The Senate HELP Committee today released a discussion draft of legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). BIO represents many small- and mid-size companies that are at the heart of the type of public-private partnerships that are critical to the development of medical countermeasures. Phyllis Arthur, Senior Vice President for Infectious Disease and Emerging Science Policy at BIO, released the following statement:     “The inclusion of a reasonable pricing clause in the PAHPA reauthorization will effectively shut down private sector investment and the type of public-private partnerships that are vital to the development of life-saving medical countermeasures (MCMs). This is especially true for many MCMs that have a limited or no commercial market and rely on these partnerships. It will make us less safe as we work to ensure that our nation’s intelligence, defense and healthcare agencies have the tools they need to defend all Americans from chemical, biological, radiological and nuclear threats, including threats from our adversaries, and to be better prepared for future pandemics.     “Reasonable pricing clauses have been tried in the past at NIH and failed – slowing private investment and engagement across the agency. Once they were revoked, critical partnerships resumed and increased. HELP Committee Chairman Bernie Sanders has indicated that he wants to enact this policy across the government. The result will be that the very sustainable, trusted partnerships that have led to the innovations that protect the nation will be seen as risky investments.  “BIO greatly appreciates the interest in incentives for investment in MCMs and strongly supports those policies in the draft. Efforts to spur innovation, the development of new and faster response capabilities, and prepare for all types of national hazards has always been the purpose of PAHPA, and BIO is committed to supporting provisions that achieve…

The Centers for Medicare & Medicaid Services (CMS) today released its guidance for the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 (IRA). John Murphy, BIO’s Chief Policy Officer, made the following statement:  "As we have stated in the past, the Medicare price setting provisions of the IRA will have a profound and lasting negative impact on innovative medicine development and access in the US.  Nothing in the final guidance released today will change that. Unfortunately, patients – and their loved ones – will be robbed of the future medical innovation that they're so desperately waiting for as this law rolls out.   "CMS took some limited steps in the final guidance that will modestly improve the environment around transparency. Although much more could have been done.   "Notably, we were pleased to see CMS take the reasonable position of allowing affected manufacturers to control some of their own disclosures and confidentiality protections surrounding the negotiation process.   "Similarly, CMS clarified the ability of interested parties and patients to have a voice in the negotiation process.  Moreover, Part D plans are now on notice that MFP-selected drugs are going to have to be accessible to patients once negotiated. Although, it remains unclear how much CMS will increase formulary review to ensure unreasonable utilization management is not implemented as a barrier to access.   "Yet the Agency missed the opportunity to repair damage to the rare disease community and support more meaningful investment in orphan research by allowing new but unapproved orphan designations to retain the orphan exclusion.  We believe CMS has the authority and discretion to make this clarification and to support rare disease patients.  "BIO and our members will continue to pursue all avenues available to protect patient access to…