Gilead Sciences, Inc. continues to engage in efforts with the Food and Drug Administration (“FDA”) and other regulatory agencies to remove counterfeit or tampered with medications from the supply chain. As part of these efforts, Gilead is reportedly pursuing action against pharmacies that have purchased Gilead-branded medications from suppliers suspected to have distributed counterfeit or infringing products. In recent months, several pharmacies have reported receiving inquiries from State Boards of Pharmacy regarding purchases of Gilead products. The nature and form of these inquiries suggest that Gilead is behind these investigations.
Beginning in 2021, Gilead initiated a large-scale lawsuit regarding the distribution of certain HIV/AIDS medications. As of last year, Gilead has sued over 400 individuals and companies involved in buying and selling allegedly counterfeit Gilead-branded medications. These lawsuits primarily target suppliers, but in some instances, pharmacies that purchased from those suppliers have also been named.
Even when a pharmacy is not named directly in the litigation, Gilead appears to be monitoring its purchasing activity. Gilead has begun submitting complaints to various authorities such as the FDA and various Boards of Pharmacies naming pharmacies that purchased from the targeted suppliers between 2019 and 2021. In response, the Boards of Pharmacies have issued cease and desist letters and in some cases, formal disciplinary actions. Penalties imposed by the Boards of Pharmacy may include fines, license suspension or revocation, and formal reprimands. The impact of such disciplinary actions by a State Board of Pharmacy can present a multitude of problems for pharmacists and pharmacy operations.
As the State Boards of Pharmacy ultimately have great discretion in the severity of disciplinary actions, the appropriate response strategy will vary from state to state. In some states, a Board of Pharmacy may have alternatives to formal disciplinary action, therefore, it is crucial that a pharmacy or pharmacist facing inquiries or enforcement actions should consider conferring with legal counsel to understand their rights, obligations and options – and to develop a tailored response that mitigates risk and protects licensure.
These actions serve as a reminder that pharmacies dispensing medications are encouraged to independently verify records of their purchase information. In keeping complete and exact information related to its purchases, pharmacies should independently verify all purchase history through documentation independent of wholesalers, particularly where wholesalers may provide inaccurate information. Furthermore, obtaining corresponding “T3,” or pedigree information is particularly important, when obtaining drug products through a pharmacy-to-pharmacy transfer or purchasing from a secondary or tertiary wholesaler.
If you are a pharmacy, pharmacist or wholesaler, who has received a complaint, subpoena or other correspondence related to this matter, contact a Frier Levitt attorney.
Senior Counsel
