Health Care: Donnelly Co-Authors Bipartisan Bill to Speed Up FDA Approvals for Devices; Young Reaches Across the Aisle on ACA

Senators Joe Donnelly (D-IN) and Cory Gardner (R-CO) have re-introduced the bipartisan FDA Regulatory Efficiency Act, which would allow the Food and Drug Administration (FDA) to bring innovative medical devices to market more quickly.

Donnelly stated, “As scientists and innovators across Indiana and our country work to find new cures and therapies, we should be making it easier for them to bring these products safely to those who need them. I’m proud to work with Sen. Gardner on this bipartisan legislation to cut through the red tape at the FDA and safely speed up the approval process.”

The FDA Regulatory Efficiency Act would help the FDA concentrate on high-priority activities by authorizing third parties to approve quality systems of device companies. Authorized third parties could only approve changes that do not involve major technology changes or changes in the use of the product. The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA. Donnelly and Gardner first introduced the legislation in October 2015.

Health Care Reform Notes
Freshman Sen. Todd Young has reached across the aisle in an attempt to find common ground on health care. He recently sent a letter to all Democratic senators urging them to share their views on what’s working and what’s not with the Affordable Care Act. Young is a member of the Senate Health, Education, Labor and Pensions Committee, which will have a key role in shaping the Senate’s version of health care reform.

Congresswoman Jackie Walorski (IN-02) is touting the American Health Care Act (AHCA), as passed in the U.S. House of Representatives, and how it “brings us closer to a better health care system that puts patients first.” Her editorial appeared Sunday in the South Bend Tribune.

Congressman Larry Bucshon, M.D. (IN-08), who sits on the House Committee on Energy and Commerce where he is a member of the Subcommittees on Health, is using his web site to promote the Washington Post’s fact-checking of several recent claims about the AHCA. One is on coverage for those with pre-existing conditions and the other on classification of assault as a pre-existing condition; both claims were deemed untrue.

Chamber Goes to D.C., Talks Top Member Issues With Hoosier Delegation

The Chamber’s Caryl Auslander met with Sen. Todd Young last Wednesday in Washington, D.C.

Indiana Chamber members were once again represented in Washington as Caryl Auslander, VP of federal relations, returned to meet with over half of Indiana’s congressional delegation last week. On the agenda: the most pressing public policy matters the Chamber hears about from its member companies throughout the state.

On this trip, Auslander met with Sen. Todd Young, Rep. Susan Brooks (IN-05), Rep. Larry Bucshon, M.D. (IN-08) and Rep. Trey Hollingsworth (IN-09), as well as with key legislative staffers from the offices of Rep. Jim Banks (IN-03), Rep. André Carson (IN-07) and Rep. Pete Visclosky (IN-01).

Below are the five main policy areas discussed with these delegation members:

Health Care Reform
The Indiana Chamber wants to see lower health care costs and improvement to the overall system. We believe the Affordable Care Act is overly complex, administratively burdensome and financially unsustainable as-is. We support a “repeal and replace” approach, but in the absence of that, substantial changes should be made to make the law more workable and viable for the long term.

Infrastructure
The Chamber is looking for a stable, long-term way to pay for highway infrastructure, with a separate, sustainable and dedicated transportation funding source. Whatever the upcoming Trump and congressional plans entail, Indiana deserves its fair share of federal transportation dollars. Equity guarantee would ensure that all states receive a minimum level of funding relative to other states. All states should receive a minimum of 95% return on their share of fuel tax contributions and on any additional funding sources. Without an equity guarantee, overall funding may increase; however, Indiana could receive less overall or comparatively.

Regulatory Reform
The federal government has consistently overreached its authority, which has left Hoosier companies facing a multitude of complicated and changing federal regulations. It’s not only burdensome and time-consuming, but has created a lot of business uncertainty and hinders the ability to expand in the U.S. NOTE: Auslander reiterated the top regulations to overturn from the Chamber’s standpoint and gave the delegation another copy of the list.

Rural Broadband
The Chamber believes that advanced communications and digital infrastructure is critical to long-term economic development. Yes, we have come a long way, but still not enough is happening and not quickly enough. We encouraged our delegation to find more ways to bring the most rural parts of the country and state up to date technologically to help reverse downward economic trends. Broadband in rural communities helps businesses, schools and communities at-large; it is no longer a luxury but now a necessity.

Tax Reform
We need a tax code that is certainly simpler. It’s complicated and it costs way too much to comply with. Lowering the corporate income tax rate – which puts us at a competitive disadvantage globally – is something virtually everyone agrees on. We also urged getting rid of the ineffective alternative minimum tax (AMT) and the federal estate tax, which poses a real threat to small businesses and family farms. And while it is important for comprehensive tax reform, we need to do it in a way that does not increase the deficit.

