Is the Drug Enforcement Administration (DEA) Overreaching Its Authority?
This article, in a slightly edited form, first appeared on Pain News Network on May 5, 2019.
Why Is the DOJ Conducting Criminal Investigations?
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 1970, the United States Congress passed, and the president signed into law, the Federal Controlled Substances Act (CSA).
In its broadest sense, the CSA 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.
Medical boards are established by the authority of each state’s medical practice act to protect the health, safety, and welfare of health care consumers through proper licensing and regulation of physicians and other health care practitioners.
If a provider engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that provider is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ as well as state regulators.
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. The phrase “legitimate medical purpose” can be reduced to “medical purpose” without changing its meaning.
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.
In an attempt to address opioid problem, 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.
Using deviations of “standard of care” as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling 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 car 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.
Again, the DEA is the government agency charged with enforcing the controlled substances laws and regulations of the United States. The information it provides in its newsletter isn’t an opinion. It’s the law.
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.
They have and continue to do so Horribly! They are Extremely Crooked!
Unfortunately this needs amending to include what happens to abandoned patients from the fear mongering the happening to Doctors. Doctors fear writing “legitimate” prescriptions and care. When a patient is dropped without care or detoxification worse things happens which is why patients are committing at higher suicide rates!
Get the out of here!
Thank God for you, Dr. Webster! Your blogs are the only thing keeping me from going insane these past three (3) years, and it is you that has kept me educated on all of the ridiculous measures perpetrated, primarily by the CDC. You have given me faith that there are those in the medical profession who called out this insanity early on, when the CDC released their tremendously-flawed “Guideline,” with it taken as a “Mandate,” by doctors, pharmacists, insurance companies, and in the minds of a tremendous number of Americans, who didn’t, and still don’t, know any better. It didn’t take a Rocket Scientist to see what was coming from this misguided attempt to quell overdoses. Good ole common sense indicated that there would be horrible ramifications from this mess caused by the CDC,DEA and other less-bright people,with the later group unfortunately also in power over such matters. I personally knew that it would result in suicides and forcing chronic pain patients to the streets to find drugs to replace their much-needed opioids to treat their unrelenting, chronic pain. Plus – the overdose deaths have continued to rise all during this time anyway, which we also knew would happen! The CDC just added to the death toll! As a Chronic Pain Patient, I could foresee these ramifications – so why could no one at the State or Federal level foresee this too? I am one of the few pain patients, blessed with a kind, caring, and insightful doctor, who did not alter my medications in any way, through this entire time, although my pharmacy made it most difficult to get my pain medications, insurance company wouldn’t cover initially, and there were countless problems just getting my meds, financially and otherwise. One month I had to pay $1200 for just one of my monthly medications, but now that my insurance company has gotten their head out of, well, you can guess, they have now ‘approved’ both of my monthly opioid pain meds, and both meds have been at the SAME strength and dosage, for over 27+ years. Now, most unbelievably, my insurance company has given my my pharmacy, a ‘blanket approval indefinitely’ for both of my pain meds! My doctor has given me refills for 3 months at a time; changing both of these hoops to the most liberal actions I have ever received. I have a feeling they’re all just stinkin tired of jumping through the CDC/DEA hoops and are now doing what is the easiest route to take, and good for them!!! I obviously have truly been one of the lucky ones, but my story is the exception, and I will not be silenced on behalf of my brothers and sisters in chronic pain and still stuck in this horrible mess. In spite of my personal situation, I continue to write my Political representatives and anyone else I can think of. I will get on my soapbox and tell people what is REALLY GOING ON, even if it’s just one person. As an aside, I am also not immune to the overdose deaths that arise from these street meds, which IS what is causing all of the overdoses that continue to rise. Recently, a 19-year old friend of our family, died from what they originally thought was an Oxycontin overdose. I really found that difficult to believe. As it turns out, the drug Fentanyl was also within the pill she took, and at such a large amount, she died. So, Fentanyl was the ultimate cause of death and NOT Oxycontin.. Of course, we were all