WASHINGTON, D.C., (February 26, 2009) – The following statement was issued today by Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood regarding the FY 2010 budget proposal released by President Barack Obama:
"BIO shares President Obama's goal of ensuring that all Americans have access to high quality health care and we applaud and support his call for a regulatory pathway for the review and approval of biosimilars. We look forward to working with President Obama and the Congress to achieve these goals.
"In his budget proposal, President Obama has laid out an ambitious plan to help increase access to affordable, high quality health care. We strongly believe that all patients who can benefit from the medications and therapies developed by our companies should have access to them.
"To that end, we are pleased that through his proposed budget President Obama is calling for a regulatory pathway for biosimilars. We support the development of a biosimilars pathway and have been working with Members on both sides of the aisle to encourage the passage of this important legislation. As we have long said, an approval pathway for biosimilars must focus on ensuring patient safety, be based on sound science and preserve incentives for the continued development of medical breakthroughs such as vaccines for cancer and HIV prevention, and improved treatments, therapies and potential cures for diabetes, Alzheimer’s, Parkinson’s disease, cancer and a host of rare diseases. The measure of a successful pathway will be that it is balanced as the Hatch/Waxman approach is for small molecule pharmaceuticals. Any biosimilars legislation must expand access and lower costs while preserving the incentives necessary for the development of new therapies and treatments as well as research leading to significant second generation improvements in safety and efficacy to innovative products.
"We want to work with Congress and the Administration to ensure that new health care policies keep at their center the fundamental principles necessary to achieve the President’s goals. Namely, any approach to universal coverage must preserve patient safety, leave medical decisions in the hands of patients and their health care providers, rely on market competition to drive down prices and enhance patient choice, and promote continued medical advancements and breakthroughs that lead to advanced treatments and cures for diseases such as cancer, Parkinson's and HIV/AIDS.
"We agree with the President that achieving universal access requires universal responsibility on the part of all stakeholders: individuals, employers, physicians, manufacturers, insurers, hospitals, and society as a whole. We stand ready to do our part. We also believe that market-based reforms provide the best opportunity to achieve universal access while providing high quality care and incentives for the discovery and development of medical breakthroughs throughout the health care delivery system.
"While we continue to review the President's budget proposal in greater detail, we are concerned that some of the proposals intended to provide budgetary savings may impede the medical advancements and breakthroughs all of us wish to see. On these matters we will work with the President and the Congress.
"As the President said in his Inaugural Address, we must ‘restore science to its rightful place and wield technology’s wonders to raise healthcare’s quality and lower its cost.’ Biotechnology can provide the technologies necessary to bring needed innovation to health care that will help increase access, lower costs, create greater efficiencies and provide advanced therapies and cures for debilitating diseases. We believe we provide the best hope for reaching President Obama's visionary goal of curing cancer 'within our time.'
"We pledge our support to work with the Obama Administration and the Congress to reform our nation's health care system to bring affordable, high quality health care to all and meet President Obama's challenge. We will work to ensure that any approach to reform recognizes that innovation in health care - including new therapies, vaccines and diagnostics - has always been and will continue to be central to realizing our shared goals to reduce costs, increase access and continue needed medical breakthroughs."
Upcoming BIO Events
March 16-18, 2009
BIO IP Counsels' Committee Conference
March 25–27, 2009
BIO National Venture Conference
March 31–April 1,2009
BIO Windhover 2009
April 13-15, 2009
New York, NY
BIO-LES Business Development Basics Course
May 15–17, 2009
BIO-LES Advanced Business Development Course
May 15–17, 2009
BIO Executive Presentation Workshop
May 17, 2009
BIO Human Resources Conference
May 17-19, 2009
2009 BIO International Convention
May 18-21, 2009
June 9-10, 2009
World Congress on Industrial Biotechnology & Bioprocessing
July 19-22, 2009
Montreal, Quebec, Canada
BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.