help foreign manufacturers stay on the U.S. market for the long term, in an effort to diversify the formula supply here.
Califf previously predicted the formula shortage could last until July. He said Tuesday that retail data show that supplies have improved with increases in both U.S. production and imports.
“What you’re going to see is a gradual climbing out of the current situation as more and more formula becomes available,” Califf said.
In May, Califf testified before Congress about missteps that slowed the agency’s response to contamination problems at the Michigan formula plant that triggered the shortage. While many of the problems happened before Califf started on the job, he struggled to explain who was ultimately responsible for food safety within FDA’s bureaucracy.
FDA’s food program has a byzantine leadership structure in which there is a director for food and a separate deputy commissioner for “food policy and response.” The deputy commissioner has more of a safety focus, but has no direct authority over food center staff nor regional personnel who inspect plants.
“You have serious structural leadership issues,” Rep. Rosa DeLauro told Califf during the hearing.
DeLauro, a Connecticut Democrat, said Tuesday the FDA’s evaluation must contain input from non-FDA experts and interest groups to be credible.
“A report that includes recommendations to preserve the status quo is unacceptable,” she said in an emailed statement.
Responding to multiple crises is a standard part of leading the FDA, which regulates industries that account for an estimated one-fifth of all U.S. consumer spending.
Despite the recent controversies, some experts say Califf has done a good job, considering the increasing polarization surrounding the issues and products FDA oversees.
“Leading the FDA is becoming as complicated as, maybe more complicated than, leading a cabinet-level executive department,” said Daniel Carpenter, a professor of government at Harvard University. “I think Califf has navigated a pretty politically fraught environment and he has done it with remarkable skill.”
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Follow Matthew Perrone on Twitter: @AP_FDAwriter
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.