Enabling Innovation for Biological Product Safety

By: Leslie Kux, J.D.

Last year President Obama issued Executive Order (EO) 13563, “Improving Regulations and Regulatory Review.”  This EO directs Federal agencies to review existing regulations to determine whether a regulation is outmoded, ineffective, insufficient, or excessively burdensome.  One of FDA’s main goals as we implement this Executive Order is revising our regulations to promote innovation and advance the use of new technology.

Syringe plunged into vial I’m pleased to announce that, based on a retrospective review, we are finalizing a rule to modernize the agency’s regulations for sterility testing requirements for most biological products, for example, vaccines such as flu vaccines. These regulations have an important public health purpose – to make sure that products such as vaccines do not contain any organisms that could cause illness. During our review, FDA determined that the existing regulations were too narrow in light of new technology and new products. The final sterility rule supports state-of-the-art testing technologies that give accurate and reliable results, often quicker and with less effort than the methods required in the current regulations. The rule will not add any additional regulations to those already followed by the industry and will not place significant burdens on small companies that make these products. Manufacturers can keep their existing procedures for sterility testing or take advantage of modern methods as they become available, provided that the modern methods meet certain criteria.

These changes reflect FDA’s approach to ensuring both biological product safety and getting patients these products as rapidly as possible. The changes also exemplify FDA’s broad vision for advancing regulatory science and its potential to improve public health by developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

Leslie Kux, J.D., is Assistant Commissioner for Policy in FDA’s Office of the Commissioner

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