U.S. Pain and 31 patient and professional groups have submitted a letter to Congress urging it not to repeal the Ensuring Patient Access and Effective Drug Enforcement Act of 2016, which would upend essential protections for some of the most vulnerable patients in the country. The law aims to prevent the Drug Enforcement Agency (DEA) from limiting controlled substance pain medication distribution in a that way lacked transparency, due process, or safety.
The sudden move to repeal it was prompted by a CBS “60 Minutes” story, “Ex-DEA agent: Opioid crisis fueled by drug industry and Congress,” which aired in October, says U.S. Pain National Director of Policy and Advocacy Cindy Steinberg, who helped spearhead the group letter along with Jan Chambers, president of the National Fibromyalgia and Chronic Pain Association.
“The ‘60 minutes’ story focused on claims that this law derails DEA’s ability to pursue legitimate prescription opioid distributors,” says Steinberg. “This is simply not true. The DEA is still allowed to immediately suspend a registration. The law clarified the DEA’s authority; it did not diminish that authority.”
Prior to the enacting of the 2016 law, the DEA had undefined discretion to immediately shut down distributors and pharmacies without notice and without informing them of their suspected violations while the agency investigated. As a result, patients struggling with debilitating, painful diseases and conditions and, in some cases, dying Americans were suddenly unable to access prescribed and medically necessary treatment.
The problem was underscored in December 2013, when the National Community Pharmacists Association, which then dispensed nearly 40% of all prescriptions, conducted a survey of their membership. Key highlights of the survey included the following:
- Approximately 75% of respondents experienced three or more delays or issues caused by stopped shipments with their controlled substance orders, over the past 18 months.
- On average, 55 patients per pharmacy were impacted by these delays.
- 89% of impacted pharmacies received no advanced notice of the delay; they only found out when their order arrived and included just noncontrolled substances.
- 60% said the delays in receiving these requested medications lasted at least one week.
- 67.9% were unable to procure controlled substances from an alternate source, such as a secondary wholesaler.
Most reported having to turn patients away.
In response to concerns about legitimate patient access, due process and lack of opportunity for corrective action, the 2016 law established new rules: if the DEA suspects that an individual or entity registered to distribute or dispense controlled substances is not maintaining effective controls, the DEA is required to: (1) inform them that they are under investigation; (2) inform them what measures they are suspected of violating; and (3) provide 30 days to correct the situation.
The law additionally authorized the DEA to bypass this process and immediately suspend a registration in cases where “there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.”
“The simple fact is that unchecked DEA authority can result in profound consequences for chronic pain sufferers,” wrote Steinberg and Chambers. “A balance is needed to ensure that patients have access to the life-saving—and life-improving—medication they need while preserving DEA’s authority to go after the truly bad actors. The Ensuring Patient Access and Effective Drug Enforcement Act is a reasonable approach that strikes that balance. Congress should keep the law in place to help protect patients with severe pain.”
If you share concern that repeal of this law could harm your ability to access legitimate, medically necessary treatment, you are urged to write to Sen. Claire McCaskill (D-MO), Joe Manchin (D-WV), and to House and Senate leadership.