Legislation to Overturn Supreme Court Decision Threatens Medical Device Makers
Democrats in the House, led by Reps. Henry Waxman (D-Los Angeles) and Frank Pallone (D-NJ), introduced legislation on Thursday, June 26, that would overturn the recent Supreme Court ruling in Riegel v. Medtronic, protecting medical device makers whose Class III products have been granted U.S. Food and Drug Administration (FDA) approval against state tort lawsuits.  Under the ruling, a company that knowingly withholds information from the FDA during the pre-market approval process or that manufactures a product that does not meet the approved standards could still face litigation under state law.  CHI believes that H.R. 6381, the Medical Device Safety Act of 2008, would undermine the FDA by allowing lay juries to second-guess the FDA’s expert scientific analysis regarding a device’s safety and effectiveness.  Subjecting device manufacturers to inconsistent state laws would generate widespread regulatory confusion and discourage research and development of important new devices.  California co-sponsors include Reps. Joe Baca (D-San Bernardino), Howard Berman (D-Van Nuys), Lois Capps (D-Santa Barbara), Bob Filner (D-Chula Vista), Zoe Lofgren (D-San Jose), Jerry McNerney (D-Pleasanton), Lucille Roybal-Allard (D-Los Angeles), Adam Schiff (D-Pasadena), Hilda Solis (D-El Monte) and Pete Stark (D-Fremont).

CBO Scores Follow-on Biologics Legislation
On Wednesday, June 25, the Congressional Budget Office released a report projecting cost savings from S. 1695, the Biologics Price Competition and Innovation Act of 2007.  The legislation, sponsored by Sen. Ted Kennedy (D-MA), would create a pathway at the FDA for the approval of “follow-on” biologics.  The report projects cost savings of $200 million from 2009 to 2013 and savings of $25 billion from 2009 to 2018.  Since most cost savings will be realized several years after a pathway is established, CHI believes that Congress should act on this important legislation this year.  While follow-on biologics will offer real savings, the total will amount to just 0.065 percent of total healthcare spending during the period covered by the CBO study.  Congress must enact legislation that contains adequate incentives and patent protections to sustain future biomedical innovation.

CHI Joins Stakeholders Calling for National Pedigree Standard
On Monday, June 30, CHI joined other drug supply chain stakeholders as signatories to a letter to Congress in support of H.R. 5839, the Safeguarding America's Pharmaceuticals Act.  The legislation addresses the serious threat that counterfeit medicines present to our nation's public health by establishing a single national standard that would require the unique identification of individual medicines to permit the electronic tracking and tracing of products as they move from the manufacturer to patients.  CHI has met with the bill sponsors, Reps. Steve Buyer (R-IN) and Jim Matheson (D-UT), as well as members of the California Delegation to outline the needs of our membership.  Specifically, CHI believes that any national legislation should contain: 1) a uniform national standard; 2) a phased-in approach that is based on risk of counterfeiting; and 3) an interoperable, standards-based approach that is technology neutral.

Medicare Bill Fails in the Senate
Proponents of H.R. 6331, the Medicare Improvements for Patients and Providers Act of 2008, were unable to gather enough votes to cut off debate and bring the legislation to the Senate floor before the congressional recess.  The legislation, which was approved by the House on June 24, would eliminate significant Medicare payment cuts to physicians that went into effect on July 1.  Republicans in the Senate have called for a 30-day delay of the cuts to grant Congress additional time to work on a compromise.  CHI continues to monitor the progress of the Medicare package, focusing on language pertaining to comparative effectiveness research, remote monitoring, and diagnostics reimbursement, that may be included in a final package.

CHI Roundtable Features Congressman Kevin McCarthy
On Thursday, June 26, CHI hosted a discussion with Rep. Kevin McCarthy (R-Bakersfield) as part of its series of policy roundtables with members of the congressional delegation.  The meetings provide an opportunity for the CHI membership to discuss issues of importance to California's biomedical research and development community.  Rep. McCarthy, first elected to Congress in 2006, previously served in the state Assembly and was the 2005 recipient of CHI's Visionary Award.  For information on future roundtable discussions, please contact Todd Gillenwater, CHI vice president-public policy (202-974-6313 or gillenwater@chi.org).

Appropriations Update
Labor, Health and Human Services (HHS), Education and Related Agencies – On Thursday, June 26, the Senate Appropriations Committee approved a $154.9 billion FY 2009 Labor HHS spending package ($9.5 billion above the administration’s request).  The legislation provides $30.2 billion to fund biomedical research at the National Institutes of Health (NIH), $1.025 billion more than FY 2008.  The House subcommittee passed its version of the legislation allocating $30.4 billion for the NIH.  CHI continues to advocate for additional funds to foster basic biomedical research, highlighting information from our recent report, The National Institutes of Health (NIH): Fueling Healthcare Innovation in California.

Agriculture, Rural Development, FDA and Related Agencies – HHS Secretary Michael Leavitt announced last week that the $150 million received by the FDA in this year’s supplemental spending package should count toward next year’s budget.  The House Appropriations Subcommittee approved its version of the bill on June 19, granting a $325 million increase over last year.  CHI continues to advocate for additional resources for the agency to offset industry user fees that will better equip the FDA to safely and efficiently bring new drugs and devices to market.

Homeland Security – Rep. Jo Ann Emerson (R-MO), as she has for the past two years, placed an amendment in appropriations legislation relating to the importation of prescription drugs.  The language, which is usually housed in the Agriculture Appropriations package, would restrict the U.S. Customs and Border Patrol from using any funds allocated through federal appropriations to prevent the importation of prescription drugs.  The legislation contains a narrow exemption for biologic products.  CHI continues to oppose price control efforts that will disrupt the fragile environment for biomedical innovation.