FDA foreign force multiplier demo'd in API inspections

International regulatory collaboration has passed an important early test, providing the faintest glimmer of hope that the FDA might actually be able to achieve some of the conflicting goals handed down by Congress. Results of the two pilot programs, through which European and Australian regulators worked with the FDA on drug quality and safety tasks, may hint that cross-border cooperation can be a tool to help keep up with the explosion of drugmakers in developing countries. 

One of the two programs is specific to manufacturing, with a focus on the makers of active pharmaceutical ingredients (the other program involves clinical trials, which we won't cover here). The just published report on the joint API inspections pilot details methods and results of information-sharing among the FDA, European Medicines Agency, several national European regulators and Australia's Therapeutic Goods Administration.

The upshot is that pilot participants have agreed to continue their collaborative efforts and eventually extend the program. Future participants will include those having regulatory information on API makers that they can share, including inspection reports and an inspection planning schedule, says FDA spokesperson Shelly Burgess in an email. Additional requirements: prospective partners must have an active group of organized and qualified API manufacturer inspectors as well as an inspectorate with ICH Q7 expertise.

The pilot API effort involved a voluminous exchange of information concerning about 100 API-making sites common to the three regions represented by the participating regulators. The agencies then settled on 9 sites for joint inspections. Presumably the FDA--and the other regulators--gained inspection reports on some of the 100 sites it had not visited, providing at least some degree of knowledge about the operation it didn't have before.

The FDA used the reports to help decide whether to inspect a facility. Information in the reports led to it prohibiting some API imports based on negative findings in a European inspection, according to an FDA statement.

Developing the multi-agency inspections was also part of the pilot effort. This work led to "increased levels of understanding between the agencies, and a greater number of inspections of value to more than one authority," according to Dow Jones.

- see the release
- here's the report
- here's the Dow Jones story