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Politico
4 days ago
- Business
- Politico
How much money will the FDA get next year?
Presented by Driving The Day FDA APPROPS INCHES FORWARD — House appropriators advanced a bill to fund the FDA for fiscal 2026 on a party-line vote out of a subcommittee Thursday — but the bill has a long path ahead before it potentially becomes law. The topline number from the House bill aligns with President Donald Trump's budget proposal, which sought $6.8 billion for the FDA. That includes $3.2 billion in direct appropriations, with the remainder coming from user fee revenue. But that represents roughly a $300 million cut in taxpayer funding compared to what the House Appropriations subcommittee sought last year for fiscal 2025 — a fact Democrats seized on during the hearing. 'We need to embrace transparency, and the FDA should be able to effectively and quickly share information,' said Rep. Sanford Bishop (D-Ga.), ranking member of the subcommittee, which is in charge of approving funds for the FDA. 'It needs the resources to do this.' But Rep. Andy Harris(R-Md.), subcommittee chair, said the figure represents 'modest constraint' that will still allow Americans access to a safe food and drug supply. But the Senate is likely to fund the agency at a higher level than the House. The Republican senator in charge of FDA appropriations, Sen. John Hoeven (R-N.D.), told Prescription Pulse on Wednesday that Trump's proposal is a starting point. 'We now have the president's budget proposal,' Hoeven said. 'But we're going through our process now, and it will be different. … I think that you'll see when we bring it out that we adequately fund FDA.' IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We can't help but notice the FDA's advice for the 'fellas' cautioning about over-the-counter sexual enhancement supplements. Send your tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). POLITICO PRO SPACE — Need an insider's guide to the politics behind the new space race? From battles over sending astronauts to Mars to the ways space companies are vying to influence regulators, this weekly newsletter decodes the personalities, policy and power shaping the final frontier. Find out more. Eye on the FDA CELLS IN THE SPOTLIGHT — The FDA's top biologics regulator said Thursday he's willing to consider surrogate endpoints — markers believed to correlate with clinical benefit in a drug — as part of the agency's approach to approving rare-disease therapies by using 'gold-standard science and common sense.' 'We will rapidly make available therapies at the first sign or promise of biomedical success or action, but we're also going to follow up overall survival and quality of life on the back end,' Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, said during an agency roundtable on cell and gene therapies. Prasad added he's often asked whether he's 'solely' interested in randomized controlled trials and said he's open to a variety of methodologies demonstrating a drug's benefit. Background: His remarks come weeks after he and Commissioner Marty Makary unveiled a new Covid-19 vaccine framework that limits approvals of future formulation changes to people 65 and older and younger individuals with an underlying condition — and requiring new RCTs to prove the shots are safe and effective for young, healthy people. Cell and gene therapies are often discussed in the context of rare diseases, as the technologies can address root causes instead of solely managing symptoms. But a condition's rarity hinders a company's ability to conduct a large-scale trial for a drug candidate, an issue with which regulators and industry have long struggled. The FDA launched a rare-disease 'hub' last year to better align its drug and biologics regulators in their approach to considering those therapies for the market. In Congress O'NEILL CONFIRMED — The Senate voted to confirm Jim O'Neill to be HHS deputy secretary by a 52-43 vote Thursday — elevating an ally of early Trump backer and tech billionaire Peter Thiel, who previously worked as HHS principal associate deputy secretary during the George W. Bush administration. O'Neill advocated in 2014 for the FDA to approve drugs once they're verified as safe, instead of also requiring effectiveness data — and was considered as an FDA commissioner candidate during President Donald Trump's first term. REPUBLICANS PLAN SUPPLY-CHAIN HEARING — Top Republican health lawmakers on the House Energy and Commerce Committee want to reduce America's reliance on other countries for medicines and other health care products — and plan to hold a hearing Wednesday on how to incentivize a stronger supply chain. 'We have long been champions of policies that support efforts to onshore U.S.-based manufacturing and bolster our domestic supply chain, while, at the same time, strengthening our national security interests and economic goals,' E&C Chair Brett Guthrie (R-Ky.) and Health Subcommittee Chair Buddy Carter (R-Ga.) said in a news release. Over in the Judiciary Committee, lawmakers are scheduled to examine the 'privacy and national security implications' of the 23andMe bankruptcy Wednesday at 10:15 a.m. A BIPARTISAN PUSH? Lawmakers on both sides of the aisle indicated Wednesday that reauthorizing the FDA's over-the-counter user fee program could be a bipartisan effort — and the agency's over-the-counter sunscreen regulation has yielded bipartisan frustration. Sen. Bill Cassidy (R-La.), chair of the Senate Health, Education, Labor and Pensions Committee, and other lawmakers questioned the FDA's top drug regulator why more drugs are not being moved to OTC status more rapidly — and Democrats questioned if job cuts at the FDA could impact new approvals. Document Drawer The FDA granted Florida a second extension for its drug importation program, extending the state's authorization to Nov. 6. But before drug imports can start, importers must file a pre-import request, which the FDA must grant, making it unclear whether the program will be used. The top FDA medical device regulator, Dr. Michelle Tarver, met with Johnson and Johnson last week to discuss 'general medical device updates,' according to a public calendar disclosure. Also last week, the FDA deputy commissioner for strategic initiatives, Lowell Zeta, met with Eli Lilly to discuss 'pharmaceutical updates.' The Government Accountability Office convened a roundtable of 19 experts to discuss how HHS can improve testing efforts during a public health emergency and released a report containing their nearly 100 recommendations. WHAT WE'RE READING STAT's Elaine Chen explores how Novo Nordisk's recent challenges competing with Eli Lilly relate to a cautious culture at the Danish drugmaker.
