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Lawmakers Press FDA to Target Knockoff Weight-Loss Drugs
(Bloomberg) -- Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid mounting concerns over their potential safety risks. Trump Awards $1.26 Billion Contract to Build Biggest Immigrant Detention Center in US The High Costs of Trump's 'Big Beautiful' New Car Loan Deduction Can This Bridge Ease the Troubled US-Canadian Relationship? Salt Lake City Turns Winter Olympic Bid Into Statewide Bond Boom Trump Administration Sues NYC Over Sanctuary City Policy On Friday, a group of more than 80 bipartisan lawmakers asked the US Food and Drug Administration to stop counterfeit and copycat versions of GLP-1 drugs like Wegovy and Zepbound from flooding the market — a problem that emerged over the last year. 'We are concerned about recent reports revealing a surge in illegal and counterfeit anti-obesity medications,' they wrote in a letter to FDA Commissioner Marty Makary. 'Undoubtedly, illegal counterfeit medications pose an increased risk to patient safety with sometimes fatal consequences.' The group — spearheaded by Representatives Richard Hudson of North Carolina and Herb Conaway of New Jersey — asked the agency to ramp up enforcement over illegally imported weight-loss drugs. They suggested issuing warning letters and better monitoring non-compliant online retailers and so-called compounding pharmacies that sell the medicines. The lawmakers also said the FDA should work in tandem with US Customs and Border Patrol agents to stop Chinese entities from shipping unsafe weight-loss drugs into the US. They requested an update on the FDA's efforts by July 30, given the 'urgency' of the situation. A spokesperson for the FDA said the agency will work with the US Department of Health and Human Services to provide a 'complete and thorough' response to the issues raised in the lawmakers' letter. 'Any effort to undermine America's supply of safe medicines is an issue that FDA takes seriously,' the spokesperson said. 'And we are deeply committed to strengthening the oversight of imported products at US ports of entry.' In recent years, the popularity of GLP-1 drugs has led to an explosion of copycats and counterfeits made by companies seeking to capitalize on the hype. State-licensed pharmacies were temporarily allowed to make copies of the drugs during a supply shortage, but are no longer permitted to do so after Novo Nordisk A/S and Eli Lilly & Co. boosted production. Still, some pharmacies have refused to wind down their operations while others have pivoted to selling the drugs in lower doses in order to avoid regulatory scrutiny. Counterfeit drugs are made by unregistered entities typically using illegally imported ingredients. As recently as April, there continue to be instances when counterfeit Ozempic pens covertly enter the drug supply chain undetected. Some patients are also purchasing ingredients directly from online sellers in an attempt to make the drugs themselves at home. In both cases, the medications don't go through the same rigorous approval process as brand-name drugs made by Novo and Lilly. Experts worry the lack of oversight is putting patients at risk. The FDA has said it's aware of hospitalizations potentially linked to the copycat drugs, but that adverse events are likely being underreported. 'We support the bi-partisan call for the FDA to crack down on counterfeit and illegally sold weight-loss drugs,' said a spokesperson for Hims & Hers Health Inc., one of the telehealth firms that sells compounded GLP-1s. 'We appreciate lawmakers' recognition that legitimate compounded medications dispensed by state-regulated pharmacies are not counterfeit. Patient safety must always come first.' Novo and Lilly have discouraged consumers from using compounded and counterfeit products, including suing telehealth firms that sell the copycat versions and working with border agents to seize illegal shipments. Under the Biden administration, the companies repeatedly urged the FDA to take action, but the agency mostly limited its actions to issuing consumer warnings — even as its top drug official publicly acknowledged safety concerns. Under the Trump administration, the HHS has also focused more heavily on other issues, such as banning food dyes and examining vaccine schedules. Meanwhile, lawmakers are ramping up their calls for action. State attorneys and other lawmakers have sent letters to the FDA and Federal Trade Commission advocating for greater transparency around the treatments and more scrutiny around marketing practices. (Updates with statement from FDA in sixth and seventh paragraphs.) 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Yahoo
2 minutes ago
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What does Trump's college sports executive order mean? Breaking down the impact
