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CLSA Wire

Washington Report — Nov. 14, 2014
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California Congressional General Election Recap

The Nov. 4 elections brought sweeping changes to the balance of power in Washington. In the House, Republicans increased their advantage, adding at least 10 seats to expand their majority. In the Senate, GOP candidates took control of seats held by Democrats in eight states – more than enough to seize control of the chamber for the first time since 2007. Republicans were less successful in California, with one seat switching from red to blue (CA-31 in the Inland Empire region), but did give Democrats a run for their money – as of press time, three Democratic incumbents are still in too close to call races with Republican challengers.

Of California’s 53-member congressional delegation, at least 44 incumbents will return to Washington, D.C. to serve in the 114th Congress. However, at press time, at least 21 members of California’s congressional delegation in the 114th Congress will be in their first or second term of federal office. CHI is well positioned to represent the state’s life sciences sector in the upcoming Congress, having held numerous meetings and developed strong relationships with returning and newly elected members. We are excited for the opportunity to engage with these new legislators, to help them better understand and appreciate our state’s unique biomedical innovation ecosystem. We will continue our efforts familiarize them with important federal issues – NIH research funding, FDA regulatory processes, CMS payment and access policies, tax, trade and intellectual property policies – that collectively drive our nation’s biomedical innovation sector.

Last week, CHI released a comprehensive election report newsletter, providing detailed results for Federal and State Races. Click here to read the report.

Notably, 11 of last congress’ landmark 14-member freshmen class have secured re-election:

  • Rep. Doug LaMalfa (R-CA-1)
  • Rep. Jared Huffman (D-CA-2)
  • Rep. Paul Cook (R-CA-8)
  • Rep. Eric Swalwell (D-CA-15)
  • Rep. David Valadao (R-CA-21)
  • Rep. Tony Cardenas (D-CA-29)
  • Rep. Raul Ruiz, M.D. (D-CA-36)
  • Rep. Mark Takano (D-CA-41)
  • Rep. Alan Lowenthal (D-CA-47)
  • Rep. Juan Vargas (D-CA-51)
  • Rep. Scott Peters (D-CA-52)

California’s congressional delegation in the 114th Congress will also include at least six new members – comprised of five current state senators and one city mayor – who will replace retiring incumbents:

 

  • CA-11: In the East Bay, State Sen. Mark DeSaulnier (D) defeated retired immigration judge Tue Phan (R) to replace retiring 20-term incumbent Rep. George Miller (D).
  • CA-25: In Los Angeles/Ventura County, State Sen. Steve Knight (R) defeated former state senator Tony Strickland (R) to replace retiring GOP Rep. Buck McKeon.
  • CA-33: In Santa Monica/Los Angeles County, State Sen. Ted Lieu (D) defeated L.A. deputy district attorney Elan Carr (R) to replace retiring 20-term incumbent Rep. Henry Waxman (D).
  • CA-31: Redlands Mayor Pete Aguilar (D) defeated challenger Paul Chabot (R) in this Inland Empire race to replace retiring GOP Rep. Gary Miller.
  • CA-35: State Sen. Norma Torres (D) secured 63.3 percent of the vote and will replace retiring freshman Rep. Gloria Negrete McLeod (D) in this Inland Empire seat.
  • CA-45: State Sen. Mimi Walters (R) won 65.4 percent of the vote and will replace retiring Rep. John Campbell (R) in this Orange/San Diego County congressional district.

Three races remain still too-close-to-call:

  • CA-7: Former Representative Doug Ose (R) was initially ahead in early vote counts, but as of press time is 711 votes behind freshman incumbent Rep. Ami Bera, M.D. (D) in this Sacramento district.
  • CA-16: The race in this Merced/Fresno/Madera County seat remains too-close-to-call, with incumbent Rep. Jim Costa (D) just 86 votes ahead of his challenger, dairy farmer Johnny Tacherra (R).
  • CA-26: In Ventura County, incumbent freshman Rep. Julia Brownley (D) has a 2,687 vote lead over challenger Jeff Gorell (R), who currently serves as Vice-Chairman of the California Assembly Budget Committee.  Although AP has called this race for Brownley, Gorell has yet to concede, stating he will wait until more of the remaining 12,000-15,000 ballots are counted.

