Consider the statement of Francesca Grifo, a director at the UCS, â€œGiven FDA's track record in the past, I'm not confident in their ability to create something that is free of influence from industry."
Believe it or not, this statement was aimed at, of all things, the bi-partisan crown jewel of current FDA reform legislation â€“ the Reagan/Udall Foundation (aka â€œthe Crtitical Path Foundationâ€), approved by Congress and signed into law late last month, allowing the FDA to work with both industry and academe to accelerate the nascent sciences of genomics and proteomics to help realize the very real potential of a new kind of medicine â€“ personalized medicine -- capable of tailoring highly effective treatments against the underlying causes of specific diseases in individual patients â€“ and perhaps even preventing those diseases from occurring or progressing in the first place
According to Senator Ted Kennedy, the Reagan-Udall Foundation "will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients."
Just what track record is Ms. Gifo referring to anyway?
The hard truth is that many of the most dramatic scientific advances in basic research are difficult to translate into safe and effective medical treatments for patients. Isnâ€™t this something that â€œconcernedâ€ scientists should be concerned about?
Despite the increase in R&D spending, the number of new innovative products being submitted to the FDA for approval is decreasing and the rate of failure is increasing. Almost 50% of applications are failing in late-stage Phase 3 trials. This costs companies millions of extra dollars and is driving up the cost of successfully bringing a new drug to market. In 2003, researchers at Tufts Center for the Study of Drug Development estimated these costs to be $802 million, and some sources suggest that the total cost is closer to $1.7 billion.
As the late Senator Everitt Dirksen said, â€œA billion here and a billion there, and pretty soon youâ€™re talking about real money.â€
Think about the millions of dollars, pounds and Euros that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process.
IP questions? You bet â€“ itâ€™s the 800 pound gorilla sitting in the corner. But we must acknowledge, address, and overcome this and other obstacles. Bumps along the road of all sizes must not allow the Critical Path to be the path less traveled.
FDA must assume the lead organizational role, because the agency is at the crossroads of the translational process. FDA is uniquely suited to take a major role in this effort because of their unique cross-industry and cross-cutting knowledge of the hurdles companies and products encounter that are causing them to fail in late stage clinical trials.
The Critical Path must be blazed in partnership. Regulators and industry, patient groups and legislators, FDA and EMEA must work together to help bridge the widening canyon between bench and bedside.
The Union of Concerned Scientists thinks the FDA has â€œan agendaâ€ â€“ and theyâ€™re right â€“ itâ€™s to protect and advance the public health.