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FDA: How can we improve it?

July 20, 2011
By Stephen Sherwin, Former Chairman of BIO

As Congress and the President work together to hammer out a new, national economic roadmap, it is important to point out to those working in, and interested in, our industry that we too have recently assembled a roadmap - one designed to fully realize the promise our industry holds for people everywhere.

Several weeks ago, at the 2011 BIO International Convention in Washington, DC, BIO unveiled its first ever 5 year strategic plan that will help guide the organization's policy agenda for the near future.  The plan, crafted after consultation with industry experts, academics and BIO's board, is designed to minimize the regulatory and legal burdens that hinder our ability to cure disease, feed the hungry and develop newer, cleaner forms of energy.  The plan seeks to accomplish this in two over-arching ways: incentivizing private and public investment in solving these problems, and enhancing the science-based regulation of our industry to ensure that new biotech therapies, cures and other bio-based products become available in a timely manner.

Much of the plan is focused on ways to improve the function of the U.S. Food and Drug Administration (FDA) - an agency many of us work with on a frequent basis.  Our experience suggests that the hard working and dedicated staff of the FDA would welcome the increased resources that we are advocate. Moreover, our proposals could help modernize the agency and enhance the transparency and predictability of its review processes and decision-making.

In the coming weeks and months, as BIO's staff works with policymakers to craft the legislation that will deliver these changes needed to cure disease and save lives, BIO will continue to keep member companies apprised of actions they can take to help create the climate needed for passage of such measures.  In the meantime, we encourage everyone to review the following document to gain greater insight into this exciting new plan -