Opioid distributors point the finger back at DEA for not stopping the epidemic
The distributors argue that if anyone is to blame, it’s the Drug Enforcement Administration, which oversees their regulatory requirement
By Mark Young
The Bradenton Herald
ARLINGTON, Va. — With municipalities across the country, including Palmetto and Manatee County, filing or considering lawsuits against major pharmaceutical companies and distributors for damages relating to the opioid epidemic, the blame game is in full swing.
Distributors are trying to separate themselves from the crisis because they neither manufacture nor prescribe the drugs. They argue that if anyone is to blame, it’s the Drug Enforcement Administration, which oversees their regulatory requirement and has the authority to control the flow of opioids, as well as see the bigger picture better than any single distributor.
“When we talk about who is controlling supply and demand, the DEA plays a huge, huge role in determining how many entities can write, dispense and transport medicine,” said Clare Krusing, with the Healthcare Distribution Alliance, a national trade association representing major distributors. “That’s the key job the DEA has, but also to oversee the annual quota production. They have the authority to set the yearly limit that determines how much can be in the market. So the idea that distributors are responsible for flooding the market is factually not correct.”
DEA public affairs spokesman Wade Sparks said many factors are taken into consideration when establishing a quota. They range from estimates of the legitimate medical need, estimates of retail consumption, history and forecasts, and data from the DEA’s internal system.
In correlation with the rising overdose death numbers, the DEA reduced the amount of opioids in the market beginning in 2016 and did so again in 2017. Before that, Krusing notes, the DEA increased the supply quota year after year.
An example of how effective a cut can be is when the DEA, in the 1970s, reduced the amphetamine quota to successfully combat the abuse of speed.
In the next decade, the DEA was successful again in reducing the illicit use of Quaaludes. The DEA also is responsible for licensing how many entities can write and dispense prescriptions, as well as how many distributors can transport the product and those numbers continue to rise.
According to the Department of Justice, the state of Florida has 90,192 retail controlled substance registrants and 862 wholesalers as of November. In November 2016, there were 81,108 retail dispensers and 841 wholesalers. Similar increases have occurred during the past few years.
“From our standpoint, why didn’t the DEA exercise the quota authority they have?” Krusing said. “The number of registrants and the quota are key issues. A lot of these lawsuits mischaracterize distributors alerting regulators for suspicious orders. One distributor only knows what it ships to a particular hospital or pharmacy. Say for an example, they ship 100 pills to the CVS down the street. That distributor doesn’t know if a competitor also is shipping to that same CVS as well. The only agency that captures the full picture is the DEA.”
Sparks said the DEA was not going to comment on Krusing’s claims, but said distributors can help simply by following the law.
“All registrants, including distributors, should be following all the rules and regulations which apply to them under federal law,” Sparks said. “And if they do not, DEA uses all available means – administrative and criminal – to ensure that it’s 1.7 million registrants (across the U.S.) handling prescription drugs comply with the law.”
Krusing couldn’t speak on where manufacturers come into play, but noted, “Again, they produce the amount based on quotas set by the DEA.”
The federal Centers for Disease Control and Prevention recently released disturbing numbers in relation to the epidemic. More than 42,000 Americans died from overdoses in 2016, a 28 percent increase from 2015. The number of deaths related specifically to fentanyl and other synthetic opiates more than doubled from 9,580 in 2015 to 19,413 in 2016.
The Healthcare Distribution Alliance represents some of the largest distributors in the country, including Cardinal Health, AmerisourceBergen and McKesson, which was recently fined $150 million after the DEA spent two years investigating the company. The DEA agents in the case wanted criminal charges filed, but the Justice Department reached a settlement in the case with McKesson, which creates $200 billion in annual revenue. McKesson also was able to keep all of its licenses for more than 70 distribution centers.
The DEA accused McKesson of ignoring its requirement to report suspicious orders. Krusing said the reality is that there is little a distributor can do to influence medical decisions and prescription practices.
“We don’t have clinical guidance,” she said. “But we can work hard within our supply chain to make them aware of the provisions. We do have a list of solutions we feel are common sense and practical changes. One of the biggest is the existing technology that uses a database that would alert to those who cross state lines to get a drug they can’t get in their state. Unfortunately, a lot states have it, but don’t mandate its use that would improve tracking on a provider level.”
Who is ultimately to blame may play itself out in the courts. Jessica Husley Nickel, president of the Addiction Policy Forum, said the solution is everyone’s responsibility. In an email to the Bradenton Herald, Nickel said we are losing a generation of Americans to preventable and treatable addiction.
“To put the numbers in perspective, we lose the equivalent of nearly three sold out 747s every week to drug overdose deaths ... Enough is enough,” Nickel said. “We simply don’t have a moment to waste when it comes to helping families who are struggling. We must get people access to quality care, resources and information they need. We need everyone at the table to address this crisis and help save lives.”
John Parker, senior vice president for Healthcare Distribution Alliance, said distributors want to be at the table, but won’t accept being a law enforcement scapegoat.
“As distributors, we understand the tragic impact the opioid epidemic has on communities across the country,” Parker said. “We are deeply engaged in the issue and are taking our own steps to be part of the solution. But we aren’t willing to be scapegoats ... Given our role, the idea that distributors are solely responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and how it is regulated.”
The Healthcare Distribution Alliance reviews key priority issues and advocates on behalf of its pharmaceutical distributor members for standards, public policies and business processes that ensure a safe and efficient supply chain, according to its website.
Distributor AmeriasourceBergen is another Fortune 500 company, ranked 11th with a $150 billion annual revenue. In 2014, the corporation established the AmerisourceBergen Foundation, a not-for-profit philanthropic arm of the corporation. The foundation is offering municipalities drug deactivation resources that use technology combined with water to deactivate opioids in a safe manner, rendering them useless and safe for disposal.
“The epidemic of opioid abuse demands action, attention and a collaborative approach,” said Gina Clark, president of the foundation, who also is executive vice president and chief communications and administration officer at AmerisourceBergen Corp. Clark says the company is united, “in our responsibility to create healthier futures. Through this program, we will provide communities with the resources needed to deactivate prescription medications in a safe and effective manner, and help advance their efforts to prevent opioid abuse.”
Copyright 2017 The Bradenton Herald