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2014 Midterm Elections Update - Harry Sporidis & Tim Perrin Polsinelli LLP NAIC Action Alert - Joel White, Horizon Government Affairs Achieving a Better Life Experience (ALBE) Act - Ginny Sessions, National Down Syndrome Society Newborn Screening Saves Lives Re-Authorization Act - Natasha Bonhomme, Genetic Alliance FDA Seeking Patient Input in Drug and Device Approvals Jennifer Bernstein Gabriella Miller Kids First Research Act Appropriations - Max Bronstein, EveryLife Foundation Caucus Briefing Action Alert - Andy Russell, RDLA

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Polsinelli PC. In California, Polsinelli LLP The 2014 Midterm Congressional Elections Impact, Analysis and Outlook November 6, 2014 | Washington, D.C. Polsinelli Public Policy Group

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real challenges. real answers. sm The 113 th Congress: What Once Was 4 United States House of Representatives United States Senate

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real challenges. real answers. sm 2014 Midterm Election Results 5

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real challenges. real answers. sm 2014 Midterm Election Results 6 Political gridlock is synonymous with todays legislative (in)action Even with political gridlock, measureable results are still possible A more focused, nuanced approach is necessary

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real challenges. real answers. sm Factors Impacting 2014 Midterm Elections Obama Approval /Public Opinion Makeup of Midterm Electorate /Voter Turnout Higher GOP Motivation Economy Senate Map favoring GOP Affordable Care Act Ebola Response /Foreign Affairs

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real challenges. real answers. sm 8 2014 Midterm Election Results: The United States House of Representatives The House has gone from 233 Republicans to 243 Republicans The House has gone from 199 Democrats to 178 Democrats The Republicans keep Majority of the House of Representatives The are currently 17 undecided races

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real challenges. real answers. sm 2014 Midterm Election Results: The United States House of Representatives 9 United States House of Representatives United States House of Representatives 113 th Congress 114 th Congress

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real challenges. real answers. sm 10 114 th Congress: House Leadership Speaker of the House: Rep. John Boehner (R-OH) Majority Leader: Rep. Kevin McCarthy (R-CA) Majority Whip: Rep. Steve Scalise (R-LA) Republican Conference Chairman: Rep. Cathy McMorris Rodgers (R-WA) Republican Policy Committee Chairman: TBD Democratic Leader: Rep. Nancy Pelosi (D-CA) Democratic Whip: Rep. Steny Hoyer (D-MD) Assistant Democratic Leader: Rep. James Clyburn (D-SC) Democratic Conference Chairman: Rep. Xavier Becerra (D-CA)

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real challenges. real answers. sm 11 114 th Congress: Possible House Committee Leadership CommitteePossible ContendersAnticipated ChairmanAnticipated Ranking AgricultureConawayMichael Conaway (R-TX)Collin Peterson (D-MN) AppropriationsHarold Rogers (R-KY)Nita Lowey (D-NY) Armed ServicesThornberry, ForbesMac Thornberry (R-TX)Adam Smith (D-WA) BudgetPriceTom Price (R-GA)Chris Van Hollen (D-MD) Ed and WorkforceKline, FoxxJohn Kline (R-MN)Bobby Scott (D-VA) Energy and Commerce Eshoo, Pallone for RankingFred Upton (R-MI)TBD Natural ResourcesBishopRob Bishop (R-UT)TBD Oversight & Govt Reform Issa, Chaffetz, Turner, Jordan, Mica Jason Chaffetz (R-UT)Elijah Cummings (D-MD) Small BusinessChabot, Tipton, Hanna, CollinsSteve Chabot (R-OH)Nydia Velazquez (D-NY) Transportation and Infrastructure Bill Shuster (R-PA)Peter DeFazio (D-OR) Veterans AffairsMiller, Bilirakis, Lamborn, Roe, Flores Jeff Miller (R-FL)Corrine Brown (D-FL) Ways & MeansRyan, BradyPaul Ryan (R- WI)Sander Levin (D-MII) IntelligenceNunes, King, PompeoDevin Nunes (R-CA)C.A. Dutch Ruppersberger (D-MD)

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real challenges. real answers. sm 12 2014 Midterm Election Results: The United States Senate The Senate has gone Republican Red! The Senate has gone from 45 to 52 Republican Seats For the First time since the 109 th Congress (2005-07) the Senate Majority is the Republican Party. The Senate now stands at 52-R, 44-D, 2-I and 2 undecided races. The Senate has gone from 53 Democrats to 44 Democrats

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real challenges. real answers. sm 2014 Midterm Election Results: The United States Senate 13 113 th Congress 114 th Congress United States Senate

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real challenges. real answers. sm 14 114 th Congress: Senate Leadership President Pro Tempore: Sen. Orrin Hatch (R- UT) Majority Leader: Sen. Mitch McConnell (R-KY) Majority Whip: Sen. John Cornyn (R-TX) Republican Conference Chair: Sen. John Thune (R- SD) Minority Leader: Sen. Harry Reid (D- NV) Minority Whip: Sen. Richard Durbin (D-IL) Democratic Policy Committee Chair: Sen. Chuck Schumer (D-NY)

