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Makary Reveals What's Broken Inside the FDA

Makary Reveals What's Broken Inside the FDA

Bloomberg11-07-2025
After 100 days as FDA Commissioner, Dr. Marty Makary lays out his vision for reform, starting with the broken systems he's uncovered inside the agency. He confronts the FDA's failure in the opioid crisis, acknowledges the loss of public trust during COVID, and calls out regulatory capture and internal conflicts of interest, including practices that allowed FDA staff to block their own drug safety reviews. Makary announces a new policy to publish drug rejection letters and introduces a priority review voucher program to fast-track approvals for companies that align with U.S. public health goals, including lowering drug prices to match those in other wealthy nations. 'This president,' he says, 'does not like to see Americans getting ripped off.' He also pledges to modernize food chemical oversight, reform the outdated GRAS system, and cut bureaucratic bloat to refocus the FDA on science, safety, and common sense. (Source: Bloomberg)
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Leadership Isn't Masculine—Or Feminine. It's Human
Leadership Isn't Masculine—Or Feminine. It's Human

Fast Company

time18 minutes ago

  • Fast Company

Leadership Isn't Masculine—Or Feminine. It's Human

When Melanie Dulbecco became CEO of Torani Syrups 34 years ago, she stepped in as its first non-family leader with less than $1 million in annual sales and an uncertain future. What happened next defied expectations. Under her leadership, Torani has averaged more than 20% annual growth year over year for three decades—doubling in size every few years. In 2024, the company reached $500 million in sales and is on track to hit $1 billion by 2030. Dulbecco's unexpected success is attributable to her untraditional leadership style. She says, 'Those financial numbers are the lagging indicators. The leading indicators have everything to do with the growth and development of our people.' Dulbecco's part of a growing wave of leaders embracing a more holistic model with the belief that the most effective leaders aren't defined by gendered traits—they draw from the full range of human strengths. By blending a wide range of 'masculine' and 'feminine' traits like care, vulnerability, confidence, and decisiveness, these leaders are building the most resilient, high-performing organizations today. This shift in approach challenges decades of conventional wisdom, dating back to Dr. Virginia E. Schein's 1973 'think manager, think male' study. Schein identified a persistent association between leadership and traditionally masculine qualities. This 'think manager, think male' effect wasn't just American—it was global, and it's been replicated in numerous studies ever since. This narrow definition of leadership has long devalued traits like empathy, care, and emotional intelligence, often deemed 'soft skills.' This overemphasis on masculine leadership leaves many leaders worrying about expressing anything deemed feminine in the workplace—especially women leaders in male-dominated environments concerned about being taken seriously. Studies show that, while effective leaders display traditionally 'masculine' qualities like confidence, strategic thinking, and decisiveness, they also display 'feminine' traits like collaboration, empathy, resilience, and communication. Here's how three of these often-overlooked traits drive exceptional results: How Caring Boosts Engagement, Retention, and Growth Care isn't a 'soft skill.' It's a strategic one. In 2024, employee engagement dropped to 21%, only the second decline in more than a decade (the other during the COVID-19 pandemic). This disengagement—70% of which is tied to a person's manager—is estimated to cost the global economy over $400 billion in lost productivity last year. Leaders who can engage their teams will shape the future of work, and all they have to do is go back to the basics: caring for people. Employees who feel cared for are three times more likely to be engaged, 70% less likely to experience burnout, and 36% more likely to report thriving outside of work. Yet only 25% of employees feel their manager genuinely cares about their well-being. Cofounder and co-CEO of California-based EO Products Susan Griffin-Black prioritizes a caring leadership approach, striving to ensure her employees feel cared for. 'We're all human and want the same things: safety, belonging, meaning, and to be loved and cared for,' she says. Her people-first leadership is one reason the company's engagement rates rank 33 points above the industry average. Care also drives retention. Nearly 75 % of employees say they want a manager who leads with empathy and support. When they have one, they're 70% less likely to be looking for a new job. Pete Stavros, co-head of global private equity at KKR, recently brought the head of Stanford's Neuroscience Lab Jamil Zaki in to stress test Stavros's observation that the best-performing CEOs in KKR's portfolio were the most empathetic. The results? The CEOs who indexed highest on empathy had retention and engagement rates 1.5 to more than 2 times stronger than the benchmark. Why Deep Listening Builds Trust, Fuels Innovation, and Enhances Belonging Great leadership is built on deep listening. When managers are attentive and communicate openly, they drive higher engagement, stronger retention, and better team performance. But too many leaders still miss the mark: 86% of employees say not everyone in their organization is fairly heard—and more than 60% say their leaders have ignored their voice. When employees feel heard, they're 4.6 times more likely to perform at their best. They're also more likely to report a sense of belonging—and have some of the highest engagement levels in the organization. Griffin-Black says deep listening is one of the leadership skills she leans on most, just like other holistic leaders such as restaurateur Erin Wade. When Wade opened mac-and-cheese restaurant Homeroom in Oakland in 2011, she set out to restore dignity in food industry jobs. Her core strategy? Listening to her team. Wade held optional, paid weekly meetings for her entire 100+ person team—from dishwashers to managers—to hear their perspectives and co-create decisions. She practiced open-book management, shared company financials, and reviewed daily employee feedback each week. The message was clear: your voice matters here. At Homeroom, employee tenure averaged 2.5 years, compared to the industry norm of just 90 days. Financially, the restaurant consistently ranked in the top 1% nationwide while Wade was at the helm. The Critical Link Between Vulnerability and Team Performance While Dr. Brené Brown has brought more attention to the importance of vulnerability—which she defines as 'uncertainty, risk, and emotional exposure'—to leadership, many leaders still struggle with being vulnerable at work. Just 24% of senior leaders say they show vulnerability in the workplace. It's not surprising though, given that many were taught to equate leadership with invulnerability. But those who break that mold call vulnerability a game-changing skill. Vulnerable leaders admit mistakes, acknowledge what they don't know, and stay open to others' ideas. CEO of Charter Next Generation (CNG) Kathy Bolhous—one of the leaders in KKR's portfolio who scored highest on the empathy index—regularly solicits opinions and ideas for improvement from her more than 2,000 employees. When she does so, she's open about the fact that she doesn't have all the answers. 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This shift isn't about gender. It's about range. The leaders who succeed in the modern workplace are those who know when to be bold, when to be quiet, when to challenge, and when to nurture. They don't perform a role. They embody their whole humanity.

