UTAH – Acting Utah Attorney General Brian Tarbet and 41 other state and territorial attorneys general are asking the U.S. Food and Drug Administration to require manufacturers of generic prescription pain relievers to develop tamper-resistant versions of their products.
Tamper-resistant technology generally seeks to prevent opioids that are designed to time-release over a period of hours from being effectively modified such that a person can receive the full dosage in a pop rather than over a the tablet’s time-release period. Some ways that people modify these drugs are through chewing, crushing, altering it for injection, or combining it with alcohol.
In a letter sent today to the FDA, the attorneys general state that prescription drug abuse has reached epidemic levels in many states; requiring abuse-deterrent pain killing prescription drugs, opioids, is a commonsense improvement for the fight against this epidemic.
There are various ways that drugs may be made tamper-resistant, Kristina Fiore wrote in an Oct. 28 article for MedPage Today. “… companies have come up with a number of ways to deter that kind of abuse, such as making the tablet turn chunky instead of powdery when crushed, or turning it thick and sudsy when mixed with a liquid and drawn into a syringe.
“Some have even combined their opioids with anti-opioid agents, such as naltrexone, which block opioid receptors in the brain to send abusers into withdrawal rather than getting them high.”
“Prescription drug abuse has been a major issue in the state of Utah and one we believe we can do something about,” Tarbet said. “When more people are dying of drug overdoses than traffic accidents you have to ask what more we can do to save lives through prevention.”
In their letter to FDA Commission Margaret Hamburg, the attorneys general thanked the FDA for their recent efforts to require abuse-deterrent formulations for branded opioid drugs. However, they also urged the FDA to go even further by ensuring that generic opioids have abuse-deterrent properties.
Attorneys general have been combating prescription abuse by sponsoring prescription drug take-back efforts, spearheading legislative and law enforcement initiatives in their respective jurisdictions, and mandating state level prescription drug monitoring programs.
The 42 attorneys general who signed the NAAG letter are from: Alabama, Arizona, Arkansas, Colorado, Delaware, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Utah, Vermont, Washington, West Virginia and Wisconsin.
See the full letter here: 20131216 Attorneys General letter to FDA
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