Latest news with #ProPublica
Forbes
2 days ago
- Business
- Forbes
A New IRS Commissioner And The Promise Of More Efficient Tax Audits
WASHINGTON, DC - AUGUST 18: The Internal Revenue Service (IRS) building on Thursday, Aug. 18, 2022 ... More in Washington, DC. (Kent Nishimura / Los Angeles Times via Getty Images) The Senate has officially confirmed that former Missouri Congressman Billy Long will serve as the IRS commissioner in Trump's second term. While some cabinet appointees have cruised through their confirmation hearings with limited scrutiny, Long did not have the same luck as many Senators expressed concerns over his checkered past. Long ultimately prevailed under the platform of reshaping the taxing authority to be more like a private sector entity. This article discusses why he faced so much scrutiny, what his vision can look like once instituted, and what recently published academic research says about the current and future state of the tax audit process. Long was a sitting Congressman in Missouri from 2011 to 2022. Before joining the House of Representatives, he was an auctioneer and a talk radio host. He left office to run for Senate, where Long ultimately lost in the Republican primary. Following this stint, he served as a tax consultant for Lifetime Advisors and Commerce Terrace Consulting, followed by working as a realtor with Murney Associates. Much of this variation in Long's background led to his nomination to be somewhat unique and trying. This scrutiny is headlined by Long's tax qualifications centered around being a Certified Tax & Business Advisor, which, as reported by ProPublica, is a dubious title that is nowhere close to the same as a professional accountant like a CPA, CIA, or CMA. In fact, Long's accounting and tax experience are minimal, which many questioned as he was vying to take on the role of head of the tax authority. Beyond his qualifications, the AP highlights his suspect activities related to promoting unusually aggressive uses of tax credits like the employee retention tax credit and tribal tax credits. Despite some of these concerns, following this seventh-month process, the Senate confirmed Long by a vote of 53-44. As discussed in a Forbes article, one of the positives of his nomination is Long's vision of modernizing and streamlining the taxing authority. Long specifically points to taking clues from the private sector and eliminating programs that he deems wasteful, like Direct File. While Long was vague about what he meant by this modernization vision, FedScoop reports that individuals within the IRS believe that Long's vision of modernizing the IRS will include a clearer embrace and usage of AI and automation in the audit process. This anticipation comes as numerous IRS positions are being eliminated, as reported by Politico, leading to questions about the agency's future. In a study forthcoming in Contemporary Accounting Research titled 'Tax audits and the policing of corporate taxes: Insights from tax executives,' the authors provide evidence of inefficiencies in the way extant IRS audits are being conducted as they pertain to corporations. This study is authored by Jeri Seidman (University of Virginia, McIntire School of Commerce), Roshan Sinha, and Bridget Stomberg (both of Indiana University, Kelley School of Business). This study finds inefficiencies in the current tax audit process. Sinha notes the key takeaways from the study are as follows, 'First, financial statement audits are both so regular and so thorough that tax executives view tax audits as redundant. Thus, tax audits may have limited ability to deter tax noncompliance. Second, tax executives are not passive actors in the tax audit process; they take deliberate actions to shape audit outcomes. Third, tax audits are less efficient for everyone when taxpayers perceive them as procedurally unfair because they are less likely to accept the outcome.' A key theme across the findings is the notion that the tax authority views its role in the process as a police officer. While it is one method of enforcement, the study finds that angle tends to put corporations on the defensive from the get-go, adversely affecting the relation between the IRS auditor and corporation and potentially negatively affecting the end outcome of the tax audit. To conduct the analysis, the study performs 26 interviews with tax executives (directors and VPs of tax) at publicly traded U.S. companies. These interviews allowed executives to share detailed experiences and examples from their interactions with the IRS, state tax authorities, and international tax agencies. The interviews were semi-structured, which meant that although we had a list of questions we wanted to cover, there was flexibility to let the conversation flow to unscripted topics and ideas we had not anticipated. Given the type of analysis, the responses led to several surprising findings. Seidman notes three, in particular, related to how the executives respond to the audit process. 