WOTUS Executive Order Highlights Recent Federal Activity

  • On February 28, the White House announced that President Trump signed an executive order directing the administrator of the Environmental Protection Agency and the assistant secretary of the Army for Civil Works (Corps of Engineers) to review the Waters of the United States (WOTUS) Rule and restore the rule of law. Congressman Jim Banks (IN-03) praised this action that would ensure the rule promotes economic growth and minimizes regulatory uncertainty: “I hear repeatedly from my constituents that the main thing holding back small business owners and farmers is over regulation. The WOTUS rule is an example of Washington overreach that is affecting businesses, utilities, manufacturers, farmers and land owners across northeast Indiana. I’m pleased to see President Trump make the review and revision of this rule a priority.” As a reminder, the Indiana Chamber mentioned WOTUS as a burdensome regulation in its list of regulations we sought repeal of in a letter to Vice President Mike Pence and sent to the delegation.
  • The White House sent its initial budget guidance to federal agencies this week, outlining a $54 billion increase in defense spending and corresponding reductions to most non-security agencies. An Office of Management and Budget official told reporters that the Trump administration will propose a 10% increase in defense spending and funding bumps for national security-related efforts. But that will mean cuts to domestic programs as well as foreign aid.
  • Former Indiana Sen. Dan Coats – President Trump’s nominee for director of national intelligence – faced questions from the Senate Intelligence Committee as phase one of his confirmation process.
  • Hoosier Seema Verma moved another step forward in her confirmation as the next administrator for the Centers for Medicare & Medicaid Services. On Thursday, the Senate Finance Committee voted 13-12 in support of her nomination, which now goes before the full Senate.
  • Senator Todd Young recently introduced the Investing in Student Success Act of 2017 as an out-of-the-box method of financing higher education. According to the Washington Examiner, “…the funding would not come from the federal government, but private companies who sign ‘income-sharing agreements’ with students. As the name implies, the investor finances the student’s tuition, in exchange for a percentage of the individual’s income for a set number of years after graduation.” According to Sen. Young, “Big picture here: There’s currently $1.2 trillion in outstanding student loan debt held by the federal government, and 43% of the roughly 22 million Americans with loans weren’t making payments as of Jan. 1. There’s certainly a need for some sort of way to finance your college education that does not place the risk on taxpayers.”
  • Congresswoman Susan Brooks (IN-05) invited former Indiana Chamber board member and current Indiana Economic Development Corporation President Elaine Bedel to be her guest at President Trump’s speech this week to the joint session of Congress.
  • I recently visited D.C. and met with the offices of congressional representatives Banks, Brooks, Bucshon, Hollingsworth and Messer. We discussed repeal and replacement of the Affordable Care Act, regulatory reform and our D.C. Fly-in event in September. Look for more in-depth information on my visits in next week’s report.

The Week in Federal Affairs

  • Congresswoman Susan Brooks (IN-05) launched a new video series this year called, “What I’m Hearing.” In each episode, she discusses one issue based on concerns from her constituents. The most recent episode is focused on health care coverage for people with pre-existing conditions. Brooks states that this coverage is a priority for her and for her colleagues in Congress.
  • Last week, the House Energy and Commerce Committee chairman introduced
    legislation, H.R. 1121, Pre-Existing Conditions Protection Act, and Rep. Brooks is an original co-sponsor. This bill confirms guaranteed health care access, ensures a person cannot have benefits excluded from a plan due to pre-existing conditions and makes sure that people will not pay more for coverage based off of how healthy or sick they may be. This bill will be debated and discussed in the Health Subcommittee, of which she is a member, in coming weeks.
  • Senators Joe Donnelly and Todd Young, along with local and federal officials, met with Governor Eric Holcomb in East Chicago to discuss the lead crisis after the Governor declared it a disaster emergency earlier this month.
  • Yesterday was confirmation hearing day for Indiana’s former Sen. Dan Coats, who is President Trump’s pick to be director of national intelligence. Coats will appear before the Senate Select Committee on Intelligence.
  • Representatives Brooks and Larry Bucshon (IN-08) were recently in Japan to discuss economic opportunities and partnerships.
  • Congressman Andre Carson is hosting a Youth Opportunities Fair on March 6 for potential jobs, internships and volunteer opportunities at the Central Library in Indianapolis.

Around the Horn on Federal Legislative Issues

As part of the Indiana Chamber’s robust federal advocacy program, Caryl Auslander will be working with the Indiana delegation (both in Washington, D.C. and here in Indiana) throughout the year. Look for additional stories and coverage of our federal efforts on your behalf in these reports and through other communications.

