WASHINGTON — With the implementation of new legislation since 2007 at the Federal Drug Administration (FDA), patients waiting on new medical developments may be forced to continue waiting, Dr. Timothy R. Franson of B&D; Consulting wrote in an opinion article published in the February issue of
Clinical Pharmacology and Therapeutics.
New drug development and innovation in the U.S. are taking a backseat to post-approval commitments, such as risk evaluation, according to Franson, a Senior Vice President in the firm's health and life sciences sector.
Under the FDA Amendments Act of 2007 (FDAAA) which constitutes the 4th iteration of the Prescription Drug User Fee Act (PDUFA), there is a shift away from pre-approval development improvements in prior PDUFAs toward post-approval matters such as safety surveillance and enforcement. PDUFA funding, which was originally conceived to improve the new drug review process to allow patients access to ground-breaking treatments, is now being significantly rechanneled toward overseeing previously approved drugs and biologics.
These FDAAA trends, Franson wrote, are serving as unintended disincentives to innovation. Refocusing on innovations to address unmet patient needs is vital to halting the recent decline in new drug approvals in the U.S., he pointed out.
"There are reasons to be hopeful that the current dismal trends in tone, focus and productivity can be reversed by collective attention to restoring basic interests," Franson wrote. "A re-emphasis on benefit-risk, instead of safety in isolation, along with a commitment to collaboration — remembering that disease is the enemy, not each other (and that this foe is a huge but vulnerable adversary, with many chronic diseases being manageable of preventable with effective programmatic approaches) — should be cornerstones in refocusing on the throughput of new cures in the development process."
Franson leads B&D; Consulting's regulatory affairs practice. He was the founder and president of Franson PharmAdvisors LLC, a clinical and regulatory pharmaceutical development consulting firm that merged with B&D; Consulting. From 1986 to 2008, Franson worked at Eli Lilly and Company, serving as Vice President of Global Regulatory Affairs at Lilly Research Laboratories for the last five years.
Franson received his M.D. with honors from the University of Illinois College of Medicine in 1978. He completed a fellowship in infectious diseases and epidemiology from the Medical College of Wisconsin from 19981-83 and internal medicine training from the University of Iowa from 1978-81.
To read Franson's article in Clinical Pharmacology and Therapeutics, click here.
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B&D; Consulting is a national advisory and advocacy firm based in Washington, D.C. since 1985. Whether developing a business or advancing a mission, the firm's professionals serve clients across key sectors of the U.S. economy, including local government, health and life sciences, energy, education, and financial services. B&D; Consulting is a division of Baker & Daniels LLP, an international law firm with offices in Indiana, Chicago, Washington, D.C. and Beijing. For more information about B&D; Consulting or Baker & Daniels, visit www.bakerdconsulting.com or www.bakerdaniels.com.