Why are biologics regulated under the PHS Act?
As mentioned above, biologics are subject to provisions of both the FD&C Act and the PHS Act. Because of the complexity of manufacturing and characterizing a biologic, the PHS Act emphasizes the importance of appropriate manufacturing control for products. The PHS Act provides for a system of controls over all aspects of the manufacturing process. In some cases, manufacturing changes could result in changes to the biological molecule that might not be detected by standard chemical and molecular biology characterization techniques yet could profoundly alter the safety or efficacy profile. Therefore, changes in the manufacturing process, equipment or facilities may require additional clinical studies to demonstrate the product’s continued safety, identity, purity and potency. The PHS Act also provides authority to immediately suspend licenses in situations where there exists a danger to public health.
