Medical Marijuana Access & Patient Safety Inc. filed a lawsuit in Commonwealth Court Feb. 10 seeking to stay the actions of the Department of Health restricting access to approved medications.
The coalition of patients and the medical cannabis industry said, “This action has needlessly alarmed thousands of medical cannabis patients in Pennsylvania, who rely on these products for personal medical needs. MMAPS is united in our concern for patient safety and is seeking immediate injunctive relief to protect the patient population and their access to approved and tested medication.”
Judith Cassel, Hawke, McKeon & Sniscak LLC, who represents MMAPS, said more than half a million patients are affected by the removal of certain vaporized medical marijuana products that contain terpenes, an ingredient found in foods and medical marijuana edible and topical products.
“These medications, all previously approved and deemed appropriate for patient treatment by the Department, have been removed from dispensary shelves without any adverse event reports. The Department’s action deprives access to medicine, continuity of care and continuation of established treatment regiments for over a half million Pennsylvanians suffering from serious medical conditions without notice,” the complaint says. “The categorical removal of access to medication that many patients have been relying upon for the past four years in the absence of a health or safety reason to do so itself creates a health and safety risk for patients”.
“We are at a loss to understand (this action), Cassel said. “There have been no proven adverse effects so there is no reason to take them off the shelf.” She said an inquiry to the DOH revealed nothing to support its decision.
In an email to patients and caregivers on Feb. 4, the Department of Health said, “The Department of Health is committed to ensuring that the Medical Marijuana Program is operating appropriately and effectively. As you know, the Department has recently conducted a statewide review of all vaporized medical marijuana products containing added ingredients. After finishing this review, the Department has determined that certain vaporized medical marijuana products containing some added ingredients have not been approved for inhalation by the United States Food and Drug Administration (FDA).”
“Although some of these added ingredients be considered safe in other non-inhaled products, patient safety is the top priority of the Medical Marijuana Program. Therefore, the Department has issued mandatory recall for all affected vaporized products,” the DOH letter said.
Cassel said the statement is interesting because the FDA does not test medical marijuana products because, on the federal level, medical marijuana is not legal.
She said concern for patient safety is the reason MMAPS filed its litigation – because the Department’s actions, no matter how intended, threaten that safety. The recall removed access to critical medications immediately without any consideration for a supply of cannabis-based medication alternatives.
“This is not about vaping,” Cassel said. “And we are on the same page as the DOH. They have done a good job at setting this program up and monitoring it. We just disagree on this.”
This immediate reduction in overall supply of medication available will create shortages, she said. This will inevitably lead to patients seeking cannabis in the untested illicit market, where no testing or safety regulations are, or have ever been, available, she said.
Unlike the illicit market alternatives, the medications recalled were previously approved by the Department, tested, and used without incident. They are a critical part of patients’ treatment regimen, making limited access a patient safety concern. Additionally, the recall of these medications now is not based on any triggering event threatening patient health and safety – it is based on an erroneous interpretation of new statutory language, the complaint says.
Barry Ciccocioppo, communications director for the DOH, said beyond the letter, the Department doesn’t comment on ongoing litigation.
“MMAPS seeks a resolution that prioritizes patient safety and access to medication subject to consistent testing and safe dispensation. While MMAPS is seeking legal relief, it remains our goal to re-initiate a collaborative process with the Department so it will reverse its course and make these critical medications available to the patient population once again,” a MMAPS statement said.
The threat to safe access to patient medication by this recall warranted immediate legal action even as MMAPS seeks to find a solution through a collaborative process with the Department.
“It is our position that the best way to ensure and protect patient safety is to maintain the comprehensively and stringently regulated program built over the last six years, and MMAPS is committed to ensuring that through the legal process, if necessary,” the coalition said.
Cassel said she is seeking a preliminary injunction in hopes the DOH will reconsider its decision.