I don’t agree with this author’s opinion of what the overturning of Chevron doctrine is going to do to necessarily harm our society’s health. One of the biggest generators of CO2 is the biological functions of most organisms’ metabolism.

One thing that appears that could happen is that the DEA will have its hands tied in generating new interpretations of the CSA. I doubt that anyone within the chronic pain community believes that there is anyone working in the DEA who is an expert on controlled substances’ appropriate use in treating chronic pain and other appropriate uses for controlled meds?  Does anyone think that anyone within the DEA has a clue about the underlying causes of addiction and substance abuse, nor have a working knowledge about how to help those who are labeled as a addict and wish to get sober?

Then there is this little law that has been “on the books” since 1935

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

With the End of Chevron, Health and Environmental Experts’ Hands Are Tied

We need the rule of law to protect public health

https://www.medpagetoday.com/opinion/climate-checkup/110995

The irony of a jubilant Fourth of July parade I attended with my kids last week — with marching bands, people in costume, and colorful floats — is that the U.S. government has never been more chaotic. The fragility of our democracy has been thrown into sharp relief over the past few months with a partisan Supreme Court placing a heavy finger on rightward leaning scales and the great unknown of November elections. The legislative branch of government, with all its foibles, then becomes the most secure path forward for those of us who like to breathe air, drink water, and not overheat.

The Supreme Court’s ruling in Loper Bright Enterprises v. Raimondo on June 27 overturning what’s known as “Chevron deference” prioritizes business interests over public health in a decision that weakens the ability of agencies to enforce regulations, such as restricting power plant pollution It says that agencies like the Environmental Protection Agency (EPA) are actually not the experts in environmental protection, but rather judges are. Now, agencies must go to court with industries that dump pollutants into the water or that poison our air because their right to make money precedes everyone’s right to breathe.

There is an obvious problem with this: judges are not experts in everything, only the law. When I take care of patients, I don’t present a variety of therapeutic approaches to a judge so they can adjudicate what I should prescribe. I work with my patient to find the right treatment for them. Similarly, I don’t want a judge and an oil company deciding how much environmental damage is just enough because they are decidedly not experts in environmental or public health protection, nor do they necessarily have the public interest at heart.

The downstream consequences of the ruling are broad. Anything that requires regulation could be affected: from publicly funded health insurance programs (CMS) to the food and drug review systems (FDA) to our environment. For decades, Chevron deference has protected programs like Medicare and Medicaid, with expert federal agencies like CMS being charged with interpreting and implementing the regulations. Issues related to environmental, public, and individual health are extremely complex and should be in the hands of experts, but after this Supreme Court ruling, experts’ hands are tied.

Those of us working to protect public health have supported regulations to advance air quality standards and to limit toxic substances like PFAS. Environmental regulations form a bulwark, checking the potential unregulated greed of industries whose corporate goals are profit and not public health (not even the public health of their shareholders). The hostility to government regulation also comes at the expense of the lives of the hostile: overturning rules that protect all of us will harm the entire country. It amounts to shooting ourselves in the foot, with the caveat that insurance companies can argue in court if they want to cover the doctor bills.

Many medical societies came together to draft an amicus brief  from which Justice Elena Kagan drew on in her dissent as she highlighted the “judicial hubris that the court has demonstrated in its overreaching power play. The long-standing rule of Chevron deference has allowed agencies to protect and advance the public’s health and has ensured that healthcare laws are interpreted and implemented appropriately. Since the Supreme Court’s conservative majority seeks to up end  the power of administrative agencies to do their jobs, legislation appears to be one of our few options to protect public health from climate and environmental degradation.

For example, one legal theory that has come up time and again is a carbon price that would function independently of a biased judiciary and would nudge the economy toward clean energy options and thus a healthier planet. Such federal legislation would acknowledge the health costs of climate change and fossil fuel pollution and be an effective means to reduce climate pollution. Congressional authority to cap carbon dioxide emissions was even noted by Chief Justice John Roberts to be a “sensible solution,” although the Chevron ruling curtails EPA’s ability to engage in cap-and-trade systems. Federal legislation that places a steadily increasing carbon fee at the source (where coal, oil, or gas comes out of the ground or into the country), rather than cap-and-trade, may circumvent those limitations while at the same time catalyzing the predictable transition to healthy non-carbon forms of energy throughout the country.

