Provisions in Appropriations Bill to Improve FDA’s SPA Program Draw Support from Venture Capital Industry

ARLINGTON, VA – The National Venture Capital Association (NVCA) today endorsed language in the FY 2015 House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill directing the Food and Drug Administration (FDA) to make improvements to the Special Protocol Assessment (SPA) process.

In a letter to the leadership of the House Energy and Commerce Committee, Bobby Franklin, NVCA President and CEO, expressed support for provisions in the appropriations bill that directs the FDA to treat drug sponsors fairly and abide by congressional standards for rescinding SPA agreements.  Franklin also endorsed the Appropriations Committee’s direction to require FDA to revise and reissue its existing guidance concerning SPA agreements in order to clarify the agency’s interpretation of the statutory standard governing the treatment of such agreements.

“The SPA program has long provided venture capital investors with a degree of transparency and predictability that has aided in mitigating the risks associated with new product development, thus helping to attract needed investment capital,” wrote Franklin.  “In particular, some of the most innovative product development concepts with the greatest potential for improving patient care rely most heavily on the SPA program.  Without confidence in this imperative regulatory risk mitigation program, the development of many new medicines will be stifled.”

In the letter, Franklin urged the Energy and Commerce Committee to oversee the process to improve SPA agreements and asked for the committee to continuously review the FDA to ensure the agency is compliant with existing SPA program standards.

The full letter can be downloaded here: [wpdm_file id=4]