House Concurrent Resolution No. 48




            Whereas, it is the goal of the Missouri General Assembly to promote better health outcomes for Missourians by exploring innovation and life sciences, high-tech jobs, and economic growth; and


            Whereas, bioscience firms conducting business in Missouri are actively facilitating life science discovery to develop medicines targeting cancers, rare diseases, and other critical conditions which will lead to significant economic development opportunities; and


            Whereas, biopharmaceutical companies supported a total of 65,192 jobs in Missouri in 2006 - 10,884 directly in the sector and 54,307 in other sectors; and


            Whereas, direct biopharmaceutical wages in Missouri were estimated to be $1 billion in 2006, resulting in an estimated $251.1 million in federal taxes and $39.5 million in state taxes; and


            Whereas, in 2008, United States scientists and researchers were conducting 21,795 studies to develop medicines targeting cancers, rare diseases, and other important conditions, with 2,397 of these trials active in Missouri; and


            Whereas, Missouri has research universities and bioscience companies which play a key role in the discovery of cures and treatments for diseases that were previously thought incurable, and the Missouri General Assembly wishes to ensure that these universities and companies remain viable to develop medicines that promote public health, encourage job creation, and foster economic growth; and


            Whereas, on average, it requires over $1.2 billion and 10-15 years to discover, develop, and secure United States Food and Drug Administration (FDA) approval to bring a new biologic medicine to the market, and it is imperative that bioscience companies are able to recoup sufficient financial returns to justify investing in this critically important enterprise; and


            Whereas, biologics are today's most advanced medicines and include many of the latest breakthrough medical therapies for serious and life-threatening illnesses such as cancer, multiple sclerosis, diabetes, HIV/AIDS, and many serious rare diseases; and


            Whereas, the Missouri General Assembly believes that balanced biosimilar legislation should include a provision that provides pioneer bioscience companies with 14 years of exclusive use of the costly, proprietary data they must produce to secure FDA approval before a biosimilar manufacturer may acquire this data without cost; and


            Whereas, the Missouri General Assembly wishes to ensure that patient safety is the primary concern of the FDA when approving both pioneer and biosimilar drugs, and the Missouri General Assembly recognizes that biosimilar manufacturers may not be required to duplicate all tests required of the pioneer manufacturer; and


            Whereas, the Missouri General Assembly believes that all Missourians will benefit from more affordable and more innovative biological medicines to improve health outcomes, as well as by the creation of jobs and economic growth associated with bioscience research and development activities conducted by universities and bioscience industry:


            Now, therefore, be it resolved that the members of the House of Representatives of the Ninety-fifth General Assembly, First Regular Session, the Senate concurring therein, hereby urges the United States Congress to adopt balanced biosimilar legislation that provides reasonable incentives that will foster the research and development of next generation, life-saving biological medicines as well as job creation and economic expansion, and encourages the creation of a transparent, science-based regulatory review system that will allow a fair and prompt FDA review of biosimilar products so consumers may benefit from increased price competition as soon as appropriate; and


            Be it further resolved that the Chief Clerk of the Missouri House of Representatives be instructed to prepare properly inscribed copies of this resolution for the President of the United States Senate, the Speaker of the United States House of Representatives, and each member of the Missouri Congressional delegation.