FDA Not Focusing Inspection Resources Appropriately

The FDA is wasting its time conducting multiple GMP inspections of domestic manufacturers while not applying the same surveillance standards to production facilities overseas, a recent citizen petition says.

“Not all domestic firms are treated similarly by FDA. To put it bluntly, some firms are inspected an inordinate number of times when the use of those agency resources may not be justified,” law firm Alston & Bird claims in the petition, which was submitted on behalf of an anonymous pharmaceutical manufacturer.

When agency audits in the U.S. result in cGMP inspection observations, the FDA conducts a follow-up to verify the firm deployed the appropriate corrective actions. However, the agency is not inspecting facilities overseas that manufacture products competing with domestic manufacturers, according to the law firm.

During a congressional hearing late last year, Marcia Crosse, director of public health and military care issues at the Government Accountability Office, detailed the problems the FDA has with its foreign inspections program. The citizen petition highlights Crosse’s testimony.

The petition can be accessed at www.fda.gov/ohrms/dockets/dockets/07p0475/07p-0475-cp00001-vol1.pdf.