Redistricting Commission Releases First Draft of Legislative District Maps

The California Citizens Redistricting Commission released its first draft of congressional, state Assembly, state Senate and state Board of Equalization (BOE) districts, and will begin holding public comment hearings until August. The commission will certify and submit final maps to the secretary of state on August 15. The commission released "visualizations" of legislative and congressional districts two weeks ago, and last week's first draft release refines those proposals. The final maps could pit incumbents of the same party against one another and some legislators could possibly be "drawn" out of their current legislative districts, meaning they would have to relocate in order to run in redrawn districts. According to a recent article in The Hill , early analysis points to a potential advantage for Democrats at the federal level. The analysis suggests that the redistricting threatens a number of the delegation's members, including current House Rules Committee Chairman David Dreier (R-San Dimas), Elton Gallegly (R-Simi Valley), Brian Bilbray (R-Carlsbad), Lois Capps (D-Santa Barbara) and Bob Filner (D-San Diego), who has recently announced his intention of running for mayor. An interesting head-to-head match-up for Democrats includes veteran Reps. Howard Berman (D-Los Angeles) and Brad Sherman (D-Sherman Oaks). Given the new maps, it is also likely that a number of members of the state Legislature will launch congressional bids. Click here to read more analysis from The Hill.

House to Consider Patent Reform this Week, House Appropriators Voice Opposition

This week, the House is expected to take up H.R. 1249, the America Invents Act. The Senate overwhelmingly passed its version of the bill — which CHI supported — in March. The House passed its version out of the Judiciary Committee in April by a 32-3 vote. However, it has encountered roadblocks as of late. The current obstacle is a challenge from House Appropriations Committee Chairman Hal Rogers (R-KY) and Budget Committee Chairman Paul Ryan (R-WI) regarding U.S. Patent and Trademark Office (USPTO) fee revenue (Section 22 of the House bill). In a recent letter , Rogers and Ryan suggest that allowing the USPTO to keep funds would undermine congressional oversight and accountability.

In response to the Rogers/Ryan letter, CHI and 150 other organizations, companies and research universities signed on to a letter sent to House leadership expressing support for Section 22 of H.R. 1249. Section 22 creates a mandatory revolving fund within the U.S. Treasury Department to secure all user fees collected by the USPTO, and allows for their expenditure for no other purpose than funding the agency. Section 22 would not interfere with congressional oversight; Congress would still be able to direct money where needed within the USPTO. But, Congress would not be able to divert funds or reduce revenues. CHI strongly opposes any amendment to strip this provision.

CHI has consistently supported balanced and reasonable efforts to improve the U.S. patent system. As Congress prepares H.R. 1249 for floor consideration, CHI continues to engage with members of the delegation and other interested stakeholders to further improve the intellectual property ecosystem.

Lawmakers Urge Support for NIH Funding

On May 20, a "dear colleague" letter was sent to House Labor-HHS Appropriations Subcommittee Chairman Denny Rehberg (R-MT) and Ranking Member Rosa DeLauro (D-CT) urging support for continued funding of the National Institutes of Health (NIH). The letter was signed by 13 members — including 12 Republicans — in response to the potential cuts the Labor-HHS budget faces in the House plan, which total approximately $18 billion. Republicans in support of the NIH noted the essential function of the agency to maintain U.S. global leadership in innovation and biomedical research, and to help curb long-term healthcare costs. Two members of the California delegation signed on to the letter: Rep. Brian Bilbray (R-Carlsbad) and Rep. Elton Gallegly (R-Simi Valley). The Appropriations Subcommittee is expected to mark up the Labor-HHS budget on July 26 and the full committee will take it up the following week. A similar "dear colleague" is being circulated in the Senate by Sens. Bob Casey (D-PA) and Richard Burr (R-NC) that will be submitted to appropriators.

House Approves Cuts to FDA, Fate of Biosimilars Unknown
On May 31, the House Agriculture Appropriations Committee, which includes in its jurisdiction the U.S. Food and Drug Administration (FDA), approved legislation that would pare $285 million from the FDA's fiscal year 2012 budget compared with 2011 spending levels. This amounts to an 11.5 percent spending cut and is more than 20 percent less than the amount President Barack Obama requested. Preliminary analysis indicates that the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Drug Evaluation and Research (CDER) — FDA units of particular importance to California's innovative medical technology and biopharmaceutical sectors — would each face 13 percent cuts. According to a recent article in InsideHealthPolicy, one effect of the proposed cuts would be to stall the implementation of biosimilars regulation.

