Archive for the ‘Policy’ Category

Hoosiers Work for Health Partners Promote Indiana Innovation on Capitol Hill

August 5, 2019

July, 2019 – During a recent visit to Washington, D.C., Hoosiers Work for Health partners met with the members of Indiana’s congressional delegation to provide updates on the state’s growing health and life sciences sector which now supports more than 165,000 Hoosier jobs. Partners Eli Lilly and Company, Indiana Biosciences Research Institute, Indiana Health Industry Forum and Quality Connection spoke to members of Congress and their staffs about collaboration within Indiana’s life sciences ecosystem along with the latest research happening in Indiana to address conditions such as diabetes and Alzheimer’s Disease. They also discussed key policy issues including ways to lower costs for seniors enrolled in Medicare.

Source: Hoosiers Work for Health

McAdams and Hollingsworth offer bipartisan bill to ease red tape on promising start-ups

July 24, 2019

July 24 , 2019 – Washington DC—Congressman Ben McAdams (D-UT) and Congressman Trey Hollingsworth (R-IN) have introduced bipartisan legislation to provide commonsense regulatory relief for America’s growing companies, including many in the bioscience sector.  The Fostering Innovation Act is a narrow fix that allows small emerging growth companies to keep public capital working to fund business needs, such as innovative medical research, rather than expensive regulatory filings.

“The initial years after a company goes public are a critical time for that company’s success and every penny counts.  This bill narrowly targets a subset of public companies that would receive an additional five years of cost-savings through an exemption from an expensive regulatory requirement. That money can then be plowed back into product-testing and development and move them towards becoming more stable and sustainable businesses,” said McAdams.

“America has always been a leader in scientific and medical innovation,” said Rep. Trey Hollingsworth (IN-09). “The Fostering Innovation Act will update our federal regulations, ensuring they do not get in the way of allowing America to develop the next generation of cures.”

The bill extends a Securities and Exchange Commission (SEC) exemption from an external audit requirement for an additional five years for a small subset of emerging growth companies with annual revenue of less than $50 million and less than $700 million in public float. The legislation would be particularly important for Utah’s life science industry, as most biotechnology companies lack revenue for at least a decade as they work towards their first product approval.

“For emerging biotech companies, one-size-fits-all compliance burdens present a costly roadblock to growth and medical progress,” said Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood. “These companies typically operate for many years without product revenue, meaning that funds needed to comply with unduly burdensome regulations are diverted from their intended purpose – scientific advancement for the benefit of patients and consumers. The Fostering Innovation Act would reduce the cost of Sarbanes-Oxley compliance for these companies – without undermining important investor protections – allowing them to utilize investment capital to spur job creation and advance their potentially life-saving research.”

BioUtah President & CEO Kelvyn H. Cullimore said the legislation will allow capital provided from public financing to more effectively sustain promising companies.

“I commend Representatives Ben McAdams and Trey Hollingsworth for championing the Fostering Innovation Act. Many of Utah’s emerging biotech companies are small start-ups and do not yet generate product revenue. Accessing capital through public financings can be a key tool in sustaining the efforts of these companies in developing technologies that extend and save lives. This pro-business bill will enable those companies to focus critical resources in the lab and not on unnecessary regulatory burdens,” Cullimore said.

“The Fostering Innovation Act makes good business sense for Indiana and our state’s emerging biotech companies by reducing the cost of burdensome regulations,” said Kristin Jones, President and CEO of the Indiana Health Industry Forum. “This bill builds upon the success of the JOBS Act and will enable emerging biotechnology innovators to devote more of their limited resources to potentially lifesaving research and development activities. On behalf of Indiana’s innovative biotechnology companies, I commend Representatives Trey Hollingsworth and Ben McAdams for their leadership.” 

A bipartisan companion bill has been introduced in the Senate.

