The Alabama Board of Pharmacy members spent a significant portion of a recent meeting debating a proposed civil penalty schedule, underscoring the difficulty of crafting enforcement scales that distinguish between minor in-state violations and serious misconduct by large, often out-of-state drug companies.
Board staff explained that the civil penalty schedule is intended to apply across regulated entities, including pharmacists, pharmacy technicians, retail pharmacies, medical oxygen and supply providers, manufacturers, wholesale and private-label distributors and third-party logistics providers.
Attorneys advising the board cautioned that the penalty ranges may appear higher than those the board has historically imposed because the statute does not allow fines to be assessed on a per-occurrence basis.
Staff said the schedule was designed to allow flexibility based on the seriousness of the conduct. In addition to fines, the schedule includes non-monetary options such as corrective action plans for businesses and additional continuing education for pharmacists, depending on the frequency of the penalties.
The discussion quickly turned to concerns about how the board handles bad actors from outside the state of Alabama. One board member described frustration with cases involving out-of-state companies that had already faced severe penalties elsewhere, but their conduct was not reviewed when considering their license in-state.
“I remember sitting here for a case where a business was asking for a pharmacy license. In another state, they had been fined $300,000 for all the violations they did,” said Susan Alverson, Director of Regulatory Affairs. “The judge made them sign a statement admitting to all the pharmacy laws they had broken… and you give them a license.”
“In another case weighing, I’ve looked up the federal charge,” Alverson said. “The federal charge is a million dollars and three years in jail. He gave them a license recently.”
Alverson stressed that the board often lacks access to the full scope of misconduct when making licensing decisions. “You can’t act on information you don’t have,” Alverson said.
“An applicant who wants to come here and comes before this board to be approved and has the types of infractions or the types of disciplinary history that Dr. Alverson is referring to, those are not going to be able to be addressed by this chart, because again, they’re applicants. So I don’t, but to her point, there is no financial remedy to that. We either grant those applications, or we do not as applications,” said Jennifer Nuemann, Board counsel.
Board members stressed that the penalty schedule is not intended to punish Alabama pharmacists for minor errors.
“Those types of entities are worlds apart from your Alabama pharmacist who forgot to turn in a form,” Nuemann said. “Those two things have always been apples and oranges.”
Timing emerged as a major concern as Nuemann warned that the board’s ability to adjudicate cases involving monetary penalties is limited without a finalized schedule. “We really can’t process any hearings until after January 1st,” said one member. “We’re not going to be able to adjudicate any of these major issues until we get this done.”
Board members agreed to ask staff to review the proposed penalty ranges against real past cases and return with revisions early in the new year. The discussion concluded with a call for better communication between investigators, staff and board members so civil penalties enforcements are informed by complete information on the current landscape.
