Industry and FDA collaborate
Among the most significant but least-known developments contributing to this legislative success is the fact that, at a time
when company budgets are tight and economic uncertainty runs high, generic-drug producers voluntarily agreed to pay these
fees to avoid another heparin-like tragedy. Improving the safety of drugs throughout the supply chain will come at great expense
and will only succeed through the diligence of all stakeholders. FDA must be attentive with its drug approval and inspection
procedures, and drug producers must remain committed to manufacturing drug ingredients governed by cGMPs. The pharmaceutical
industry becomes more global each day, and it becomes increasingly clear that all manufacturers must work to implement quality
As the law is implemented in stages over the next few years, the hope is that the industry will see results from these major
steps taken to safeguard the drug supply. The ongoing dialogue between drug manufacturers and FDA has led to a path forward
that can hopefully ease the minds of consumers. However, there is more work to be done. Currently, foreign over-the-counter
(OTC) drug manufacturing is not being inspected, nor is their inspection included in the passage of the FDA Reform Act. Hopefully,
a risk-based inspection approach will be applied to OTC products as well in the future.
John DiLoreto is executive director of the Bulk Pharmaceuticals Task Force, an affiliate organization of the Society of Chemical Manufacturers
and Affiliates (SOCMA).
1. B. Nychis, Import of Human Drugs and Human Drug Components, CDER Office of Compliance, Office of Drug Security, Integrity & Recalls, Division of Import Operations & Recalls, Import
Operations Branch (IOB), Presentation (June 2011).
2. FDA, Pathway to Global Product Safety and Quality, A Special Report, Revised (July 2011).
3. FDA, Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but
More Progress Is Needed, United States Government Accountability Office, Report to the Committee on Oversight and Government Reform, House of Representatives,
GAO-10-961 (September 2010).
4. FDA, Fact Sheet: New User Fees for Generic Drugs Will Enhance Americans' Access to Less Expensive Drugs and Generate Major Cost
Savings, GDUFA Performance Goals and Efficiency Improvements, Inspection Metrics (July 9, 2012).