Is the DEA Overreaching Its Authority?

Is the Drug Enforcement Administration (DEA) Overreaching Its Authority? – 4th May, 2019 – By Lynn Webster, M.D. – (This article, in a slightly edited form, first appeared on Pain News Network on May 5, 2019.)

Why Is the DOJ Conducting Criminal Investigations?

This is an excellent question because:

Medical practice is regulated by the states,
not the federal government.

The U.S. Department of Justice (DOJ) does not have the authority to determine which health care activities constitute a “legitimate medical purpose under Federal Drug Enforcement Administration (DEA) regulations.  

However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of the law.

In its broadest sense, the CSA [Controlled Substances Act] regulates every aspect of  controlled substances, from production to delivery, distribution, prescribing, possession, and use.

The CSA’s everyday impact is far-reaching; the Act touches many different sectors of our society, including

  • healthcare,
  • pharmaceuticals,
  • law enforcement,
  • politics, and
  • the state and federal judiciaries.

Legal Authority Rests With State Governments

According to the Act, a prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. This statutory language is at the root of the issue.

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken an active approach in determining which medical practices have a “legitimate medical purpose” and which do not.

This hands-on approach is in direct contravention with the CSA.

The DEA is effectively preempting state law as it relates to the regulation of controlled substances.

In Gonzales v. Oregon, 546 U.S. 243 (2006), the United States Supreme Court held that the authority to determine legitimate medical purpose rests with the state governments.

This means it is state lawmakers, not federal government officials, who should regulate the practice of medicine.

Legitimate Medical Purpose

The key phrases — “legitimate medical purpose” and “in the usual course of a professional practice” — are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years.

The only way the phrase “legitimate medical purpose” would have a legal meaning would be if the concept of “illegitimate medical purpose” were defined by the CSA — and it is not.

Moreover, the words “legitimate” and “medical” are redundant. The practice of medicine is inherently legitimate, according to the CSA.

Any practice that is medical is legitimate, and its actions should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

However, the DOJ is now using deviations of standard of care to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids.

…the DOJ has hired medical experts who testify that a deviation of standard of care is consistent with practicing without a legitimate medical purpose. In some instances, the government’s experts have even used the CDC dose limit recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose

In Gonzalez v Oregon, 126 S. Ct. 904 (2006) that states “he [the Attorney General] is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ.

This is supported by a 1983 statement by S. Stone in a United States Drug Enforcement Administration (DEA) newsletter that declares acts of prescribing or dispensing controlled substances which are done within the course of a provider’s professional practice are, for purpose of the CSA — which is the primary law that governs controlled substances — lawful. Even if a physician’s behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard.

It is not the DOJ’s role to determine the quality or boundaries of the practice of medicine.

After reading this article, I simply cannot understand how this situation was allowed to evolve into the nightmare of today’s policies when doctors must fear for their livelihoods when they prescribe effective medication for intractable pain.

Without such compassionate care, these patients would be (and are) left in agony for the rest of their lives.

Other thoughts?

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