Below are some of the top recent Indiana news items:

  • Congressman Trey Hollingsworth spoke on the House floor in support of the REINS Act during his first week on the job; the measure to curb unnecessary government regulation passed the House on Wednesday. Hollingsworth has also been placed on the House Financial Services Committee.
  • A Hoosier connection remains on the House Ways and Means Committee with Rep. Jackie Walorski (IN 2) receiving a nod; Sen. Todd Young was most recently on this important committee.
  • Chairman alert: Rep. Susan Brooks (IN 5) has officially taken the helm of the House Ethics Committee.
  • This week, freshman Rep. Jim Banks (IN 3) presided over the House floor debate of a statement of opposition to the recent U.N. Resolution on Israel; the measure passed the House easily.
  • Newly sworn-in Sen. Young was assigned to four important Senate committees: Foreign Relations; Health, Education, Labor and Pensions; Commerce, Science and Transportation; and Small Business and Entrepreneurship.
  • Retirement is on hold for former Sen. Dan Coats, who was announced as President-elect Donald Trump’s pick for Director of National Intelligence.
  • Indiana’s now senior Sen. Joe Donnelly was awarded the Department of Defense Medal for Distinguished Public Service; Donnelly is a member of the Senate Armed Services Committee.
  • Senators Donnelly and Young were successful in getting the Government Publishing Office to formally designate Indiana residents as “Hoosiers” (bye-bye “Indianans”) and celebrated with this video announcement.
  • South Bend Mayor Pete Buttigieg threw his hat into the ring for chairman of the Democratic National Committee.

Indiana Chamber Reaffirms Endorsement of Todd Young for U.S. Senate

youngAt a series of press conferences Aug. 29, the Indiana Chamber reaffirmed its endorsement of Congressman Todd Young (R-IN, 9th District) for the U.S. Senate. The announcement was first made at the Associated Builders and Contractors training facility on the east side of Indianapolis, followed by stops in South Bend and Fort Wayne.

The organization previously had endorsed Young in the primary before Evan Bayh, former U.S. senator and Indiana governor, emerged as the Democrat candidate.

Once Bayh entered the race, our congressional affairs committee thought the appropriate action was to take another look at this race and talk with him about policies important to the business community.

We were able to do that recently and appreciate Sen. Bayh’s willingness to have that discussion. At the end of the day, however, our committee overwhelmingly decided to keep our endorsement with Congressman Young.

His military, business and government experience have him prepared to take this next step of leadership. Young is also an economic-minded individual who has repeatedly demonstrated prudent decision-making on issues that are vital to jobs and economic growth.

Additionally, Young’s engagement with the business community and his focus on economic, fiscal and regulatory issues were key factors. After he was appointed to the Ways and Means Committee, the congressman sought substantial feedback on potential federal tax reforms and what would have the most impact on Hoosier companies and their employees. He listened to our members – through personal conversations and a survey – using their insights to help form his pro-economy agenda.

The Indiana Chamber frequently hears from its members about burdensome federal regulations. They bring uncertainty and put a stranglehold on job creation. Congressman Young understands these frustrations and has sought to remedy that. In each session, he has introduced legislation (the REINS Act) that would require members of Congress to vote on major rules before they go into effect.

At both the state and federal levels, Indiana Chamber endorsements are driven by vote scores on pro-jobs, pro-economy issues. For state endorsements, the Indiana Chamber relies on its Legislative Vote Analysis report.

Congressional endorsements are based on a combination of the U.S. Chamber’s own vote scores and an analysis of votes on Indiana Chamber federal policy positions. The U.S. Chamber’s lifetime congressional voting record for Bayh is 55%; Young is at 91%.

The Indiana Chamber’s congressional affairs committee, which determined Young’s endorsement, is a nonpartisan group comprised of volunteer business leaders from around the state.

Representatives of the U.S. Chamber, which also is supporting Young’s general election campaign, joined the Indiana Chamber for the press event.

2016 Primary Illustrates Rapidly Changing State, National Political Landscape

60498552To describe the 2016 primary elections in Indiana as anything less than dramatic and jarring seems an understatement. Two years ago, record low turnout tipped the balance to ideological sub-groups of motivated voters. This year, unprecedented turnout in both parties was the environment.

In the same election where Hoosier voters overwhelmingly chose “anti-establishment” leaders in Donald Trump (R) and Bernie Sanders (D) in their respective party primaries for president, Hoosier Republicans preferred by a 2-1 margin Todd Young over the conservative, Freedom Caucus poster-boy Marlin Stutzman. This seeming contradiction carried down into state legislative races.

A large majority of Hoosiers detest the federal government, distrust both political parties, and want someone or something to lash out at. With Republicans in charge of both houses of the General Assembly by strong quorum-proof majorities, if you’re looking for some political payback in Indiana, the Republicans are the ones calling the shots.

