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Teva has asked the Supreme Court to look at a judgment in a $235 million patent dispute with GSK that it claims could undermine the ability of generic drugmakers to bring new products to market, and thereby help reduce drugprices. The substance patent expired in 2007.
Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drugprice negotiations.
General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare DrugPrice Negotiation Program (DPNP). It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.
In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”.
3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. 11, December 2017, [link] www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight- Vol11-Dec-2017.pdf. 29 Julia C.
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