BIO Submits Comments on FDA's Strategic Plan, 2014-2018

 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”

BIO believes the Strategic Plan is thoughtful and well-crafted, and we appreciate the forward-looking transparency that the document offers to both the public and regulated industry. BIO is also pleased to see that FDA’s priorities are aligned with many of those of the biotechnology industry. For example, FDA’s goals and priorities reflect the Agency’s intent to make the regulatory process more consistent, transparent, and predictable—goals that are especially important to BIO member companies, who rely on investment capital that is highly influenced by the predictability of regulatory outcomes.
FDA’s plan also focuses on other priorities our members have identified as critically important, such as the application of 21st Century science and technology, including biomarkers, surrogate endpoints, and adaptive trial design, to help speed the development of medicines. FDA’s discussion of “smart regulation,” which both encourages and speeds innovation, seems to recognize that accelerating and facilitating patient access to new medicines is a fundamental element of promoting and protecting the public health.
Finally, we note that throughout this strategic priorities document, FDA emphasizes the importance of enhancing communication between the Agency and Sponsors to improve the efficiency of drug development—one of BIO’s highest priorities over many years.