What we have seen the Supreme Court do is the exact opposite of democracy. It pins the biases of a minority against the welfare and well-being of the majority. With a judicial branch in the pocket of big business and fossil fuel, it becomes even more important to support legislation that cannot be so easily undone. Putting a price on carbon pollution is one example of commonsense and economically feasible legislation that has a chance to extend the environmental protections our communities deserve.

I waved my flags with everyone else at that July 4 parade, but that doesn’t mean I’m satisfied with the current state of the government. I want our leaders to do better to support us and our health.

Elizabeth Cerceo, MD, is an associate professor, academic hospitalist, and director of climate health at her medical school. Cerceo also co-chairs the Education Committee and Climate-Smart Health Care Committee for the Medical Society Consortium on Climate and Health. Her views do not necessarily reflect the views of her employer.

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Two dozen members of Congress sent a letter recently to the assistant secretary of defense for health affairs and the director of the Defense Health Agency regarding concerns about Express Scripts and how it’s running the Tricare pharmacy program. Led by Sen. Elizabeth Warren (D-Mass.) and Rep. Buddy Carter (R-Ga.), the letter highlights that the second largest PBM in the nation is both administering the program and participating in it, raising the bipartisan concern that it’s using this exclusive contract to overcharge taxpayers and drive out competition at the expense of our service members. It also quotes Hugh Chancy, NCPA’s immediate past president, who spoke at a House Oversight Committee hearing in September 2023 and described the harms of ESI’s steering practices on one of his patients, helping to illustrate the problems people are experiencing as a result. We applaud the legislators for holding the Department of Defense and ESI accountable and pushing to preserve patient access to medications and pharmacies.

https://ncpa.org/newsroom/qam/2024/07/09/icymi-legislators-slam-express-scripts-re-tricare-pharmacy-program

you will have to CLICK  ONCE OR TWICE TO GET GRAPHIC TO BE READABLE

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NY State’s Self-Congratulatory BS Report on Opioid ‘Progress’

https://www.acsh.org/news/2024/06/28/ny-states-self-congratulatory-bs-report-opioid-progress-48835

Let’s have a round of zero applause for the New York State Department of Health for its June 24th publication to physicians, misnamed “Data to Action Opioid Prescribing in New York State.” In a mastery of the self-evident, the authors reached this lame conclusion: if New York State actively discourages opioid prescriptions, then there will be fewer opioid prescriptions written in the state. Unstated is that this antiquated notion is doing far more harm than good, something that should be quickly apparent.

Intro: SOSDD (1)

The document starts with the traditional faux attempt to appear impartial.

“When used properly, opioids can provide benefits to the patient suffering from pain.”

If this isn’t the perfect time for the word “however” I’ll eat my shoes. 

“However, there are inherent risks to the use of these medications such as unintended overdose, substance use disorder, and negative societal impacts.”

My shoes are safe. And so are the antiquated beliefs, overblown fears, and downright lies about opioid use that should have been put to rest long ago:

• Prescription opioids actually have very little to do with overdose deaths, unintended or otherwise. Even the miscreants at PROP have changed their tune, now acknowledging that illegal drugs like illicit fentanyl, either with or without some of the current additives are responsible for overdoses.
• Substance use disorder? Why single out opioids – useful and essential medicines – rather than street drugs like cocaine, and methamphetamine as well? Let’s put them in.

Here are data from the CDC on the number of drug overdose deaths from different drugs in 2023:

• Illicit fentanyl, analogs, and other synthetic additives: ~74,000
• Psychostimulants (mostly methamphetamines): ~36,000
• Cocaine: ~30,000
• So-called “semisynthetics” (prescriptions like oxycodone, hydrocodone): ~10,000

Doing the “new math,” of the roughly 108,000 people who died from drug overdoses in 2023 only 9% did so from prescription pain medications. But the percentage is actually smaller. Significantly smaller.