Other notable races:

  • CA-3: This race unexpectedly went down to the wire, with incumbent Rep. John Garamendi (D) finally prevailing with a 5.4 percent narrow victory over north state Assemblyman Dan Logue (R) in this Colusa/Sutter/Yuba County district.
  • CA-15: In this East Bay Area district, freshman Rep. Eric Swalwell (D) secured an easy victory over Hugh Bussell (R) with 69 percent of the vote. In the June primary, Swalwell and Bussell both beat out Democratic State Sen. Ellen Corbett, who was backed by former Rep. Pete Stark (D), the 20-term congressman ousted by Swalwell in 2012.
  • CA-17: In the South Bay Area, 7-term incumbent Rep. Mike Honda (D) edged out attorney and former Obama administration official Ro Khanna (D) by about 5 points. The Honda-Khanna race was one of the most costly and competitive intra-party races of the year.
  • CA-18: In Silicon Valley, 24-year incumbent Rep. Anna Eshoo (D) sailed to victory with 66.3 percent of the vote.  Eshoo is currently seeking the Democratic top slot (Ranking Member) of the House Committee on Energy & Commerce, which has jurisdiction over many of CHI’s key policy priorities (including, for example, legislation related to public health and research, regulation of drugs/devices/biologics, and Medicare/Medicaid reimbursement). In December, the Democratic Caucus will choose between her and New Jersey Rep. Frank Pallone (D), who currently serves as ranking member of the Health Subcommittee, for this leadership position.
  • CA-24: In Santa Barbara, Rep. Lois Capps (D) survived a closer than expected race with a 3.2-point victory over challenger Chris Mitchum (R), an actor and former vice president of the Screen Actors Guild. Generally considered a safe seat for the Democratic party, Mitchum narrowed the gap in late October but was ultimately unable to edge past Capps.

Congress Reconvenes for Lame-Duck Session

Following the Nov. 4 mid-term election, Congress reconvened this week for a lame-duck session to consider several time sensitive issues before adjourning for the year:

  • FY15 Funding: In Sept., Congress passed a continuing resolution (CR) to fund the federal government for fiscal year 2015 until Dec. 11, 2014. Congress will move to approve legislation to extend FY15 funding through next year and avoid a government shutdown. It is still unclear what the duration or content of the CR will be beyond continuing FY14 funding levels into 2015. It is likely, however, that the CR will further address the Ebola outbreak in Africa, expired tax extenders, and the temporary authorization to arm and train Syrian forces in the U.S.-led coalition against the Islamic State.
  • Funding for the Ebola Outbreak in Africa: Congress included $400 million for response to the Ebola outbreak in Africa in the CR package passed in September and is likely to include further funding in the lame-duck CR package. The Obama Administration has asked Congress for an additional $6.18 billion in emergency funding for the federal government’s Ebola response efforts, which includes $4.64 billion for immediate response and $1.54 billion in contingency funding. The Senate Appropriations Committee held a hearing this week to evaluate the government’s Ebola response, as well as to consider a $6.2 billion request from the Obama administration for emergency funds to stop the spread of the deadly Ebola virus. Homeland Security Secretary Jeh Johnson, Health and Human Services Secretary Sylvia Mathews Burwell and other top administrative officials made the case for the increased funding, which is expected to be one of the few issues on which lawmakers can agree during the lame-duck session.
  • Tax Extenders: The package of tax breaks and credits, including an extension of the R&D tax credit – a CHI priority – are expected to be addressed during the lame-duck session. The Expiring Provisions Improvement Reform and Efficiency (EXPIRE) Act, a Senate Finance Committee bill, will likely be part of the discussion as well as several House proposals, including making the R&D tax credit permanent.

CHI Submits Comments to House Energy & Commerce Committee on Landmark 21st Century Cures Initiative

Since the launch of its 21st Century Cures initiative in April, the House Committee on Energy & Commerce has released four white papers raising specific questions on select topics for stakeholder reaction and response, and hosted a total of 12 hearings and roundtables in Washington, DC. Members of the Committee are also convening field hearings in their home states of Colorado, Illinois, Indiana, New Jersey, Florida, Massachusetts, Ohio, Pennsylvania, Michigan, Virginia and Washington.

The Committee’s work is expected to result in sweeping recommendations for legislative and administrative changes that will implement major reforms across the biomedical research, regulation and reimbursement enterprises. Draft legislation is expected to be released in early 2015, with Committee and floor action to follow shortly thereafter.

Oct. 31, CHI submitted formal written comments to the initiative’s co-chairs, Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) in response to their call for proposals. CHI’s comments focused on the “discovery” component of the biomedical innovation ecosystem and outlined new and novel ways to bridge the gap between basic science and the private market. These recommendations included increasing research productivity, promoting federal agency collaboration and public-private partnerships, and modernizing the scientific workforce for today’s research needs. While our comments focus exclusively on the discovery element, we continue to work with AdvaMed, BIO, PhRMA, and others to be as supportive as possible of their proposals, which generally address “development” and “delivery” reforms – CHI believes these elements are all critically important to the overall mission of the 21st Century Cures Initiative.  A copy of our comments is available here.