'We were surprised by the extent to which tax executives share information with their peers, essentially comparing notes with competitors about specific tax agents and audit strategies. Even more striking was their perception that financial statement audits already impose such stringent oversight on their taxes that income tax audits become redundant.' Second, Seidman highlights that 'when tax executives perceive audits as unfair, they are less likely to accept the outcome. Instead, they may pursue costly appeals, which can drag on for years. Interestingly, these protracted battles often conclude with no additional taxes owed, highlighting inefficiencies in the current system where both taxpayers and tax authorities expend significant resources, yet generally end up with the same resolution anyway.' Lastly, Seidman states, 'in addition to the negative comments directed at the IRS in terms of agent training or education and culture, interviewees also regularly comment on how far behind the IRS is technology-wise, especially compared to Europe and Australia.' This point emphasizes the need for the IRS to invest more in its physical infrastructure to remain on par with other developed nation's tax authorities. The study concludes by suggesting that the tax authority can develop novel and more efficient ways to conduct their audits in the new era of budget limitations and financial statement disclosures. As for policymakers, Stomberg states that they can 'consider whether the current system, particularly the frequent 'game of attrition' between tax authorities and taxpayers over the course of long audits, represents an optimal use of resources. In particular, interviewees largely herald cooperative programs, though they had less positive things to say about CAP than about other country's programs.' Given the mission Long depicted for a new modern IRS, this study provides several important takeaways that can be considered to achieve this modernization without sacrificing the taxing authority's grip on funding the federal government. For instance, if the financial statement audits are already adequately reviewing the tax financial statement disclosures, then perhaps the IRS can utilize that information already available to deter tax noncompliance. The IRS can even go as far as to work with auditing governing bodies like the PCAOB to develop standards that can provide greater oversight over publicly reported tax information. This notion carries even heavier weight with the impending change to financial accounting standards over corporate tax disclosures, which the FASB is implementing starting in 2025. Lastly, while it costs money to enhance the IRS's technology, it appears as though an investment in physical infrastructure may be warranted. However, much of the possible improvements appear to stem from the tone and relation between the tax authority and tax executives. The study notes significant differences between the education, experience, and conduct of tax auditors, even among countries. For example, participants in the study applaud the HMRC from the U.K. on these dimensions in contrast with the U.S. auditors. These suggestions come at a critical time when the federal government wants to cut as much as 20% of IRS employees in 2026, according to The Journal of Accountancy. Despite these cuts, the IRS is currently rolling out improvements to auditing process, such as the recent adoption of an improved pre-filing program to aid certainty among corporate taxpayers. If the U.S. can continue to invest more in its auditors and technology, then a cost-effective way might emerge to efficiently achieve better tax audit outcomes.
Boston Globe
3 days ago
- Health
- Boston Globe
Concerns over FDA's drug supply quality: for over a decade factories supposably banned from US were allowed to ship drugs
Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were 'blackish' from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown 'extraneous matter' were used anyway, mixed into batches of drugs. Sun Pharma's transgressions were so egregious that the Food and Drug Administration imposed one of the government's harshest penalties: banning the factory from exporting drugs to the United States. Advertisement But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America's drug supply. A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy. Advertisement The FDA didn't routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them. And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details. In the hands of consumers, according to the FDA's longtime head of drug safety, the information would have caused 'some kind of frenzy.' 'We felt we didn't have to make it a public thing,' said Janet Woodcock, who spent nearly four decades at the agency. The exemptions for Sun weren't a one-time concession. A ProPublica investigation found that over a dozen years, the same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India. All told, the group allowed into the United States at least 150 medications or their ingredients from factories with mold, foul water, dirty labs or fraudulent testing protocols. Some of the drugs were recalled — just before or just after they were exempted — because of contaminants or other defects that could cause health problems, government records show. And a ProPublica analysis identified more than 600 complaints in the FDA's files about exempted drugs at three of those factories alone, each flagging concerns in the months or years after they were excluded from import bans in 2022 and 2023. The 'adverse event' reports about drugs from the Sun plant and two others run by Indian drugmaker Intas Pharmaceuticals described medication with an abnormal taste, odor or residue or patients who had experienced sudden or unexplained health problems. Advertisement The reports cite about 70 hospitalizations and nine deaths. And those numbers are conservative. ProPublica limited its count to reports that linked problems to a single drug. However, the total number of complaints to the FDA that mention exempted drugs is in the thousands. 