Let’s add in the 178,000 annual deaths from excess alcohol (why this is not included in the discussion isn’t clear) and now the annual deaths from substance abuse (not counting cigarettes) are about 278,000, with a whopping 3.6% of these due to prescription pain meds. This is what we’re still getting hysterical about? 

And even that number is artificially high because in overdose deaths where a prescription opioid is implicated multiple other drugs are frequently found, contributing to the lethality of the opioid. Suffice it to say that prescription opioid drugs only when taken properly and under medical supervision are minuscule contributors to overdose death totals, probably in the 1-2% range.

 New York State to the rescue! Not. 

State and federal regulators “have employed various strategies in response to the opioid crisis and its impacts.”

Here are a few of the “accomplishments” that New York DOH brags about.

1. Prescription Monitoring Program Registry (PMP) and electronic-only prescribing
2. The limitation of initial opioid prescriptions for the treatment of acute pain
3. A provision requiring providers to prescribe an opioid antagonist yearly when certain risk factors are present

How’s that working out?

Not so well, really.

(Top) Between 2013 and 2022 the rate of opioid prescriptions in NY State was cut by half. (Bottom) During that same time, overdose deaths nearly tripled. How exactly does this represent progress?

More on the “accomplishments,” such as they are.

PDMS’s

Prescription drug monitoring plans made sense when pill mills were alive and well in the US. NY State fails to recognize that pill mills, which peaked around 2010, were largely gone in Florida – ground zero for illegal opioids – by 2015. 

Now I don’t even know where operators of “mills” would get pills to sell. Since 2013, oxycodone production quotas (set by the DEA) have decreased by 65% and oxycodone is now on the drug shortages list. PDMPs have morphed into a law enforcement tool to invade doctor and patient privacy and create an atmosphere of fear for physicians and guilt for anyone who dares fill a prescription for Ambien, especially if they have other scheduled drugs on their “records.” (3)

An arbitrary 7 days

New York, much like other states, has determined that 7 days is the magic number after which people no longer have acute pain. Notably absent is that different surgeries and conditions have very different pain levels and timelines for recovery and the wide variation in individual response to opioids. One size fits none. Seven days may or may not be appropriate. Let’s let physicians and patients, not the government, make that determination.

Obligatory naloxone – just plain dumb

Requiring that physicians write prescriptions for Narcan/naloxone when they prescribe opioids for certain people? (2) I’ll let my frequent writing partner Dr. Jeffrey Singer of the Cato Institute and also a practicing surgeon tackle this:

This is a stupid one-size-fits-all edict that assumes our patients are too dumb to follow our instructions and haven’t yet heard that it is possible to overdose on opioids. I usually tell my patients, ‘I have to prescribe Narcan for you, but you don’t have to pick it up from the pharmacist and pay for the drug unless you think you might not follow my instructions about what other substances to avoid while taking the pills or if you think you might ignore the dosage instructions and take too many pills at once.’

That’s enough ragging on New York for now. However, perhaps it’s time to update the logo:

The AI-generated image above may be humorous, but New York’s nonsensical antiquated policies are anything but. Much like the damaging “voluntary” guidelines concocted by the CDC in 2016 they need to go away.

NOTES:

(1) SOSDD is an acronym for “same old s### different day.”

(2) The “certain people” include those who are prescribed “a high dose” of opioids (90 morphine milligram equivalents or more), have a history of “substance use disorder,” and are also taking a sedative like Valium.

(3) PDMPs do have a legitimate function: To alert physicians to other medications being taken a valuable tool in a fragmented system where electronic health records do not “speak” to one another. This is fine. Punitive use by law enforcement? Not so fine.

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This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Pharmacists play a critical role in ensuring the safe and effective use of medications. There are several clinical and regulatory reasons why a pharmacist might refuse to fill a prescription without first contacting the prescriber. These reasons generally fall into categories related to patient safety, legal compliance, and prescription validity.

