https://www.healthnewspapers.com/policy The FDA, the CDC, the courts, coverage, and what things cost. en-us https://www.healthnewspapers.com/policy/military-emergency-eua-acute-pain-drugs https://www.healthnewspapers.com/policy/military-emergency-eua-acute-pain-drugs A section 564 declaration, prompted by a July determination from the Secretary of War, opens the door to authorising unapproved drugs for acute pain in combat and CBRN casualties. Fri, 04 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/vaccine-integrity-project-respiratory-vaccines https://www.healthnewspapers.com/policy/vaccine-integrity-project-respiratory-vaccines The Vaccine Integrity Project, formed in 2025 amid disruptions to the CDC's immunisation advisory committee, sets out its process for reviewing 2026–2027 respiratory-season vaccines. Thu, 03 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/nih-mifepristone-license-hypercortisolism-insulin-resistance https://www.healthnewspapers.com/policy/nih-mifepristone-license-hypercortisolism-insulin-resistance The patented method uses mifepristone for hypercortisolism-related insulin resistance, with dosing capped to avoid over-activating the stress-hormone axis. The public can object before the deal closes. Thu, 03 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/respiratory-season-vaccine-effectiveness-2026-2027 https://www.healthnewspapers.com/policy/respiratory-season-vaccine-effectiveness-2026-2027 JAMA published paired systematic reviews for the coming respiratory season. Both found vaccines reduced hospitalisation across age groups, with no new safety signals, though protection wanes over time. Wed, 02 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-hepatic-impairment-pk-guidance-update https://www.healthnewspapers.com/policy/fda-hepatic-impairment-pk-guidance-update A draft replacing a 2003 document would extend hepatic-impairment dosing studies to biologic drugs and to drug effects, not just blood levels. It is open for comment before the agency finalises it. Wed, 02 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/niaid-division-clinical-research-abolition https://www.healthnewspapers.com/policy/niaid-division-clinical-research-abolition A Federal Register notice opens a five-day comment window in September. The stated goal is to realign clinical operations across the institute and align with Presidential priorities. Tue, 01 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/list-price-versus-net-price-drug-gap https://www.healthnewspapers.com/policy/list-price-versus-net-price-drug-gap The list price is the sticker; the net price is what the maker keeps after rebates. For one insulin, list rose 27% over five years as the net price fell 10%. Who you are decides which you pay. Tue, 01 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/ema-nams-voluntary-data-submission-pilot https://www.healthnewspapers.com/policy/ema-nams-voluntary-data-submission-pilot The 2012 safe harbour for 3Rs data was barely used. The replacement is a voluntary pilot that takes submissions independently of a marketing application, running until the third quarter of 2027. Tue, 01 Sep 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/saudi-road-traffic-injury-decline https://www.healthnewspapers.com/policy/saudi-road-traffic-injury-decline A review by the country's Public Health Authority credits enforcement and awareness campaigns for falls in crashes, deaths and injuries from 2013 to 2023 — while naming what still holds the Vision 2030 target back. Mon, 31 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/esc-2026-guidelines-heart-failure-kidney-rehabilitation https://www.healthnewspapers.com/policy/esc-2026-guidelines-heart-failure-kidney-rehabilitation The ESC released updated heart failure guidance plus first-ever guidelines on cardiac rehabilitation and on cardiovascular disease with chronic kidney disease. All three sit behind a paywall. Mon, 31 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/medicaid-work-reporting-variable-hours-risk https://www.healthnewspapers.com/policy/medicaid-work-reporting-variable-hours-risk A study of Current Population Survey data finds 19.8% of likely expansion enrollees sit near the 20-hour threshold or report variable hours. Women are at higher risk than men. Fri, 28 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/medical-debt-and-health-what-evidence-shows https://www.healthnewspapers.com/policy/medical-debt-and-health-what-evidence-shows Americans owed about $140 billion in medical bills in collections. But two randomized experiments that relieved debt found no average effect on credit, financial distress or mental health. Thu, 