In the 2016 primary elections, only one Democrat incumbent legislator faced a primary election challenger. However, 14 Republican legislators faced primary election challengers. The 2016 primary elections – just like in 2014 – were about the Republicans.

Two years ago, candidates at the primary election faced a likewise frustrated and ideologically-driven electorate feeding tough challenges from the right. In 2014, the very low turnout election resulted in highly-energized subgroups of voters – those angry and motivated to vote against someone – to turnout to vote. This year, huge volumes of new GOP primary voters, motivated by the presidential race and “anti-establishment” anger, washed over races like tsunamis of discontent.

In state legislative races, incumbents and new candidates alike who distinguished themselves in both aggressive personal contact with voters, organized and efficient campaign operations and who positioned themselves solidly to the right or left with their party’s bases were generally successful. There were exceptions, but this continues to be the formula to win in primary elections.

A fundamental, foundational shift appears to be underway in the Hoosier electorate. This is not unique to Indiana, but the state does appear to continue to be on the cutting-edge of political conflict and change. A relatively “conservative” state in terms of culture and political attitudes, Indiana has not been a sleeper state in terms of policy and political conflict.

Back-to-back legislative battles over highly-charged social issues of abortion, LGBT civil rights protections, RFRA, and gay marriage aren’t the only policy battlegrounds. Infrastructure, tax cuts, education reforms, right to work, and more have been a focus.

There hasn’t been much “sleepy Indiana” to be found in policy debates or political activities in the state for some time. The ingredients of conflict in this political soup are a product of significant and often rapid changes in our culture, society, economy and workplaces. Our political system is where these competing priorities and often difficult personal and societal transformations are debated and competed over at the ballot box.

Indiana Business for Responsive Government (IBRG), the non-partisan political action program of the Indiana Chamber of Commerce, was heavily engaged in the primary election cycle to help elect pro-jobs, pro-free enterprise candidates to the Indiana General Assembly. Unlike most other PAC programs, IBRG is not in the business of “picking the winners,” but being there to defend incumbents with strong voting records and to challenge those who do not.

IBRG continued its record of election successes with 18 of 22 endorsed primary election candidates winning.

Indiana Chamber Endorses Rep. Todd Young for U.S. Senate

young pic camera (2)The Indiana Chamber is endorsing Congressman Todd Young (R-IN, 9th District) in his candidacy for the U.S. Senate. The announcement was made today at a press conference at Indiana Chamber headquarters in downtown Indianapolis.

“We believe Todd Young is the most qualified and most economic-minded individual running for the Senate seat,” said Indiana Chamber President and CEO Kevin Brinegar. “He has repeatedly demonstrated sound fiscal policy and prudent decision-making on issues that are vital to jobs and economic growth.”

Brinegar further emphasized Young’s engagement with the business community and his focus on economic, fiscal and regulatory issues.

“After he was appointed to the Ways and Means Committee, the congressman sought substantial feedback on potential federal tax reforms and what would have the most impact on Hoosier companies and their employees. He listened to our members – through personal conversations and a survey – using their insights to help form his pro-economy agenda.”

The Indiana Chamber’s nonpartisan congressional action committee, comprised of volunteer business leaders from around the state, determined Young’s endorsement.

At both the state and federal levels, Indiana Chamber endorsements are driven by vote scores on pro-jobs, pro-economy issues. For state endorsements, the Indiana Chamber relies on its Legislative Vote Analysis report. Congressional endorsements are based on a combination of the U.S. Chamber’s own vote scores and an analysis of votes on Indiana Chamber federal policy positions.

Representatives of the U.S. Chamber, which also is supporting Young’s campaign, joined the Indiana Chamber for the press event.

Chamber Promotes Life Sciences in D.C.

7324001The Indiana Chamber is a proud partner in Hoosiers Work for Health, which promotes the biopharmaceutical and life sciences industry, and visited with Indiana’s elected representatives in Washington, D.C. July 15-16 to discuss issues such as patent
reform, taxation and FDA regulatory procedures.

The Chamber joined several other Hoosiers Work for Health representatives for office visits on Capitol Hill. The group met with Reps. Susan Brooks (R-5th District) and Larry Bucshon (R-8th District), both members of the House Energy and Commerce Committee, as well as Rep. Todd Young (R-9th District), who serves on the House Ways and Means Committee. The group also visited with key staff members for Sens. Dan Coats (R) and Joe Donnelly (D) while the Senate held floor votes on an education bill.

It is clear from the conversation with Indiana’s elected officials that they understand the importance of the biopharmaceutical/life sciences sector to the economic health of Indiana. This sector directly supports more than 20,000 jobs across the state and generates $19 billion in economic output. By creating high paying jobs, biopharmaceutical companies build a strong foundation from which we can grow our state economy – providing stability and prosperity into the future.