
Blog | 5/16/2025
Trump Administration Healthcare News: May 16, 2025
Health Advances weekly healthcare tracker focused on top level government administration news.
NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).
This issue reflects news as of 11 AM on May 15, 2025. The details and broad themes may have changed.
KEY HEALTH NEWS (Global)
European governments scramble to interpret Trump's new drug pricing order
- European governments are examining whether U.S. President Donald Trump can force them to pay more for prescription medicines, after he issued an executive order to lower U.S. drug prices, roiling the global pharmaceutical industry.
- On Monday, Trump took aim at governments paying a fraction of what Americans have to shell out for their medicines, and directed the use of trade policy to force other nations to pay more for prescription drugs.
- The Trump administration wants to reduce the gap between U.S. drug prices and those in other developed countries such as many in Europe, where prescription drugs cost, on average, one-third, opens new tab what they do in the United States.
- Denmark's industry and business minister Morten Bodskov plans to meet with drugmakers based in his country to discuss the order. He did not give details about the meeting.
- In the U.S., drug prices are shaped by complex negotiations involving pharmacy benefit managers that act as middlemen between drugmakers and employer clients and health insurers and have been criticised for inflating costs. In Europe, countries generally have public health systems that negotiate directly with manufacturers and keep costs down.
- The European Commission, the EU executive, will assess the impact of Trump's order on European companies, a spokesperson told reporters on Tuesday.
- https://www.reuters.com/business/healthcare-pharmaceuticals/european-governments-scramble-interpret-trumps-new-drug-pricing-order-2025-05-14/
WHO trims top management ranks amid financial crunch
- The World Health Organization, which faces an extraordinary financial crunch in the wake of the U.S. withdrawal from the agency, has dramatically trimmed its top management.
- Gone from the leadership is Mike Ryan, who has led the Health Emergencies Program since 2019 and who has been with the WHO, off and on, for decades. Recently Ryan has also been serving as the WHO’s executive director.
- The change, the most notable of a number of departures from the WHO’s management team, was announced Wednesday by Director-General Tedros Adhanom Ghebreysus in a speech to the opening of the meeting of the program, budget, and administration committee of the global health agency’s executive board in advance of the World Health Assembly, which begins next Monday.
- https://www.statnews.com/2025/05/14/world-health-organization-trims-management-ranks/ (subscription required for full-text)
Vital HIV testing down by a fifth in South Africa after Trump aid cuts
- Crucial testing and monitoring of vulnerable South African HIV patients has fallen by up to a fifth since Donald Trump cut aid to health workers and clinics, government data shows.
- The testing to monitor blood virus levels has fallen by 17 per cent in young people, and by 21 per cent in pregnant women.
- The data reported by Reuters also shows that testing in infants has fallen by a fifth and is one of the most concrete signs yet of the effect the aid cuts are having on the country with the highest number infected by HIV.
- Aaron Motsoaledi, health minister, admitted the funding cuts had caused problems, but strongly denied suggestions the country’s anti-HIV campaign was close to collapse.
- Modelling released in March has already predicted the cuts could trigger soaring rates of global HIV infections and millions of deaths.
- There could be between 4.4m to 10.8m additional new HIV infections by the end of this decade in low-and-middle income countries according to the forecasts published in the Lancet journal.
- Regular testing of HIV patients is considered vital for managing the long-running outbreak because it tells whether treatment is keeping the virus in check, and whether it is sufficiently suppressed to prevent it spreading to others.
- https://www.telegraph.co.uk/global-health/science-and-disease/hiv-testing-and-monitoring-down-after-trump-aid-cuts/
KEY FEDERAL GOVERNMENT NEWS
House Energy and Commerce Committee advances Medicaid overhaul after marathon session
- Republicans managed to will a bill through the House Energy and Commerce Committee by a party-line vote, which would see a federal mandate for Medicaid work requirements for able-bodied adults.
- The bill also allows recipients to be charged a $35 copay (PDF) starting in October 2028.
- Moderates and Freedom Caucus members disagreed on how much of Medicaid to cut, but chose to advance the legislation despite the rallying cries of Democratic lawmakers, advocacy groups, the hospital lobby and on-the-ground protestors. The markup hearing lasted nearly 27 hours, with Democrats introducing amendment after amendment to no avail.
- The next step for the bill is to see a vote on the House floor. There is also skepticism the reconciliation bill will survive in its current form once the Senate begins debate.