Trump signs executive order to stop banks from cutting off crypto
Trump signs executive order to stop banks from cutting off crypto

Yahoo

time26 minutes ago

  • Yahoo

Trump signs executive order to stop banks from cutting off crypto

Trump signs executive order to stop banks from cutting off crypto originally appeared on TheStreet. On Aug. 7, President Donald Trump signed an executive order aimed at what the administration characterizes as the ideological "debanking" of crypto individuals and organizations from U.S. banks. The order explicitly instructs federal banking regulators to eliminate 'reputational risk' as a basis for scrutinizing or severing relationships with customers. The White House argued that this vague term — often used by the Federal Reserve and FDIC — has been weaponized to cut off crypto firms from the U.S. financial system. 'The digital assets industry has also been the target of unfair debanking initiatives,' the White House said in a fact sheet. 'These practices erode public trust in banking institutions and regulators, harm livelihoods, freeze payrolls, and impose significant financial burdens on law-abiding Americans.'Trump's move directly targets what the crypto industry has long described as 'Operation Choke Point 2.0' — a term popularized by Castle Island Ventures co-founder Nic Carter in 2023 to describe an alleged backdoor campaign by regulators to isolate crypto businesses from the banking sector. The original Operation Choke Point was a 2013 DOJ initiative that pressured banks to de-risk from entire industries like payday lenders and firearm can't blacklist crypto The executive order mandates that federal agencies such as the Federal Reserve, OCC, and FDIC remove 'reputational risk' considerations from their internal guidelines and training materials. The Fed previously defined reputational risk as the 'potential that negative publicity regarding an institution's business practices… will cause a decline in the customer base.' Crypto advocates say that definition allowed regulators to subtly discourage banks from servicing crypto firms without having to admit bias. The order further directs regulators to audit prior debanking incidents and provide a report detailing whether any financial institution denied services unlawfully based on ideology. Those found guilty could face sanctions, including fines and restitution. Gemini-JPMorgan dispute intensified pressure The executive order comes weeks after a public clash between crypto exchange Gemini and JPMorgan, where the bank refused to onboard the exchange. Gemini co-founder Tyler Winklevoss accused JPMorgan of carrying out a 'modern-day Operation Choke Point,' aimed at suffocating fintech innovation. Ten exchanges reportedly sent a joint letter to President Trump shortly after the incident, urging the administration to act. The August 7 order appears to be a response. Financial institutions regulated by the Small Business Administration are also now required to review accounts previously closed on ideological grounds — and reinstate them where appropriate. Trump signs executive order to stop banks from cutting off crypto first appeared on TheStreet on Aug 7, 2025 This story was originally reported by TheStreet on Aug 7, 2025, where it first appeared. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

