BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BRAHM FISHER ESQ., JAY K. JOSHI MD., MBA, JOSEPH WEBSTER MD., ESTER HYATT PHD., BRAHM FISHER ESQ., MICHELE ALEXANDER, BERES E. MUSCHETT, STRATEGIC ADVISOR
INSPIRED BY POPE FRANCES AND THE LITTLE GIRL:
“These agencies have failed to recognize a people’s chronic disease conditions of intractable pain, while further failing to understand or comprehend human suffering, the science of clinical medical treatment and the value of human life.”
norman j clement rph.,dds…July 2021
Truth, Justice and The United States Drug Enforcement Administration
The Drug Enforcement Administration has no steady-state of enforcement and it more than appears they are led to apply arbitrary rules to justify selective enforcement tactics targetted now against Chronic Pain patients and hospitals, clinics, and license medical practitioners.
While uncontrolled pain has led thousands of Americans and US veterans to commit suicide every year because life with pain becomes intolerable with death by suicide as the only escape. Pharmacists, family physicians, pain specialists, 10 million patients (3%) with chronic and rare diseases, have stood strong, willing to testify that 3000 people per day are being forced off, without medical justification as the result of DEA bullying of the medical profession.
Thus the DEA is an agency of the United States Federal Government that operates as a criminal enterprise that is a direct threat to medical care and public health and must be abolished by Congress and the Biden Administration.
THE ROLE OF THE DEA AND THE CONTROLLED SUBSTANCES ACT (CSA)
The Controlled Substances Act (CSA) and its implementing regulations established a closed system of distribution to ensure appropriate medical care and to maintain the integrity of the system through an accountability process. One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner, that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice. The United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a).
Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.
DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.
DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.
While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.
Therefore, it is important for you to check with your state medical board, as the issues that you have raised, maybe the result of new laws or regulations enacted by your state. Where state law or regulations impose requirements beyond those in federal law and regulations, practitioners must comply with the additional state requirements, provided such state requirements do not conflict with the Federal requirements. (1)
HOWEVER, CONGRESS DON’T BE FOOLED BY DEA RHETORIC
“The misguided emphasis on purported red flags conflates an elemental analysis with an essential analysis, allowing individual actions, taken out of context, to constitute the full understanding of the term, “prescribing outside of the scope of professional practice”, without incorporating the full context of clinical behavior – a logical fallacy that has allowed certain individuals to pass investigational fraud as inductive legal arguments, and to retroactively redefine interpretations of hopelessly vague statutes.”
“HOW THE WAR ON DRUGS IS WORKING 1990”
The DEA Redflag Guidelines
Case Of
Walmart Pharmacy vs Department of Justice 2020
DEA States:
“While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine. “
However in the Walmart Pharmacy Complaint
“The DOJ complaint also includes more than 190 mentions of “red flags” about suspicious opioid prescriptions. It claims Walmart often didn’t adequately resolve them and sometimes knowingly filled illegitimate prescriptions despite the warnings.”
“Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.“
“Walmart notes in its lawsuit that the Controlled Substances Act “and its implementing regulations do not include the concept of red flags, let alone identify any particular factors as a red flag.”
Opioid Policies Based On Morphine Milligram Equivalents Are Automatically Flawed MAY 24, 2021
Josh Bloom PHD., wrote:
” I wrote the science behind US opioid policies was deeply flawed, in particular, the use of Morphine Milligram Equivalents (MME) to quantify recommendations, policies, or laws. I argued that any use of MME was automatically flawed because it ignored even the most basic tenets of pharmacology..”
DEA States:
“While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.”
