The Herald-Leader's editorial criticizes the Food and Drug Administration and Purdue Pharma for opposing the entry of generic copies of the original formulation of OxyContin® tablets after Purdue introduced a reformulated product designed to deter misuse and abuse of the medication.
The criticism is unfortunate and disappointing.
Generic medications are an important part of our health-care system. However, we are concerned that an influx of generic OxyContin tablets that lack abuse-deterrent properties would lead to more abuse.
Public officials in Kentucky share this concern and feared a new wave of overdose deaths and illegal trafficking if non-abuse deterrent generics were approved.
Sign Up and Save
Get six months of free digital access to the Lexington Herald-Leader
As such, it makes no sense to allow a generic version to be sold without important abuse-deterrent technologies.
Since we learned about growing reports of abuse in Kentucky and other states more than a decade ago, Purdue has been working with health-care professionals, law enforcement and community groups to combat prescription drug abuse.
Among many efforts, we are supporting independent medical education and offering free programs to help health-care professionals understand the proper use of these medicines and how to spot attempts to obtain prescriptions by fraud and deception.
Since more than 70 percent of teens 12 to 17 who abuse medications report getting them from a friend or family member, Purdue, the National Community Pharmacists Association, and the U.S. Conference of Mayors have worked to educate parents and grandparents about how to store, monitor and dispose of prescription medications properly in the home through the Safeguard My Meds program.
Purdue's Law Enforcement Liaison and Education program provides training on pharmaceutical diversion to police and sheriffs' departments and our RxPATROL program provides tips to pharmacists on how to protect themselves from pharmacy crime and has helped law enforcement apprehend more than 100 pharmacy crime suspects.
In 2001, we started work to reformulate the medication to make it less attractive to drug seekers. It was a difficult task.
Two of our earlier attempts at reformulation failed before we succeeded. All in all, it took 10 years and considerable effort and resources to develop, and gain FDA approval of, the reformation of OxyContin.
We believe that the benefits of abuse-deterrent technologies will be realized when all or substantially all opioid pain medications employ such technology. We are already working on developing other pain medications that also employ abuse-deterrent technologies. But these efforts will not address the millions of generic tablets currently on the market that lack abuse-deterrent features.
The editorial's comment that "The action also means Purdue Pharma retains its monopoly on any version of OxyContin and can, therefore, maintain higher prices," is simply not true.
Generic manufacturers have the option to develop their own abuse-deterrent technology or seek a license from Purdue or another company to use their existing patented abuse-deterrent technology.
In fact, following the FDA decision, the generic manufacturers' association acknowledged the value of abuse-deterrent opioids and expressed a willingness to create products that incorporate those features.
The best chance for reducing the abuse of prescription drugs and protecting patient care is for everyone to work together in a concerted manner. Purdue Pharma is committed to being part of the solution.
At issue: April 19 Herald-Leader editorial, "FDA's Oxy action has side effects; Costs stay high for those in true need"