Last week I had the opportunity to participate in FDA’s public meeting on the Implementation of Drug Supply Chain Provisions of Title VII of FDASIA.
The meeting was hosted by Steven M. Solomon, D.V.M., M.P.H., Associate Director for Global Operations and Policy, Office of Global Regulatory and featured presentations from FDA’s top brass including:
- Margaret A. Hamburg, M.D., Commissioner of Food and Drugs
- John M. Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy
- Howard R. Sklamberg, Director, Office of Compliance, CDER
- Denise Esposito, Deputy Chief Counsel for Program Review for Drugs and Biologics
- Jarilyn Dupont, Director of Regulatory Policy, Office of the Commissioner
- Douglas Stearn, Deputy Director for Policy and Analysis, Office of Compliance, CDER
- Domenic J. Veneziano, CAPT U.S. Public Health Service, Director, Division of Import Operations, ORA
FDA Inspections Paradigm Shift
A number of provisions in Title VII of FDASIA point to a Paradigm Shift in FDA Inspections. The Agency is shifting from on-site bi-annual inspections, to remote risk based e-Inspections.
Our analysis of the act shows that this is achieved through a three-pronged approach
1- Section 705 of the Act requires the Secretary, acting through one or more officers or employees, to inspect establishments that are engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs in accordance with a risk-based schedule.
2- Section 706 of the act provides the FDA with the authority to request from manufacturers any records or other information FDA may inspect in electronic form in lieu of an inspection.
3- Section 706 of the act prohibits registered establishment owners, operators, or agents from delaying, denying, limiting, or refusing and FDA inspection. This section includes the provision of electronic records covered in Section 705.
At the meeting, the Commissioner announced that FDA issued draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection“.
Armed with this trifecta, FDA no longer needs “Boots on the Ground” to conduct establishment inspections, whether they are located around the corner or halfway around the world.
With these new authorities, FDA investigators need only make electronic requests for auditable records and conduct e-Inspections remotely.
Inspections Based on Analytics and Intelligence
Based on these new authorities, the Agency plans to request that manufacturers periodically provide common quality measures already in use such as:
- Batch Failure Rates
- Right First Time
- Out Of Spec
Based on these indicators, FDA would use business intelligence and analytics tools to compile aggregate data and create industry wide rankings. According to Howard R. Sklamberg, Director, CDER’s Office of Compliance, a firm that falls in the bottom 20% of the rankings, it should expect in depth scrutiny from the agency.
The act has been in effect for over a year, so don’t be surprised is your next FDA Inspection begins with an email in your inbox rather that a knock at the door.