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Senators offer drug safety options
Washington, D.C.-After months of negotiations, Sens. Mich?l Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) unveiled their long-anticipated bill to improve FDA oversight of drug safety. By including something for everybody-registration and results disclosure of clinical trails, limits on advisory committee conflicts of interest, support for Critical Path research-the legislation (S. 3807) puts down a marker for Congressional action on drug safety next year.
WASHINGTON, D.C.-After months of negotiations, Sens. Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) unveiled their long-anticipated bill to improve FDA oversight of drug safety. By including something for everybody-registration and results disclosure of clinical trails, limits on advisory committee conflicts of interest, support for Critical Path research-the legislation (S. 3807) puts down a marker for Congressional action on drug safety next year.
Unlike earlier legislation sponsored by Sens. Charles Grassley and Chris Dodd, the bill does not establish a separate FDA drug safety office, and it does not give FDA specific authority to mandate post-marketing studies. Instead, the measure sponsored by these leaders of the Senate's Health, Education, Labor and Pensions (HELP) Committee clarifies FDA authority to require risk management plans and to levy fines for non-compliance.
The centerpiece of the bill requires manufacturers to develop Risk Evaluation and Management Strategies (REMS) as part of drug development. Such plans would explain a company's adverse events monitoring program and whether there was a need for post-approval studies, additional patient information or restrictions on product distribution and advertising. The legislators anticipate that only a few drugs would warrant limits on distribution and use, as has been the case in the past. Disputes between FDA and manufacturers over risk management strategies would be resolved by a set system to avoid lengthy delays and costly legal fights. But companies that fail to comply with a REMS element would face strong penalties.
The bill calls for a new system for screening candidates for FDA advisory committees to reduce conflicts of interest, and it provides government support for a new research institute to develop tools to facilitate assessment of drug safety and efficacy.
Bridging the Diversity Gap in Rare Disease Clinical Trials with Harsha Rajasimha of IndoUSrare
November 8th 2023Briana Contreras, an editor with Managed Healthcare Executive, spoke with Harsha Rajasimha, MD, founder and executive chairman of IndoUSrare, in this month's episode of Tuning in to the C-Suite podcast. The conversation was about how the disparity in diversity and ethnicity in rare disease clinical trials in the U.S. has led to gaps in understanding diseases and conditions, jeopardizing universal health, and increasing the economic burden of healthcare.
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Managing Editor of Managed Healthcare Executive, Peter Wehrwein, had a discussion with William Shrank, M.D., a venture partner with Andreessen Horowitz, a venture capital firm in Menlo Park, California, about how artificial intelligence's role is improving healthcare, where we are today with value-based care and the ongoing efforts of reducing waste in the healthcare space for this episode of the "What's on Your Mind" podcast series.
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Air Pollution May Negatively Affect Male Reproductive Health
November 30th 2023A potential mechanism by which air pollutants may affect reproductive health is by endocrine disruption. Air pollutants are made up of mixtures of particulate matter that may include endocrine disruptors, such as polycyclic aromatic hydrocarbons (PAHs) and heavy metals.
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35th World AIDS Day Marks 20 Years of PEPFAR: Challenges and Strategies to Combat HIV/AIDS
November 29th 2023PEPFAR, having invested $100 billion and saved 25 million lives in the global fight against HIV/AIDS, faces Congressional hurdles in its reauthorization due to abortion debates. Despite widespread support and no evidence of abortion-related activities, the legislative process is at a standstill. Members of PEPFAR and authors of a recent editorial stress the significance of PEPFAR and advocate for integrating behavioral and social science into healthcare programs to achieve UNAIDS targets and address barriers in HIV/AIDS testing and treatment.
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