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Should the FDA Be Split In Two? And Other Industry Musings

The FDA is grossly underfunded, resulting in spotty oversight and slow drug approval processes, leading some to speculate that America might be better served by two agencies instead: one for food safety and another for drug oversight.

But today industry insiders* downplayed the idea of carving up the FDA. Their reasoning? First of all, it would be too complicated to untether the two areas of oversight. Secondly, America is redoubling its preventive health efforts, including healthy eating and regular exercise as a means to reduce the chronic disease burden. Billy Tauzin, CEO of PhRMA, commented, “We are what we eat. We should keep food and drug oversight closely aligned.”

Other industry concerns voiced on the conference call included:

1. A wish for the FDA to enter the 21st century by accepting digital filing and analysis of clinical trial data. Currently, they accept paper copies only.

2. A call for an experienced executive leader to become the new FDA Commissioner. One conference participant stated that “The FDA has been a rudderless ship for too long. We need someone who has the courage to say that there’s no such thing as a risk-free drug, and then speed up the approval process based on the best science available. The FDA is the world’s leading regulatory agency but is losing respect on the international stage, while Europe’s FDA equivalent is increasing in prestige.”

3. A desire for the new FDA Commissioner to be “above politics” and objective about science. A fixed term for the position was proposed.

4. A request for transparency in the drug approval process. One call participant said, “The FDA’s decision-making process is a black box. That really slows down our ability to get effective drugs to market.”

5. A cautious approach to approving biosimilar (or follow-on biologics) treatments. “At least 14 years are needed to demonstrate the interchangeability of biologic therapies,” said one biotech industry leader. “There’s a big difference between creating generic molecules of a common drug, and reproducing safe and effective treatments derived from living organisms.”


*The conference call was called, “The Obama administration and the new congress: good medicine for the pharma, biotech, and medtech industries?” sponsored by Ernst and Young. Recordings of the conference are not yet available to the public. Participants included:

Billy Tauzin, President and CEO of PhRMA
Jim Greenwood, President and CEO of the Biotechnology Industry Organization
Brett Loper, Executive Vice President, Government Affairs from AdvaMed

Special guest:
Mark B. Hassenplug, Global Pharmaceutical Markets Leader, Ernst & Young LLP

Anne Phelps, Prinicpal, Washington Council Ernst & Young LLP
Carolyn Buck Luce, Global Pharmaceutical Sector Leader, Ernst & Young LLP

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