Thursday, November 12, 2009

The FDA's To-Do List

by Margaret Anderson, COO, FasterCures

The U.S. Food and Drug Administration’s priority to-do list is long. Dr. Joshus Sharfstein, FDA's Principal Deputy Commisioner spent some time recently addressing the list with members of the Alliance for a Stronger FDA. At the top of the list was transparency, a critical priority and one that the agency is addressing through a Task Force dedicated to delve deeper into this area. Also on the list were credibility, standards, global supply chain, guidance, integrity, enforcement. FDA’s credibility is of paramount importance, without it the medical research enterprise and health care delivery system will come to a grinding halt. "If we can successfully build something with all these strands together it will be more than the sum of its parts."

I asked about how the agency can work more closely with companies so there is more predictability. We’ve all heard stories of promising compounds languishing because the regulatory hurdles were high and in the end, the patients pay the ultimate price if that promise sits idle.

The expansion of the agency’s commitment to advance regulatory science spans work in the Critical Path shop, the Reagan-Udall Foundation (of which FasterCures is a recent supporter), and a list of key science areas that could make a big difference in the markers of whether something works. In order for the baton to be passed from NIH-funded work to translation at companies into products, the FDA needs to be ahead of the innovation curve. Sounds like the topic is clearly on the to-do list.

The Alliance for a Stronger FDA has made a huge difference in the FDA’s funding levels. Its only goal is to get the agency more appropriated dollars and I 'm proud to be a Board member. If your organization is not a member, I urge you to get engaged. The agency’s funding situation has improved, but we have a long way to go to ensure FDA gets to where it wants to be vis-à-vis innovation in all areas, but particularly in medical research.

Which makes FasterCures' Partnering for Cures meeting all the more timely and relevant. To be held December 1-3 in New York, we're bringing together medical research leaders, investors, and decision-makers, including Dr. Sharfstein, to explore innovative approaches to pursuing high-risk, long-term investments that could lead to therapeutic breakthroughs. Joining Dr. Sharfstein on the speaker roster are some of the most forward-thinking leaders in medical research: Pfizer CEO Jeffrey Kindler, Cystic Fibrosis Foundation's Bob Beall, NIAID's Anthony S. Fauci, Harvard Stem Cell Institute's Doug Melton. The list goes on...but what I think is most interesting is the coming together of sectors to explore partnerships needed to turn a scientific discovery into a viable therapeutic option. Learn more and be a part of this first-of-its-kind effort:

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