- https://www.fiercehealthcare.com/payers/health-plans-advocacy-groups-descend-dc-ahead-medicaid-hearing
What’s in Trump’s big bill? Trillions in tax cuts, changes to Medicaid and more
- Here’s a look at what’s in and out of the legislative package so far:
- States to pick up more of the tab for food assistance: House Republicans are looking to shift some of the cost of the Supplemental Nutrition and Assistance Program, known as SNAP, to the states. States would shoulder 5% of benefit costs under the bill beginning in fiscal year 2028. The share could also go higher for those states with high rates of overpayments and underpayments. The bill would also require states to pick up 75% of the administrative costs.
- New work requirements for Medicaid: A centerpiece of the package is more than $900 billion in reduced spending, most of that coming through the Medicaid program. To be eligible for Medicaid, there would be new “community engagement requirements” of at least 80 hours per month of work, education or service for able-bodied adults without dependents. The new requirement would not kick in until Jan. 1, 2029. People would also have to verify their eligibility to be in the program twice a year, rather than just once.
- https://apnews.com/article/trump-tax-cuts-bill-medicaid-work-requirements-17cbde167f3b434e925a199c3253b8e1
Medicare innovation lab plays up patient choice, preventive care
- Medicare's innovation center plans to put more emphasis on empowering consumers to make personal choices in health care, and on promoting healthier lifestyles to prevent diseases, officials wrote in a strategy memo released Tuesday.
- Why it matters: The low-profile office created as part of the Affordable Care Act has wide latitude to try out different health policy experiments and could be a useful lever to implementing Health and Human Services Secretary Robert F. Kennedy Jr.'s agenda.
- What they're saying: "The Innovation Center's next phase will focus on testing models that transform the U.S. health system into one that builds healthier lives — through prevention, individual empowerment, and choice and competition," director Abe Sutton wrote in the strategy document.
- State of play: The Center for Medicare and Medicaid Innovation has a budget of $10 billion over a decade to run time-limited programs that experiment with alternative ways of paying health care providers in Medicare and Medicaid, with the aim of saving taxpayer dollars and improving care quality.
- Going forward, the center will tailor payment models to promote evidence-based preventive care, focusing on health and nutrition counseling, cancer screenings and blood pressure control, Sutton wrote.
- Quality evaluations will focus on preventive health outcomes and disease prevention.
- Value-based payment models have already allowed some providers to offer services like medically tailored meals and nonemergency medical transportation.
- Press: https://www.axios.com/2025/05/14/medicare-innovation-memo-patient-choice-preventive-care
- Additional Press: https://www.fiercehealthcare.com/payers/chronic-disease-prevention-pillar-new-maha-ified-cms-innovation-center-strategy
- CMS Statement: https://www.cms.gov/priorities/innovation/about/cms-innovation-center-strategy-make-america-healthy-again
RFK Jr. pushes forward on deregulation with information request, guidance rescindments
- Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is moving forward with President Donald Trump’s 10:1 deregulation agenda with a call for public input and the immediate rescindment of four guidance documents.
- Tuesday morning, RFK Jr.’s department and the Food and Drug Administration launched a 60-day request for information (RFI). The department and its subagency are interested in hearing about “outdated or unnecessary regulations” that the secretary said are hampering competition and restricting the practice of healthcare.
- “HHS needs to make sure that our regulatory framework is clear, predictable and allows providers to focus on preventing and treating chronic disease instead of clearing unnecessary regulatory hurdles,” RFK Jr. said in a video announcement.
- In line with the president’s Jan. 31 executive order, the HHS will be pulling 10 or more regulations for every new one that is introduced, and the total cost of all new regulations in the current fiscal year will be “significantly less than zero.” Included among those are formal regulations, guidance documents, memoranda, policy statements and other directives.
- Concurrently, RFK Jr. also filed a notice Tuesday morning in the Federal Register (to be published Wednesday) ordering four informal guidance documents be rescinded immediately.
- The documents, he wrote, “have been superseded, are unduly burdensome, no longer represent the considered legal judgment of HHS, and/or are otherwise appropriate for rescission.” The guidances were promulgated without a notice and comment period—though one should have been—and so may be rescinded in the same manner, “especially following a change of administration now that they are defunct,” he wrote.
- The four rescinded guidance documents comprised a July 2021 action designating certain scarce health resources as necessary to the COVID-19 response, which had been terminated later that year; a March 2001 action that shifted the starting and ending date of certain opioid regulations; an April 2021 action on buprenorphine administration; and a May 2021 action that had included sexual orientation and gender identity among Affordable Care Act discriminations on the basis of sex.