'Abdominal pain … stomach was acting very crazy,' one report said about a woman using a seizure drug from Sun Pharma. The FDA received the complaint in 2023, nine months after it excluded the medication from the import ban. 'Feeling really hot, breaking out with hives, hard to breathe, had confusion, glucose level was high, heart rate went up and head, arms and hands got numb,' noted another report about a patient taking a sedative from Intas. The complaint was sent to the FDA in June 2023, the same month the agency exempted the medication. The outcomes described in the complaints may have no connection to the drug or could be unexpected side effects. In some cases, the FDA received complaints about the same drugs made by other manufacturers. Still, the seriousness of the reports involving exempted drugs did not galvanize the agency to investigate, leaving the public and the government with no way of knowing whether people were being harmed and, if so, how many. Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a 'cascade of failure' at one of the Intas plants, Advertisement The FDA barred both plants in 2023 from shipping drugs to the U.S. Then the agency simultaneously granted more than 50 exemptions to those banned factories — the broadest use of exclusions in ProPublica's analysis. Intas, whose U.S. subsidiary is 'Intas is well on its way towards full remediation of all manufacturing sites,' the company said. Sun did not respond to multiple requests for comment. When the FDA imposed the ban, Both companies' factories are 'We're supposed to have the best medicine in the world,' said Joe DeMayo, a kidney transplant patient in Philadelphia who took an immunosuppression medication made by Intas until December 2023, unaware that a month earlier the FDA had excused the drug from an import ban. 'Why are we buying from people who aren't making it right?' Advertisement Game of Chance How the United States wound up here — playing a game of chance with risky drugs made thousands of miles away — is the story of an agency that has relentlessly pressed to keep the supply of low-cost generics flowing even as its own inspectors warned that some of those drugs posed a potentially lethal threat to the American public. The vast majority of the prescriptions filled in the country are for generic drugs, from penicillin to blood thinners to emergency contraception, and many of those come from overseas, including India and China. For years, the FDA has That guarantee came under serious question in 2019 when journalist Katherine Eban published a breakthrough book, ProPublica identified another alarming level of entrenched failure: Even when the agency did investigate and single out factories that were among the worst in India, it still gave them access to American consumers. All the while, patients took their medicine without question, trusting an agency that has long been considered the gold standard in drug regulation. While specialized business publications have sometimes reported on exemptions when they happen, they've offered little context and few specifics. The FDA in many ways put itself in this untenable position, forced to decide between not having enough drugs or accepting potentially dangerous ones, interviews and government records show. Advertisement For years, the agency gave companies with a history of manufacturing breakdowns approval to produce an increasingly larger share of generic drugs, allowing them to become a dominant force in American medicine with the power to disrupt lives if production lines were shuttered. 'It's our own fault,' said former FDA inspector Peter Baker, who reported a litany of failures during inspections in India and China from 2012 to 2018. 'We allowed all these players into the market who never should have been there in the first place. They grew to be monsters and now we can't go back.' The decisions to weaken penalties and allow banned factories to continue sending drugs to the United States were approved by Woodcock, one of the agency's most powerful administrators. For more than two decades, she led the Center for Drug Evaluation and Research, the arm of the FDA that serves as the country's gatekeeper for new and generic drugs. In a series of interviews with ProPublica, Woodcock said she supported the use of exemptions 'as a practical approach.' 'We had to kind of deal with the hand we were dealt,' she said. Woodcock said she didn't see a need to inform the public because the agency believed the drugs were safe. She said she mentioned the practice periodically in closed-door meetings with congressional staffers, but she did not provide specifics about those conversations. After Woodcock left her post in 2020 to help lead the agency's response to the COVID-19 pandemic, the exemptions — including those for Sun and Intas — continued under her successor, Patrizia Cavazzoni. Cavazzoni, who left the agency earlier this year and rejoined Pfizer, declined to comment. Former FDA Commissioner Robert Califf, who led the agency when Sun and Intas received exemptions, told ProPublica that tough calls had to be made and the practice did not worry him. The FDA did not respond to questions about who made those decisions or how the drugs were evaluated, and it declined requests for interviews with officials who currently oversee drug regulation. In an email, the agency said the exemptions are 'thoroughly evaluated through a multi-disciplinary approach.' Years after the FDA started granting exemptions, some current and former officials say they wrestle with a lingering fear that bad drugs are circulating in the United States. 