With TX lawmakers in toe, CA Dems tie redistricting efforts to Trump opposition
With TX lawmakers in toe, CA Dems tie redistricting efforts to Trump opposition

Yahoo

time29 minutes ago

  • Yahoo

With TX lawmakers in toe, CA Dems tie redistricting efforts to Trump opposition

Six Texas state Democrats appeared in Sacramento on Friday, backed by Gov. Gavin Newsom and House Speaker Emerita Nancy Pelosi, and said despite legal threats, they would not back down from their efforts to retaliate against Republican efforts to recarve congressional districts. In June, Trump began pressing Texas Republican leaders to consider redrawing their congressional districts to ensure the GOP retained its razor-thin House majority in the 2026 midterms. Dozens of Texas Democrats fled Austin Sunday to California, New York, Illinois and Massachusetts to break the Republicans' quorum and stop them from moving forward. In response, Texas GOP leaders have issued arrest warrants, issued the lawmakers $500 daily fines, and filed lawsuits to force them from office. 'We are running from nothing,' Texas Rep. Ann Johnson said during a press conference with Newsom, Pelosi, and other California Democrats. 'We are running to the front lines to stand with other Democrats across the state of Texas, across the state of California, across this nation, to ensure that each and every individual has the opportunity to pick, to decide that government is for the people by the people, and not the politicians selecting them.' Newsom has become the Democrats' most public champion to respond in kind by asking the legislature to approve a November special election that would ask California voters to temporarily approve new congressional boundaries. He and state leaders tied their efforts, which would move more liberal voters to five districts currently held by Republicans, to voters' growing discontent with Trump on issues like immigration enforcement, tariffs, and a $1 billion fine that his administration levied on UCLA this week, which Newsom called 'extortion.' 'That's what's at stake with this all about elevating the deeper consciousness of the line that Donald Trump continues to cross,' Newsom told reporters. 'It's not about him playing by a different set of rules. There are no rules for Donald Trump. This is a serious moment in American history.' Pelosi compared the absconding Texas Democrats to the Founding Fathers, calling them 'defenders of democracy.' 'We thank you not only for your courage, but for your patriotism,' she said. 'At the beginning of our country, Thomas Paine said, 'The times have found us.' And now the times have found us, especially our Texas delegation, to save our constitution.' Legislative Democrats overcame their initial reticence and have thrown their weight behind Newsom, who has asked that new maps be drawn for the 2026, 2028, and 2030 election cycles. If he succeeds, congressional redistricting power would revert back after 2030 to the independent Citizen Redistricting Commission. Assembly Speaker Robert Rivas, D-Hollister, said Friday that the map would come out next week, ahead of the Aug. 22 deadline that Secretary of State Shirley Weber set for lawmakers to decide if the election will take place. The Legislature returns from summer break on Aug. 18, and is expected to immediately begin work on related legislation. The Republican effort to redraw districts in their favor has now expanded to Indiana, Missouri, and Florida, all states where redistricting power lies with Republican-held legislatures, making it likely that even if California successfully redistricts, it won't be enough to offset the GOP's gains. Newsom said few other states could act with the 'scale and scope' of California: 'It's always the right thing to do the right thing.' 'California has to be prepared to respond. It is our sacred responsibility to California, to our country, and we know that there is no bottom to Trump's dystopian plan,' said Senate President pro Tem Mike McGuire, D-Santa Rosa. 'I'm firm in my belief that if the legislature puts a redistricting initiative on the ballot, I believe the people of the Golden State will do the right thing. I trust the voters of California more than I would ever trust Trump and his lackeys in Texas.'

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