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real challenges. real answers. sm 15 114 th Congress: Possible Senate Committee Leadership CommitteeAnticipated ChairmanAnticipated Ranking Armed ServicesJohn McCain (R-AZ)Jack Reed (D-RI) AppropriationsThad Cochran (R-MS)Barbara Mikulski (D-MD) Banking, Housing and Urban Affairs Richard Shelby (R-AL)Sherrod Brown (D-OH) BudgetJeff Sessions (R-AL)Sheldon Whitehouse (D-RI) Commerce, Science and Transportation John Thune (R-SD)Bill Nelson (D-FL) Energy and Natural Resources Lisa Murkowski (R-AK)Mary Landrieu (D-LA) (Depending on the LA runoff election) Environment and Public Works James Inhofe (R-OK)Barbara Boxer (D-CA) FinanceOrrin Hatch (R-UT)Ron Wyden (D-OR) HELPLamar Alexander (R-TN)Patty Murray (D-WA) Homeland Security and Governmental Affairs Ron Johnson (R-WI)Thomas Carper (D-DE) Veterans AffairsJohnny Isakson (R-GA)Bernard Sanders (I-VT) IntelligenceRichard Burr (R-NC)Dianne Feinstein (D-CA) Committee on AgingSusan Collins (R-ME)Bob Casey (D-PA)

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real challenges. real answers. sm 2014 Midterm Election Results: Legislative Agenda Outlook 16 Legislation Agenda Lame Duck 114 th Congress Affordable Care Act Appropriations Debt Ceiling Energy EPA Regs Export-Import Bank FCC Legislation Agenda Lame Duck 114 th Congress Foreign Policy Highway Trust Fund Immigration Online Sales Tax SGR Tax Extenders Tax Reform Trade Unlikely Up for Debate Must Pass

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real challenges. real answers. sm 2014 Midterm Election Results: Impact on 2015 and Beyond 17 House Dynamics Remain Same Budget Battles Cooperatio n between House and Senate Increased Oversight White House/ Congress Dynamic Legislative Winners and Losers

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real challenges. real answers. sm 2014 Midterm Election Results: All Eyes on 2016 18 Jeb Bush (R-FL) Chris Christie (R-NJ) Rand Paul (R-KY) Hillary Clinton (D-NY) Joe Biden (D-DE) Elizabeth Warren (D-MA)

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real challenges. real answers. sm Questions and Answers: Challenges, Impact and Opportunities

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real challenges. real answers. sm Polsinelli provides this material for informational purposes only. The material provided herein is general and is not intended to be legal advice. Nothing herein should be relied upon or used without consulting a lawyer to consider your specific circumstances, possible changes to applicable laws, rules and regulations and other legal issues. Receipt of this material does not establish an attorney-client relationship. Polsinelli is very proud of the results we obtain for our clients, but you should know that past results do not guarantee future results; that every case is different and must be judged on its own merits; and that the choice of a lawyer is an important decision and should not be based solely upon advertisements. 2013 Polsinelli PC. In California, Polsinelli LLP. Polsinelli is a registered mark of Polsinelli PC

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During the November 2014 Midterm Elections the Rare Disease Congressional Caucus lost 2 elections to the House: Bruce Braley (D) IA-1 Carol Shea-Porter (D) NH-1 8 members did not seek re-election to the House: Spencer Bachus (R) AL-6 Phil Gingrey (R) GA-11 Tim Griffin (R) AR-2 Rush Holt (D) NJ-12 Tom Latham (R) IA-3 Jon Runyan (R) NJ-3 Henry Waxman (D) CA-33 Frank Wolf (R) V-10 To see complete election results of all Caucus Members & incoming Representatives go to: - Rareadvocates.org/CaucusElectionResults

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NAIC Action Alert Joel White Horizon Government Affairs jwhite@horizondc.com

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ACHIEVING A BETTER LIFE EXPERIENCE (ABLE) ACT (H.R. 647/S.313) Ginny Sessions Manager, Grassroots and Development Programs National Down Syndrome Society gsessions@ndss.org

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Newborn Screening Saves Lives Re-Authorization Act Natasha Bonhomme, Genetic Alliance

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FDA Seeking Patient Input in Drug and Device Approvals Jennifer Bernstein

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OPEN ACT: Incentives for Drug Development Dr. Emil Kakkis

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Max G. Bronstein, EveryLife Foundation

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Diverts funding from public campaign fund to pediatric cancer research at NIH Authorized ~$12 million/year for 10 years

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Former Majority Leader Eric Cantor (R-VA)

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Program has been authorized Challenge is to get it appropriated Government is currently funded by a continuing resolution, expiring Dec. 11 Our goal: get the funding appropriated during Lame Duck, before holiday recess

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Sign-on letter to Congressional Appropriations Committees Email mbronstein@everylifefoundation.org to get your organization signed-on

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Rare Disease Legislative Advocates and EB Research Partnership in coordination with Rare Disease Congressional Caucus Co-Chairs Representatives Leonard Lance (R-NJ) and Joe Crowley (D-NY), will host a briefing on: "Creating Economic Incentives to Spur the Development of Treatments for Ebola and Other Life-Threatening Rare Diseases" Thursday, November 13, 2014 12:00 noon 1:30 pm Rayburn House Office Building, Room: B-318 Lunch will be provided by event sponsors Shire, Alexion, Novartis & Sarepta Help us spread the word and participate in our action alert!

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The EveryLife Foundation will convene the first Community Congress meeting to bring rare disease stakeholders together to help work on urgent policy and science issues. Community Congress is a membership-based program dedicated to bringing patient organizations, industry leaders, and other rare disease stakeholder organizations together. Current planned working groups include Public Policy, Science/Regulatory Policy, and Newborn Screening. Date: Thursday, November 13, 8:30am-11:00am, Breakfast Provided Location: Darlington House, 1610 20 th St, NW Washington, DC 20009 More info at:

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The 3 rd Annual RareVoice Awards Gala will honor rare disease advocates, congressional leaders, and top agency officials. This no- cost, widely attended event will include a celebrity guest! Please join us to recognize and honor these distinguished advocates. Date: Thursday, November 13, 6:00pm-9:00pm, Drinks & Food Provided Location: Arena Stage, 1101 Sixth St SW, Washington DC 20024 More info at www.rarevoiceawards.org