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AdvaMed Statement on Medical Device Tax Repeal Bill

April 10, 2019

FOR IMMEDIATE RELEASE                                                              

April 10, 2019

House Bill Targets Looming $20 Billion Tax On MedTech Industry

WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on introduction of bipartisan legislation (H.R. 2207) in the U.S. House of Representatives to permanently repeal the medical device excise tax:

“America’s medical technology industry is facing a $20 billion tax increase at year-end, when the current medical device tax suspension expires. Urgent action is essential to protect future medtech innovations that benefit patients and to avoid putting good-paying U.S. jobs at risk.

“House introduction today of the ‘Protect Medical Innovation Act of 2019’ in the 116th Congress brings us one step closer to ensuring this innovation-stifling burden on the medtech industry never returns, supporting continued American leadership of this vital industry.

“We thank the bill’s lead sponsors, Reps. Ron Kind (D-Wis.), Jackie Walorski (R-Ind.), Scott Peters (D-Calif.), and Richard Hudson (R-N.C.) for their leadership on this issue. This bill – and the strong bipartisan support they have gathered – reflect the high priority this Congress places on patients, jobs, and future investment.

“While past suspensions of the medical device tax have enabled manufacturers to invest in R&D, infrastructure and new hiring – which in turn benefits patients and the U.S. economy – these benefits are at risk. Now that bipartisan legislation to permanently repeal the device tax has been introduced in both the House and Senate, AdvaMed will urge Congress and the administration to act as expeditiously as possible to get rid of the tax once and for all this year.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

Congressman Hollingsworth Honored as Innovator in Biotechnology

April 9, 2019

Hollingsworth award

Pictured above: Amy Walker, BIO, Kristin Jones, IHIF, Rep. Trey Hollingsworth (IN-9), and Chris Wilson, Hoosiers Work for Health

 

Washington, D.C. (April 4, 2019) – Congressman Trey Hollingsworth was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Congressman Hollingsworth received the award in conjunction with today’s BIO Legislative Day Fly-In.

 

BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries.

 

“The life sciences industry in Indiana provides jobs for over 58,000 people. Congressman Hollingsworth has been an invaluable advocate for the biotechnology community – both in Indiana’s 9th District and the nation at large,” said Kristin Jones, President & CEO of the Indiana Health Industry Forum. “On behalf of the Indiana life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”

 

“Congressman Hollingsworth has been a stalwart advocate for sound public policies that advance the jobs creating potential of America’s biotechnology industry as we address the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world,” said BIO President and CEO Jim Greenwood. “His commitment to support the needs of America’s innovative life science companies allows them to focus on what matters – delivering life-saving and life-enhancing products.”

 

More than 200 biotechnology industry representatives from over 40 states, representing hundreds of thousands of American workers, will participate in hundreds of meetings with Members of the House and Senate during the BIO Legislative Day Fly-In. Participants will discuss issues critical to the biotechnology industry, including drug development, discovery and delivery reforms, targeting abuses of the U.S. patent system while protecting innovation, providing adequate reimbursement for vital therapies under Medicare, FDA funding, trade, tax policy, Farm Bill Implementation, protecting the Renewable Fuel Standard and capital formation issues relevant to biotechnology companies.

Senator Young Honored as Innovator in Biotechnology

April 9, 2019

Young Award Washington, D.C. (April 4, 2019) – Senator Todd Young was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Senator Young received the award in conjunction with today’s BIO Legislative Day Fly-In.

 

BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries.

 

“The life sciences industry in Indiana provides jobs for over 58,000 people. Senator Young has been an invaluable advocate for the biotechnology community – both in Indiana and the nation at large,” said Kristin Jones, President & CEO of the Indiana Health Industry Forum. “On behalf of the Indiana life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”

 

“Senator Young has been a stalwart advocate for sound public policies that advance the jobs creating potential of America’s biotechnology industry as we address the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world,” said BIO President and CEO Jim Greenwood. “His commitment to support the needs of America’s innovative life science companies allows them to focus on what matters – delivering life-saving and life-enhancing products.”

