Can a 21st Century FDA Accelerate Biotech Innovation to Cure Disease and Save Lives?

FDA should incorporate the latest advances in regulatory science into its operations.
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In an article for FDLI’s Food & Drug Policy Forum, BIO President and CEO Jim Greenwood discusses several of BIO’s policy proposals for creating a 21st Century FDA. These proposals are part of BIO’s Unleashing the Promise of Biotechnology initiative.

I. Introduction

Biotechnology innovation offers some of the most promising opportunities for achieving the important national goals of improving healthcare and reducing the human and financial burden of chronic disease on society.

But regulatory review processes are not keeping up with rapidly advancing science and are making the environment for developing new treatments and preventions for deadly and debilitating diseases more difficult. Unleashing the promise of biotechnology requires a comprehensive national strategy that fine-tunes some policies and overhauls others.

That strategy should include a U.S. Food and Drug Administration (FDA) that recognizes its national role in advancing innovation by reviewing innovative products in a timely manner and promoting a consistent and science-based decisionmaking process that is reflective of patient needs. By creating a 21st century FDA and a more patient-centric clinical research and development process, we can establish a clear and effective pathway for turning hope into cures.

FDA should incorporate the latest advances in regulatory science into its operations and should have transparent review processes and requirements that are understood by patients, physicians, industry, investors and policymakers. Also, the agency must find better, more collaborative ways to incorporate the views of patients when evaluating the health products it regulates.

The Biotechnology Industry Organization (BIO) worked with other stakeholders to develop policy proposals designed to accomplish these ends. These are specific legislative and administrative changes to the structure, mission and processes of FDA.

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