Gillibrand Seeks More HPAI Info; CDC Reports Second Human Case

The Centers for Disease Control and Prevention (CDC) has identified a second human case of highly pathogenic avian influenza (HPAI or H5N1), coming as the agency advises health entities to keep up monitoring of flu cases throughout the summer for unusual signs and a member of the Senate agriculture committee asks the White House for more information on how it’s responding to the virus. CDC reported Wednesday (May 22) a second U.S. case of HPAI in a human has been...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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CDER, CBER Heads Avoid Weighing In On IRA Innovation Impacts

While emphasizing FDA’s support for innovative drug development, the directors of FDA’s drugs and biologics centers declined to comment on how the Inflation Reduction Act’s (IRA) Medicare drug price negotiation program could impact investment in drug research and development, when asked by House lawmakers Wednesday (May 22) for their take on recent remarks by a high-level biologics official that the law is deterring some investment. The center directors were asked about the issue by Rep. Buddy Carter (R-GA), who described...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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Patient Advocates Tell Congress More NIH Long COVID Funding Needed

Long COVID patient advocates plan to attend a Senate Appropriations Committee hearing Thursday (May 23) on the NIH budget to call for more funding of treatments and cures for patients with lingering symptoms following COVID-19 infection. The organizations Long COVID Campaign, Long COVID Moonshot and Patient Led Research Collaborative are asking Congress to appropriate at least $1.2 billion in fiscal 2025 for long COVID research at the National Institutes of Health. Senate health committee Chair Bernie Sanders (I-VT) has proposed...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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Lawmakers, Health Orgs Advocate Clinical Trial Diversity Steps

Lawmakers have introduced a new bill offering solutions to reduce the financial obstacles to diverse clinical trial participation, while FDA and other agencies undertake multiple initiatives to boost trial diversity -- but FDA’s commissioner acknowledged there are difficult obstacles to overcome in a system not set up for equitable access to care. Rep. Raul Ruiz (D-CA) and Rep. Larry Bucshon (R-IN) recently introduced the Clinical Trial Modernization Act that would incentivize trial diversity in a number of ways, including allowing...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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New Bill Aims To Limit ‘Revolving Door’ Between FDA And Industry

High-level officials at FDA along with the Centers for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) would be barred from working in regulated industry for eight years, in addition to other new ethical requirements aiming to limit the “revolving door” between companies and federal agencies, under recently introduced legislation. While sponsored by Republicans and aimed squarely at public health officials the GOP has targeted since the COVID-19 response, the bill could attract some support from...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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NIH Issues First Policy For Equitable Medicine Access, Price-Control Groups Call It ‘Narrow’

The National Institutes of Health has issued a first-ever policy proposal to use its licensing process to achieve equitable and affordable access to drugs, vaccines, devices and treatments developed from NIH-owned inventions. The move comes as Senate health committee Chair Bernie Sanders (I-VT) and drug price control groups push to expand HHS’ best-price provisions in Project NextGen pharmaceutical contracts to NIH-developed drugs. But the price control groups describe the newly unveiled NIH proposal as “narrow,” as it would only apply...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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Wyden To CMS: Crack Down On Unauthorized ACA Enrollments, Plan Switching

Senate Finance Committee Chair Ron Wyden (D-OR) says CMS should penalize agents and brokers who enroll consumers into Affordable Care Act coverage or switch plans without consent, and have the agency take additional steps, like issuing clear guidelines on acceptable marketing practices, to protect Americans seeking ACA coverage from unauthorized activity that has skyrocketed this year. Wyden also plans to introduce legislation that would let CMS hold agents/brokers criminally liable for their actions. “I write to express my outrage with...
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CMS Issue: 
Inside CMS - 05/23/2024
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Vol. 27, No. 21
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Judiciary Members Seek Floor Vote On Patent Reforms, Schumer Receptive

Members of the Senate Judiciary Committee called on Senate Majority Leader Chuck Schumer (D-NY) to schedule floor votes on bipartisan drug patent reform bills previously passed out of the committee during a Tuesday (May 21) hearing on the prescription drug market, and Schumer’s office told Inside Health Policy he hopes to move them soon. “Sen. Schumer is supportive of the bills and wants to move them at the next available opportunity. In terms of how to spend the savings...
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IDP Issue: 
Inside Drug Pricing - 05/27/2024
IDP Volume: 
Vol. 7, No. 22
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PTs Wary Of Temporary Telehealth Extensions

Updated Story Physical therapists are concerned the two-year telehealth and certain permanent extensions bills from the House Energy & Commerce and Ways & Means committees do not directly mention virtual physical and speech therapy reimbursement, creating uncertainty over whether therapists should invest in telehealth technology. Therapists and physical therapist organizations are supportive of payment parity between in-person and virtual appointments due to the increased cost incurred by new technology and assistants in brick-and-mortar offices. The additional guardrails...
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Experts See Possible Funding, Public Trust Pitfalls In HPAI Response

Experts on public health preparedness and viral surveillance are praising the federal government’s coordinated response so far to the ongoing outbreak of highly pathogenic avian influenza (HPAI or H5N1), but they see potential obstacles ahead for public health agencies, including a lack of ongoing funding and genomic surveillance as well as distrust from farmers who will need to cooperate with testing efforts. FDA, the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture are leading the...
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FDA Issue: 
FDA Week - 05/24/2024
FDA Volume: 
Vol. 30, No. 21
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