It’s not hard to find employees at large- or small-molecule drug companies who have gripes about FDA. On and off the record, people have complained that the agency’s review process is slow and that its decisions can be erratic. Perhaps hoping to make a positive contribution to this discussion, the Biotechnology Industry Organization (BIO) made several proposals last week for improving FDA’s operations.
BIO’s ideas for enhancing regulatory science at the agency interest me most, and they likely would have a direct effect on the companies that the agency regulates. One suggestion relates to the independent nonprofit foundation created by Congress to support public–private partnerships that advance FDA’s mission. To help the foundation do its work, Congress should give FDA greater ability to transfer federal funds to it, according to BIO. The idea is worth discussing, but I think it would be even better in the context of an overall increase in FDA funding.
FDA has undertaken many initiatives for enhancing regulatory science, but has been slow to translate results into action. BIO suggests creating an entity within FDA that analyzes the findings from these initiatives and conducts pilot programs to try out promising scientific and regulatory approaches. I think this is an excellent idea. Establishing an office whose duty is to improve regulatory science would lessen the burden of other agency employees. It seems like an efficient way of keeping the agency abreast of current science.
Anyone can criticize FDA, but coming up with ideas for solving the agency’s perceived problems is a tougher job. BIO’s proposals should inform a discussion that involves regulators, representatives from industry, and independent scientists. A collaborative and transparent effort among these parties could help ensure that FDA upholds its reputation as a world-class regulatory agency.