Setting the Record Straight on Our Anti-Diversion Programs
Purdue’s strong record of coordination with law enforcement has been acknowledged by the DEA and other law enforcement stakeholders who’ve used the information we’ve provided.
Beginning in 2007, Purdue provided Los Angeles-area law enforcement information that helped lead to the convictions of the criminal prescribers and pharmacists referenced by the LA Times.
The LA Times wildly distorts the role that Purdue, a company representing two percent of opioid prescriptions, plays in policing the pharmaceutical supply chain.
Contrary to the paper’s implications, we cannot simply order a wholesaler to stop shipping a product. However, we can and have reduced products shipped to a wholesaler if we have concerns about the pharmacy customer.
When Purdue learned that the original formulation of OxyContin® was being abused, the company spent more than a decade developing an abuse-deterrent formulation, which received FDA approval in 2010. This innovation is intended to make opioids less attractive on the black market, a point the LA Times acknowledges in its article.
Read the complete responses we provided to the Los Angeles Times below:
Comments Attributable to Philip C. Strassburger, General Counsel
Abuse & Diversion Detection
Purdue’s industry-leading Abuse & Diversion Detection (ADD) program, launched in 2002 and publicly disclosed in 2003, is one of several Purdue initiatives designed to help address our nation’s opioid epidemic.
Purdue’s programs to combat opioid abuse and diversion have been reviewed by law enforcement agencies and government officials. In fact, after reviewing our program, an attorney general required another opioid maker to implement a similar ADD program.
Our procedures help ensure that whenever we observe potential abuse or diversion activity, we discontinue our company’s interaction with the prescriber or pharmacist and initiate an investigation.
While we make information in our ADD program available to law enforcement and state medical boards, it would be inappropriate to direct every single anecdotal and often unconfirmed claim of potential misprescribing to these organizations.
Lake Medical Group
In 2007 Purdue began sharing information with state and federal law enforcement regarding potential criminal drug diversion in California. In the matter of Lake Medical Group, Purdue was proud to assist federal authorities in their prosecution of that criminal drug ring, which led to several convictions. Federal prosecutors in that case employed information obtained through Purdue’s ADD and OMS programs.
Purdue informed local and federal law enforcement about our concerns regarding Lam’s Pharmacy and potential drug diversion in Nevada. We also met with multiple wholesalers to discuss these concerns. As a result of this coordination, several wholesalers discontinued shipping product to the pharmacy, and Purdue significantly reduced its product flows to a third wholesaler. This episode demonstrates that no one drug company can control the entire supply chain, and it’s why the Controlled Substances Act relies on the coordination of all players.
Importantly, Lam’s was also apparently serving many legitimate patients, which is why steps to reduce product flows need to be carefully implemented, to avoid hurting appropriate patients.
Controlled Substances Act
We have robust programs designed to ensure that Purdue is compliant with the Controlled Substances Act and have at all times complied with the law. Furthermore, we have a long record of close coordination with the DEA and other law enforcement stakeholders to detect and reduce drug diversion. The Agency is familiar with our programs, as well as our record of providing them with valuable information.
When in 2001 Purdue learned that two employees had stolen controlled substances from a manufacturing facility, we alerted and cooperated with law enforcement to bring an immediate halt to the illegal conduct and assist the prosecution of those employees. Since that time, we’ve continuously refined our programs.
Order Monitoring System
All DEA registrants, including pharmaceutical manufacturers and wholesalers, are required to monitor and report suspicious orders to the DEA. This information can be used to alert DEA and other law enforcement agencies about potential diversion. Purdue does not ship prescription products directly to retail pharmacies; it sells only to authorized wholesalers, who maintain their own order monitoring programs.
Supply Chain Responsibility
The CSA is designed to form a network of supply chain participants monitoring and acting on available market information, and Purdue has fully participated in that process in compliance with the law.
Each registrant in the supply chain is responsible for monitoring and reporting suspicious orders to DEA. Once Purdue identifies the potential suspicious activity of a wholesaler’s customer, Purdue informs the wholesaler, so they can perform their due diligence based on their broad access to all the pharmacy’s products, not just Purdue products.
While Purdue cannot compel a wholesaler to discontinue shipping to one of its customers, we can and have reduced the product we ship to a wholesaler if we have concerns about the customer at the end of the supply chain.
Need for Confidentiality
A degree of confidentiality regarding the details of these programs is essential to their effectiveness. Improperly disclosing the workings of these programs is irresponsible and only aids those seeking to divert and abuse prescription opioids, potentially worsening a national health crisis.
ADD & OMS Program Limitations
With the benefit of hindsight, it’s easy to criticize private sector programs for failing to detect every instance of sophisticated and covert criminal activity, but law enforcement considers these programs important tools in helping identify inappropriate opioid prescribing and diversion.