## Clinical Reasons

### **1. Missing or Incomplete Information**
A prescription must contain specific information to be valid, including the patient’s full name, medication name, dosage, quantity, instructions for use, and prescriber details. If any of this information is missing or incomplete, the pharmacist must contact the prescriber to obtain the necessary details before filling the prescription[1][2].

### **2. Potential Drug Interactions or Allergies**
Pharmacists are responsible for checking for potential drug interactions and known patient allergies. If a prescribed medication could potentially interact with another medication the patient is taking or if the patient has a known allergy to the medication, the pharmacist must contact the prescriber to discuss alternative options or confirm the prescription[6].

### **3. Dosage Concerns**
Incorrect dosages can pose significant health risks. If the pharmacist believes the dosage prescribed is too high or too low, they must verify the correct dosage with the prescriber to ensure patient safety[2][6].

### **4. Suspected Prescription Errors**
Handwritten prescriptions can sometimes be difficult to read, leading to potential errors. If a pharmacist cannot clearly read the prescription, they must contact the prescriber to confirm the details[2].

### **5. Potential Misuse or Abuse**
Pharmacists have a duty to prevent the misuse and abuse of medications, especially controlled substances. If there are red flags indicating possible misuse or abuse, such as frequent refills or high quantities of controlled substances, the pharmacist must verify the prescription with the prescriber[3][6].

## Legal and Regulatory Reasons

### **1. Controlled Substance Regulations**
Prescriptions for controlled substances must comply with specific regulations, including having the prescriber’s DEA number and being written on tamper-resistant paper. If these requirements are not met, the pharmacist must contact the prescriber to rectify the issue[1][5][6].

### **2. Prescription Validity**
Pharmacists must ensure that prescriptions are valid and legally compliant. This includes verifying that the prescription is not post-dated, altered, or missing a required signature. If any of these issues are present, the pharmacist must contact the prescriber to confirm the prescription’s validity[1][5].

### **3. Ethical and Professional Responsibility**
Pharmacists have an ethical duty to ensure that the medications they dispense are appropriate and safe for patients. If a prescription raises ethical concerns, such as being for a medication that the pharmacist believes is not in the patient’s best interest, they must discuss these concerns with the prescriber[3][6].

In summary, pharmacists may refuse to fill a prescription without contacting the prescriber for reasons related to incomplete or missing information, potential drug interactions or allergies, dosage concerns, suspected prescription errors, potential misuse or abuse, controlled substance regulations, prescription validity, and ethical responsibilities. These measures are in place to ensure patient safety and compliance with legal and regulatory standards.

Citations:
[1] https://www.ncbi.nlm.nih.gov/books/NBK538424/
[2] https://medicopharmacyrx.com/reasons-why-a-pharmacist-might-refuse-to-fill-your-prescription/
[3] https://journalofethics.ama-assn.org/article/pharmacist-and-prescriber-responsibilities-avoiding-prescription-drug-misuse/2021-06
[4] https://rules.sos.ga.gov/gac/480-22
[5] https://gdna.georgia.gov/prescribers
[6] https://puschnguyen.com/understanding-your-rights-exploring-the-possibility-of-suing-a-pharmacist-for-refusing-to-fill-your-prescription/
[7] https://law.justia.com/codes/georgia/2022/title-16/chapter-13/article-2/part-1/section-16-13-41/

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This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Does the DEA have any statutory authority to establish medical standard of care and best practices under the controlled substance act?

The Drug Enforcement Administration (DEA) does not have statutory authority to establish medical standards of care and best practices under the Controlled Substances Act (CSA). The DEA’s role under the CSA primarily involves the regulation and enforcement of controlled substances, including their scheduling based on factors such as potential for abuse, medical use, and safety or dependence liability[1][2].

The CSA outlines a collaborative process where the DEA works with the Department of Health and Human Services (HHS) to evaluate and recommend the scheduling of substances. This process involves scientific and medical evaluations conducted by HHS, which includes input from the Food and Drug Administration (FDA) and other relevant bodies[1][2]. However, the DEA’s responsibilities do not extend to setting medical standards of care or best practices, which are typically within the purview of medical and health organizations.