'It's not even a hypothetical,' said one senior FDA employee familiar with the exemptions, who, like others, spoke on the condition of anonymity because they were not authorized to speak publicly. 'It's not a question of if — it's a question of how much.' 'It Was Rotten Eggs' Although the FDA has been giving companies a way around import bans since at least 2013, the internal process was so secretive that many current and former FDA officials said they have no idea how many exemptions have been granted or for what drugs. In an email, the agency said it did not maintain a comprehensive list. Even two high-level FDA staff members who worked on drug shortage challenges for the agency said in interviews they had never heard of the exemptions. Congress required the FDA in 2012 to provide specific information every year about how and when the agency relaxed its rules for errant drugmakers to prevent shortages. But the FDA did not mention exemptions to import bans until 2024 — and only then ProPublica uncovered the frequent use of exemptions by searching for the 'import alert' list published on the FDA's website that names factories banned from the U.S. marketplace. Because the agency publishes only a current list and doesn't make the old ones public, the news organization used internet archives and FDA documents maintained by the data analytics company ProPublica reviewed scores of inspection reports and corporate documents for overseas factories and interviewed more than 200 people, including current and former officials of the FDA, to understand the little-known practice and the ongoing threat posed by the agency's decisions. The investigation revealed not only how many drugs received exemptions from import bans, but also how long the FDA allowed those exemptions to stay in place — in some cases for years. The agency has removed exemptions when there is no longer a shortage concern. In those cases, the drugs are then banned along with the others at the factory. Both Sun and Intas have had drugs that lost their exemptions. Two and a half years after the Sun factory was banned, five drugs are still exempted. Intas, whose factories were banned in 2023, currently has 24 drugs on the list. The bans themselves are removed only after companies fix the problems. Earlier this month, the FDA went back to the Sun Pharma factory for a surprise inspection and found ongoing problems, The FDA said it put protections in place for exempted drugs: Manufacturers are required to conduct additional quality checks before they are sent to the United States. That has included extra drug-safety testing, in some cases at an independent lab, and bringing on third-party consultants to verify the results. The agency did not provide ProPublica with the names of the third-party consultants hired by Sun and Intas. Intas declined to name its consultants. 'The odds of these drugs actually not being safe or effective is tiny because of the safeguards,' said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. 'Even though the facility sucks, it's getting tested more often and it's having independent eyes on it.' But current and former FDA inspectors said those safety measures require trusting the vigilance of companies that were banned, at least in part, for providing unreliable or deceptive test results to the government or failing to investigate reports about drugs with contaminants or other quality concerns. The FDA could have done its own routine testing of the exempted drugs but chose not to. The agency said in an email that it tests the drugs using a 'risk-based approach' but would not provide ProPublica with any information about which drugs have been tested and what the results were. Woodcock said testing was expensive and budgets were tight. She acknowledged that regularly assessing the exempted drugs for quality or safety concerns 'would have enhanced our confidence … and made everyone more comfortable.' The European Union, by contrast, requires drugs made in India and China to be checked for quality on EU soil. And the U.S. Department of Defense is conducting its 'If you don't know about the quality of the product, why are you letting it in?' said Murray Lumpkin, the FDA's former deputy commissioner for international programs, who left the agency in 2014 before most of the exemptions were granted. Beyond the lack of testing, the FDA didn't actively look for patterns of harm among the exempted drugs in its ProPublica's analysis of that data found thousands of reports both before and after the factories were given a pass to sidestep import bans. The reports described unexpected cases of cardiac arrest, blurred vision, choking, vertigo and kidney injuries, among other issues — and in some instances identified specific concerns about how the drugs were made. One person who took Intas' clonazepam, a sedative and epilepsy drug, reported getting 'brain zaps' and bright blue teeth from the coating of dye on the drug. The FDA received the complaint the same month the agency exempted the drug from the import ban. Even before the FDA exempted Intas' antidepressant bupropion, consumers reported that it made them sick, wasn't always effective and had an abnormal odor, which pharmacists and others say can happen when an inactive ingredient breaks down. 