WA Leaders Shape Health Care Reform Legislation
October 8, 2009
Seattle Post-Intelligencer
By Jim Greenwood
Washington state has long been a home for innovative thinkers. From Boeing to Microsoft to Amazon.com, companies based in Washington have pushed the envelope on what’s possible. Senator Patty Murray (D, WA) and Representative Jay Inslee (D, WA-1) have followed suit with their leadership on legislation that would enable biotech companies in Washington and across the nation to continue their quest for innovative cures and therapies to address unmet medical needs.
The most promising medical innovations are coming from biotechnology companies in Washington and across the United States. Among the most advanced innovations are biologics – complex proteins produced by living cells that have been custom designed using our newly acquired understanding of human genetics and DNA. Biologics have added major therapeutic options for the treatment of debilitating diseases (such as cancer, HIV/AIDS, Alzheimer’s, multiple sclerosis and many rare diseases) including some for which no effective therapies were available and others for which previously existing therapies were clearly inadequate.
Because the cutting-edge technology used to create biologics is far more complex than the process used to manufacture chemical-based drugs such as aspirin, there is currently no regulatory pathway for the approval of biosimilars (medicines that are similar to, but not the same as, innovator biologics).
Done correctly, the approval process for biosimilars will protect patient safety, expand competition to reduce costs for consumers, and provide fair incentives for continued biomedical innovation.
During its recent consideration of health care reform legislation, the Senate Health, Education, Labor and Pensions (HELP) Committee adopted an amendment supported by Senator Murray which will provide out a safe, effective and reasonable pathway for approval of biosimilars. The amendment, approved by a bipartisan vote of 16-7, strikes the right balance between expanding competition to lower costs for consumers and preserving incentives for continued biomedical innovation by providing a 12 year period of data exclusivity (during which the Food and Drug Administration cannot rely on the innovator biologic’s safety and efficacy data to approve a competitor’s products). A similar process and timeline currently guides the development of generic versions of traditional pharmaceutical drugs.
The House Energy and Commerce Committee also adopted an amendment to create a pathway for biosimilars during its consideration of healthcare reform legislation. Rep. Inslee championed the amendment which was approved by an overwhelming bipartisan majority in a vote of 47-11. This amendment, like the one approved by the Senate HELP Committee, would provide a safe and reasonable pathway for biosimilars. Rep. Inslee is also a lead sponsor of stand-alone legislation, H.R. 1548, to create such a pathway.
Biotechnology is a capital-intensive sector with a long investment timeline. On average, it takes more than a decade of research and testing and more than one billion dollars to develop a new biotech therapy for patients. The biotech industry consists primarily of small start-up companies that rely on venture capital investment to fund the research and development that leads to breakthrough medicines. In considering biosimilars legislation, Congress must maintain incentives for continued investment in order to realize the full potential of this sector to provide new therapies and even cures to patients.
This issue is particularly important for Washington. The bioscience industry in Washington employs more than 23,000 people. Academic bioscience research expenditures totaled $685 million in 2006, and the state ranked eighth nationally in funding from the National Institutes of Health and outpaced national growth.
Senator Murray and Representative Inslee recognize that incentives for biomedical innovation are critical for patients and their families, and necessary for the biotechnology sector to succeed and grow in Washington.