WASHINGTON, D.C. – Today, U.S. Senator Jacky Rosen (D-NV), a member of the Senate Committee on Health, Education, Labor and Pensions, and the Senate Special Committee on Aging announced the introduction of her Expanding Access to Affordable Prescription Drugs and Medical Devices Act. This legislation would help reduce the cost of prescription drugs and medical devices, decrease the frequency of drug shortages, boost domestic production, and create jobs in America by providing federal support for nonprofit prescription drug and device manufacturers through cooperative agreements, improved access to capital through a revolving low-interest loan program, and clarification of tax-exempt status.
According to data from the Kaiser Family Foundation, 79 percent of Americans think the cost of prescription drugs is unreasonable, with nearly three in ten American adults saying that they haven’t taken medication as prescribed due to cost.
“I’m proud to introduce this legislation which will take steps to lower the often high costs of prescription drugs and medical devices for countless Americans,” said Senator Rosen. “Whether it’s access to cancer-treating medication or insulin pumps, my legislation would help reduce costs and improve the domestic supply chain by providing support to nonprofit pharmaceutical and medical device manufacturers in an effort to bring more medications and devices to market at a reasonable price, while creating jobs right here at home. I will never stop fighting to ensure the health of Nevadans and Americans who depend on affordable, accessible care.”
“We applaud Senator Rosen for her leadership to address the cost of prescription drugs – a top concern for so many people and their loved ones. We firmly believe everyone should have access to safe, effective and essential prescription medicines when they need them and at a price they can afford,” said Justine Handelman, Senior Vice President of the Office of Policy and Representation for the Blue Cross Blue Shield Association. “The bill’s promotion of non-profit prescription drug manufacturers is consistent with our support and existing partnership with CivicaScript to bring more affordable generic drugs to market by 2022, which we anticipate will save hundreds of millions of dollars. Thank you Senator Rosen for introducing the Expanding Access to Prescription Drugs and Medical Devices Act, and we urge Congress to pass this important piece of legislation.”
“As a non-profit generic drug company established to tackle chronic drug shortages, we applaud Senator Rosen for developing legislation that will help us and others serve patients,” said Martin VanTrieste, President and CEO of Civica Rx. “For us, serving patients means making quality medicines accessible and affordable to everyone.”
“For far too long the only direction prices of prescription drugs have gone is up, leaving Americans to subject to impossible choices between affording life sustaining medications or food and rent,” said Shelley Lyford, President and CEO of the West Health Institute. “This is unacceptable, and something has to give. One of the surest ways to improve value, increase price transparency, and lower costs is to ensure availability of generic medications. We applaud Senator Rosen for leading this charge.”
“On behalf of our nonprofit organization, I wish to voice our strong support of your legislation that would, for the first time, acknowledge the growing contribution of nonprofits to the healthcare infrastructure in our country,” said Jim Wilkins, Ph.D., President and Founder of Fair Access Medicines. “The proposed legislation acknowledges a growing sentiment that healthcare is a fundamental human right and that we must do more to ensure more equal access to all citizens regardless of their economic circumstances. Your legislation is fundamentally important to the continued growth and evolution of a nonprofit sector in the pharmaceutical space that will not only help to provide affordable healthcare products and services, but help to convince our fellow citizens that we are working to level the playing field in healthcare.”
“As a nonprofit pharmaceutical organization, Medicines360 has long worked to remove cost as a barrier to health by developing and providing quality, affordable women’s health products,” said Andrea Olariu, M.D., Ph.D., Interim CEO of Medicines360. “We thank Senator Rosen for her leadership on this issue and are proud to endorse this bill. This pioneering legislation is the first step in clearing the path for nonprofit pharmaceutical organizations to advance their missions to address the systemic issues in drug supply, access, and affordability.”
“NP2, a nonprofit pharmaceutical organization, is delighted to support this important legislation,” said William Buhles, Ph.D., Board President of NP2. “Our goal is to improve public health by making prescription drugs available to those who, for financial reasons, would not otherwise receive treatment. Senator Rosen's bill establishes a legal framework in which nonprofit drug firms can operate and provides for financial support of such endeavors.”
“The battle for lower drug prices and greater access to lifesaving medicines can only be won if there are competitors on the field who force the issue, by providing truly competitive products to the market,” said Michael Hufford, Ph.D., Co-Founder and Chief Executive Officer of Harm Reduction Therapeutics. “
BACKGROUND: The Expanding Access to Affordable Prescription Drugs and Medical Devices Act would provide support for domestic nonprofit prescription drug and device manufacturers and distributors through:
- Authorization of a cooperative agreement funding program to support bringing an eligible drug or medical device to market within five years.
- Creation of a low-interest loan program to assist in bringing nonprofit drugs and devices to market. Loans shall have an interest rate no greater than three percent, and shall be no greater than $5 million per loan. Repayments will be made to a revolving loan fund to support future loans.
- Clarification of nonprofit tax-exempt status to provide specific guidance to Internal Revenue Service (IRS) regarding qualifications for entities to qualify as nonprofit drug or medical device manufacturers.
To be eligible for support and funding, manufacturers must be based in the United States.
Priority for cooperative agreements and loans is given to entities that are expected to take eligible drugs or devices to market at a price that is lower than existing treatments for the same disease or condition, or for drugs or devices identified as a public health priority by the U.S. Health and Human Services (HHS) Secretary.
The bill also requires reports from the Congressional Budget Office (CBO) and HHS on cost savings for investment in the nonprofit drug and medical device model, and provides a waiver for these nonprofit manufacturers from Food and Drug Administration (FDA) user fees if they are not receiving a loan or cooperative agreement funding.
In addition to Blue Cross Blue Shield Association (BCBSA), CivicaRx, Fair Access Medicines, Harm Reduction Therapeutics, Medicines 360, and NP2, the Expanding Access to Affordable Prescription Drugs and Medical Devices Act is endorsed by the American Cancer Society Cancer Action Network, West Health Institute, Drew Quality Group (DQG), and Intermountain Healthcare.