DEA’s REGULATION AND CONTRADICTION VS. PRONTO PHARMACY LLS, TAMPA FLORIDA
SUMMARY OF TESTIMONY RICHARD JAMES ALBERT
Pronto Pharmacy LLC GOVERNMENT’S PREHEARING STATEMENT
John E. Beerbower
Attorney
Diversion and Regulatory Litigation Office of Chief Counsel
8701 Morrissette Drive
Springfield, Virginia 22152
Office: (571) 362-7905
DI Albert will testify that, in June 2018, he conducted an analysis of information reported to the Florida Prescription Drug Monitoring Program (“PDMP”) by Respondent regarding Respondent’s dispensing of controlled substances from August 2017 to March 2018. DI Albert will testify that he identified approximately 600 patients that traveled in excess of two hours to fill their prescriptions for controlled substances at Respondent.
“While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine..” Most importantly, there are no laws that restrict the distance a person can travel to have their prescriptions filled for themselves, or for someone else.”
He will further testify that all of those prescriptions were paid for in cash.
DI Albert will also testify that, in June 2018, he conducted an analysis of the batch records for hydromorphone and oxycodone that were provided pursuant to the September 2017 subpoena.
“DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.”
“The drug cartels depend on America imposing ridiculous sentences on drug crimes. Drug crimes are not a big problem in America today. It’s the intentional weakening of the American middle class. Greed and corruption is the problem”
He will testify that the only ingredients identified in the batch records for the compounding was the relevant controlled substance and “lactose.” DI Albert will testify that he spoke by telephone with a Senior Pharmacist at the Florida Department of Health who informed him that lactose would only be used as a “filler” ingredient in the compounding of capsules.
DI Albert will testify that members of the Tampa District Office served the Order to Show Cause/Immediate Suspension Order in this matter along with a criminal search warrant at Respondent’s registered address on August 29, 2019.
He will testify that, during the execution of the warrant, DEA investigators searched a safe (located in the pharmacy’s private office) in which DEA investigators found numerous unlabeled pill bottles which contained capsules of hydromorphone or oxycodone.
SUMMARY OF TESTIMONY DONALD L SULLIVAN WILL TESTIFY
Donald L. Sullivan
Donald Sullivan will testify as an expert in pharmacy practice in the State of Florida and with respect to the federal regulations governing the dispensing of controlled substances by a pharmacy in the United States.
“Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.”
Dr. Sullivan will testify that he reviewed dispensing and prescription logs and patient information maintained by Respondent and provided to him by DI Albert. He will testify that he also reviewed the Florida PDMP report of Respondent’s dispensing behavior.
” Sullivan conduct no interviews, examines any patient reviews no patients records, request no physician progress reports, interviews no prescribing practitioner makes no attempt to inquire of any disease state of the patients”
“SUICIDE IS PERHAPS THE MOST DEVASTATING CONSEQUENCE OF THE CRACKDOWN ON OPIOID PRESCRIPTIONS.”
He will testify that he concluded that Respondent repeatedly filled prescriptions for controlled substances without resolving obvious red flags of abuse and/or diversion and in violation of the pharmacist’s “corresponding responsibility” under federal law. Dr. Sullivan will testify that Respondent violated the minimum standard of care for a Florida pharmacy and operated outside of the usual course of professional practice.
“Controlled Substances Act “and its implementing regulations do not include the concept of red flags, let alone identify any particular factors as a red flag.”
Dr. Sullivan will testify regarding the standard of care for a Florida pharmacy. He will testify regarding the requirements of Florida law for pharmacists, including the requirements imposed by Fla. Admin. Code r. 64B16- 27.810, Fla. Admin. Code r. 64B16-27.800, Fla. Admin. Code r. 64B16-27.800 & Fla. Admin. Code r. 64B16-27.831.
“While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.”
“DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.”
He will testify regarding a Florida pharmacist’s responsibilities under federal law, including regarding a pharmacist’s “corresponding responsibility” to ensure that a prescription for a controlled substance is legitimate prior to filling it.
“Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.”
He will testify that a pharmacist has an affirmative obligation to identify and resolve various indicia of suspiciousness (i.e., certain “red flags”) prior to dispensing controlled substances.