27 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/medicaid-expansion-severe-maternal-morbidity https://www.healthnewspapers.com/policy/medicaid-expansion-severe-maternal-morbidity Across 26 states, expansion raised the Medicaid-paid share of deliveries by 5.2% and changed the severe maternal morbidity rate by 0.02% — an interval that includes zero in both directions. Thu, 27 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/zepbound-label-update-surpass-cvot-retinopathy https://www.healthnewspapers.com/policy/zepbound-label-update-surpass-cvot-retinopathy A supplement approved on 26 August adds SURPASS-CVOT to the prescribing information and rewrites the eye warning so it is addressed to patients with a history of retinopathy rather than to patients with diabetes. Wed, 26 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/what-is-a-pbm-why-it-affects-what-you-pay https://www.healthnewspapers.com/policy/what-is-a-pbm-why-it-affects-what-you-pay Pharmacy benefit managers sit between you, your insurer and the pharmacy. The three largest process nearly 80% of US prescriptions, and a federal regulator says the structure can raise costs. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/pepfar-hiv-funding-disruption-amfar-survey https://www.healthnewspapers.com/policy/pepfar-hiv-funding-disruption-amfar-survey Seventy-seven thousand fewer children got PEPFAR-supported HIV treatment in 2025 than the year before. UNAIDS warns permanent cuts could mean millions of additional infections and deaths by 2029. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/nih-fy2026-funding-congress-rejects-cuts https://www.healthnewspapers.com/policy/nih-fy2026-funding-congress-rejects-cuts The administration wanted to consolidate NIH's 27 institutes into eight and cut roughly $18 billion from its budget. The signed law does neither. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/nhs-heatwave-record-ae-demand-2026 https://www.healthnewspapers.com/policy/nhs-heatwave-record-ae-demand-2026 England's A&E departments handled 2.5 million attendances in July alone. Nursing staff say wards without air conditioning are becoming an occupational-safety problem, not just a patient-comfort one. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/medicare-telehealth-extended-through-2027 https://www.healthnewspapers.com/policy/medicare-telehealth-extended-through-2027 The pandemic-era rules letting Medicare patients see a doctor from home, anywhere in the country, are now locked in through the end of 2027 — the longest extension since they were created. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/medicare-drug-price-negotiation-permanent-framework https://www.healthnewspapers.com/policy/medicare-drug-price-negotiation-permanent-framework The public comment window just closed on a proposal that would govern how up to 20 high-cost drugs a year get their Medicare prices negotiated, starting with prices that take effect in 2029. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/medicaid-work-requirements-judge-denies-injunction https://www.healthnewspapers.com/policy/medicaid-work-requirements-judge-denies-injunction Twenty-five states wanted the rule paused while they sued. The judge said the 90% federal reimbursement for setup costs undercut their case for emergency relief — not that their underlying legal argument was wrong. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/idaho-abortion-health-exception-ruling https://www.healthnewspapers.com/policy/idaho-abortion-health-exception-ruling The court didn't strike down Idaho's ban. It said the state can't prosecute doctors for abortions performed to protect a patient's health, not just her life. Idaho is appealing. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/generic-drug-tariffs-phased-plan https://www.healthnewspapers.com/policy/generic-drug-tariffs-phased-plan The administration wants pharmaceutical manufacturing back on US soil. The runway it's offering is shorter than the time it typically takes to build and validate a new drug plant. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/gavi-600-million-funding-released-mercury-dispute https://www.healthnewspapers.com/policy/gavi-600-million-funding-released-mercury-dispute HHS Secretary Kennedy held the money over Gavi's use of a mercury-based preservative most safety reviews call harmless in trace amounts. Gavi says it was already phasing the ingredient out. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-zenbexus-iberdomide-multiple-myeloma-celmod https://www.healthnewspapers.com/policy/fda-zenbexus-iberdomide-multiple-myeloma-celmod Zenbexus didn't have to outlive patients in a control arm to win approval — it had to clear their bone marrow of detectable disease faster. That shortcut is becoming the norm, not the exception. