[Submitted electronically via www.regulations.gov]
Drug Enforcement Administration
Attn: DEA Federal Register Representative/DRW
8701 Morrissette Drive
Springfield, VA 22152
RE: Controlled Substances Quotas [Docket No. DEA-508P]
The undersigned groups thank the Drug Enforcement Administration (DEA) for the opportunity to comment on its proposed rule regarding controlled substances quotas. Although we support DEA’s efforts to combat diversion, we are concerned that the proposed rule is focused on diversion to the exclusion of another critical factor – drug shortages. To ensure that legitimate medical needs are met, it is imperative that drug shortages be considered as aggregate production quotas (APQ) are set and adjusted.
As DEA is aware, hospitals and other providers continue to face critical shortages of a number of injectable opioid medications, including fentanyl, sufentanil, and hydromorphone. Intravenous (IV) opioids are used in a variety of practice settings within hospitals and ambulatory surgical centers for the treatment of acute, acute on chronic, or chronic pain that cannot be managed because the patient has a contraindication for oral opioid medications. Some opioids, such as fentanyl, also are used for sedation. Injectable opioids are critical to treating the pain needs of patients undergoing interventional procedures (e.g., cardiac catheterization or colonoscopy) and surgeries. These medications are also frequently used in intensive care units for surgical, trauma, burn, or oncology patients, when it is not clinically appropriate to use oral opioids. Having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients in addition to creating burdensome workarounds for healthcare staff.
In previous comments to DEA regarding the ongoing CII shortages, we highlighted the necessity of APQ flexibility until the IV opioid shortages resolve. In response, DEA did adjust APQ limits for certain manufacturers, which we greatly appreciated. However, injectable opioids have been in shortage since 2017. These recurring shortages are unlikely resolve in the near term, so additional adjustments to APQs will be needed to ensure adequate supplies are available for legitimate medical purposes.
Although DEA regulations do not require consideration of shortage data per se, they do require that DEA review the “total actual (or estimated) inventories of the class or chemical and of all substances manufactured from the class or chemical, and trends in inventory accumulation.” DEA’s discussion of the factors it reviewed when setting the proposed APQs fails to acknowledge shortages as a relevant factor.
We request that DEA reconsider the depth of the cuts to quotas for drugs that are currently in shortage. FDA can provide shortage data broken down by dosage form, which will help contextualize the actual supply and availability of medications. This may also provide a clearer picture of diversion risk, as IV opioids dispensed in clinical settings pose a far lower risk of diversion than other dosage forms dispensed directly to patients. Further, we urge the agency to facilitate APQ flexibility as necessary to ensure that the APQs provide adequate supplies for “legitimate medical needs.” Proactively considering shortages when setting and adjusting APQs will safeguard patient health and safety and ensure critical needs are met.
Thank you for your consideration of our comments. We continue to support DEA’s efforts to combat the opioid crisis, and we stand ready to assist the agency in any way possible. If you have questions, the appropriate contact person for each of the signatories can be found below.
Ambulatory Surgery Center Association
Contact: Kara Newbury Director, Government Affairs & Regulatory Counsel
American Hospital Association
Contact: Ashley Thompson Senior Vice President, Public Policy
American Society of Anesthesiologists
Contact: Ashley Walton Pain Medicine and Federal Affairs Manager
American Society of Clinical Oncology
Contact: Karen Hagerty Director, Reimbursement Policy
American Society of Health-System Pharmacists
Contact: Jillanne Schulte Wall Director, Federal Regulatory Affairs
Federation of American Hospitals
Contact: Paul Kidwell Vice President, Policy
Institute for Safe Medication Practices
Contact: Allen Vaida Executive Vice President