Yahoo
12-04-2025
- Business
- Yahoo
Pratt and Whitney celebrate 100-year anniversary
COLUMBUS, Ga. () — Pratt and Whitney are flying high as they celebrate their centennial anniversary. For 100 years, Pratt and Whitney – an aircraft engine manufacturer has been transforming military and commercial aviation with the R-1340 Wasp engine that is still in use today. The company was founded in 1925 and kicked off their centennial anniversary in Columbus where they've been for 41 years. In 1981, the company broke ground on the Columbus location. Congressman Sanford Bishop was in attendance. 'I was just recalling that i'm perhaps one of the dinosaurs around, but it means a great deal to be able to watch the growth and development to have a part in it as a member of Congress now.' Bishop says. 'It's a sense of pride, a pride for the people here, but also our country that we have such innovative and creative people that are doing such important and significant work for our country.' The Georgia Congressman presented a congressional recognition to the company for their outstanding achievement, service, and public distinctions. Pratt and Whittney did not only receive gifts but gave them. The company has had a 17 yearlong partnership with Columbus Technical College. They pledged $250,000 for the school's capital campaign. Jay Kosmas is the General Manager for the Columbus Engine Center. Kosmas says, 'They've helped us fill critical engineering roles as well as shop floor mechanic roles. And we couldn't do it without our local, local technical schools.' State and local dignitaries cut the ribbon on the company's 100 year anniversary exhibit. The exhibit showcases the R-1340 Wasp Engine and the original shovels and ribbon used for the groundbreaking of the Columbus location. Columbus was the first stop on the tour. There are plans to visit Quebec, Poland, Oklahoma, North Carolina, and Connecticut. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
08-04-2025
- Business
- Yahoo
Leaders expect big enlisted pay raise won't cause new financial woes
Service officials don't anticipate that the military's recently enacted junior enlisted pay raise will hurt young families' ability to qualify for federal nutrition assistance programs, but promised they will closely monitor the issue to ensure the extra money doesn't cause unintended problems. During testimony before the House Appropriations Committee on Tuesday, senior enlisted officials from each of the armed forces testified on quality-of-life initiatives and efforts to help families facing challenges because of the rigors of military life. Those included a congressionally approved pay raise for junior enlisted troops that went into effect this month. Under legislation signed into law by President Joe Biden last year, troops ranked E-4 and below saw a 10% boost in monthly salaries, compared to their 2024 paychecks. The move will bring paychecks for nearly all troops to more than $30,000 annually. E-2s with two years in service now have a base salary rise of about $31,000, up from $27,000 last year. E-4s with three years in the ranks saw their pay rise from $35,000 a year to more than $40,000 now. What troops need to know about the basic pay raise in 2025 But lawmakers on Tuesday expressed concerns that the higher pay could also eliminate some families' eligibility for support services like the Supplemental Nutrition Assistance Program and Special Supplemental Nutrition Program for Women, Infants and Children. They warned that while the higher pay will offset some of the need for federal support services, the extra monthly money may not completely eliminate those financial hardships. 'Are we simply canceling out good intentions of pay increase?' asked Rep. Sanford Bishop, D-Ga. Military officials said they do not believe so, but are closely monitoring the situation to ensure the extra pay doesn't cause different financial problems. 'We've only had this in place since April 1, but what I would say is that we're watching this closely,' said Sergeant Major of the Marine Corps Carlos Ruiz. 'The data tells us that with any change — this raise, or maybe a spouse gets employment or gets promoted — [families] would not climb more than one bracket in their childcare fees. That's what I have so far.' Air Force Chief Master Sergeant David Flosi said they expect only a small number of families to be impacted negatively by the extra paycheck boost, but promised that officials are monitoring those issues to ensure such problems can be addressed. 'If a family member or a service member demonstrates a financial need, we can adjust fees for child care or other services, to make sure we head off any financial crisis,' he said. Past department surveys have shown that up to 3% of military families have accessed federal nutrition support programs in the past. All troops received a 4.5% pay raise in January, the third consecutive year of paycheck boosts of more than 4%. Lawmakers on the House Armed Services Committee have discussed a targeted pay boost for senior enlisted troops next year, as a way to help retention among those personnel.
Yahoo
17-02-2025
- Politics
- Yahoo
Over 1,000 people gather for 40th annual Black History Month breakfast at Columbus Trade Center
COLUMBUS, Ga. () — A sold out crowd gathered Monday morning at the Columbus Trade Center to celebrate the 40th annual Black History Month Observance Breakfast. More than 1,300 broke bread, honored local civic leaders and listened to Texas Congresswoman Jasmine Crockett. The event is sponsored by Georgia Congressman Sanford Bishop, who represents the 2nd District that includes most of Columbus. Crockett, a Democrat from the Dallas area, challenged those in attendance to not only celebrate black history but to push back when people try to erase or alter it. The Legacy of Leadership was given to Dr. Robert Wright, a Columbus business, political and civic leader. There were also other honors given to those in the community who are Points of Light or emerging leaders. 'We feel that the community has supported the annual Black History observance over the years,' said Democratic Rep. Sanford Bishop of Columbus. 'And I'm grateful that we've been able to bring such dynamic individuals who are history makers for our country to the Chattahoochee Valley to be with and to inspire the folks here.' Congresswoman Crockett, an attorney, spoke for more than a half hour She told the story of how Congress was the last place she expected to be. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