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-orzeyful-oveporexton-narcolepsy-type-1-approval https://www.healthnewspapers.com/policy/fda-orzeyful-oveporexton-narcolepsy-type-1-approval Orzeyful replaces signaling from the brain chemical narcolepsy patients lack, rather than stimulating wakefulness around the gap. Two-thirds of patients on the higher dose had trouble sleeping. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-gras-reform-ultra-processed-food-definition https://www.healthnewspapers.com/policy/fda-gras-reform-ultra-processed-food-definition For decades a manufacturer could add a new ingredient and privately decide it was generally recognized as safe without telling the FDA. A proposed rule would end that loophole. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-genglycos-gene-therapy-gsdia-approval https://www.healthnewspapers.com/policy/fda-genglycos-gene-therapy-gsdia-approval GENGLYCOS treats the cause of glycogen storage disease type Ia, not just the symptoms cornstarch regimens manage — but it carries a long list of serious risks and an accelerated-approval asterisk. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-aletta-robotic-blood-draw-device https://www.healthnewspapers.com/policy/fda-aletta-robotic-blood-draw-device The Aletta still needs a trained supervisor in the room, but it locates the vein, inserts the needle and fills the tubes on its own — and one person can now watch three of them at once. Sun, 23 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/hospital-prices-vary-transparency-rules https://www.healthnewspapers.com/policy/hospital-prices-vary-transparency-rules Since 2021, hospitals must post the rates they negotiate with each insurer. The data confirms the same procedure at the same hospital varies widely by which insurer is paying. Thu, 20 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/prior-authorization-what-evidence-shows https://www.healthnewspapers.com/policy/prior-authorization-what-evidence-shows Physician surveys report delays and abandoned treatment; those are self-reported. A harder number: a federal audit found 13% of Medicare Advantage denials met Medicare's own coverage rules. Tue, 18 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/cancer-screening-ages-why-guidelines-disagree https://www.healthnewspapers.com/policy/cancer-screening-ages-why-guidelines-disagree US guidance recommends mammography from 40. A Canadian review of the same randomised evidence put the benefit at 0.27 fewer breast cancer deaths per 1,000 women aged 40-49 over ten years. Tue, 18 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/why-insulin-still-expensive-after-caps https://www.healthnewspapers.com/policy/why-insulin-still-expensive-after-caps Medicare's cap is statutory; the commercial version is a voluntary manufacturer promise with conditions. Before the caps, 1.3 million adults rationed insulin because of cost. Thu, 13 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/acip-immunization-schedule-court-stay https://www.healthnewspapers.com/policy/acip-immunization-schedule-court-stay The advisory committee that shaped U.S. immunization policy for decades was replaced, then bypassed. In March a judge stayed the result. Wed, 12 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/medicare-negotiation-what-changed-which-drugs https://www.healthnewspapers.com/policy/medicare-negotiation-what-changed-which-drugs The prices apply only to 10 drugs, only in Medicare, and only from January 2026. Here is exactly which drugs, by how much, and who actually sees the difference. Tue, 11 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/turkey-physician-brain-drain https://www.healthnewspapers.com/policy/turkey-physician-brain-drain A study of 1,331 physicians put violence ahead of pay. Of 32 doctors who had already emigrated, two were considering coming back — and none of the women were. Wed, 05 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/why-us-drug-prices-highest-how-set https://www.healthnewspapers.com/policy/why-us-drug-prices-highest-how-set Across all drugs, US prices are 2.78 times those in 33 other wealthy countries. The gap is not that Americans use more medicine — it is that no one sets the launch price. Tue, 04 Aug 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-glp1-503b-bulks-list-comment-period-closes https://www.healthnewspapers.com/policy/fda-glp1-503b-bulks-list-comment-period-closes In February, FDA said it intended to act against compounded GLP-1 supply without saying