- https://www.fiercehealthcare.com/regulatory/kennedy-pushes-forward-deregulation-information-request-guidance-rescindments
Trump administration cut $2.7 billion in NIH research funding through March, Senate committee minority report says
- The Senate Health, Education, Labor and Pensions Committee’s minority staff report, released Tuesday and authored by Sen. Bernie Sanders, I-Vermont, says that in the first three months of this year, the Trump administration cut $2.7 billion in National Institutes of Health funding for research.
- That figure is much higher than some separate estimates that previously suggested targeted grant terminations have affected more than $1.8 billion in NIH funding.
- One analysis finds that federal funding to support cancer research was cut 31% from January through March compared with the same timeframe last year.
- https://www.cnn.com/2025/05/13/health/trump-administration-nih-funding-sanders-report
Court Issues Widescale Ban on RIFs, Reorganizations; Administration Appeals
- A federal court has ordered that federal agencies stop conducting RIFs and reorganizations under a Trump administration executive order and follow-up guidance, a ban that the administration immediately appealed.
- The temporary restraining order issued May 9 by Judge Susan Illston of the U.S. District Court for the Northern District of California blocks further actions for 14 days while she considers further steps. The case, brought by a coalition of unions including the AFGE, non-profit organizations and local governments, is the most wide-reaching of numerous legal challenges to the administration’s efforts to cut federal employment in general and to abolish or virtually abolish various individual agencies.
- https://www.fedweek.com/fedweek/court-issues-widescale-ban-on-rifs-reorganizations-administration-appeals/
KEY REVERSALS – RESCINDED ITEMS
HHS backtracks on firing hundreds of federal health workers
- The Department of Health and Human Services on Tuesday reinstated 328 federal employees who faced terminations, including those involved in screening for “black lung” disease in coal miners and for health issues in 9/11 first responders.
- The reinstated employees are part of the National Institute for Occupational Safety and Health (NIOSH), a division of the Centers for Disease Control and Prevention that is focused on preventing and responding to work-related illnesses.
- The Trump administration previously aimed to eliminate the majority of NIOSH’s more than 1,300 employees, part of a broader plan to downsize the federal workforce.
- Hundreds of NIOSH staffers received termination letters in April and May, though some were temporarily brought back to complete certain tasks, while their terminations remained in effect for June. HHS’ acting chief human capital officer, Tom Nagy, told some employees on Tuesday that their terminations were “hereby revoked,” according to a memo obtained by NBC News.
- https://www.nbcnews.com/health/health-news/hhs-reinstates-hundreds-health-workers-rcna206856
Trump administration to 'reconsider' mental health parity rule
- The Trump administration revealed in a court filing that it does not intend to enforce a key regulation on mental health parity while it gives the rule another look.
- In the final months of the Biden White House, the departments of Labor, the Treasury and Health and Human Services finalized a rule that sought to strengthen requirements under the 2008 Mental Health Parity and Addiction Equity Act, which mandates that mental health services are covered on par with physical health benefits.
- In a court filing related to a lawsuit challenging the regulation, the Department of Justice (DOJ) said the administration will not enforce the rule as it considers its next steps, either by ultimately modifying it or rescinding it entirely. The DOJ is also asking the court to suspend the case while it works.
- "Postponing further litigation pending the completion of this process will thus promote the efficient and orderly disposition of this litigation," the agency said in the filing.
- https://www.fiercehealthcare.com/regulatory/trump-administration-reconsider-mental-health-parity-rule
KEY BIOPHARMA NEWS
President Trump Issues Most Favored Nations Drug Pricing Executive Order
- White House made news with release of a new executive order (EO) aimed at bringing “most favored nation” (MFN) pricing to prescription drugs.
- The new EO, while similar in concept to its predecessor CMS proposal, goes much further. It seeks to reduce prices for all consumers and would apply to all pharmaceuticals, not just certain high-cost drugs. Specifically, the EO includes several directives:
- The secretary of commerce and the US trade representative must take action to ensure foreign countries are not engaging in practices that force US customers to pay more than their fair share for global pharmaceutical research and development.
- The secretary of health and human Services (HHS) is to facilitate direct-to-consumer programs that allow Americans to access drugs at MFN prices.
