Senate Approves FDASIA, Legislates to Enhance TDP Tax Credit

On May 24, Biotechnology Industry Organization (BIO) reported on two important and exciting developments in the U.S. Senate: the approval of the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA), and the introduction of legislation to extend and expand the Therapeutic Discovery Project (TDP) Tax Credit.

BIO President and CEO Jim Greenwood commented that the FDASIA “will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review.” The FDASIA also “enables a transparent, predictable and balanced regulatory framework for the review and approval of biosimilars by establishing reasonable performance goals and dedicated, independent funding for biosimilar review activities.  This will allow the FDA to continue to prioritize the review of innovative drugs and biologics so that safe and effective new therapies -- many for currently serious, untreatable diseases -- can be available to the patients who need them.  The provisions included in FDASIA will encourage continued investment in pediatric research and help ensure that new drugs and biologics can be used safely and appropriately in pediatric patients.”

BIO also reported that in addition to supporting the approval of the FDASIA, Senator Robert Menendez (D-NJ) introduced “The Extension of the Therapeutic Discovery Project Tax Credit" (S. 3232), which will extend and expand the Therapeutic Discovery Project program.  Jim Greenwood, in his press release, stated that "in 2010, the TDP provided $1 billion in support to nearly 3,000 small companies across the country.  This bill will extend and improve the TDP to allow more groundbreaking companies to invest in the medical breakthroughs of tomorrow and the jobs and economic growth that come with them.  It also refines the program to ensure that taxpayer dollars go to the most deserving and innovative companies and projects with the most significant potential to meet the medical challenges that America faces.”


For more information on the Therapeutic Discovery Project, including a series of videos highlighting the reasons why this program should be extended and expanded, please visit 

Jaime Gilmore is an Audit Director performing audit services as well as SEC compliance, revenue recognition, equity based compensation and other complex equity instruments.

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