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www.newsindiatimes.com – that’s all you need to know News India Times (December 6, 2025 - December 12, 2025) December 12, 2025 4 Analysis Disclaimer:The views and opinions expressed on this page are those of the authors and Parikh Worldwide Media does not officially endorse, and is not responsible or liable for them. ADozen Former FDA Commissioners Condemn Plan To Tighten Vaccine Approvals A dozen former leaders of the Food and Drug Administration warnedWednesday (December 3, 2025) that plans for a stricter approach to vaccine approvals risk undermining the nation’s ability to fight infectious diseases and could threaten the health of vulnerable Americans. In the New England Journal of Medicine, the for- mer FDA commissioners wrote that they were “deeply concerned” with plans the nation’s top vaccine regulator, Vinay Prasad, laid out Friday in a leaked internal email. They argued that his approach represents a major shift that could delay the arrival of vaccines better matched for evolving viruses, make it potentially prohibitively expen- sive for new shots to come to market, and slow expanded approval of vaccines for more people. Prasad is challenging long-standing vaccine policy, urging the FDA to rethink its framework for annual flu shots, examining whether Americans should receive multiple vaccines at the same time, and requiring larger studies to gain approval for certain shots. “These measures, and the unilateral way they are being imposed, undermine the public interest,” the com- missioners wrote in a piece titled “A Threat to Evidence- Based Vaccine Policy and Public Health Security at the FDA.” “They are the latest in a series of troubling changes at the FDA, including substantial departures of FDA staff, that could diminish both the FDA’s strength and Ameri- cans’ health and safety,” the former officials added. The warning from both former permanent and acting FDA commissioners – including Scott Gottlieb, Norman “Ned” Sharpless and Brett Giroir, who all served in the role during President Donald Trump’s first administration – is the latest of several admonishments issued by former health officials from both parties. Nine former leaders of the Centers for Disease Control and Prevention raised concerns about Health Secretary Robert F. Kennedy Jr.’s leadership days after the August firing of then-CDC Director Susan Monarez. Six former surgeons general, including Jerome Adams, who worked in the first Trump administration, contended in an Oc- tober op-ed that Kennedy’s actions are “endangering the health of the nation.” Department of Health and Human Services officials defended Prasad’s work. “The fact these criticisms are coming from former FDA officials who opposed raising the bar for vaccine science confirms we are on the right track,” HHS spokes- person Andrew Nixon said in a statement. He added: “Dr. Prasad’s email lays out a philosophical framework that points us toward that higher standard.” Kennedy, the founder of a prominent anti-vaccine group, has a lengthy history of disparaging vaccines. He has countered that he is simply seeking better data before recommending shots. Prasad’s vaccine strategy aligns with some changes Kennedy and his allies have sought for years. Some Kennedy allies have previously criticized some of the former FDA commissioners who co-wrote the NEJM piece, arguing they are part of a revolving door of agency officials who later join the boards of pharmaceuti- cal and other companies they used to regulate. In his internal email, Prasad said the new approach to vaccines was necessary after his team concluded that coronavirus vaccinations had contributed to the deaths of at least 10 children. He did not detail the evidence behind the claims. “[FDA] staff will be tasked with writing guidelines to reflect these changes, and the mission of CBER will change to reflect this worldview,” Prasad wrote, refer- ring to the Center for Biologics Evaluation and Research. “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it.” He added that staff who disagree with the core principles of his new approach should submit their resignation letters. Public health experts have called on the agency to release more details on how it performed its review and on the planned changes to vaccine regulation. Nixon said officials “will soon release documents lay- ing out that framework and data confirming how the CO- VID-19 vaccine resulted in children’s deaths that previous leadership failed to properly investigate.” The former commissioners wrote that the reports of potential vaccine deaths to federal health agencies had been carefully reviewed by FDA staff, “who drew different conclusions.” They wrote that Prasad’s memo did not in- dicate why the new assessment “should justify wholesale