'It was rotten eggs,' Nari Miller, a geologist in California who took the pills in 2022 and had severe stomach pain, told ProPublica. 'I opened it and smelled it when I got home and it was awful.' Intas said it could not respond to specific complaints and that all drugs have side effects. 'Intas and Accord pay attention to each and every adverse event report,' the company said, adding, 'Accord and Intas are committed to continuing to bring safe and effective medicines to patients.' In its statement, the FDA said the database is monitored weekly for new reports in general. Woodcock, however, acknowledged the reports about exempted drugs, ideally, 'would be under much more scrutiny.' Excerpt from an FDA inspection of the Sun Pharma factory that led to an import ban Credit:Animation by Lisa Larson-Walker/ProPublica Too Big to Fail Decisions made by the FDA decades ago gave rise to the use of exemptions and the risks that now confront the American public. When new brand-name drugs come to market, they are protected by patents and exclusive sales rights that make them generally expensive. When patents expire, generic drug companies rush in to make their own versions, which are supposed to be equivalent to the brand. Generics are often far cheaper, and insurance companies typically insist that patients use them. In the 2000s, as the cost of brand-name drugs soared, the FDA began to approve large numbers of generics. The agency, however, gave hundreds of those approvals to foreign manufacturers that had been in trouble before, companies well known to the inspectors working to stamp out safety and quality breakdowns at overseas factories, ProPublica found. The FDA granted Sun Pharma alone more than 250 approvals for generic drugs since the late 2000s, when the company started amassing violations, records show. The agency's decisions helped to transform the company from a local provider in India to one of the leading exporters of medications to the United States, with The approvals kept coming as inspectors continued to More problems were found at a factory that Sun had acquired in Detroit, where the diabetes drug metformin was contaminated with metal scrapings. The rapid expansion of Sun and other foreign drugmakers set off new alarms among inspectors, their supervisors and advisers to Woodcock. 'In a rational system, you would have said, 'This company is not producing properly, so let's not approve any more of their drugs,' said William Hubbard, former FDA deputy commissioner for policy, planning and legislation. 'The agency in a sense kind of let this happen.' Ajaz Hussain, the former deputy director of an FDA office that oversaw pharmaceutical science, said that after leaving the agency and becoming a consultant, he made his concerns known in meetings with Woodcock and others. 'They can't manufacture it. Why do you keep approving it?' Hussain recalled in an interview with ProPublica. 'I said, 'Wake up.' … But they didn't listen.' Hussain in 2012 went to work for Wockhardt, one of the largest pharmaceutical companies in India, but quit eight months later after he said he told his superiors about manufacturing failures in the company's factories. Although The FDA could have denied generic drug applications — nothing in the law prohibits the agency from saying no to companies with spotty track records. In an email, the FDA said it considers a company's history and conducts inspections in some cases before issuing approvals. Woodcock said the agency knew which factories were poor performers but feared being sued by companies blocked from introducing new drugs based on past behavior. Instead, she said that she tried to convince drugmakers to invest in equipment and practices that would turn out higher-quality drugs. 'We had many meetings about this, and we agonized about all these problems,' she said. But little changed. Shortages vs. Quality In 2008, dozens of Americans were killed by contaminated blood thinner from China. So when Margaret Hamburg was appointed commissioner of the FDA in the aftermath of the crisis, she Her efforts ran headlong into what would become the worst drug shortage in modern history. By 2010, cancer drugs were scarce. So were the drugs on hospital crash carts. In all, more than 200 critical medications were in short supply. Razor-thin profit margins had limited the number of companies that were willing to make generic drugs. And the FDA's enforcement overseas had forced some manufacturing lines to temporarily shut down, which exacerbated the problem. LeRoy Hubley, whose wife and son died after taking a tainted generic blood thinner from China, testified before Congress in 2008. The crisis helped prompt the FDA, under Commissioner Margaret Hamburg, to ramp up inspections of overseas drugmakers. Credit:Brendan Smialowski/Bloomberg News At the time, the FDA had a small team focused on shortages that operated on the edges of Woodcock's 4,000-person Center for Drug Evaluation and Research. With the pressure on, Woodcock elevated the team in 2010 to report directly to her deputy, a move that gave those staff members a commanding voice at the highest levels of the agency, several former staffers told ProPublica. After 16 years in top leadership roles, Woodcock was formidable enough to force a culture change. Standing 5'2' in FDA conference rooms where she had often been disregarded as the lone woman, Woodcock had fought for her status — sometimes, she said, pushed nearly to tears with frustration. The