Changes in Biologic Drug Approval at FDA

Abstract

Over the next 5 yr at FDA, there is a great need for the agency to continue its efforts to evolve and collaborate with the pharmaceutical industry to promote rationale drug development. The agency is dynamic, and whereas plans are in place that may provide some concept of the direction of future changes for both drug and biologics reviews, local and world events often cause a reactionary response at the FDA that is often unpredictable. What is clear is that the agency will need strong leadership and should continue to make every effort to improve the regulatory review process and its ability to assess safety and efficacy of new medicinal products in a carefully managed and balanced process. Some of the safety concerns raised after the withdrawal of a number of commonly used medicinal products of the past 10 yr have shifted FDA’s attention and resources away from critical programs intended to facilitate drug development and provide some regulatory relief to a struggling industry. To achieve improvements in both safety and efficacy assessments as well as review timelines and consistency in reviews within the agency, the FDA will have to further consolidate medicinal product reviews in alignment with therapeutic indications.

The FDA can provide both the biotechnology industry and the public great benefits in the future by revitalizing the effort to define critical path for medicinal product development and creating new methodologies to work with industry to accelerate product approval. The next 5 yr will be a critical period during which the FDA will need strong leadership to take managed risks to move forward a number of important initiatives intended to accelerate the drug development process. The leadership must also consolidate and focus internal resources within the agency to maintain consistent requirements for a therapeutic indication and continue to improve review processes.