'President Donald J. Trump Saves College Sports.' If only it was that simple. The 176th executive order President Trump signed in the past seven months was announced Thursday with an audaciously headlined statement from the White House. We don't know how this will play out long term. But these are the key facts surrounding the executive order and the questions that need to be answered. What's happened in college sports that brought it to the federal government? The NCAA has been under attack on numerous legal fronts for more than a decade, particularly when it comes to paying athletes. Its policy for decades was strict amateurism — any compensation athletes received beyond their scholarships would render them ineligible. The model began cracking through a series of antitrust cases brought by former athletes, most notably Alston vs. NCAA in 2021. The Supreme Court ruled 9-0 that schools must be allowed to provide additional academic awards. By then, states began passing legislation allowing athletes to earn money from their name, image and likeness — i.e. endorsement deals — in direct opposition to the NCAA's longstanding ban. On July 1, 2021, the NCAA relented and began allowing NIL payments, which touched off another antitrust case, House v. NCAA. A class of former athletes sued for back pay for missing out on NIL opportunities. The defendants agreed to a $2.8 billion settlement, part of which allows schools to pay athletes directly for the first time, up to $20.5 million. A judge approved the settlement on June 6, 2025. But the lack of an organized NIL system has led to chaos, with boosters exploiting the lack of enforcement. And with other legal challenges forcing the NCAA to eliminate its longstanding rules about transfers, athletes now routinely hop from one school to another in search of their next payday. Desperate for regulation, college sports leaders have been lobbying Congress for help in the form of a federal law for years, but not until recently has there been any significant movement on a bill. What are the key takeaways of the executive order? The order essentially makes recommendations for how college athletic departments should operate and directs several government agencies to weigh in on issues that will shape the future of college sports. It also delivers the NCAA and conferences much of what it has been lobbying for on Capitol Hill. However, the order's ability to turn ideas into action is questionable. The order: Gives a nod to protecting women's and Olympic sports by setting benchmarks for scholarships and opportunities based on the amount of money an athletic department makes. Bans 'pay-for-play' to athletes by schools, a bedrock principle of the NCAA and college sports that leaders are still clinging to. The order does try to carve out exceptions for endorsement and sponsorship deals with third-party businesses. Calls on the Secretary of Labor and the National Labor Relations Board to clarify the employment status of student-athletes. Under a Republican administration, that likely decreases the chances athletes would have the right to organize. Directs the Attorney General and the Chairman of the Federal Trade Commission to find ways to hand rule-making power back to the NCAA, conferences and other college sports governing bodies and away from courts and state legislatures. Who benefits from this? Considering how much it falls in line with what college sports leaders have been asking for, it would be difficult to call it athlete-friendly. Yes, it tries to protect non-revenue programs and force schools to fund a wide-range of teams for athletes to participate in college sports, but limiting compensation by regulating NIL compensation and banning pay-for-play has been at the root of problems for decades. 'Looks like an NCAA press release,' said Marc Edelman, professor of sports law at Baruch College and antitrust expert who has been a critic of NCAA policies. Several ideas for student-athlete compensation have emerged over the years to help relegate the market, from collective bargaining agreements to defining student-athletes as university employees. Though how much athletes actually want those things is hard to say; with more than 190,000 athletes competing in Division I sports, gauging consensus is tricky. Will this actually change anything? In the short term: no. In the long term: maybe. The biggest possible downside of the executive order is it could create more uncertainty for college sports, creating policies that may or may not hold. 'It very much depends on how this gets enforced moving forward, and whether it gets enforced moving forward,' said Sam Ehrlich, assistant professor at Boise State's college of business and economics. 