FDA has published a direct final rule to alter what it calls “outdated” requirements on biologic inspections.
Previous requirements mandated that drug and biologic manufacturing facilities be inspected at least once within two years of FDA registration, and then at least once every two years following. Pointing to the 2012 FDA Safety and Innovation Act, the agency noted that it is now required to inspect drug establishments on a risk-based schedule.
In addition, the rule also removes outdated “duties of inspector” requirements. FDA has deemed that it was unnecessary to list these obligations in the document, because those duties are duplicated in the Federal Food Drug and Cosmetic Act. The removal of these regulations, however, does not change the inspection requirements.
Biologics make up 10% or ~$5 billion of the total worldwide orthopaedic market, by ORTHOWORLD estimates. Orthobiologics represent significant industry advancements, but are complicated to manufacture.
While this final rule does not remotely clear the convoluted regulatory pathway for biologics, it does represent an attempt by FDA to remove inefficient policies that add to costs and reduce access without improving safety. This final rule, which goes into effect June 12, also helps implement the Agency’s regenerative medicine framework.