CHI Responds to Congressional Follow-On Biologics Questions
On Friday, May 2, CHI submitted responses to questions provided by the Chairman and Ranking Member of the House Energy and Commerce Committee's Health Subcommittee about establishing a pathway for the approval of follow-on biologics, or biosimilars.  The nearly 50 questions addressed topics including science and safety, regulatory and administrative, interchangeability, patents, incentives, exclusivity and investment, economic impact, and the European model's abbreviated approval pathway.  Considering the complexity of genetically engineered product development and manufacturing, CHI believes that it is possible to develop a successful, science-based follow-on biologics approval pathway. CHI hopes our responses to these important questions will be considered during the development of the pathway.  For more information, contact Todd Gillenwater, CHI vice president-public policy (202-974-6313 or gillenwater@chi.org).

Energy and Commerce Committee Focuses on Drug Safety
Over the past two weeks, leaders from the U.S. Food and Drug Administration (FDA), including Commissioner Andrew von Eschenbach and Deputy Commissioner Janet Woodcock, have testified at a series of hearings at the House Energy and Commerce Committee about the ability of the agency to monitor the safety of drugs, biologics, medical devices and other imports entering the U.S.  In the wake of the recent heparin crisis, where a tainted ingredient by a Chinese manufacturer led to 81 deaths in the U.S., Congress has stepped up its oversight of the FDA as lawmakers look to move legislation to ensure the safety of imported goods.  During testimony, both von Eschenbach and Woodcock focused on a lack of resources, telling lawmakers that the agency will need hundreds of millions of dollars annually to be able to inspect foreign sites every other year as outlined in the legislation.  CHI continues to advocate for a higher level of federal funding to provide FDA with the resources necessary to effectively fulfill its mission.  Committee Chairman John Dingell, who is sponsoring the bill, has proposed raising $300 million in industry user fees to cover the costs.  Also central to hearings and the legislation is the issue of a national pedigree or track and trace standard that will monitor and regulate all dangerous drugs sold in the U.S.  CHI has been active on this issue in California, and will work with policy makers and stakeholders to ensure that patients have access to safe and reliable medicines.  For more information, contact David Burt, CHI legislative director (858-551-6677 or burt@chi.org).

CMS Releases Proposed Inpatient Rule
On April 14, the Centers for Medicare and Medicaid Services (CMS) released its proposed hospital Inpatient Prospective Payment System (IPPS) rule.  In the proposed rule, CMS addressed a number of issues important to the CHI membership, including charge compression, new technology add-on payments, gainsharing and completion of the three-year phase-in of cost-based weights and the two-year phase-in of Medicare Severity Diagnosis Related Groups (MS-DRGs).  CHI's Coverage Working Group will review the proposed rule and submit comments in response to CMS by the June 13, 2008 deadline.  For more information, contact Todd Gillenwater (202-974-6313 or gillenwater@chi.org).

California Biomedical Industry Honors Congressman Mike Thompson
Congressman Mike Thompson, (D-St. Helena), was honored by the California Healthcare Institute on Wednesday, April 23, for his thoughtful leadership in advancing biomedical science, biotechnology, pharmaceutical and medical device innovation.  The award was presented by CHI Chairman Henry L. Nordhoff, chairman and chief executive officer of Gen-Probe, Incorporated, at a CHI dinner in Washington, D.C.  As a member of the House Ways and Means Committee, Congressman Thompson has been influential in support of the state’s life sciences community, harboring relationships and discussions that help lead to sound policy decisions that promote continued medical innovation in the state.  In his acceptance speech, Thompson talked about our industry’s need to build stronger political support to achieve its goals of continuing innovation and improving access to advanced medicine.

Californians Pushing for Seats on Committee of Importance to CHI
Congressman Jerry McNerney (D-Stockton) and Congresswoman Doris Matsui (D-Sacramento) have joined a short list of Democratic lawmakers vying for one of three opening seats on the House Energy and Commerce Committee.  Rep. Albert Wynn (D-MD) is scheduled to leave office in June, and Reps. Darlene Hooley (D-OR) and Tom Allen (D-ME) will be leaving at the end of the calendar year.  Democratic leadership and rank-and-file sources have said that one of the Californians has the inside track to become Wynn’s replacement.  The Energy and Commerce Committee has jurisdiction over issues critical to the CHI membership, including biomedical research and development, health and healthcare facilities, public health as well as general interstate and foreign commerce.