board-certified internist asserted her authority by wielding data, what she called 'brute force' and the soft persuasion of an occasional gift of an orchid, picked from her garden in suburban Maryland. By 2010, Woodcock had marshalled the center into a powerhouse with great independence — in many ways, outside the reach of the political whims of the commissioners who came and went. Those who worked with her over the years said despite her approachable manner, she fiercely guarded her territory. In the conference room next to Woodcock's office, the drug shortage staff began to weigh in whenever the FDA's compliance team moved to penalize wayward drugmakers because of bad inspections, according to several former FDA officials involved in the deliberations. Sometimes the small group would decide that a factory could no longer ship drugs to the United States and would try to get other manufacturers to make more. And other times, the group determined that exemptions from import bans were the only course. Discussions could be tense and often lasted for weeks. A former employee on the compliance team told ProPublica that they repeatedly argued to impose a total import ban on a foreign factory because they feared the drugs couldn't be trusted. They were left feeling uncomfortable about an exemption granted anyway — for a product that they would not use themselves. Without exemptions, Woodcock told ProPublica, Current and former FDA officials said the concessions became a yearslong practice rather than a stopgap measure and that the protections put in place by the agency were not sufficient. They question why Woodcock and her successor didn't do more to raise alarms with Congress or the public about the decision to rely on inadequate factories for critical drugs. Woodcock said she thought the exemptions were a symptom of larger issues involving the drug supply that the FDA had no control over — the agency, for example, can't force companies concerned about slim profit margins to produce generic drugs. Two former FDA commissioners told ProPublica they knew about the practice but were not included in the decision-making. Hamburg, who spent six years at the agency under the Obama administration, said the extent of the practice surprised her. 'Had I known that it was sort of an open-ended policy, I would have been disturbed,' she said. One of her successors, Stephen Hahn, appointed during President Donald Trump's first term, said more people should have been involved in the decisions. 'You're talking about a drug of questionable quality being brought into the country,' he said. Woodcock said she did not believe she needed their input. 'I didn't think in the individual circumstances it was necessary to elevate,' she said, 'because what could they do?' 'We Know What Was Found' In 2020, the billionaire founder of Sun Pharma joined a pivotal conference call with FDA compliance and investigative staff. Among other drugs, the plant produced at least 16 sterile injectables for the U.S. market, according to In 2018 and 2019, The company also had to On the call with the FDA, according to the agency official, Shanghvi assured the government that the Halol plant was turning out high-quality products. Yet, when the three investigators went back to the factory that scorching morning in 2022 for the surprise inspection, it was clear within days that the FDA would have to take swift action. Splitting up to check different parts of the plant, the inspectors quizzed workers about cleaning procedures and looked at disassembled equipment to see if it was contaminated with residue from old drugs. At one point, they spotted water leaking near areas where sterile drugs were made, an alarming observation because water can introduce contaminants capable of causing infections or even death. Digging through company records and test results, they found more evidence of quality problems, including how managers hadn't properly investigated a series of complaints about foreign material, specks, spots and stains in tablets. The 2022 FDA inspection report of Sun's Halol plant described metal particles in vials of injectable medication. Credit:Obtained by ProPublica. Highlighted by ProPublica. Several FDA employees familiar with the 'We know what was found,' said the FDA official who attended the meeting with Shanghvi. 'How could you trust [those] drugs?' Sun did not respond to questions about the recalls or its regulatory history with the FDA. In its 2023-24 The specific findings of the FDA's latest inspection of the Sun plant conducted this month have not yet been made public, and the company did not respond to a request for comment. To some current and former FDA officials and other experts, plugging a supply shortage with drugs that may be contaminated or ineffective is no solution at all. 'That might be helping a shortage but might be creating a new problem,' said Lumpkin, the former deputy commissioner. Last summer, a pair of FDA investigators arrived at another manufacturing plant in India that had a bustling production line. After more than a week at the Viatris factory, they left with a familiar list of safety and quality violations. In a statement to ProPublica, Viatris said it immediately worked to resolve the FDA's concerns. 'Patient safety remains our primary and unwavering focus,' Just before Christmas, the FDA banned the facility from exporting drugs. Then the agency gave the factory a pass, and four of its drugs are still bound for the United States.
