FDA opened 72 new counterfeit cases in 2010--a new record
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.”
Protecting Temperature-Sensitive Pharmaceuticals, Without Unnecessary Plastic Waste
March 24th 2025Advances in the life sciences are driving a significant increase in the number of temperature-sensitive pharmaceuticals. The packaging industry is meeting the moment with advances of its own, including high-performance, environmentally-friendly materials that allow life science companies meet stringent thermal requirements and ambitious CO2e reduction goals. In this episode, TemperPack’s CEO Peter Wells shares insights from working with life sciences to move to certified biobased, home compostable, and curbside recyclable shipping solutions.