- The HHS secretary, CMS administrator, and assistant to the president for domestic policy must communicate MFN price targets to drug manufacturers within 30 days of the EO.
- If the HHS secretary determines that significant process toward MFN pricing isn’t being made, HHS is to propose rulemaking to “impose” MFN pricing and consider certifying that drug importation is safe and would lead to significant reductions in drug costs for Americans. If the secretary makes that certification, the EO directs the commissioner of the US Food and Drug Administration to grant waivers (on a case-by-case basis) that allow importation of prescription drugs.
- Relevant agencies are to take enforcement actions against anticompetitive prices, take action to address global freeloading and price discrimination practices, and modify or revoke approvals for drugs that may be unsafe, ineffective, or improperly marketed.
- EOs don’t actually effectuate new policies, but rather provide directions to federal agencies to carry out certain priorities articulated in the EO. In this EO, the president calls on several of his cabinet secretaries to take action, and we will have to wait and see how each agency responds to the directive.
- Since the policies in the EO have the potential to be extremely far-reaching and impact all drugs marketed and sold in the United States, some federal agencies could face challenges during the implementation process. For example, it could be difficult to establish an MFN price target within 30 days for a very large set of drugs.
- Analysis: https://www.mcdermottplus.com/blog/regs-eggs/president-trump-issues-most-favored-nations-drug-pricing-executive-order/
- Executive Order: https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/
White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing
- This is President Trump’s second go at an MFN model for U.S. drug pricing.
- The administration’s stated intent for the EO is to “equalize” drug prices worldwide.
- What the EO says: The EO directs the Secretary of Commerce and U.S. Trade Representative to “take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair U.S. national security and that has the effect of forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value in foreign countries.”
- What it doesn’t say: What constitutes an “unreasonable or discriminatory” practice? How will the “fair market value” of pharmaceutical products be assessed?
- What the EO says: The Secretary “shall propose a rulemaking plan to impose most-favored-nation pricing.”
- What it doesn’t say: What is the scope and timing of the potential rulemaking? Is it intended to create the direct-to-consumer program or impose MFN pricing in Medicare and Medicaid, or both? If applicable to Medicare, to what extent will any rulemaking follow the same model put forth by the first Trump administration?
- https://www.hoganlovells.com/en/publications/white-house-raises-more-questions-than-answers-in-executive-order
Roche to reconsider US investment projects if Trump follows through on pricing order
- On the heels of Trump's recent "Most Favored Nation" executive order on drug pricing, Roche is signaling that it could reconsider its U.S. investment plans.
- "Should the proposed Executive Order go into effect, Roche’s ability to fund the significant investments previously announced in the US will be in question," a spokesperson said via email. "Overall, we are concerned that the Executive Order will undermine the US’s position as the world’s leading pharmaceutical and healthcare ecosystem, as well as dampen economic growth and lead to job losses in the US."
- Before the executive order, Roche recently laid out plans to swell its U.S. footprint through a $50 billion investment over five years. The investment push includes several new manufacturing plants and an expansion and upgrade of pharma and diagnostics R&D centers in several states.
- https://www.fiercepharma.com/pharma/roche-questions-us-investment-projects-wake-trumps-international-pricing-order
CMS may add Part B drugs to negotiation program under draft guidance
- The Trump administration has issued new draft guidance for the third cycle of Medicare drug price negotiations.
- The proposals seek to boost transparency in the program and put a focus on negotiating for the drugs that come at the highest cost to Medicare. The agency is also aiming to avoid negative impacts from the negotiated prices on U.S.-based pharmaceutical innovation, according to an announcement.
- Under the guidance, drugs administered under Medicare Part B would be potentially included for the first time. The agency is looking for feedback in comments on how to manage access to the maximum fair price negotiated for Part B drugs.
- The guidance also outlines that the Centers for Medicare & Medicaid Services (CMS) may choose to renegotiate the prices for certain drugs already set for 2026 or 2027.
- Press: https://www.fiercehealthcare.com/regulatory/cms-may-add-part-b-drugs-negotiation-program-under-draft-guidance
- Draft Guidance: https://www.cms.gov/newsroom/press-releases/cms-releases-draft-guidance-third-cycle-medicare-drug-price-negotiation-program-lower-drug-prices
Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program
- A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program (Negotiation Program).
- Third Circuit’s decision is significant because that court has appellate jurisdiction over five of the nine cases challenging the Negotiation Program.