Throughout the appropriations and budget cycles, CHI has worked to illustrate that appropriate funding for science research and the FDA are necessary to promote innovation, save lives and encourage economic growth and job creation. CHI submitted a letter to Appropriations Committee Member Sen. Dianne Feinstein (D-CA), urging support for steady and sustained congressional commitment to FDA agency funding.

Hearings and Briefings

CHI Hosts House Majority Whip at Informal Roundtable Discussion

As House Majority Whip, the third most senior position in the House leadership, and a former California Assemblymember, Kevin McCarthy has been a champion for the biomedical industry and its growth in California. CHI's private roundtable at Gilead Sciences in Foster City, Calif. offered a unique opportunity for a select group of life science industry leaders, such as The J. David Gladstone Institutes, Amgen, Thallo Bioscience, Proteus Biomedical, and Abbott Vascular, to share their perspectives on policies that will position California to maintain its leadership as the world headquarters for biomedical R&D. CHI's Vice President of Business Development, Molly Ingraham, and President and CEO, David Gollaher, Ph.D., were also in attendance. Click here to read a recap of the event on the CHI Blog.

CHI Participates in MDMA Annual Conference

From June 8-10, CHI's Caitlin Doyle attended the Medical Device Manufacturers Association (MDMA) annual conference, "Protecting the Future of Innovation," in Washington, D.C. The central theme of the meeting was to promote a dialogue about how the United States can remain a global leader in medical technology innovation, and to further engage and be present in future legislative and regulatory policies. CHI was a proud co-sponsor of the event. Representatives from the FDA, including Commissioner Dr. Margaret Hamburg and CDRH Director Dr. Jeffrey Shuren were featured speakers. Multiple break-out sessions were conducted, and many participants represented California medical technology innovation. NuVasive Chairman and CEO Alex Lukianov and ExploraMed Founder and CEO Josh Makower served on a panel regarding FDA reform and ways industry can work with the agency.

House Oversight Subcommittee Hearing on FDA Medical Device Approval Process

On June 2, the House Oversight and Government Reform Subcommittee on Health Care, District of Columbia, Census and the National Archives held a hearing titled: "Pathway to Medical Device Approval: Is There a Better Way?" CHI's President and CEO, David L. Gollaher, Ph.D., testified based on a recent report published by CHI in collaboration with the Boston Consulting Group on competitiveness, regulation and the FDA. The hearing was previously scheduled for April 14 but was postponed. The committee also heard from Rep. Erik Paulsen (R-MN); FDA Center for Devices and Radiological Health (CDRH) Director Dr. Jeffrey Shuren; Dr. Rita Redberg, professor of medicine and director of women's cardiovascular services in the division of cardiology at the University of California, San Francisco; and Jack Lasersohn, a general partner at The Vertical Group. Speakers discussed the importance of the medical device industry to the United States, focusing on improvements to patient care, job creation, and economic competitiveness. Additionally, they discussed some of the challenges companies are increasingly facing due to uncertainty at the FDA. For more information on the hearing or CHI's efforts regarding regulatory policy issues, contact Todd Gillenwater, CHI's senior vice president of public policy (Gillenwater@chi.org or 202-974-6313).

Click here to read the CHI press release.

Click here to read the CHI testimony.

Click here to listen to The Burrill Report podcast.

Senate Judiciary Hearing on Intellectual Property Enforcement Efforts

On Wednesday, June 22, the Senate Judiciary Committee will hold a hearing titled: "Oversight of Intellectual Property Law Enforcement Efforts." The hearing will take place at 10 a.m. in 226 Dirksen. CHI's Caitlin Doyle will attend.