In summary, while the DEA plays a crucial role in regulating controlled substances and enforcing the CSA, it does not have the authority to establish medical standards of care and best practices. This responsibility lies with medical and health authorities, such as HHS and the FDA.

Citations:
[1] https://en.wikipedia.org/wiki/Controlled_Substances_Act
[2] https://www.dea.gov/drug-information/csa
[3] https://sgp.fas.org/crs/misc/R45948.pdf

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This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Is there any clinical justification to establish fixed opioid doses to treat chronic pain less than the FDA dosing guidelines

Based on the available information, there is generally no clinical justification to establish fixed opioid doses below FDA guidelines for treating chronic pain. The current clinical practice guidelines emphasize individualized patient care and avoiding inflexible dosing standards. Here are the key points:

1. Individualized approach: The CDC Clinical Practice Guideline for Prescribing Opioids for Pain (2022) emphasizes that recommendations should not be applied as inflexible standards of care across patient populations[1]. The guideline stresses the importance of individualized patient care and careful consideration of the benefits and risks of all treatment options.

2. Avoiding dosage thresholds: The CDC guideline specifically discourages the misapplication of opioid pain medication dosage thresholds as inflexible standards[1]. Instead, it emphasizes principles such as avoiding increasing dosage above levels likely to yield diminishing returns in benefits relative to risks to patients.

3. Regular evaluation: The Medical Board of California’s guidelines recommend regularly evaluating the benefit and harm of opioid therapy for chronic pain after starting treatment or following dose escalation[5]. This suggests that dosing should be adjusted based on individual patient response rather than adhering to fixed doses.

4. Patient-centered goals: The VA/DoD Clinical Practice Guidelines for Use of Opioids in the Management of Chronic Pain (2022) emphasize assessing patient-centered goals and improvements in function, rather than focusing solely on fixed dose limits[2].

5. Risk-benefit assessment: The FDA and other regulatory bodies consistently emphasize the need for careful risk-benefit assessment when prescribing opioids for chronic pain[4]. This approach is not compatible with establishing fixed doses below FDA guidelines without considering individual patient needs.

6. Transparency in decision-making: The FDA has been encouraged to be more transparent about its comprehensive, systems approach for incorporating public health considerations into regulatory decisions for opioid analgesics[6]. This suggests a move towards more nuanced and context-specific guidance rather than fixed dosing limits.

It’s important to note that while there is no general clinical justification for establishing fixed opioid doses below FDA guidelines, there may be individual cases where lower doses are appropriate based on patient-specific factors. Clinicians should consider factors such as the patient’s pain severity, functional improvement, risk factors for opioid-related harms, and individual response to treatment when determining appropriate dosing[1][5].

In conclusion, current clinical practice guidelines and regulatory approaches emphasize individualized patient care, regular assessment of benefits and risks, and avoiding inflexible dosing standards. Establishing fixed opioid doses below FDA guidelines for chronic pain treatment would not align with these evidence-based recommendations.

Citations:
[1] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[2] https://www.healthquality.va.gov/guidelines/pain/cot/
[3] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM522688.pdf
[4] https://www.fda.gov/drugs/information-drug-class/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose
[5] https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf
[6] https://www.fda.gov/media/165238/download
[7] https://www.fda.gov/media/86875/download
[8] https://health.ri.gov/healthcare/medicine/about/safeopioidprescribing/

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Here is a published MME calculator https://globalrph.com/medcalcs/morphine-equivalent-dose-med-opioid-conversions/   This is the infamous MME system that those “so-called experts” based their 2016 CDC opioid dosing guidelines and what many bureaucracies – like the DEA & VA – seemed to have codified those guidelines as a standard of care and best practices as well as maybe 30+ states have codified the same at the state level. 

This is a graphic representing the fictitious clinical facts that are starting to hit the fan

Does the Morphine Milligram Equivalent system have any clinical studies supporting its conclusions?

The Morphine Milligram Equivalent (MME) system has some clinical basis, but there are significant limitations and concerns about its scientific foundation and broad application:

1. Limited clinical evidence: The MME system is based on small clinical studies with limited populations[1][2]. These studies were originally intended to assist clinicians in determining initial doses when converting an individual patient’s opioid therapy, not as a broad risk assessment tool.