- The Third Circuit rejected AstraZeneca’s sole constitutional claim arguing that the Negotiation Program violates AstraZeneca’s procedural-due-process rights under the Fifth Amendment.
- The court of appeals also dismissed AstraZeneca’s Administrative Procedures Act (APA) challenges to CMS’s Negotiation Program Guidance. AstraZeneca argued that CMS guidance outlining the bona fide marketing standard and choosing to aggregate different products approved under different NDAs and BLAs is unlawful.
- https://natlawreview.com/article/appeals-court-rejects-astrazenecas-challenge-medicare-drug-price-negotiation
Sanofi hops on the US investment bandwagon with $20B commitment through 2030
- On Wednesday, Sanofi said it will invest at least $20 billion through 2030 to beef up its R&D and manufacturing operations in the U.S.
- The Paris-based company said it will expand its manufacturing capacity at its current U.S. sites and will enhance its partnerships with other domestic manufacturers to help “ensure the production of medicines in the U.S.” The increased investment will “create a significant number of high-paying jobs in multiple states,” Sanofi added.
- With the plan, Sanofi joins other pharma giants such as Eli Lilly, Johnson & Johnson, Gilead Sciences and Novartis, which have each touted their U.S. investment plans in recent weeks.
- https://www.fiercepharma.com/pharma/sanofi-hops-us-investment-bandwagon-20b-commitment
Gilead Pumps $11B More Into US Manufacturing, Hopes To Add 3,000 Jobs
- Gilead Sciences is investing $11 billion more into its U.S. operations, the company announced Wednesday, following in the footsteps of a gaggle of its Big Pharma peers that in recent weeks have announced multibillion-dollar domestic manufacturing packages.
- Wednesday’s announcement supplements Gilead’s already planned $21 billion R&D and manufacturing commitment to the U.S. All told, the $32 billion sum is expected to “create $43 billion in value to the U.S. economy” over the next five years, according to the pharma’s statement.
- Gilead will use this money to construct three new facilities and upgrade three other existing sites, while also “investing in new technology and advanced engineering initiatives,” as per Wednesday’s release. The company estimates that its latest investment will create some 3,000 new jobs in the U.S. by 2028, including 800 direct positions and 2,200 indirect opportunities.
- Like Gilead, several of the industry’s biggest players have recently pumped billions of dollars into their U.S. footprints. Most recently, Bristol Myers Squibb unveiled a $40 billion investment, a somewhat unexpected move given the pharma’s aggressive ongoing cost-cutting initiative and layoffs. BMS plans to disburse this sum over the next five years, with a particular focus on upping its radiopharmaceutical manufacturing and artificial intelligence capacities.
- https://www.biospace.com/business/gilead-pumps-11b-more-into-us-manufacturing-hopes-to-add-3-000-jobs
KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS
ADLM calls on HHS to reinstate essential committee that is needed to ensure the safety and efficacy of clinical laboratory tests
- The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) has sent a letter to Secretary of the Department of Health and Human Services (HHS) Robert F. Kennedy Jr. urging HHS to reinstate the Clinical Laboratory Improvements Advisory Committee (CLIAC). As part of an aggressive campaign to downsize and restructure HHS, the Trump administration recently eliminated this vital committee — a move that could threaten the quality of clinical laboratory tests, which play a central role in diagnosing and treating conditions ranging from infectious diseases to cancer and cardiovascular disease.
- With CLIAC's elimination, the laboratory medicine community has also lost its premier forum for ensuring that the regulations for clinical labs continue to meet the changing needs of the healthcare community. As emerging research and technology have advanced clinical testing, many in the medical community have pushed for the modernization of the Clinical Laboratory Improvement Amendments (CLIA), which are the federal regulations that establish quality standards for clinical testing.
- Press: https://www.prnewswire.com/news-releases/adlm-calls-on-hhs-to-reinstate-essential-committee-that-is-needed-to-ensure-the-safety-and-efficacy-of-clinical-laboratory-tests-302456752.html
- Letter: https://myadlm.org/advocacy-and-outreach/comment-letters/2025/hhs-cliac-final
KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS
Access to Prescription Digital Therapeutics Act reintroduced in Congress
- Senators Shelley Moore Capito, R-W.Va., and Jeanne Shaheen, D-N.H., reintroduced the Access to Prescription Digital Therapeutics (PDT) Act on Thursday to expand access to software-based treatments.