For more information on the 21st Century Cures initiative, visit the Committee’s website on the initiative here and participate in the discussion on social media by using “#Path2Cures” on Facebook and Twitter.

CHI & UCSF Host Rep. Diana DeGette to Discuss 21st Century Cures Initiative

Oct. 17, CHI partnered with the University of California, San Francisco to offer a private, invitation-only opportunity to CHI board members and senior executives from across our membership to engage in an informal luncheon discussion with Rep. DeGette about the unique biomedical innovation ecosystem that exists in California. The discussion also featured representatives from across UCSF’s academic research community. The conversation focused on the many ways public-private collaborations are translating basic research into cures. Rep. DeGette also shared her candid perspective on the future of federal support for biomedical research and potential policy changes for research and regulatory agencies like NIH and FDA.

New CHI & BCG Report Highlights FDA Medical Device Review Performance

Last month, CHI and BCG published a detailed report on FDA device review performance activities. The report,”Taking the Pulse of Medical Device Regulation & Innovation,” shows significant improvements in overall FDA device review times, but also illustrates significant differences between PMAs and 510(k)s, as well as a nearly 3-5 year lag time between the approval of products in Europe and the US. In addition, the report stressed the importance of protecting user fees from sequestration via legislation like the Food and Drug Administration Safety Over Sequestration (SOS) Act (H.R. 2725). Ultimately, the report reflects a positive step in effectuating the goals of FDASIA, but notes there is still much to be done to advance the Agency’s twin goals of protecting patient safety and promoting patient health through timely approval of and access to innovative medical technologies.

Oct. 28, The Hill’s Congress Blog featured an op-ed by Todd Gillenwater, CHI’s president & CEO, entitled “How is the FDA doing on medical device review times,” highlighting several aspects of this report.  A copy of the CHI/BCG report is available here.  Gillenwater’s op-ed is available here.

CHI Supports Expanded Access and Coverage of Anti-Obesity Therapies

The growing obesity epidemic costs Americans more than $190 billion each year in obesity-related medical expenses. In 2013, the American Medical Association (AMA) officially declared obesity a disease, and while private health insurance policies are beginning to include coverage for anti-obesity drugs, Medicare does not. Changing the rules to allow Medicare coverage of new FDA-approved anti-obesity therapies could save the country billions in healthcare costs. To that end, CHI has worked with both the California delegation and the House Committee on Energy and Commerce to support this effort through legislation and letters to the Administration.

CHI is supportive of H.R. 2415/S. 1184, the Treat and Reduce Obesity Act, legislation introduced in the House and Senate to provide Medicare coverage of medication for treatment of obesity or for weight loss management for an overweight individual with one or more comorbidities. 114 Representatives and five Senators have signed on as cosponsors for the legislation, including 19 members of the California congressional delegation: Reps. C√°rdenas, Costa, Davis, Eshoo, Hunter (R), Lofgren, Matsui, Napolitano, Negrete McLeod, Nunes (R), Peters, Roybal-Allard, Ruiz, Linda S√°nchez, Loretta Sanchez, Speier, Takano, Valadao (R) and Vargas.

Sept.19, The Hill‘s Congress Blog featured an op-ed by Jenny Carey, CHI’s director of federal government relations and alliance development, urging Congress to pass H.R. 2415 and highlighting the tremendous cost savings to federal health plans that could be achieved through Medicare beneficiary access to obesity medications. Click here to read the op-ed.

Late this fall, CHI actively engaged with the California delegation in support of an October letter to HHS Secretary Burwell written by the bill’s lead sponsors, Sens. Lisa Murkowski (R-Alaska) and Tom Carper (D-Del.), and Reps. Bill Cassidy (R-La.) and Ron Kind (D-Wis.), urging the department to extend coverage of FDA-approved obesity medications through the Medicare prescription drug benefit. This bipartisan, bicameral letter was ultimately supported by 98 cosigners, including 16 members of the California delegation: Reps. C√°rdenas, Costa, Davis, Honda, Hunter (R), Lofgren, Matsui, McNerney, Peters, Ruiz, Sanchez, S√°nchez, Speier, Takano, Valadao (R) and Vargas. To read the letter to HHS, click here.

