FDA Officials Eye AI Integration In Clinical Trials, Grapple With Bias Concerns

FDA’s medical policy chief signals that the agency is open to various uses of artificial intelligence, including integrating the technology into the design and conduct of clinical trials. At the same time, FDA and other health agencies are grappling with how to ensure the data in AI models don’t reproduce bias or produce recommendations that can’t be explained. The remarks by the drug center official cast a more optimistic light than recent statements by the FDA commissioner and biologics center...
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FDA Issue: 
FDA Week - 06/14/2024
FDA Volume: 
Vol. 30, No. 24
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J&J’s Stelara Deemed Unaffordable For Colorado Residents By PDAB

Colorado’s prescription drug affordability board (PDAB) unanimously voted Friday (June 7) that Janssen Biotech’s Stelara, approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, is unaffordable for the state’s residents despite protests from the company. Although the board hasn’t yet decided whether to set an upper payment limit mandating lower pricing, the decision raised concerns from some members of the public that it could lead to Stelara no longer being sold in Colorado. Johnson &...
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FDA Issue: 
FDA Week - 06/14/2024
FDA Volume: 
Vol. 30, No. 24
CMS Issue: 
Inside CMS - 06/13/2024
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Vol. 27, No. 24
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J&J’s Stelara Deemed Unaffordable For Colorado Residents By PDAB

Colorado’s prescription drug affordability board (PDAB) unanimously voted Friday (June 7) that Janssen Biotech’s Stelara, approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis, is unaffordable for the state’s residents despite protests from the company. Although the board hasn’t yet decided whether to set an upper payment limit mandating lower pricing, the decision raised concerns from some members of the public that it could lead to Stelara no longer being sold in Colorado. Johnson &...
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IDP Issue: 
Inside Drug Pricing - 06/10/2024
IDP Volume: 
Vol. 7, No. 24
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Moderna Submits JN.1 COVID Vaccine Application Following FDA Advice

Moderna has submitted an application to FDA for a 2024-2025 formula of its mRNA COVID-19 vaccine targeting the JN.1 strain of the virus, the company announced Friday (June 7), after receiving guidance from the agency advising that strain should be used. FDA’s top biological official Peter Marks sparred with agency advisors over strain selection this week, with Marks advocating for selecting the KP.2 strain, which only mRNA vaccine makers can produce in time for the fall respiratory virus season, while...
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FDA Issue: 
FDA Week - 06/14/2024
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Vol. 30, No. 24
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CMS Approves Oregon’s BHP Blueprint, With Coverage To Begin In July

CMS approved Oregon’s basic health program (BHP) blueprint Friday (June 7), and coverage for residents earning just above the income threshold for Medicaid will start on July 1. Enrollees will receive a benefits package, including all essential health benefits listed in the Affordable Care Act (ACA), and will not be charged premiums or other cost sharing. Oregon estimates about 102,000 residents will enroll in the BHP by 2025. The ACA created the BHP model, which is a health care program...
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CMS Unveils Primary Care Flex Model RFA, Opens Application Window

CMS last Thursday (May 30) published its request for applications (RFA) for the previously announced model meant to test payment mechanisms that support primary care in lower revenue accountable care organizations (ACOs) participating in the ongoing Medicare Shared Savings Program (MSSP). The agency is accepting applications through Aug. 1, which is the first of a three-phase application process for the ACO Primary Flex Model (PC Flex Model) that also demands ACOs provide CMS with a spending plan, a roster of...
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CMS Issue: 
Inside CMS - 06/13/2024
CMS Volume: 
Vol. 27, No. 24
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Admin Unveils Data Showing Coverage Gains, Announces $500M In Navigator Grants

The Biden administration on Friday released new data illustrating the gains in health care coverage, particularly in minority communities. The administration also announced $500 million in grants will be made available to navigators over the next five years, starting with $100 million in fiscal 2024, the largest investment in the program to date. The coverage gains are partially due to the administration’s efforts to increase access to care, especially in underserved communities, HHS says in a release that also highlights...
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Inside CMS - 06/13/2024
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Vol. 27, No. 24
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Coalition Presses Senate Finance To Hold Hearing On Site-Neutral Policies, APTCs

A coalition of nearly 50 organizations, including advocates, businesses, unions, providers, and other health care stakeholders, is urging the Senate Finance Committee to hold a hearing on the high cost of health care in America and specifically discuss enacting site-neutral payments for drug administration services and requiring off-campus hospital outpatient departments (HOPDs) to use separate billing identifiers to prevent overcharging -- policies from the House's landmark health care transparency package that passed last December but has yet to be taken...
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CMS Issue: 
Inside CMS - 06/13/2024
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Vol. 27, No. 24
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Safety Concerns Remain Ahead Of FDA Ad Comm On Donanemab

FDA is widely expected to approve Eli Lilly’s Alzheimer’s drug donanemab following a meeting of its Peripheral and Central Nervous System Drug Advisory Committee meeting Monday (June 10). But some scientists are warning that Lilly’s trial data of the drug is incomplete, and FDA would be relying on the company to make safety and efficacy decisions on the drug. In a briefing document posted online Thursday (June 6), FDA said brain bleeding, infusion-related reactions and hypersensitivity remain significant safety concerns...
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FDA Issue: 
FDA Week - 06/14/2024
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Vol. 30, No. 24
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Expected E&C Markup May Include Telehealth, Lawmakers Await CBO Score

Lawmakers are considering including telehealth legislation in an expected full House Energy & Commerce Committee markup on Wednesday (June 12) but will only include it if the Congressional Budget Office scores some of the bill’s provisions, sources say. Although lobbyists are unsure what bills will be included in the markup, legislation extending telehealth flexibilities for two years, the Telehealth Modernization Act, was passed out of E&C’s health subcommittee and currently is unscored by CBO. An official announcement of the markup...
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