- Advocates will bring new economic data from Germany to make the case to Congress, Centers for Medicare & Medicaid Services (CMS) Director Mehmet Oz, M.D., and Department of Health and Human Services Secretary Robert F. Kennedy Jr. to create pathways for coverage of the technologies.
- By leaning into the Make America Healthy Again (MAHA) crowd in Washington, advocates at the American Telemedicine Association's (ATA's) lobbying arm think they have an unprecedented chance to pass the bill.
- The Access to PDT Act would create a reimbursement pathway for software that treats medical conditions, like Cognoa's early autism diagnosis product and Freespira's panic attack disorder treatment. The category has broadly struggled with uptake because the Medicare program does not have the authority to cover the technologies under its existing benefit categories.
- The bill would create a new Medicare benefit category for Food and Drug Administration (FDA)-cleared prescription digital therapeutics to be prescribed to seniors in the program.
- Press: https://www.fiercehealthcare.com/regulatory/access-prescription-digital-therapeutics-act-reintroduced-congress
- Bill: https://www.congress.gov/bill/117th-congress/senate-bill/3791/text
KEY MEDTECH NEWS
AdvaMed presses Congress for tariff exemptions on the medtech industry
- Medtech association AdvaMed went to Capitol Hill today to make the case that the medical device industry should be exempt from the global tariffs pursued by the Trump administration.
- AdvaMed’s president and CEO, Scott Whitaker, testified before the Senate’s finance committee during a hearing on the current state of U.S. supply chains, which also included witnesses focused on rare-earth minerals and semiconductor chips, as well as soybeans.
- “To be clear, we applaud the president’s efforts to bring more manufacturing back to the U.S. and fix trade imbalances,” Whitaker told the committee. “But the reality is, up to 70% of the medtech used in America is already made in America.”
- “The U.S. is the largest medtech market in the world, accounting for 40% of global sales, and it is unquestionably the global leader in innovation,” he added. “If there is a breakthrough in medical technology, chances are it was developed right here. Tariffs could put all of this at risk.”
- Whitaker also highlighted the complexity of today’s medical devices—some of which may contain hundreds of different parts, sourced and assembled from multiple countries.
- “We source things from all over the country, and all over the world as well,” Whitaker said. “From plastics to rubber to tungsten, the list goes on and on.”
- “Having open access to those markets—without large tariffs assigned to those—makes it easiest for us to import back into this country, and then finish those products and sell them to hospitals in the U.S.,” he said.
- https://www.fiercebiotech.com/medtech/advamed-presses-congress-tariff-exemptions-medtech-industry
Roche to spend $550M building Indianapolis HQ into CGM production hub
- Roche plans to invest as much as $550 million in its Indianapolis diagnostics campus during the next five years, with plans to build it into a U.S. manufacturing and distribution hub for its wearable diabetes blood sugar sensors.
- The announced expansion follows an April commitment from the Swiss pharma to spend $50 billion on developing U.S. facilities for research, development and production by 2030—including in Indiana as well as Pennsylvania, Massachusetts, California and elsewhere, with a projection of 1,000 total new hires.
- Indianapolis currently serves as the international home of its diagnostics division, with R&D laboratories, an administrative headquarters and manufacturing lines that produce about 5.2 billion of the company’s Accu-Chek diabetes test strips per year.
- https://www.fiercebiotech.com/medtech/roche-spend-550m-building-indianapolis-hq-cgm-production-hub
- HA NOTE: a later article notes that Roche to reconsider US investment projects if Trump follows through on pricing order: https://www.fiercepharma.com/pharma/roche-questions-us-investment-projects-wake-trumps-international-pricing-order
KEY ACRONYMS
- ADLM = Association for Diagnostics & Laboratory Medicine
- APA = Administrative Procedures Act
- CDC = Centers for Disease Control and Prevention
- CLIA = Clinical Laboratory Improvement Amendments
- CLIAC = Clinical Laboratory Improvements Advisory Committee
- CMMI = Center for Medicare and Medicaid Innovation
- CMS = Center for Medicare & Medicaid Services
- DOJ = Department of Justice
- E&C = House Energy and Commerce Committee
- EO = Executive Order
- HHS = Department of Health and Human Services
- IRA = Inflation Reduction Act
- MAHA = Make America Healthy Again
- MFN = most favored nation
- NIH = National Institutes of Health
- NIOSH = National Institute for Occupational Safety and Health
- PDT = Prescription Digital Therapeutics RFI = request for information
- SNAP = Supplemental Nutrition and Assistance Program
- WHO = World Health Organization