2. Lack of standardization: There is no single standard formula for calculating MMEs, leading to inconsistencies across different resources and calculators[2].

3. Oversimplification: The MME system does not adequately account for important patient and drug characteristics that can affect opioid potency and risk, such as opioid tolerance, pharmacogenetics, and differences between full and partial agonists[2].

4. Epidemiological support: While not directly validating MMEs, epidemiologic studies have shown an association between increasing daily opioid dose (measured in MMEs) and increasing risk of overdose[2]. However, these studies generally used broad MME threshold categories rather than precise conversions.

5. Concerns about misuse: Multiple experts have expressed concern that emphasizing specific MME thresholds as authoritative absolutes could lead to potentially harmful consequences, such as noncollaborative tapers[3].

6. Limited evidence for high doses: Few trials have evaluated opioid dosages of ≥90 MME/day, and there is some evidence of a plateauing effect at ≥50 mg MME/day in terms of pain relief[3].

7. Ongoing research needs: The FDA has recognized the need for further research to refine and improve the scientific basis of MME applications[1]. They held a workshop in 2021 to discuss knowledge gaps and research opportunities related to MMEs.

In summary, while the MME system has some clinical and epidemiological support, there are significant limitations in its evidence base and concerns about its broad application. More research is needed to address knowledge gaps and improve the scientific foundation of MME calculations and applications.

Citations:
[1] https://www.fda.gov/drugs/news-events-human-drugs/morphine-milligram-equivalents-current-applications-and-knowledge-gaps-research-opportunities-and
[2] https://www.fda.gov/media/150436/download
[3] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[4] https://www.jprasurg.com/article/S1748-6815%2824%2900336-X/fulltext
[5] https://meps.ahrq.gov/data_files/publications/rf45/rf45.shtml

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Here is a published BME calculator  https://globalrph.com/medcalcs/benzodiazepine-converter-dosage-conversions/   Narxcare creates what they call an LME (Lorazepam Milligram Equivalent) value and includes it in their Narxcare PDM reports on pts that authorized healthcare professional can pull up reports on pts.

This is a graphic representing the fictitious clinical facts that are starting to hit the fan

does the Benzodiazepine equivalent calculations have any clinical studies that support its conclusions?

The benzodiazepine equivalent calculations do not have strong clinical studies supporting their conclusions. There are several important points to consider regarding the evidence base for benzodiazepine equivalency:

1. Limited evidence: Unlike opioid equivalence, benzodiazepine equivalence is poorly described in the literature and lacks a robust evidence base[1]. Most equivalence estimates are based on expert opinion, uncited tables in publications, and clinical practice rather than rigorous clinical studies[1].

2. Wide variability: Due to discrepancies in the literature, many benzodiazepine conversions may have potential conversion ranges that are extremely variable, sometimes by a factor of 10x or greater[1]. This highlights the lack of firm, evidence-based literature supporting specific conversion ratios.

3. Limitations of existing data: Much of the published equivalence data comes from alcohol withdrawal settings using oral dosage forms[1]. This limits the generalizability to other clinical scenarios or routes of administration.

4. Lack of standardization: Different sources may disagree on equivalency ratios, leading to the use of dose ranges rather than fixed conversions in many equivalency charts[3].

5. Clinical judgment emphasized: Given the limitations of the evidence, resources on benzodiazepine equivalency stress the importance of clinical judgment, patient monitoring, and gradual dose titration when making conversions[1][3].

6. Some specific conversions better studied: While most conversions lack strong evidence, there are exceptions. For example, the conversion between intravenous midazolam and lorazepam has been well-studied in mechanically ventilated patients[1].

7. Ongoing research: Some studies are evaluating the effectiveness of institutional benzodiazepine conversion protocols, but these are often limited to specific settings like pediatric intensive care units[5].

In conclusion, while benzodiazepine equivalency charts and calculators are widely used in clinical practice, they are not strongly supported by clinical studies. Healthcare providers should approach these conversions with caution, recognizing the limitations of the available evidence and the need for individualized patient care.

