Former commissioner of the Food and Drug Administration Andrew von Eschenbach (2005-2009) recently wrote an op-ed article for the Wall Street Journal outlining actions which he believes will strengthen the FDA and make a more efficient path for approval of new biopharmaceutical drugs and treatments.
In this article Eschenbach, currently the chairman of the Manhattan Institute's Project FDA, points to a lack of sufficient funding of the FDA which he claims made it difficult for the agency to procure "scientific tools and resources to review complex innovations more expeditiously and pioneer regulatory pathways for state-of-the-art therapies that defy current agency conventions." These deficits, he argues, has halted the approval of treatments as the FDA scrambled to keep up with new science and techniques.
He opined,
"The FDA isn't obstructing progress because its employees are mean-spirited or foolish. But for decades, Congress has starved the agency of critical funding, limiting its scientists' ability to keep up with peers in private industry and academia. The result is an agency in which science-based regulation often lags far behind scientific discovery. This forces the FDA to slow the approval of new treatments—and at times creates acrimonious litigation between the FDA and innovators, not to mention disillusionment among desperate patients."
To alleviate this problem, Eschenbach calls for increased funding of the FDA as well as greater collaboration between this agency and other leaders in the field, such as physicians and companies currently developing new technologies and techniques. By working in tandem, Eschenbach feels the FDA would establish greater understanding of new science and be in a better position to more efficiently and accurately evaluate breakthroughs.
Read the full article here.