A Backwards Approach: Expanded Access Drives Tpoxx Trial Design That Limits Placebo Control
US may be making common crisis-era mistake with Tpoxx trial design that prioritizes access over knowledge, ultimately restraining development of data needed to make the best treatment decisions with the potential Monkeypox treatment, particularly for the most vulnerable patients.
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Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All
Media reports have emphasized the public’s frustration with gaining access to Tpoxx, an antiviral that may help treat monkeypox. But top officials at FDA, CDC and NIH defend the need to study the drug more first, even as they note they are making expanded access easier.
Convalescent Plasma EUA ‘Could Have Been Done Better’ But Not A ‘Total Catastrophe’ – FDA’s Marks
Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.
Value-Based Pricing Bill with New Protections for Medicare and Medicaid Clears House Panel
Energy and Commerce Committee made some changes to a Trump-era regulation designed to make it easier for manufacturers to enter into value-based drug pricing contracts with commercial payers to limit unintended consequences for Medicaid and Medicare, but most Democrats say the tweaks don’t outweigh the harms of codifying the regulation.