Victories for Innovation: Congress Reauthorizes the SBIR/STTR and User Fee Programs
By: Colorado BioScience Association Date: 09/30/2022
CBSA celebrates policy victories for Colorado’s life sciences community and America’s innovators, scientists, and entrepreneurs. Congress reauthorized critical SBIR/STTR and User Fee programs. Without action, they were set to expire at the end of September.
On September 29, the U.S. House of Representatives passed legislation to reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Additionally, House and Senate lawmakers agreed to a continuing resolution (CR) that would prevent a government shutdown until Congress can work out a longer-term spending bill in mid-December. The CR includes reauthorization of FDA’s prescription, generic, biosimilar, and medical device User Fee programs for another five years. This means the agency will not have to lay off user-fee funded staff. The fees support FDA resources and capacity, offering greater predictability for the industry.
The SBIR/STTR programs are vital for life sciences companies and researchers in Colorado. The three-year reauthorization addresses major concerns by establishing research security measures, increasing transparency and oversight, and focusing on commercialization. It continues programs that make a positive impact on Colorado’s economy by funding life-saving breakthroughs for patients, supporting small businesses, and creating jobs.
The programs have had a significant impact on Colorado’s life sciences growth. Our state has received more than 6,035 awards totaling more than $2.76 billion dollars since the programs began.
The CR reauthorizes FDA’s prescription and generic drug, biosimilar and medical device user fee programs for another five years. CBSA has long supported and advocated for the renewal of the critically important User Fee Agreements, including the Pharmaceutical Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA).
While CBSA applauds Congress for including the user fee reauthorization in the CR, it is worth noting that the bill lacks many riders supported by FDA and CBSA. These include the long-anticipated Verifying Accurate Leading-edge IVCT Development (VALID) Act, Predetermined Change Control Plans (PCCP) and other important policy riders.
Members of Congress have indicated that they intend to revisit these key riders later in the year ahead of the December government funding deadline. CBSA will continue to advocate for these important programs as Congress evaluates other avenues to get them done.
CBSA Thanks Our Community and Colorado’s Congressional Delegation
CBSA and our national partners see these reauthorizations as wins for our members and the Colorado life sciences ecosystem. Thank you to members of our community who helped CBSA advocate and reached out to Colorado’s Congressional Delegation to communicate the importance of these programs.
We also thank Congressional leaders and the Colorado Delegation for their efforts to reauthorize the SBIR/ STTR and User Fee programs.