FTC’s Device Patent Focus May Let FDA Off Hook On Orange Book Clarity

Drug industry lawyers say the Federal Trade Commission’s stepped-up efforts through the courts and its own regulatory actions to stop drug makers from using device patents to block marketing of generic combination products could take some pressure off FDA to clarify its Orange Book stance. FTC officials recently put industry on notice it might go after more drug companies than the 10 inhaler makers it recently sent letters to, and on Monday (April 8) again repeated their calls for drug...
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InsideHealthPolicy.com
FDA Issue: 
FDA Week - 04/12/2024
FDA Volume: 
Vol. 30, No. 15
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FTC’s Device Patent Focus May Let FDA Off Hook On Orange Book Clarity

Drug industry lawyers say the Federal Trade Commission’s stepped-up efforts through the courts and its own regulatory actions to stop drug makers from using device patents to block marketing of generic combination products could take some pressure off FDA to clarify its Orange Book stance. FTC officials recently put industry on notice it might go after more drug companies than the 10 inhaler makers it recently sent letters to, and on Monday (April 8) again repeated their calls for drug...
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InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 04/15/2024
IDP Volume: 
Vol. 7, No. 16
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CDC Provides New Recommendations, But Few Details, On Avian Flu

The Centers for Disease Control and Prevention (CDC) is issuing more recommendations in response to a human infection with a strain of highly pathogenic avian influenza (HPAI or H5N1) in Texas, but is providing limited detail on its efforts to step up surveillance and diagnostics, while European health authorities have called for response to avian flu to include seasonal flu vaccination, enhanced surveillance and access to rapid diagnostics. In response to questions from Inside Health Policy about surveillance and...
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FDA Issue: 
FDA Week - 04/12/2024
FDA Volume: 
Vol. 30, No. 15
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Experts Urge FDA To Define Key Terms In Upcoming Guidance On AI Use

As FDA’s drug center gears up to issue guidance on use of artificial intelligence to enhance its regulatory decision-making, industry experts are urging the agency to provide explicit definitions for the terms "safe," "responsible," and "ethical" use of AI rather than leaving the terms open for interpretation. Wendy Cheng, managing director in Berkeley Research Group (BRG), tells Inside Health Policy that FDA needs to clearly state in its forthcoming guidance what exactly it means for AI to be used...
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InsideHealthPolicy.com
FDA Issue: 
FDA Week - 04/12/2024
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Vol. 30, No. 15
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Schumer: Senate Could Tackle Insulin, Health Care Costs; Internet Access; Fentanyl With Bipartisan Support

Senate Majority Leader Chuck Schumer (D-NY) has an ambitious agenda for the Senate's return to Washington this week that includes lowering costs for prescription drugs like insulin, lowering other health care costs, combatting the fentanyl crisis and expanding internet access to low-income communities. However, Schumer emphasized in a Friday (April 5) Dear Colleague letter that achieving these legislative goals depends on cooperation from his colleagues across the aisle. He urged Senate Republicans to reject the "extreme MAGA demands" outlined in...
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CMS Issue: 
Inside CMS - 04/11/2024
CMS Volume: 
Vol. 27, No. 15
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House Judiciary Panel Continues Review Of AI Impacts On IP

A House Judiciary subcommittee has announced its third in a series of hearings to examine the potential impacts and the possible need for new laws and rules to protect intellectual property from emerging AI technologies. “The House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet will hold a hearing on Wednesday, April 10, 2024, at 10:00 a.m. ET” to “examine the standards and policy considerations that should be applied to whether intellectual property (IP) protection should be given to...
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House Judiciary Panel Continues Review Of AI Impacts On IP

A House Judiciary subcommittee has announced its third in a series of hearings to examine the potential impacts and the possible need for new laws and rules to protect intellectual property from emerging AI technologies. “The House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet will hold a hearing on Wednesday, April 10, 2024, at 10:00 a.m. ET” to “examine the standards and policy considerations that should be applied to whether intellectual property (IP) protection should be given to...
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InsideHealthPolicy.com
FDA Issue: 
FDA Week - 04/12/2024
FDA Volume: 
Vol. 30, No. 15
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House, Senate Commerce Chairs Unveil Privacy Bill That Wouldn’t Preempt State Health Laws, Makes FTC Enforcer

House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Commerce Committee Chair Maria Cantwell (D-WA) released draft federal privacy legislation Sunday (April 7) that aims to eliminate a patchwork of state requirements while protecting more stringent state privacy laws on health care records, information and certain medical testing, and tapping the Federal Trade Commission as the federal privacy enforcer. The draft bipartisan, bicameral legislation would set clear national data privacy rights and protections and establish enforcement mechanisms...
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House, Senate Commerce Chairs Unveil Privacy Bill That Wouldn’t Preempt State Health Laws, Makes FTC Enforcer

House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Senate Commerce Committee Chair Maria Cantwell (D-WA) released draft federal privacy legislation Sunday (April 7) that aims to eliminate a patchwork of state requirements while protecting more stringent state privacy laws on health care records, information and certain medical testing, and tapping the Federal Trade Commission as the federal privacy enforcer. The draft bipartisan, bicameral legislation would set clear national data privacy rights and protections and establish enforcement mechanisms...
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Breaking Privacy News
FDA Issue: 
FDA Week - 04/12/2024
FDA Volume: 
Vol. 30, No. 15
CMS Issue: 
Inside CMS - 04/11/2024
CMS Volume: 
Vol. 27, No. 15
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FDA Stands Up Committee For Avian Influenza Response

FDA is closely monitoring highly pathogenic avian influenza (HPAI) and has sent up a response group following a human case recently reported in Texas, the head of the agency’s human food program said. The infected individual had exposure to dairy cattle presumably infected with the disease and health officials say risk to the public remains low , but concerns have been sparked that an outbreak could have significant impacts on agriculture. Speaking in a webinar hosted by the Alliance for...
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InsideHealthPolicy.com
FDA Issue: 
FDA Week - 04/12/2024
FDA Volume: 
Vol. 30, No. 15
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