As FDA Warns Of Compounded Ketamine, Pharmacists Offer Guide

Updated Story The Alliance for Pharmacy Compounding (APC) released a best practice guide for compounding pharmacies that offers recommendations on the preparation of ketamine drugs while the advocates criticize FDA for warning consumers about safety risks of compounded ketamine therapies without taking actions to make the treatments safe. In March, FDA proposed a new rule that would create new lists of drugs that cannot be legally compounded and establish a process where stakeholders can submit products they...
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FDA Week - 04/19/2024
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CDER Director Cavazzoni Highlights Center’s Modernization Work

Updated Story FDA’s drug center is striving to keep up with innovation in medical technology and an increased amount of data to analyze around regulatory decisions for drugs, according to its director, who promotes initiatives that ramp up a focus on quantitative data analysis, encourage innovative clinical trial approaches and make sure its advisory committees are fit for purpose. In an interview with Inside Health Policy , Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni...
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E&C Explores Strategies To Curb Improper Medicare And Medicaid Payments

Congress and CMS could tackle the billions of dollars in improper payments in Medicare and Medicaid by improving data sharing between states and the agency, leveraging artificial intelligence (AI) to enhance data collection and analytics -- an idea that HHS’ OIG is now piloting -- and strengthening oversight, including by encouraging more state audits of Medicaid managed care plans, key federal officials told the House Energy & Commerce subcommittee on oversight and investigations during a Tuesday (April 16) hearing on...
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E&C Members Consider Amending HIPAA, Privacy Bill To Prevent Cyberattacks

As House Energy & Commerce Committee members weigh strategies to improve responses to future attacks on health organizations in the wake of the Change Healthcare cyberattack, a key physician group is suggesting Congress amend the Health Insurance Portability and Accountability Act (HIPAA) to give health care entities more clearinghouse options during catastrophic events. Lawmakers told Inside Health Policy modifying HIPAA and adjusting privacy legislation are strategies being considered among committee members. America’s Physician Groups are urging lawmakers to amend...
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SAMHSA Telehealth Rule Faces Obstacles From States, Payers

Though the Substance Abuse and Mental Health Services Administration codified the ability for patients in opioid treatment program to access medications through telehealth earlier this year, opioid treatment program executives say that the new regulation will not have an equal effect for patients across the country. SAMHSA set the federal floor and allowed OTPs to use telehealth for patient intake and induction to methadone and buprenorphine and gave significant flexibility for the use of audio-only telehealth to receive OTP services...
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SAMHSA Telehealth Rule Faces Obstacles From States, Payers

Though the Substance Abuse and Mental Health Services Administration codified the ability for patients in opioid treatment program to access medications through telehealth earlier this year, opioid treatment program executives say that the new regulation will not have an equal effect for patients across the country. SAMHSA set the federal floor and allowed OTPs to use telehealth for patient intake and induction to methadone and buprenorphine and gave significant flexibility for the use of audio-only telehealth to receive OTP services...
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Hospitals Slam HHS Drug Shortage Proposal For Overlooking GPOs

Industry stakeholders say HHS’ proposal to combat drug shortages by incentivizing hospitals to change their buying practices is overlooking the role of wholesalers and group purchasing organizations (GPOs) that control 90% of generic drug purchasing for most hospitals. One major hospital group says its members are “customers” in the drug supply chain and manufacturers, distributors, GPOs and FDA have a more “direct” role in ensuring the supply chain’s resilience. The Association for Accessible Medicines (AAM), which lobbies for generic drug...
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Hospitals Slam HHS Drug Shortage Proposal For Overlooking GPOs

Industry stakeholders say HHS’ proposal to combat drug shortages by incentivizing hospitals to change their buying practices is overlooking the role of wholesalers and group purchasing organizations (GPOs) that control 90% of generic drug purchasing for most hospitals. One major hospital group says its members are “customers” in the drug supply chain and manufacturers, distributors, GPOs and FDA have a more “direct” role in ensuring the supply chain’s resilience. The Association for Accessible Medicines (AAM), which lobbies for generic drug...
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FDA Issue: 
FDA Week - 04/19/2024
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Poll: Adults Less Likely To Vaccinate Themselves Than Their Children

The majority of voters favorably view vaccines approved by FDA and are optimistic about the role of future vaccines in preventing health problems, according to a poll conducted earlier this year and released by the Partnership to Fight Infectious Disease (PFID). But respondents were significantly less likely to keep up with adult vaccination than to get their children vaccinated, highlighting what some experts say is a lack of data on vaccines for adults. The PFID poll released Monday (April 15)...
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Experts Debate Vaccine Prioritization For Pandemic Threats, Neglected Diseases

Industry experts are grappling with the challenge of how to prioritize investment in vaccine development for future pandemic risks while also incentivizing development of vaccines for existing health problems like neglected tropical diseases. “One of the big issues is how do you balance the needs of pandemic threats . . . . and chronic and debilitating neglected diseases that are clearly a problem,” Peter Hotez, director of the Center for Global Health and Diseases at Baylor College of Medicine, said...
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