Los Angeles Times
3 days ago
- Politics
- Los Angeles Times
Op-Comic: SCOTUS' demolition
(Clockwise from top) Gift vacations tanked ethical norms. Martha-Ann Alito, the justice's wife, flew the Stars and Stripes upside down (an insurrectionist symbol) on their flagpole. Treated 'just friends' Justice Clarence Thomas and his wife, Virginia 'Ginni' Thomas, to posh vacations, a $19,000 Bible, property deals and more. Accepted millions in gifts and hospitality from partisans. She texted support for overturning 2020's free and fair election; he refused to recuse himself from Jan. 6 cases. Befriended Justice Clarence Thomas once he joined the court in 1991; added to Thomas' millions in initially undisclosed travel. His industries were affected by court decisions. Treated Justice Samuel A. Alito Jr. to a private-jet flight for a fishing trip to Alaska (estimated value one way: $100,000). Alito disclosed it when forced; he did not recuse himself when Singer had business before the court. Steered dollars, networking and the long game to stack the Supreme Court with conservatives and turn it to the right on voting rights, affirmative action, abortion and more. With brother David (1940-2019), invested oil-business billions to sway law and U.S. policy. Big court win: overturning the 'Chevron deference standard,' opening the door to the deregulation of everything. Another generous friend of Justice Clarence Thomas' whose largesse initially went largely undisclosed and whose business interests were, according to Pro Publica, 'significantly impacted' by court decisions. Got the justices to sign a SCOTUS code of conduct. Too bad it has no enforcement mechanism. And yet another munificent friend of Justice Clarence Thomas' whose gifts were initially largely undisclosed. (In the center) If he calls it 'my court,' is it still a co-equal branch of government? Steve Brodner is a contributing artist to Opinion. He blogs daily at
Fox News
3 days ago
- Politics
- Fox News
Chicago schools face enrollment crisis with 150 buildings half-empty
A new report showed that declining enrollment in Chicago leaves about 150 of its schools half-empty. The report, authored by ChalkBeat and ProPublica, found that 47 schools are operating "at less than one-third capacity, leading to high costs and limited course offerings." Chicago Public Schools had roughly 325,000 students enrolled this year after losing 70,000 students from a decade ago, according to the report. "District officials project that three school years from now, there could be as few as 300,000 or, in a best-case scenario, as many as 334,000 students. Those estimates are based in part on the city's sharply falling birth rates. Citywide, from 2011 to 2021, the number of births dropped by more than 43%," the authors of the report wrote. While the city faces enrollment struggles, the city spends about $18,700 per student. Some schools are "double or triple" that number the report stated. One school that enrolled 28 students costs $93,000 students. DuSable High School, which had declining enrollment, costs almost $50,000 per student, according to the report. DuSable is among 47 schools operating at less than one-third capacity. Frederick Douglass Academy High School, which has 28 students this year, reportedly costs $93,000 per student. Per the report, "Many of those schools are in historic buildings that need millions of dollars in repairs." A ProPublica and Chalkbeat analysis found that "students in the city's smallest schools have fewer courses to choose from and often miss out on clubs, extracurricular activities and sports. Chicago's underenrolled high schools are more likely to have lower graduation and college enrollment rates. They tend to struggle with chronic truancy and higher dropout rates." Chicago Teachers Union leaders reportedly look to Chicago's progressive agenda to lure families into the city to fill in classroom seats. "CTU leaders insist that the city is actually poised for a population turnaround. During President Donald Trump's second administration, Chicago under Johnson can bill itself as a progressive refuge — a place that protects immigrants, abortion care, LGBTQ+ rights and access to gender-affirming care for transgender youth and adults, said Jackson Potter, vice president of the CTU," the report stated. The report explains further that the city has avoided school closures for several years due to pressure from the Chicago Teachers Union and a closure moratorium mandated in 2013. CEO Pedro Martinez, who is leaving his position soon, told Chalkbeat and ProPublica that there are too many schools serving a few students and cited backlash for pushing to close or merge schools. Fox News Digital reached out to Chicago Public Schools, Mayor Brandon Johnson, and Frederick Douglass Academy High School for comment but did not immediately hear back.
