This week, Senator Jacky Rosen introduced a bill that would make it easier for nonprofit pharmaceutical organizations in the United States to achieve their potential. The bill is called the Expanding Access to Affordable Prescription Drugs and Medical Devices Act. Medicines360 proudly supports this legislation.
Sometimes, traditional pharmaceutical models fail to bring necessary drugs to market or bring drugs to market at unaffordable prices that keep them out of reach for the patients who need them. In certain cases, nonprofits pharmaceutical organizations have stepped in, introducing new products or new distribution models.
Nonprofit pharmaceutical companies offer a pro-competitive solution that is complementary to the traditional for-profit sector. Without the need to maximize profits for shareholders, nonprofits can focus on medicines and patients that have not been addressed under the existing model.
Despite the promise of nonprofit models, the current pharmaceutical policy environment was built around traditional for-profit companies. Right now, it’s difficult for nonprofits to unleash their full potential to make drugs more affordable and more accessible.
Waxman Strategies, a mission-driven consulting firm led by former Congressman Henry Waxman, outlined the unique challenges facing nonprofit pharmaceutical organizations in a white paper published earlier this year. As the first nonprofit to market a pharmaceutical product in the United States, Medicines360 has experienced many of these challenges first-hand. We’re excited to see some important barriers addressed in this legislation.
This bill would clear the path for nonprofit pharmaceutical organizations by:
- Establishing funding in the form of cooperative agreements and loans for nonprofit pharmaceutical organizations to research, develop, and manufacture drugs and devices that are deemed essential or urgently needed to address a public health need
- Clarifying that nonprofit pharmaceutical organizations are able to qualify for federal tax exemption
- Removing barriers to market entry by waiving FDA user fees for nonprofit pharmaceutical companies
- Allowing the FDA to prioritize product applications submitted by nonprofit pharmaceutical organizations when they commit to offering those products at significantly lower prices than comparable products.
Together, these changes would give nonprofit pharmaceutical organizations a better chance to fulfill their missions to make medicines more accessible at lower costs. This bill is a critical first step. Medicines360 thanks Senator Rosen for her leadership on this issue and calls on Congress to support the Expanding Access to Affordable Prescription Drugs and Medical Devices Act.