BIO is calling for a revamped “21st century FDA” Print E-mail
By Staff and Wire Reports   
Thursday, 07 July 2011 09:05
Imagine the FDA as an independent federal agency with a specific mission to promote innovation. The Biotechnology Industry Organization (BIO) is calling this the “21st century FDA” and is proposing legislation to Congress to reform the FDA in this way, as well as its drug approval process.
“Currently, the FDA has neither the resources nor the authority to do its job,” chief executive of BIO Jim Greenwood told delegates. “The regulatory process has become too unpredictable, time-consuming and expensive, regulatory science has not kept up with the frontiers of innovation and the agency has been given too many conflicting missions without sufficient resources to perform them.”

According to a report from Kapitall, the reforms aim to provide earlier access of new treatments to patients and to properly incentivize innovation. Under the proposals, the FDA would become an independent agency (no longer an arm of the Department of Health and Human Services) with an FDA Commissioner with a fixed 6-year term that is not tied to presidential administrations.

Instead of the currently required two “adequate and well controlled” clinical trials, BIO also proposes adopting a “weight of evidence” approach. According to chief executive of Human Genome Sciences Thomas Watkins, the FDA takes 37 months on average to approve a drug.

In talking with Congressmen, BIO also says they recognize the growing debts of Medicare and hopes to address the problem.

"Instead of Congress fixating on the cost of innovative medicines, they should consider this - a new drug that could delay the onset of Alzheimer's by even five years would save Medicare $50 billion a year," he said, adding: "that's what biotechnology can do."

During the 2011 BIO International Convention, the Biotechnology Industry Organization unveiled a strategic initiative to speed scientific breakthroughs, develop cures and grow the bio-economy. The policy proposals we presented will serve as BIO’s targeted advocacy plan for the next few years. Their comprehensive set of policy proposals address two vital needs for ensuring robust biotechnology innovation and industry growth: 1) the need to re-engineer the biotech economic model, and 2) the need to re-invent the idea-to-market pathway for biotech cures and other products. They intend to pursue these proposals by advocating for legislation, specifically by turning the relevant findings in to language that will be used to advocate for introduction and passage of legislation.

The process of putting together these proposals began last summer when interviewing thought leaders within and outside of our industry for the purpose of envisioning game-changing strategies. We contracted with Dr. Elias Zerhouni, former Director of the National Institutes of Health, to conduct an analysis of the challenges we face and a more comprehensive survey of medical experts, academic researchers and other life science leaders to suggest out-of-the-box, big ideas to significantly advance biotechnology’s chances to succeed. Additionally, during the past six months they worked with BIO Board members to review these ideas, debate their merits and create alternative and additional approaches to develop a comprehensive national policy strategy




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