Citations:
[1] https://clincalc.com/Benzodiazepine/
[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7372528/
[3] https://emedicine.medscape.com/article/2172250-overview
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4443548/
[5] https://www.researchgate.net/publication/326820719_Evaluation_of_IV_to_Enteral_Benzodiazepine_Conversion_Calculations_in_a_Pediatric_Intensive_Care_Setting

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How will the end of Chevron deference impact the DEA rules and regulations and enforcement of existing interpretations of the Control Substance Act that the DEA has made since its inception in 1973, which are now probably illegal?

The Supreme Court’s decision to overturn Chevron’s deference will likely have significant implications for the Drug Enforcement Administration’s (DEA) rules, regulations, and enforcement of existing interpretations of the Controlled Substances Act (CSA). Here are some key potential impacts:

1. Increased legal challenges: The elimination of Chevron deference opens the door for more frequent and potentially successful legal challenges to DEA regulations and interpretations of the CSA[1][4]. This could lead to a surge in litigation against the DEA’s existing rules and enforcement actions.

2. Judicial scrutiny of DEA interpretations: Courts will now be required to exercise their independent judgment when reviewing DEA interpretations of the CSA, rather than deferring to the agency’s expertise[1]. This means that judges will have more power to scrutinize and potentially overturn DEA regulations and enforcement actions.

3. Uncertainty for existing regulations: Many of the DEA’s longstanding interpretations and regulations based on the CSA may now be vulnerable to legal challenges[4]. This could create uncertainty for both the agency and regulated entities regarding which rules and enforcement practices will remain valid.

4. Potential scaling back of DEA authority: The ruling may lead to a scaling back or removal of numerous DEA rules and regulations that were previously upheld under Chevron deference[4]. This could potentially limit the DEA’s regulatory and enforcement powers in areas where the CSA is ambiguous.

5. Impact on scheduling decisions: The DEA’s authority to schedule and reschedule controlled substances may face increased scrutiny, as courts will now have more latitude to interpret the CSA’s criteria for drug scheduling independently.

6. Slower rulemaking process: The DEA may become more cautious in issuing new rules or interpreting the CSA, fearing potential legal challenges[3]. This could lead to a slower and more deliberate rulemaking process.

7. Congressional action: The ruling may prompt Congress to revisit and clarify aspects of the CSA to provide more explicit guidance, potentially reducing ambiguities that the DEA previously interpreted under Chevron deference[2].

8. Shift in enforcement strategies: The DEA may need to adjust its enforcement strategies to align with stricter judicial interpretations of the CSA, potentially affecting how it conducts investigations and prosecutions.

9. Retroactive challenges: There may be attempts to challenge past DEA actions and interpretations retroactively, although the extent to which courts will entertain such challenges remains to be seen.

10. Increased importance of statutory language: The precise wording of the CSA will become even more critical, as courts will focus more on traditional tools of statutory interpretation rather than deferring to DEA expertise[1].

It’s important to note that while many existing DEA interpretations and regulations may now be more vulnerable to legal challenges, they are not automatically invalidated by the Chevron ruling. Each regulation or interpretation would need to be challenged and evaluated individually by the courts. Additionally, while Chevron deference has been overturned, courts may still give some weight to agency expertise and experience in interpreting statutes, albeit to a lesser degree than before[1][2].

Citations:
[1] https://www.sidley.com/en/insights/newsupdates/2024/06/the-potential-implications-of-loper-bright-for-fda-and-fda-regulated-industries
[2] https://www.bhfs.com/insights/alerts-articles/2024/supreme-court-strikes-down-chevron-reshapes-administrative-law
[3] https://www.scientificamerican.com/article/supreme-courts-chevron-deference-decision-could-make-science-based/
[4] https://www.nytimes.com/2024/06/28/us/politics/chevron-deference-decision-meaning.html
[5] https://www.scotusblog.com/2024/06/supreme-court-strikes-down-chevron-curtailing-power-of-federal-agencies/

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