Time of India
5 days ago
- Politics
- Time of India
Shocking claims: U.S aid allegedly helped El Salvador's Bukele strike backdoor deals with MS-13 gang members
People have praised El Salvador's President Nayib Bukele for being tough on gang violence. But a new investigation points to a darker truth. Surprising claims suggest that Bukele's government is secretly negotiating with MS-13, potentially using funds from the US, all while presenting a public image of heroism and maintaining law and order. El Salvador leader Nayib Bukele became a close ally of the U.S. president during the early months of the Trump administration, especially after the two struck an agreement to swiftly deport Venezuelan migrants suspected of being Tren de Aragua gang members and imprison them in CECOT, the nation's mega-prison, as per a report by the Latin Times. Did Bukele really strike a deal with MS-13? An investigation by ProPublica found that El Salvador's President Bukele made secret deals with MS-13 to get political support and cut down on murders by using US aid money for other things. The investigation indicates that Bukele may have struck a deal with the MS-13 gang leaders in the early years of his presidency. In an attempt to dismantle the gang's leadership, ProPublica compiled data from a lengthy U.S. investigation of MS-13. Later, the investigation was broadened to examine whether the Bukele government struck a covert agreement with the gang during the first few years of his presidency, as per a report by the Latin Times. Live Events ProPublica claims that Bukele's supporters persecuted Salvadoran law enforcement officials who assisted the task force and prevented the extradition of gang leaders who were suspected by U.S. agents of being witnesses to the negotiations. The report says that extraditions were stopped and money may have been laundered, which hurt Bukele's tough-on-crime image and helped his support for Trump's immigration policies. The new report is released at a time when El Salvador and the United States maintain a close relationship because of the Central American nation's readiness to assist with the anti-immigration rhetoric and policies of the Trump administration. Was U.S. aid misused in the alleged pact? Joint Task Force Vulcan, a multiagency law enforcement team established in 2019 at Trump's request, led the U.S. government's report, as per a report by the Latin Times. As part of the purported agreement to give the gang money and power in return for votes and lower homicide rates, the Bukele government may have also transferred U.S. aid funds to the gang, according to the investigation. Agents created a request in 2021 to examine U.S. bank accounts owned by political figures from El Salvador in order to find proof of money laundering connected to the alleged diversion of U.S. funds. Bukele, along with other high-ranking officials and their family members, was implicated in that scheme, according to the list of names, as per a report by the Latin Times. ALSO READ: New VA policy sparks outrage as doctors may refuse treatment to Democrats and unmarried veterans alike How deep is the U.S. connection? The purported agreement between gang members and the Salvadoran government has a long-standing precedent. In exchange for reducing crime, previous Salvadoran governments had agreed to shorten the sentences of convicted gang leaders and improve prison conditions. But Bukele's government's real agreements with gang members went much further, as they were prepared to renegotiate electoral votes, USAID grants, and gang-inflicted violence. El Salvador agreed to take Venezuelan migrants who are suspected of being gang members to their maximum security prison as part of an extraordinary agreement that President Trump and President Bukele recently celebrated, as per a report by the Latin Times. FAQs What is Bukele accused of doing with US aid? He's accused of using it to facilitate backdoor deals with MS-13 for political gain. How is the United States connected to this scandal? Aid funds may have been directed to gangs, and Trump administration officials collaborated closely with Bukele on immigration and security plans.
