Documents recently unsealed in a massive federal lawsuit in Cleveland seeking to hold two dozen drug companies responsible for their roles in the opioid crisis shed light on industry efforts to lobby for a law that weakened one of the government’s most powerful drug enforcement tools.

The lawsuit, filed on behalf of more than 2,000 cities, towns and counties, alleges that the companies ignored red flags that highly addictive pain pills were being diverted to the black market. The unsealed emails, internal memos and depositions show that an industry trade association — the Healthcare Distribution Alliance — worked to persuade members of Congress and federal officials to approve the legislation, known as the Marino bill for the measure’s chief advocate, then-Rep. Tom Marino (R-Pa.). Congress passed the bill and President Obama signed it into law in April 2016. The bill created a high standard for the Drug Enforcement Administration to meet to immediately suspend a drug company’s operations, former DEA officials have told The Post.

The companies and the alliance said in statements to The Post that the bill did not weaken the DEA’s enforcement capabilities. They said it clarified enforcement standards under the Controlled Substances Act and noted that the DEA approved its final language and that Congress passed the bill without dissent. They also defended communicating with members of Congress as appropriate and part of the legislative process.

AD
AD

These are the full statements they provided:

The distributors

AmerisourceBergen: “AmerisourceBergen has supported the DEA taking steps to regulate opioids, and we continuously advocate for legislation that provides greater detail and clarity around the DEA’s expectations and demands on our company and others like it.

“The Ensuring Patient Access and Effective Drug Enforcement Act (S. 483) sought such clarity, as we worked in conjunction with DEA and other members of industry to support its passage while keeping the DEA fully empowered to issue Immediate Suspension Orders. To the extent it can be proven there were any unintended consequences of the legislation, including lessened enforcement authority by DEA, we support parts of the law being reevaluated.

AD

“Additionally, we support and applaud a number of efforts underway in Congress to help mitigate the opioid epidemic. These include achieving greater DEA ARCOS data transparency to help identify and report bad actors in the supply chain while clarifying the definition of a suspicious order. Some progress was made through last year’s passage of the SUPPORT for Patients and Communities Act to allow distributors limited access to ARCOS data. We also support the expansion of drug take-back programs and assessing the risk of abuse when setting DEA opioid quotas that provide all parties the tools to collaborate and fight the opioid epidemic.”

AD

Cardinal Health: “For decades, Cardinal Health has fulfilled an important role in the healthcare system, delivering prescription medications from manufacturers to pharmacies. What we do matters, and we are proud of our values and our people. We are committed to ensuring secure shipment of and access to prescription medications, while also working with integrity to limit the potential for them to fall into the wrong hands.

“Cardinal Health supported The Ensuring Patient Access and Effective Drug Enforcement Act, which was passed unanimously in both chambers of Congress and signed into law by President Obama, because it brought greater clarity to the regulatory landscape. The professional credentials and personal character of the Cardinal Health executives named in the reporting are unassailable and the company stands behind both their service to our country, and to Cardinal Health’s commitment to work hard every day to be a part of the solution.”

AD

McKesson Corp.: “Our nation’s drug supply chain is highly complex, so we routinely engage with elected officials and regulators to share our knowledge, experience and occasionally, recommendations. There is nothing inappropriate about companies communicating with policymakers in a transparent, law-abiding way to foster a more effective working relationship with the government.

AD

“And while it may be tempting to cherry-pick quotes from old emails and present them without context, it is a disservice to the public. This legislation was limited in scope and sought to update a small portion of a nearly 50-year-old law. It had broad bipartisan support — zero votes were cast against it, and President Obama signed it into law. Further, senior DEA officials have repeatedly said that the agency remains fully empowered and the Act has not hindered their enforcement efforts.

“McKesson is committed to maintaining strong anti-diversion programs as we deliver life-saving medications. In the end, our goal is to work together to protect the safety and integrity of the drug supply chain, so medicine can get to patients who need it.”

AD

Trade group

Healthcare Distribution Alliance: “The fundamental premise of The Washington Post’s reporting — that the passage of the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (EPAEDEA) weakened the Drug Enforcement Administration’s (DEA) enforcement authority during the opioid crisis — is factually incorrect. This is directly rebutted by the sworn Congressional testimony of a DEA official who stated there had never been an instance where the agency sought to use its authority to issue an immediate suspension order (ISO) against distributors and was in any way impeded in doing so as a result of the law. Further, this bill was not passed until 2016 — well after the peak of the crisis — and any suggestion that it could have affected actions prior to its passage defies common sense.

AD

“Distributors continuously sought guidance, as well as greater communication and coordination from the DEA, but prior to 2016, these efforts were not reciprocated. HDA supported passage of EPAEDEA (S. 483) as did numerous other organizations, and ultimately, Congress and President Obama. The intent of the law was not to decrease the DEA’s enforcement against distributors; its goal was to enhance communication between all parties in order to counter the constantly evolving methods of drug diversion. HDA believed that the legislation would help provide greater clarity to one element of DEA’s enforcement standards and encourage communication and coordination that was much-needed between the DEA and the industry.

AD

“The bill was subject to an open legislative process that involved regular, ongoing communication and consultation between congressional staff and DEA. Further, the measure passed both chambers without dissent and was signed into law by President Obama.

“We continue to advocate for policies that enhance communication between the DEA and distributors. HDA has also been proud to support legislation that further strengthens coordination and exchange of information between the industry and the DEA, such as the SUPPORT Act.

“Distributors take seriously our obligation to be part of the solution to the opioid crisis and believe that recent legislative actions as well as regulatory steps by the DEA, including their substantial reduction of opioid production quotas, have been positive.”

AD
AD