FDA opened 72 new counterfeit cases in 2010--a new record

Pharmaceutical CommercePharmaceutical Commerce - March/April 2011

Caseload reinforces concerns over illegal trade and distribution of pharmaceuticals

During a presentation at a meeting organized by the Pew Prescription Project (Washington, DC., March 7-8), deputy administor Dr. Ilisa Bernstein noted that 72 cases had been opened by FDA’s Office of Criminal Investigations in FY 2010 (which ended Sept. 30). That’s up nearly 11% from the year before, which was also an up year.

FDA is always careful to not impute too much meaning to this annual count; it is a measure as much of FDA activity as it is of the pace of counterfeiting business; moreover, one “investigation” can be a single pharmacist relabeling old product as much as an international ring importing pallet-loads of product (both of which occur). Still, this count is up for three years running, and has been at a level 3-5 times what was reported a decade ago. Recent incidents also include intrusions into the so-called “normal chain of distribution” defined in various state pedigree rules; this chain is supposed to be immune to external, unregulated activity. “Counterfeiting is like water pressure,” commented Allan Coukell, a Pew Prescription Project director, during the meeting. “It will find a way in.”

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