Matthew Tracy’s presentation in a House subcommittee meeting slammed regulators for ‘a wholesale dropping of the ball.’
Florida’s Deputy Auditor General[1] slammed the Department of Business and Professional Regulation (DBPR[2]) for lack of oversight of the Division of Drugs, Devices and Cosmetics[3].
Matthew Tracy gave a presentation before the House Administration Budget Subcommittee[4] where he took DBPR to task. The Deputy Auditor General ripped into DBPR regarding an operational audit from July 2022 to December 2023 covering controlled substances.
The analysis focused on wholesaler and manufacturer prescription drug purchasing activity that DBPR is supposed to monitor. DBPR is tasked with checking whether purchasing levels follow state law and regulations.
Tracy’s report was critical of DBPR’s performance.
“Department oversight of entities engaged in the wholesale distribution of controlled substances within the state was not sufficient to ensure entity compliance with state law or the adequate protection of the public health, safety, and welfare,” Tracy’s report[5] stated.
Some of the report’s recommendations include changing management controls, improving security controls and information technology, and increasing cybersecurity program controls.
But DBPR Secretary Melanie Griffin responded that some of the issues were beyond the Department’s control. She said high staff and leadership turnover during the audit period and immediately after is largely to blame for some of the operational issues cited in the findings. She emphasized that no records were purged, and ultimately there “were no reports of consumer harm.”
But Tracy maintained that the situation with DBPR was “a wholesale dropping of the ball.”
Tracy’s audit reviewed the records detailing inspection documents, other records and the processes DBPR had for nearly two dozen selected companies out of about 200 that submitted documents to the state. The review found oversight was not only insufficient, it “had not maintained a complete and accurate registry of entities, manufacturers and repackagers engaged in the wholesale distribution of controlled substances within the state.”
The 53-page analysis also found that many of the pharmaceutical entities filed late reports and that other information was missing, along with other procedural miscues.
Both Republican and Democratic lawmakers in the subcommittee hearing expressed surprise at the oversight issues raised by Tracy.
References
- ^ Auditor General (flauditor.gov)
- ^ DBPR (www2.myfloridalicense.com)
- ^ Division of Drugs, Devices and Cosmetics (www2.myfloridalicense.com)
- ^ House Administration Budget Subcommittee (www.flhouse.gov)
- ^ report (static-s3.lobbytools.com)