An open letter published by FedUp, which represents a coalition comprising of more than a dozen anti-addiction groups, has urged for the US Department of Health and Human Services to seek new leadership at the US Food and Drug Administration (FDA) in the wake of what the group calls “the worst drug addiction epidemic in our nation’s history.”
“We are especially frustrated by the Food and Drug Administration’s (FDA) continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths. After careful consideration we have come to believe that without new leadership at FDA the opioid crisis will continue unabated.”
In October last year, drugmaker Zogenix received FDA approval for its extended release opioid agonist drug Zohydro (hydrocodone bitartrate). However, the letter claims the drug is easily crushable and was granted approval despite an 11-2 vote by the FDA’s scientific advisory committee to keep the drug off the market.
Meeting medical needs
Speaking in April at the 2014 Rx Prescription Drug Abuse Summit, FDA Commissioner Margaret Hamburg, who has been in the job since May 2009, said the “FDA places a high priority on abuse-deterrent technology, and we strongly encourage the research community and companies to continue their efforts to develop meaningful approaches." However, she added it was essential to meet the medical needs of approximately 100 million Americans who live with severe chronic pain or are coping with pain at the end of life.
“The science of abuse-deterrence is still in its infancy and has yet to be fully tested or proven in actual market or use conditions. There are even limits to the abuse-deterrence of OxyContin [made by Purdue Pharma], the only opioid with a claim on its label that the drug has abuse-deterrent properties.”
In July, Zogenix announced plans to submit a modified version of Zohydro with anti-abuse properties, while an extended-release opioid - Targiniq, made by Purdue – was approved which does feature anti-abuse technology.
However, the FedUp letter argues, while “the addition of naloxone may deter misuse by injection and snorting, it cannot exert its effect when taken orally.”
The Centre for Lawful Access and Abuse Deterrence (CLAAD) - whose members include a number of pharma firms, including Purdue - agreed there is a need for more research and development into anti-abuse technologies but spokesman Kyle Simon told this publication the FedUp letter is a “ridiculous attack on FDA.”
We also spoke to a third US advocacy group which told us: “As a general matter, there are calls for the resignation of government officials all the time—perhaps magnified in recent years by the impact of social media.”
Furthermore, we were told the US is going through a pattern this year where any perceived public offense is considered grounds by some to call for resignation, as illustrated with recent calls for the resignation of Roger Goodell, the Commisioner of the National Football League.