'Maybe this could just end up being just a statement that goes absolutely nowhere.' What can the executive order do? It's not so much what an executive order can do as what it can't. It can't make a law, it can't provide an antitrust exemption and it can't override state laws. Congress can do that. And that's what college sports needs. Any policies that come from an executive order can either be challenged in court and reversed by the next administration, which means college sports continues to operate under a blanket of uncertainty when it comes to defining the relationship between schools and athletes. That's exactly what college sports leaders are trying to stop. What power does the government have in these situations? The executive branch does not have the authority to provide straightforward solutions to college sports' problems, most importantly some form of antitrust exemption. That has to come from Congress, and right now will require bipartisan support. The president's involvement could prioritize the issues in a way that motivates lawmakers to build on recent momentum in the Republican-controlled House, where a college sports bill made it out of committee for the first time earlier this week. Or maybe pervasive political divisiveness makes Democrats recoil from the idea of giving the president a symbolic victory. While the complicated problems facing college sports now are not quite a matter of life and death, it remains to be seen if presidential involvement makes finding solutions easier or harder. What is The SCORE Act? The SCORE Act is a House bill that would provide the NCAA and conferences some antitrust protection, pre-empt state laws related to NIL compensation and bolster the terms of the House settlement. The SCORE Act made it through two Republican-led House committees on partisan lines earlier this week. No college sports bill has ever gotten so far. When Congress returns for the fall session, the bill could go to the House floor for a vote and it will probably pass. That's meaningful and a positive sign for many in college sports after years of inaction by lawmakers. The bill also has little support from Democrats in the House and stands very little chance of making it through the Senate, where seven Democrats would have to vote with Republicans to get the 60 necessary to pass. What divides Republicans and Democrats? The debate over college sports legislation on Capitol Hill is akin to a labor dispute. Republicans, who currently control both chambers and the White House, are focused on ways to shield the NCAA and college sports conferences from litigation and state laws that make it impossible for them to effectively govern national competition. Democrats are demanding greater protections for the workers (the athletes) and are hesitant to provide the antitrust protections college sports leaders have been lobbying for. The NCAA and conferences want a law that would prevent college athletes from being deemed employees. Democrats want that option left open, along with athletes' rights to organize and maybe even join unions. What precedents are there involving federal legislation and higher education in sports? The president's EO is the most significant and direct entry by the executive branch into college athletics since Teddy Roosevelt's calls for safety reforms in football led to the creation of the NCAA in 1906. Lyndon Johnson's executive order signed in 1967, led to the passage of the federal Title IX gender discrimination law, which has been credited with paving the way for an explosion of opportunities for women in college sports. What does this mean for the NCAA? The NCAA as a governing body is ceding power to conferences and the newly formed College Sports Commission. However, it played a pivotal role in lobbying for federal legislation and has been much better received by lawmakers since former Massachusetts Gov. Charlie Baker took over as NCAA president two years ago. The NCAA's future will ultimately be determined by college sports stakeholders, not politicians. Why is the president getting involved? The White House's announcement hailed Trump's long-held interest in college athletics, including preserving Olympic and women's sports amid the changing landscape. Until now, Trump's engagement with higher education has been adversarial, threatening federal funding and litigation against schools for Title IX violations or allegations of antisemitism and discrimination through the promotion of diversity at universities. Trump came away from a meeting with former Alabama football coach Nick Saban in May motivated to get involved. The formation of a presidential commission led by Saban and billionaire oil businessman Cody Campbell, a former Texas Tech football player and current board chair, was considered then put on hold as lawmakers worked on legislative solutions. This article originally appeared in The Athletic. College Football, Men's College Basketball, Women's College Basketball, College Sports 2025 The Athletic Media Company
Yahoo
2 minutes ago
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S&P 500, Nasdaq Extend Record Run as Wall Street Posts Weekly Gains
The S&P 500 and the Nasdaq Composite gained on Friday, extending their record-setting advance during 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