rewriting of vaccine regulation.” In totality, those changes mean a “substantially higher and more subjective ap- proval bar,” they wrote. Prasad argued in his internal email that the United States’ vaccine regulation related to the coronavirus “may have harmed more children than we saved.” “This requires humility and introspection,” he added. CDC staff over the summer presented data show- ing that at least 25 children who had covid-associated hospitalizations have died since July 2023. The number was probably an undercount, according to staff, and of the 16 children old enough for vaccination, none were up-to-date. The commissioners also expressed concern that the planned changes lacked transparency, arguing the agency’s expert advisers and the public should have a say in major revisions to FDA decision-making. “The people most affected by the FDA’s proposed framework will include older Americans and those with weakened immune systems who rely most on the protec- tion that timely and updated vaccines can offer,” they wrote. The concerns from former commissioners represent the latest flash point for an agency rocked by turmoil this year amid layoffs and the departures of senior officials. On Tuesday, the nation’s top drug regulator, Richard Pazdur, decided to retire three weeks after taking the job amid tensions with FDA Commissioner Marty Makary. Pazdur – who has worked at the FDA for more than 25 years – had privately raised concerns about the legality and pace of agency plans to expedite drug approval deci- sions. Pazdur had replaced George Tidmarsh, who resigned last month amid scrutiny over his critique of a treat- ment made by a company that alleged he had a vendetta against its board chair. OnWednesday, Tracy Beth Hoeg, who was a promi- nent critic of broad childhood coronavirus vaccination before becoming one of Makary’s top deputies, was named acting director of the Center for Drug Evaluation and Research. Over the summer, she was involved in the investigation into reports of potential deaths from the vaccine.. -TheWashington Post By Rachel Roubein By Katy O’Donnell US Affairs Senator Seeks To Tap Foreign Visa Program To Ease Housing Costs A rizona Senator Ruben Gallego wants to use an employment- based visa program to draw more foreign investment into the US housing market, the latest proposal from Washington aimed at easing an affordabil- ity crunch caused by years of underbuild- ing and higher mortgage rates. Gallego – a Democrat whose travel to key states this year spurred speculation of a 2028 presidential run – on Thursday introduced legislation to amend the EB-5 immigrant investor visa program in order to funnel more money into the construc- tion and rehabilitation of homes. “By steering more EB-5 investment to- wards housing, we can boost the housing supply, bring down costs, and create good jobs for American workers,” Gallego, 46, said in an emailed statement. Under the EB-5 program, foreign nationals can obtain lawful permanent resident status by investing in a new com- mercial enterprise in the US and creating at least 10 full-time jobs. The minimum investment is $1.05 million, or $800,000 if the funds are directed toward an infra- structure project or a “targeted employ- ment area” – typically rural areas and regions with high unemployment. Gallego’s bill would extend the lower $800,000 threshold to investment in proj- ects dedicated to the “production, preser- vation, or rehabilitation of rental housing or housing available for purchase only for use as a principal residence.” It would also expedite processing for applications linked to affordable housing. Voter Concerns Addressing affordability has emerged as a key political challenge ahead of the 2026 midterm elections. A Democratic sweep of three major local elections last month showed cost-of-living concerns remain a top focus for voters, and both parties are promoting proposals they say will help lower consumer costs. While it’s not clear if the Republican- controlled Senate will take up Gallego’s proposal, it won early support from some housing-industry trade organizations and advocacy groups for EB-5 investors. “This legislation gives builders, non- profits and local partners the tools they need to bring projects online faster and at lower cost,” said Kevin Brown, president of the National Association of Realtors. The bill would “help spur new construc- tion, preserve existing affordable units, create jobs and expand the pathway to stable, attainable housing,” he added. By law, the EB-5 category is limited to about 7% of the employment-based green cards awarded annually, subject to a per-country ceiling. Nearly 12,000 people received conditional permanent resident status under the program in fiscal year 2023. -Bloomberg Rajinder Kumar, the accused truck driver