“Inside the FDA” session at BIO CEO Addressed PDUFA and TREAT Acts

Last but certainly not least at the 14th annual BIO CEO & Investor Conference in New York City was the Closing Plenary Session, “Inside the FDA” which addressed one of the most critical topics in healthcare today: The reauthorization of PDUFA V (prescription drug user fee act). This is one of the largest sources of frustration currently among health care companies and investors. Drugs are taking far too long to gain approval and get to patients who are often facing life threatening illnesses. According to Dr. Steven Spielberg, FDA’s Medical Commissioner for Medical Products and Tobacco,”there is an inverse relationship between R&D and FDA approvals.” He continued with an optimistic outlook by stating that in 2011 there were 31 approvals by the FDA and so far in 2012, 14 drugs have been granted approval.

Other panelists included:  Paul J. Hastings, President & CEO, OncoMed Pharmaceuticals, Inc.; Jonathan S. Leff, Managing Director, Healthcare, Warburg Pincus LLC; and Richard Pops, Chairman & CEO, Alkermes plc.  BIO’s CEO, Jim Greenwood, moderated the hour long session.

Mr. Greenwood briefly addressed the TREAT act, a bill introduced on February 15, 2012 by Senator Kay Hagan (D-NC) saying, “The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act will help unleash the promise of biotechnology to speed life-saving cures, novel medicines and scientific breakthroughs to patients living with debilitating diseases such as cancer, HIV/AIDS, Parkinson’s and diabetes.”

He continued, “The TREAT Act will help break the institutional barriers to a faster idea-to-market pathway and speed new cures to patients most desperately in need. Through this bill, Senator Hagan has offered renewed hope to patients desperately in need of cures and breakthrough new medicines as well as a boost to our nation’s economy. The legislation will help the U.S. Food and Drug Administration (FDA) retain its leadership position as the global ‘gold standard’ for regulatory science and consumer protection”

Takeaways from the closing session were that although the FDA takes far too long for drug approvals in the eyes of drug companies and investors, the FDA is working towards improving the time frames and keeping costs down. Keywords: safety, efficacy and innovation.