DEA Comments Gaffe

The DEA (Drug Enforcement Agency) has ordained its decree: Another year, another decrease in the production quota for prescription opioids.

The Controlled Substance Act (CSA), the law which regulates the production and dissemination of drugs deemed to have high addiction potential, among other dangers, also requires the United States Attorney General (AG) to set annual production quotas. For some reason, every year the AG delegates that task to the DEA.

As a result, we have ongoing production cuts of clinically necessary medications with little clinical input. And when there’s an opportunity to offer input, it’s largely ignored. This is most apparent in the DEAs Final Order setting the 2024 opioid production quotas.

As with most administrative actions, there’s a comment period in which the public and interested parties weigh in on the proposed government action before its implementation. This time was no different. The DEA received 4,700 comments. To the agency’s credit, it tried answering some of them.

But the way the DEA responded reveals just how little it understands the drugs it’s regulating. When asked about the clinical nature of addiction, the DEA responded with bureaucratic changes and procedural tweaks. When asked about drug shortages, the DEA denied any knowledge of such shortages and passed the issue along to the FDA. It was a masterstroke in administrative rhetoric – saying nothing in as many words as possible.

But it highlights the gross disconnect between the DEA and the patients most affected by the agency’s policies.

When asked to comment about the lack of available opioid prescribers due to the fear of prosecution among physicians, the DEA sidestepped the entire issue and responded with a blanket set of platitudes.

Even the way the responses were structured reveals much about how the DEA thinks. The response to the question of prescriber fear began with a recital of the SUPPORT Act. Then the DEA stated how quotas are established, in part, to prevent diversions. But then it responded by saying it doesn’t impose restrictions on the amount of medications a licensed prescriber can write, and that it, in fact, supports the authority of individual physicians to prescribe controlled substances for the treatment of pain.

It reads like legal boilerplate, like the many indictments against physicians for prescribing controlled substances for the treatment of pain and substance dependency. It shows the DEA isn’t looking at this issue clinically and isn’t seriously considering comments from the public. The legal jargon serves as a poor façade for the overt indifference.

For example, the DEA acknowledges it received many comments about how it potentially miscalculated diversion. But it never admits to any errors in its estimates. It simply reiterates all the factors that go into its consideration and obfuscates any further coherent reading with conjectures that neither verify nor deny any implications made in the comments.

When the DEAs data collection and analysis protocol was questioned, the DEA cleverly responded with a slew of sentences structured with passive tense verbs to indicate that it’s “considering”, “determining”, “improving”, and “reevaluating” its data methodologies. Sentences written in such a way are a lawyer’s dream: give off the pretense of answering a question while redirecting any meaningful culpability or follow-up action. It acknowledges without ever answering.

The entire document reads like this. A clinical question is asked and a legal response is given. When read in its entirety, the order reads like satire. But there’s nothing humorous about the consequences of ongoing production quota cuts.

Patients will suffer. Medication won’t be available. Yet the same rhetoric will continue.

The risk of diversion is greater than the risk of not having access to medications.

That’s the fundamental issue at hand here. The DEA has ordained it, and no amount of clinical data or number of patient anecdotes will change this. When health law supersedes health care, the rights of the individual patient are forsaken for the benefit of litigious health policy.