CHI Supports Energy & Commerce Committee’s Efforts to Combat Antibiotic Resistance and Foster New Drug Development

Sept. 19, the House Energy & Commerce Subcommittee on Health convened a hearing on the current state of drug-resistant pathogens (antibiotic resistance) and the need for incentives to spur the development of new antibiotics.  CHI member Achaogen provided an expert witnesses to testify at the hearing (witness testimony available here). CHI submitted a formal statement for the record as a part of our ongoing support for antibiotic discovery and development to combat the emerging threat of antimicrobial resistance. Click here to read CHI’s antibiotic resistance hearing statement.

CHI was an early supporter of the Generating Antibiotic Incentives Now (GAIN) Act, which was signed into law as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) in July 2012, and launched an initiative in March 2012 focused on antimicrobial resistance and pathogens that are highly resistant to known medicines. Click here to read CHI’s white paper on antibiotic development.

CHI Convenes Legislator Policy Perspectives Discussions in Bay Area and San Diego

This Fall, CHI continued our Policy Perspectives series with current and incoming members of the California Congressional Delegation. CHI hosted Rep.-Elect Mimi Walters (R-Laguna Niguel) at Edwards Lifesciences in Irvine on Oct. 24, and Rep. Eric Swalwell (D-Dublin) at Thermo Fisher Scientific in Pleasanton on Oct. 28. These informal roundtable discussions offer an important opportunity for senior executives from CHI member companies to engage directly with federal lawmakers on issues key to the continued sustainability of California’s innovative biomedical ecosystem. Discussions topics included continued sustainability of California’s biomedical innovation ecosystem, the need for FDA regulatory consistency and the importance of sustained biomedical research funding, among others.

For more information about upcoming Policy Perspectives events, or if your company would like to host a similar event in 2015, please contact Jenny Carey, CHI’s director of federal government relations (carey@chi.org or 202-974-6323).

CHI Participates in Hill Briefing on Incentives for Rare Disease Therapy Development

Nov. 13, CHI participated in a briefing sponsored by the Congressional Rare Disease Caucus on “Creating Economic Incentives to Spur the Development of Treatments for Ebola and Other Life-Threatening Rare Diseases.” CHI President and CEO Todd Gillenwater moderated the discussion, which featured a panel of experts comprised of biopharmaceutical innovators, clinicians, and patient advocates. The briefing highlighted the important role of incentives – such as tax credits, intellectual property protection, and coverage/reimbursement policies – in spurring biomedical innovation and investment in therapies to treat or cure rare diseases. The briefing was sponsored by Rare Disease Legislative Advocates (RDLA) and EB Research Partnership in coordination with Rare Disease Congressional Caucus Co-Chairs Rep. Leonard Lance (R-N.J.) and Joe Crowley (D-N.Y.). CHI would like to recognize and thank Shire, Novartis, Alexion and Sarepta for supporting this congressional briefing.

Save-the-Date: CHI 2014 Annual Meeting, Nov. 20 at Stanford University

CHI’s 2014 Annual Meeting will be held on Nov. 20, 2014 from 9:30 a.m. – 5:00 p.m. (PST) at the Li Ka Shing Center at Stanford University. This year’s meeting, themed “Driving Innovation in a Transforming Healthcare Environment,” will bring together more than 200 executives from CHI’s member organizations with policymakers to discuss critical issues and opportunities facing the biomedical community. The goal of the forum is to produce a clearer understanding of the sector’s work and policy needs, and how the industry can sustain California’s leadership in medical innovation.

Click here
to for more information, including registration details and the event agenda. For additional information, please contact Molly Ingraham, CHI’s vice president of business development (ingraham@chi.org or 858-456-8884).

Save-the-Date: CHI 2014 Annual End of Year Reception, Dec. 10 at Sonoma Restaurant (Washington, D.C.)

Please join us Dec. 10, 2014 for CHI’s End of Year Reception in Washington. The event will be held from 5:30 – 7:30 p.m. (EST) at Sonoma Restaurant and Wine Bar on Capitol Hill. The reception annually brings together a wide range of government officials, legislators, staff and biomedical industry leaders in an informal setting to meet and speak one-on-one regarding the importance of biomedical innovation and scientific advancement in California and globally.

Thank you to our sponsors: AbbVie, Abbott, Allergan, Amgen, Astellas, Biogen Idec, East End Group, Endo, FaegreBD Consulting, Genentech, Gilead, McDermott Consulting, Merck, Novo Nordisk, Shire, St. Jude Medical, Takeda, Theravance Biopharma, Thermo Fisher Scientific, Vertex and XOMA.

Additional details are posted on our website here. For more information, please contact Jenny Carey, CHI’s director of federal government relations and alliance development (carey@chi.org or 202-974-6323) or Meghan Drenan, CHI’s associate director of federal government relations (drenan@chi.org or 202-974-6322).