 

More than 200 biotechnology industry representatives from over 40 states, representing hundreds of thousands of American workers, will participate in hundreds of meetings with Members of the House and Senate during the BIO Legislative Day Fly-In. Participants will discuss issues critical to the biotechnology industry, including drug development, discovery and delivery reforms, targeting abuses of the U.S. patent system while protecting innovation, providing adequate reimbursement for vital therapies under Medicare, FDA funding, trade, tax policy, Farm Bill Implementation, protecting the Renewable Fuel Standard and capital formation issues relevant to biotechnology companies.

 

 

 

2019 Indiana Session Bill Watch

January 16, 2019

House

House Public Health Committee

House Committee on Commerce, Small Business and Economic Development

1001

1029

1179

1228

1246

1249

1307

1334

1351

1354

1414

1570

1593

Senate

Senate Health and Provider Service Committee

Commerce and Technology

Tax and Fiscal Policy

SR 26

  • Patient Records Confidentiality
    • Urges Congress to amend federal law concerning confidentiality of patient records

33

133

154

157

166

176

233

242

298

312

386

415

444

563

584

585

The Indiana Health Industry Forum Announces 2018 Legislator of the Year

December 17, 2018

December 17, 2018 – INDIANAPOLIS, IN – The Indiana Health Industry Forum (IHIF) today announced Indiana Congressional Representative Trey Hollingsworth (IN-9) as the group’s 2018 Legislator of the Year. The award is presented annually to legislative leaders who demonstrate a strong commitment to public health policy and service to Indiana’s health science business community.

Trey Hollingsworth“Representative Hollingsworth has been a strong proponent of Indiana’s bioscience industry”, said Kristin Jones, President and CEO of IHIF. “We applaud his support of the Fostering Innovation Act which provides financial management tools that can considerably aid young bioscience companies here in Indiana and nationwide. He has also actively connected with life science companies in his district and shown a deep understanding of the challenges facing companies in the industry.”

“The availability and effectiveness of a cure is what stands between life and death. For generations, the United States has led the world in biotechnology innovation, successfully pushing limits to find cures for some of the deadliest diseases,” said Representative Trey Hollingsworth. “Our country’s laws should allow for continued innovation and research for these cures, not prevent new ideas from potentially saving lives.”

Representative Hollingsworth was also recognized earlier this year as one of the Biotechnology Innovation Organization (BIO)’s “Innovators in Biotechnology” in recognition of his efforts to embrace the value of biotechnology and promote public policies to unleash the potential of life-saving innovations. BIO gives this award to Members of Congress who have been collaborative partners, advocates, and champions for the biotechnology and life sciences industries.

Previous IHIF Legislator of the Year award recipients include: Senator Joe Donnelly (2017), Representative Larry Bucshon and State Senator Patricia Miller (2016), Representative Susan W. Brooks (2015), and State Representative Ed Clere (2014) and State Senator Brandt Herschman (2014).

 

About IHIF:
IHIF is a statewide trade association representing Indiana’s bioscience business community. The diverse members of the Indiana Health Industry Forum generate the collective voice of the state’s health and life science industry. Our mission is to connect key stakeholders to: enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation. To learn more, please visit www.ihif.org.
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IHIF Statement on U.S.-Mexico-Canada Agreement

October 11, 2018

INDIANAPOLIS (October 11, 2018) – Indiana Health Industry Forum President and CEO Kristin Jones released the following statement on the recent United States-Mexico-Canada Agreement:

“The new United States-Mexico-Canada Agreement (USMCA) is a positive step forward for America’s innovative health care sector. For decades, biotechnology pioneers from Indiana and across the country have been responsible for groundbreaking discoveries that have improved the lives of patients across the globe. The new business standards in this agreement will help continue this leadership by providing incentives for companies to continue to innovate, discover and grow.”

