The House Energy & Commerce Committee today unveiled a new package for the Prescription Drug User Fee Act (PDUFA). After the release, BIO’s Chief Science Officer, Cartier Esham, made the following remarks:  "For more than thirty years, the FDA user fee programs have shown tremendous results in delivering life-saving medicines to patients who urgently need them.  These agreements between the industry and FDA include important provisions to improve the use of real-world evidence, modernize, streamline, and diversify clinical trials, and ensure that the Agency has the resources necessary to support the world-leading innovation our companies bring to patients every day.    "While we are still analyzing the bill, we are pleased to see bipartisan support from the Energy & Commerce Committee for these critical public health programs.  We are further encouraged that the Committee recognizes the importance of a timely reauthorization and has worked together to develop a bill that will continue the shared goal of transforming and improving patients’ lives for years to come.  We look forward to working with the Committee on in the coming weeks to achieve that goal."

 USTR this week released its 2022 Special 301 Report. BIO, after reviewing the report, released the following statement: We welcome USTR’s efforts to address IP-related concerns for U.S.-based biotech enterprises in China, especially concerning China’s coercive technology transfer policies, patent prosecution, and patent enforcement obstacles. USTR’s emphasis on monitoring China’s progress in implementing its Phase One Agreement commitments to address these longstanding IP matters is encouraging.  U.S.-based biotech companies are drivers of economic growth and stability. In addition to spearheading innovation in their respective sectors, they employ over 1.87 million workers within U.S. borders.  IP-enabled innovations contribute to the robust strength of the U.S. economy and propel the quintessentially American entrepreneurial spirit, which is the hallmark of the biotech sector. They further promote economic development across sectors and foster inclusive and high-paying jobs for American workers.  Strong and predictable IP systems also cultivate partnerships around the world, enhance knowledge sharing, support the entrepreneurial journey, and ultimately ensure that innovation is resourced and funded appropriately. This ensures technologies with the potential to deliver better care for patients and products for consumers around the world are developed. The current, unchecked deterioration of IP rights globally has significant medium- and long-term implications for the broader U.S. private sector and, consequently, for our nation’s economic interests.  Absent adequate IP protections, U.S. biotech companies are unable to innovate, invest, and create jobs in the United States. Strengthening the global policy environment for the commercialization of IP-enabled innovations should, therefore, be a priority for this Administration.   We are nevertheless disappointed with USTR’s decision to include support for waiving critical IP…