FDA’s latest tainted dietary supplement alert seems to signal a shift in the agency’s approach to this problem. FDA alerts on these products have not typically referenced OCI investigations in this fashion. Perhaps the agency is beginning to grasp the need to attack this threat more strategically and collaboratively with OCI. I continue to support the need for FDA to spearhead a national law enforcement operation with DOJ’s Consumer Protection Branch (formerly the Office of Consumer Litigation) that targets convenience stores, gas stations, and other brick-and-mortar retailers with misdemeanor prosecutions under the FD&C Act. Such an approach (a woefully under-utilized but highly effective FD&C Act hammer) has the potential to change corporate behavior and make these dangerous products less accessible to vulnerable consumers in storefront retail establishments. See my most recent post on this topic here.
- UNRAVELING AND LEGITIMIZING MURKY SHORTAGE DRUG TRANSACTIONS WITH SECONDARY WHOLESALE DISTRIBUTOR SOURCES-A DUE DILIGENCE ROAD MAP FOR HOSPITALS January 14, 2020
- A DSCSA ENFORCEMENT STRATEGY PEP TALK FOR FDA December 19, 2019
- IT’S TIME FOR FDA TO HIT THE SHORTAGE DRUG DIVERSION FASTBALL OUT OF THE PARK! October 31, 2019
- FDA LEADERSHIP IS THE KEY TO STOPPING SHORTAGE DRUG DIVERSION SCHEMES October 29, 2019
- FDA IS EXPANDING GLOBAL LAW ENFORCEMENT OPERATIONS WHILE DOMESTIC DRUG SUPPLY CRIMES ABOUND October 22, 2019
- FEDS BUST ANOTHER MASSIVE PRESCRIPTION DRUG DIVERSION SCHEME October 21, 2019