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.
- THE UNSETTLING SHORTAGE DRUG DILEMMA FACING HOSPITALS AND MEDICAL CLINICS December 1, 2018
- A POTENTIAL SHIFT IN FDA’S APPROACH TO TAINTED DIETARY SUPPLEMENTS November 29, 2018
- FDA ALERTS THE PUBLIC TO WESTMINSTER PHARMACEUTICALS, LLC DRUG RECALL August 20, 2018
- SENTENCING ANNOUNCED IN ILLEGAL FOREIGN-SOURCED DRUG CAPER August 2, 2018
- DECEPTIVE, UNETHICAL, AND POTENTIALLY CRIMINAL SHORTAGE DRUG DIVERSION SCHEMES CONTINUE TO THREATEN PATIENTS AND OUR HEALTH CARE SYSTEM July 13, 2018
- FDA’S LATEST STATEMENT ON DRUG SHORTAGES SIDESTEPS THE ROLE OF DIVERSION-AGAIN June 1, 2018