Information Technology & Innovation Foundation High-Level Policy Forum

On Thursday, June 23, the Information Technology & Innovation Foundation (ITIF) will celebrate its fifth anniversary by hosting a high-level policy forum. A distinguished panel will discuss innovation policy over the course of the last five years and what the United States can do to meet the challenges in upcoming years. Keynote remarks will be offered by Dr. John C. Lechleiter, President and CEO of Eli Lilly and Co. Additional panelists include: Aneesh Chopra, chief technology officer of the United States; U.S. Sen. Chris Coons (D-DE) and John Engler, president of Business Roundtable. CHI's senior vice president for public policy, Todd Gillenwater, and associate director for federal government relations and programs, Caitlin Doyle, will attend. For more information about the ITIF or to sign up for the event, click here.

Note: IPAB Hearing Rescheduled to July 13

The Energy and Commerce Health Subcommittee has postponed a June 14 hearing titled: "IPAB: The Controversial Consequences for Medicare and Seniors" to July 13 at 9 a.m. in 2123 Rayburn.

Events

Today Last Day for Early-Bird Pricing on 'Take this Pill and Tweet me in the Morning'

Don't miss out! The early-bird registration deadline for CHI's "Take This Pill and Tweet me in the Morning: How Advances in Social Media and Mobile Health are Creating Consumer-centric Healthcare" ends today. The event, happening Aug. 4 in San Diego, will bring together hundreds of leaders from California's biotechnology industry and academic research community, along with entrepreneurs, investors, healthcare providers, policy experts and patient advocates. Advances in social media and mobile health technologies are giving consumers more influence than ever over their health and healthcare. The pharmaceutical and life sciences industries have officially taken note, working to understand how consumer-centric healthcare will affect their markets, and considering how they can use social media and offer "mHealth" tools and services. But there are significant policy and economic questions associated with the transition to consumer-centric healthcare. These include:

• Questions of regulatory oversight (How should mHealth tools and social media be regulated and who should regulate them)?
• Commercial viability concerns (How can providers be reimbursed for use of mHealth tools?)
• Issues of patient privacy and data security (Who owns the data generated by mHealth tools and how can privacy and security be ensured?)

Confirmed speakers include:

• David Gollaher, Ph.D., President and CEO, CHI
• NEW! Eric Topol, M.D., Director, Scripps Translational Research Institute; Chief Academic Officer, Scripps Health; Vice Chairman, West Wireless Institute
• Matthew Holt, Co-founder, Health 2.0
• Douglas Trauner, CEO, TheCarrot.com
• Ryan Sysko, CEO, WellDoc
• Derek Newell, former CEO of Health Hero Network, a unit of Bosch and maker of Health Buddy
• Jon Linkous, CEO, American Telemedicine Association
• Eve Kurtin, Senior Advisor, Vantage Point Capital Partners
• Deven McGraw, Director of the Health Privacy Project, Center for Democracy and Technology
• NEW! Benjamin Lei, Associate Director, iM eMarketing, Genentech
• NEW! Mark Carlson, M.D., Chief Medical Officer and Senior Vice President, Research and Clinical Afairs, St. Jude Medical

 
Agenda-at-a-Glance:

Click here to register for the early-bird rate of $149 for CHI members. CHI is encouraging Twitter users to follow us and retweet our event information, with the bonus of receiving $25 off the event registration. Click here for more information.

To reserve a hotel at the negotiated rate of $219 a night at the Estancia La Jolla Hotel & Spa, contact the hotel directly at (877) 437-8262 by Tuesday, July 5, and provide the CHI group name. For sponsorship opportunities please contact Molly Ingraham, vice president of business development (Ingraham@chi.org or 858-456-8884).

Sponsor Opportunities Now Available for Premier Public Policy Meeting
Explore how our industry can refine its political agenda to work most effectively with government to sustain California's leadership in medical innovation at Shifting Sands: Forces Reshaping the Biomedical Innovation Business Model, scheduled for Nov. 3 in San Francisco's Julia Morgan Ballroom. The event will bring together hundreds of the leading executives from biotechnology, medical device and pharmaceutical companies as well as leaders from the state's academic research community with policy makers to discuss critical issues and opportunities facing the biomedical community. For sponsorship opportunities, please contact Molly Ingraham, vice president of business development (Ingraham@chi.org or 858-456-8884).

For more CHI events or current happenings, visit www.chi.org.