HHS yesterday released three payment models for testing by CMS, which HHS believes will lower the cost of prescription drugs. BIO's Chief Policy Officer, John Murphy, made the following statement: "Today, the Department of Health and Human Services released a report outlining several proposals the Agency believes will lower the cost of prescription medicines. It was unfortunate to see the report repeat several long-debunked issues related to the pricing of medicines. Several of HHS’ proposed demonstration programs seem to be a positive step in delivering what BIO has long pushed the government to do: address the real problems underlying prescription drug pricing – patient out-of-pocket expenses and better payment systems that reward the value a medicine brings to the patient and the overall healthcare system. In proposing to test generic copayment caps in the Part D program and seeking to enhance access to cell and gene therapies through multi-state outcomes-based payment arrangements, HHS is making strides to deliver true relief to patients at the pharmacy counter while also ensuring incentives remain for innovation to help those patients still awaiting a discovery that one-day might help them. In these two proposed demonstration programs, BIO looks forward to working with HHS. "Unfortunately, in its third proposal, HHS misses the mark significantly. By proposing to penalize companies for utilizing surrogate endpoints in an effort to get groundbreaking and necessary treatments to patients, HHS is putting its thumb on the scale against innovation. "The accelerated approval pathway encourages scientific and medical advancement and innovation by leveraging the use of surrogate or intermediate clinical endpoints that are reasonably likely to predict clinical benefit. Drugs granted accelerated approval must meet the same statutory standards of safety and substantial evidence of effectiveness as those granted traditional approval. Innovative manufacturers…

Mexico’s new decree creates more questions than answers. The decree still wrongly calls into question the safety of products of agricultural biotechnology for human consumption by creating a non-science-based distinction of corn used for food and corn used for feed and industrial uses. The decree also does not provide any commitment that Mexico’s regulators will return to a science- and risk-based regulatory approval process for all agricultural biotechnology products in the future. BIO appreciates the U.S. government’s ongoing efforts to hold Mexico to its USMCA commitments and its recent request that Mexico provide the justification behind its past decree on biotech corn and the rejections of new biotech seed traits. While BIO has supported dialogue to resolve this issue, it has become necessary for USTR to request consultations with Mexico over its treatment of agricultural biotechnology in order to provide a framework and timeline to resolve this issue.