so saddened by her loss regardless of the reason, but she also chose to take the pill(s), surely aware of the ever-increasing overdoses, and death, from these street meds. She still decided the risk was worth whatever high she may have gotten out of it? I’ve NEVER gotten a high of any sort off of my pain medications, and with the pain and constant stress in my life, that would be a welcome relief, but, I don’t take anything chasing any kind of high. I believe, that if one is in legitimate pain, the medication will go to one’s pain receptors, truly, just taking at least the edge off of the pain. If someone is young and without measurable pain of any sort, I would presume it may cause a state of euphoria – but, I honestly don’t know. If the original ‘guideline/mandate’ weren’t bad enough, the CDC’s recent release of the very first statement from the CDC since they started this mess, was too little, too late. It’s been three (3) years since they caused all these suicides, abandonment of patients by doctors, good doctors retiring early, doctors abandoning their Chronic Pain Patients, forcing the purchase of street drugs to get any pain relief, the misappropriation of the guidelines by everyone involved, with the street med overdose deaths continuing to rise still at an alarming rate. Lastly, I would offer, that many of the people who died during the last 3 years from street med overdoses, were Chronic Pain Patients who were already being under-medicated by their doctors in the first place. Former research I had done, showed that America has the most undertreated Chronic Pain Patients in the world. Then add this CDC/DEA mess to the mix, and it was always a recipe for disaster!. Let’s all pray that 2019 will be the year that common sense will once again prevail and this insanity will be stopped permanently! Thank you…
Thank you Dr. Webster, for pointing out this fundamental discrepancy between what the CSA states and what the DOJ is doing.
It’s very clear that states are the ones to regulate medical practice, not the federal government, yet the department of justice is making decisions about what constitutes legitimate medical practice when this is clearly outside their jurisdiction. I don’t even understand how they are allowed to get away with what they’ve been doing for so long.
It seems a legal challenge might succeed on this basis, if it were possible to find a lawyer who is not terrified of taking cases that do not demonize opioids.
Thank you for your article. The VA is waving alternative therapies in front of veterans claiming that they are just as effective. I’ve tried the acupuncture and I’m sorry but all 10 punctures fell out of my ears within 5 days. Probably because my injuries don’t allow me to lay in one position beyond 5 minutes while sleeping. If anybody actually believes these are effective then my chronic pain is a 15 on the emoji panel.
I’ll never forget not forgive the VA for letting me suffer through a flare up in my cervical spine that affected my nerve. This was more painful than when I fell from a telephone pole in service. I ended up taking 1500mg of aleive qid until I started projectile vomiting blood. I understand monitoring but this has gotten to be a cruel practice now and the service organizations are just as bad for not advocating for compromise. The last time I was prescribed meds from the VA I stretched them to last 5 years. I’ve always understood that you don’t build a tolerance you only use them when you can take it anymore. Any professional on a committee that believes alternative therapy work will you please fall down a flight of steps so that I can truly appreciate your application of the remedies like lavender, psychotherapy, acupuncture, chiropractor, massage therapy. Sorry to be so cruel. I am angry because of political grandstanding and VA posturing. Let’s now request stats on suicide rates, diabetes, high blood pressure, strokes and heart attacks. Way to go DC!!
Well, obviously the answer to the question is the DEA over reaching is YES, BIG TIME! And it isn’t just what you have described in this article, they have used dirty methods like confiscating bank accounts and private property seizures before convictions so doctor’s don’t have the money to hire legal assistance, and this drives pain doctor’s out of practice so that now no one is available with the expertise to treat patients in severe pain. Treating doctor’s like drug kingpins ought to be a crime! All of this is harming legitimate medical care and helping the real drug kingpins and drug dealers. It makes me wonder if this wasn’t the idea all along. This really ought to be a huge Congressional investigation. If you think that the so called opioid epidemic is bad, this is ten times worse at least! I need to write a book and make a movie! Hollywood where are you? The lies, greed, corruption, dishonesty, cruelty, ignorance, cowardice, and arrogance is stunning. Changes need to happen NOW, before even more lives are lost. The war and genocide on disabled chronic pain patients and our veterans must stop. Those Americans who don’t suffer with serious pain have no idea! This is the cruelty of the Nazi! Please able bodied people stand up for those of us who are suffering because many of us are hurting so bad that we don’t have much strength to fight for ourselves, and someday you could be next. I was once pain free myself, now I’m not! Please help us, we are suffering and dying!