For Immediate Release - December 17, 2013

AG Coakley Calls for Tamper-Resistant Versions of Generic Prescription Pain Relievers

Requests FDA Provide Standards for Incorporating Abuse-Deterrent Technologies into Generic Opioids

BOSTON – In an effort to help put an end to the nation’s prescription-drug abuse epidemic, Attorney General Martha Coakley sent a letter to the U.S. Food and Drug Administration (FDA) urging it to require manufacturers of generic prescription pain relievers to develop tamper-resistant versions of their products.

AG Coakley, along with 41 other attorneys general, are concerned that prescription drug abuse has reached widespread levels in many states, and are urging the FDA to require that generic pain killing prescription drugs (opioids) have abuse resistant properties, making them difficult to crush or dissolve, as a commonsense improvement that provides another important tool in the fight against this epidemic. AG Coakley previously sent a letter to the FDA urging these protections for both name brand and generic pain killers in March.

“We are pleased that the FDA has ensured brand name prescription drugs have abuse-deterrent formulations, but we must continue to push for tighter restrictions across the board,” AG Coakley said. “Tamper-resistant versions of all of these products will help fight the ongoing epidemic of prescription drug abuse.”

In their letter, AG Coakley thanked the FDA for its recent efforts to require abuse-deterrent formulations for branded opioid drugs. However, the letter states the FDA should go even further by ensuring that generic opioids, like their branded counterparts, have abuse-deterrent properties and “provide clear and fair regulatory standards for the incorporation of abuse-deterrent technologies into generic opioids.”

Attorneys general remain in the national forefront 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 letter include 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.

Florida Attorney General and NAAG Substance Abuse Committee Co-Chair Pam Bondi, Georgia Attorney General Sam Olens, Kentucky Attorney General and NAAG Substance Abuse Committee Co-Chair Jack Conway, Maine Attorney General Janet Mills and Missouri Attorney General Chris Koster led the sign-on letter effort.


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