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Related Statements from IHIF Partners:

AdvaMed Statement from Scott Whittaker

PhRMA Statement from Stephen Ubl

BIO Statement from Jim Greenwood

February 2018 Life Sciences Luncheon – 2018 Public Policy Overview

February 27, 2018

Public policies are impacting the life sciences sector dynamically, with many changes at the state and federal levels targeting manufacturers. Please join us as we hear the latest on the 2018 session of the Indiana General Assembly and delve into current public policy issues for the medical device and bio-pharmaceutical sectors. This month’s program will feature an Indiana legislative leader sharing thoughts on the current session and the direction state policy makers are heading in support of innovation. This will be followed by a moderated discussion featuring local industry leaders. This is a great time to reach out – please invite your legislators to attend with you!

 

 

PANELISTS
Anne HathawayExecutive Director, Indiana Medical Device Manufacturers’ Council (IMDMC)
Michael O’ConnorSenior Director, State Government Affairs, Eli Lilly and Company
MODERATOR
Kristin JonesPresident and CEO, IHIF

 

About the Series: The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in the life sciences. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the industry. We hope you will join us.

 

To learn about upcoming lunch programs, please visit us on-line.

Hollingsworth Passes Bill to Cut Red Tape, Help Hoosier Companies Making Life-Saving Breakthroughs

February 15, 2018
FOR IMMEDIATE RELEASE Contact: Katie Webster
February 14, 2018 (202) 225-5315
 

 

WASHINGTON, D.C. – Today, the U.S. House of Representatives passed H.R. 1645, the Fostering Innovation Act, introduced by Rep. Trey Hollingsworth (R-IN) and Rep. Krysten Sinema (D-AZ), as part of a bipartisan legislative package to provide financial regulatory relief to Americans. H.R. 1645 helps ensure that costly regulations don’t stand in the way of successful biopharmaceutical research.

 

“This country has led the world in biotechnology innovation, successfully pushing limits to find cures for some of the deadliest diseases,” said Representative Hollingsworth. “The Fostering Innovation Act will right-size the regulatory environment that detracts from advancements, enabling America to develop the next generation of cures to combat illnesses that plague Hoosiers.”

 

Read the full text of the legislation, here.

 

The bioscience and biotechnology sector in Indiana has expressed strong support of the Fostering Innovation Act:

 

Kristin Jones, President and CEO, Indiana Health Industry Forum: “While the Fostering Innovation Act will be of broad benefit to companies in the bioscience sector across the country, Hoosier companies and patients also stand to benefit.  By eliminating a costly administrative burden, pre-revenue biotech companies will be able to focus more of their scarce investment funding on developing new therapies and adding high-wage jobs, instead of paying for expensive internal audits.  As more Indiana bioscience companies mature and look to IPOs as a viable fundraising option, we expect the benefits of the Act to accrue quickly.  We commend Rep. Hollingsworth for his leadership on this issue.”

 

Jeff Schwegman, Ph.D., Founder & CEO of AB BioTechnologies, Inc. (Bloomington, IN): “The Fostering Innovation Act eliminates the costly burdens of extensive audits to many of our clients, allowing them to invest further in drug development in Indiana. Ultimately these savings will be passed on to patients which benefits the community as a whole. Thanks to Representative Hollingsworth’s depth of understanding of the life sciences sector in Indiana, he was able to pass meaningful legislation that will provide a benefit to Hoosiers at all levels.”

 

 

Background

 

Currently, emerging growth companies (EGCs) are exempt from certain regulatory requirements for the first five years after their IPO.  One of the requirements EGCs are exempt from is Sarbanes-Oxley Section 404 (b) – which requires public companies to obtain an external audit on the effectiveness of their internal controls for financial reporting.  This reporting requirement is both costly and unnecessary because management is still required to assess internal controls, and these EGCs have limited public exposure.

 

H.R. 1645 is a narrowly-tailored fix that temporarily extends the Sarbanes-Oxley Section 404(b) exemption for an additional five years for a small subset of EGCs with annual revenue of less than $50 million and less than $700 million in public float. This legislation does not prohibit an external audit if the company or the majority of shareholders determine an audit is benefit.

 

 

 

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Office of Representative Trey Hollingsworth  |  1641 Longworth House Office Building, Washington, DC 20515

P: (202) 225-5315 |  www.hollingsworth.house.gov