how. The answer arrived in May: exclude semaglutide, tirzepatide and liraglutide from the list. Fri, 31 Jul 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/nmpa-fda-oncology-approvals-comparison https://www.healthnewspapers.com/policy/nmpa-fda-oncology-approvals-comparison A comparison of 2020–2025 approvals finds 94 novel oncology drugs from the NMPA against 87 from the FDA, with China's volume overtaking from 2023. The speed and first-in-class figures run the other way. Tue, 28 Jul 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-simtriyo-centanafadine-adhd-approval https://www.healthnewspapers.com/policy/fda-simtriyo-centanafadine-adhd-approval Simtriyo works on a different neurotransmitter pathway than existing stimulants. But its own manufacturer classifies it as a CNS stimulant, so a scheduling review stands before pharmacy shelves. Sat, 25 Jul 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/pbs-pharmac-cardiovascular-access-divergence https://www.healthnewspapers.com/policy/pbs-pharmac-cardiovascular-access-divergence A first consolidated audit of PBS and PHARMAC cardiovascular listings from 2023 to 2025 finds a widening access gap between two neighbouring countries with similar disease burdens. Tue, 21 Jul 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/ema-chmp-june-2026-avacopan-revocation https://www.healthnewspapers.com/policy/ema-chmp-june-2026-avacopan-revocation The CHMP's June meeting recommended pulling avacopan from the EU market on data-integrity grounds, refused three cell and biological therapies, and reversed itself on a Rett syndrome drug it had earlier rejected. Mon, 20 Jul 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/fda-lipfendra-oral-pcsk9-approval https://www.healthnewspapers.com/policy/fda-lipfendra-oral-pcsk9-approval Lipfendra cut LDL cholesterol by more than half in two trials. Its significance is less the number than the format: a once-daily tablet where every prior PCSK9 inhibitor required a needle. Sat, 18 Jul 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/acip-no-quorum-four-months-after-stay https://www.healthnewspapers.com/policy/acip-no-quorum-four-months-after-stay The appeal is moving on an expedited track, with a status report due this month. But CIDRAP's vaccine-policy trackers make a pointed argument: a working committee could exist right now, if HHS chose to seat one. Fri, 10 Jul 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/aca-marketplace-enrollment-2026-fraud-report https://www.healthnewspapers.com/policy/aca-marketplace-enrollment-2026-fraud-report A new administration analysis estimates 2.9 million people were removed from ACA exchange plans as improperly or fraudulently enrolled — and that 2.6 million more remain. Mon, 29 Jun 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/acip-charter-revised-expertise-requirements https://www.healthnewspapers.com/policy/acip-charter-revised-expertise-requirements The committee's founding document now asks for a 'balanced range' of expertise rather than vaccine-specific knowledge, and adds review of non-vaccine alternatives to its mandate. Fri, 26 Jun 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/japan-long-term-care-insurance-equity https://www.healthnewspapers.com/policy/japan-long-term-care-insurance-equity Twenty-two years of national data show income-related inequities in care use narrowing, and copayment increases for higher earners not reversing that. Services carrying extra user charges are the outlier. Tue, 09 Jun 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/anvisa-oncology-approval-lag-sus-incorporation https://www.healthnewspapers.com/policy/anvisa-oncology-approval-lag-sus-incorporation A comparison of FDA, EMA and ANVISA decisions from 2020 to 2024 finds Brazilian approvals arriving about a year later. A second study clocks the wait for public-system financing in years, not months. Thu, 04 Jun 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/ensitrelvir-xocova-post-exposure-approval https://www.healthnewspapers.com/policy/ensitrelvir-xocova-post-exposure-approval Xocova is taken after a known exposure, not after symptoms appear. In a 2,041-person trial it cut symptomatic infection by 67% through day 10. Wed, 03 Jun 2026 00:00:00 GMT policy https://www.healthnewspapers.com/policy/esc-atlas-2025-safe-hearts-plan-inequality https://www.healthnewspapers.com/policy/esc-atlas-2025-safe-hearts-plan-inequality The ESC Atlas reports 68 million disability-adjusted life years and more than three million cardiovascular deaths a year, with middle-income countries carrying roughly double the mortality of high-income ones. Thu, 28 May 2026 00:00:00 GMT policy