Key Takeaways:
– Disasterous “fentanyl lollipops” by drugmakers will be halted from sales by the end of the month.
– The decision marks the termination of controversial transmucosal immediate release fentanyl (TIRF) medicines.
– The FDA confirms that the existing stock will continue to be available for current patients under treatment.
– The companies’ aggressive marketing strategies earlier led to several legal actions and investigations towards them.
– Teva Pharmaceuticals, which acquired the FDA-approved manufacturer, Cephalon, in 2011, has chosen not to comment on the cessation of sales.
The Opioid Overdose Epidemic Comes to a Close
The U.S. Food and Drug Administration (FDA) announced this week that pharmaceutical manufacturers will stop the sale of a particularly controversial brand of fentanyl painkiller by this month-end. This decision puts an end to the contentious brand of “fentanyl lollipops” and comparable formulations that have contributed to the opioid overdose epidemic – a significant public health crisis.
Pulling the Plug on Transmucosal Immediate Release Fentanyl
Known among physicians as Transmucosal Immediate Release Fentanyl (TIRF), these medications attracted several legal actions and investigations over the years due to the aggressive marketing by drug manufacturers. TIRFs were known for their quick action and powerful effects. According to a statement issued by the FDA, less than 150 patients are currently being treated with TIRF medicines. While the selling will stop, patients undergoing treatment with these drugs will be able to continue the course until the existing supply expires.
Breaking Rules: Off-Label Prescription & Controversial Sales
Cephalon, a pharmaceutical company, had FDA approval to produce these drugs under various brand names, such as Actiq, a sweetened lozenge on a stick, and Fentora, a tablet intended to dissolve in the mouth. Both were designed for cancer patients who had built a tolerance to less potent opioids. However, investigators discovered that Cephalon’s sales teams contravened FDA guidelines that restrained the marketing of these painkillers. They influenced physicians to prescribe these addictive drugs “off-label” – beyond the narrow range approved by the FDA.
Cephalon and the $173 Million Market
Cephalon was bought by generic drug manufacturer Teva Pharmaceuticals in 2011, amidst when the market for Actiq ammounted approximately $173 million annually. The reason behind Teva’s decision to cease selling the drugs remains unclear, as their spokesperson abstained from commenting on the matter.
FDA regulations were tightened on the prescribing of these products in 2020, as data suggested inappropriate prescribing to patients without opioid tolerance. Yet, many critics questioned the FDA’s failure to prevent such misprescription in 2019, with evidence suggesting nearly half the patients taking these drugs were ineligible.
Legal Settlements and Future Directions
In 2022, Teva settled lawsuits from state and local governments accusing the company of promoting Actiq and other similar drugs to non-cancer patients and undermining the potential for addiction. Teva confirmed on their website that medical providers and doctors should cooperate with patients to transition to a non-TIRF treatment.
Last month, the FDA issued warnings about the imminent discontinuation of Actiq and Fentora, following a request initiated by the drugmaker. However, the FDA clarified that they did not demand this discontinuation, emphasizing that they cannot obligate a pharmaceutical company to create, augment, or change the distribution of a medicine.
Phasing out these controversial fentanyl medications marks a significant step in addressing the opioid overdose epidemic. As pharmaceutical companies transition towards non-TIRF treatments, the industry, medical practitioners, and patients will watch and await what comes next.