Makers of medical devices and pharmaceuticals face a significant risk of product liability litigation, but the use of third-party funding of such lawsuits is a novelty in the U.S. relative to some other Western nations. Nonetheless, a new report by the U.S. Government Accountability Office (GAO) makes clear that third-party litigation funding (TPLF) is an increasing common practice that seeks to include uninjured parties in mass tort litigation, thus endangering the fortunes of those who invest in life science companies.
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Cidara, Fabre-Kramer, Immuron, Inhibikase, Oncotelic, Poxel, Tango.
Fraud perpetrated on U.S. federal health care programs is the stuff of nightmares among U.S. enforcement agencies, and yet another pair of fraudsters have been rounded up by the Department of Justice (DOJ).
Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022.
More than one U.S. federal government agency is tasked with keeping track of fraud and abuse of federal health programs, but a new report by the Government Accountability Office (GAO) suggests there is more work to be done. The GAO report said that one of the key issues with fraud and abuse writ broadly is that the terms and definitions are used inconsistently, and that a fix for this and other problems might capture more fraud, which may in turn indirectly put more medical device makers at risk for such allegations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Geneseeq Technology, Tidepool.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Axcella, Biontech, Carina, Cullinan, Decibel, Diamond, Immpact, Kura, Oxular, Pfizer, Polypid, Verrica.
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