“Controlled Substances Act “and its implementing regulations do not include the concept of red flags, let alone identify any particular factors as a red flag.”
Dr. Sullivan will testify that Respondent repeatedly filled prescriptions without resolving the red flag of “cocktail medications” for Patients A.G.; A.H.; B.S.; C.R.; J.M.; N.B.; and R.B.
Long Distances:
Dr. Sullivan will testify that traveling long distances to obtain or fill controlled substances prescriptions is a well-known red flag of abuse or diversion. Dr. Sullivan will testify that Respondent nevertheless repeatedly dispensed controlled substances to patients who had traveled such long distances to obtain or fill their prescriptions without addressing or resolving this red flag.
RICHARD LAWHERN PH.D. “
Dr. Richard Lawhern focuses on the misdirection of the CDC guidelines on opioid prescription, and the outright extra-judicial persecution being used by DEA DoJ and others to drive doctors out of pain practice.
Dr. Sullivan will testify that (according to the Florida PDMP data), between September 10, 2018, and May 6, 2019, Respondent filled:
- 86prescriptionsforpatientswithaddressesinCapeCoral,Floridawhich is approximately 140 miles from Pronto Pharmacy;
- 145prescriptionsforpatientswithaddressesinFortMyers,Floridawhich is approximately 130 miles from Pronto Pharmacy;
- 41 prescriptions for patients with addresses in Lehigh Acres, Florida which is approximately 140 miles from Pronto Pharmacy;
- 15prescriptionsforpatientswithaddressesinImmokalee,Floridawhich is approximately 150 miles from Pronto Pharmacy;
- 15 prescriptions for patients with addresses in Naples, Florida which is approximately 170 miles from Pronto Pharmacy; and
- 11 prescriptions for patients with addresses in Opa-locka, Florida which is approximately 270 miles from Pronto Pharmacy.
Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.
“DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.“
“They all agreed I needed strong pain medicine but said they weren’t the correct doctor to help me.”
“DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.”
In addition, Dr. Sullivan will testify he looked at the long distances traveled by for Patients A.G.; A.H.; B.S.; C.R.; J.D.; J.M.; N.B; R.B.; R.G.; and R.L. and found that there was no justification for Respondent to fill these prescriptions for these patients who had traveled such long distances.
“..misapplication of the guidelines by political, state, and federal agencies including the DEA, led to a traumatic impact on chronic, severe pain patients in America ..”
General Observations
Dr. Sullivan will testify that patients who pay exclusively cash for their controlled substances is a well-known red flag of diversion or abuse. Dr. Sullivan will testify that, on average, approximately 11 percent of all prescriptions filled by independently owned pharmacies in 2018 were paid for in cash nationally. Dr. Sullivan will testify that over 90 percent of the prescriptions for oxycodone 30 mg
DEA has not promulgated any new regulations regarding the treatment of pain. Federal law and DEA regulations do not impose a specific quantitative minimum or maximum limit on the amount of medication that a practitioner may prescribe on a single prescription, or the duration of treatment intended for a particular patient.
bf966c4e-1f69-45ed-ac15-850dadfeb040-1DEA ” WE ARE GOING TO COME AFTER YOU”
and hydromorphone 8 mg filled by Respondent were paid for with cash. Dr. Sullivan will testify that this is a significant red flag that the prescriptions being filled by Respondent were being abused and/or diverted and that a pharmacist who was properly exercising his corresponding responsibility would have recognized this and refused to fill most of these prescriptions.
Dr. Sullivan will further testify that prices charged by Respondent were excessive.
Dr. Sullivan will testify that, according to the 2018 National Community Pharmacists Digest Financials, the average pharmacy makes a 22% gross margin (profit) on prescription drugs. According to their dispensing data, Respondent was making a 91% gross margin (profit) on every prescription it compounded and dispensed for hydromorphone 8mg capsules.
DEA has no authority to regulate commerce, prices or which third party providers an individual pharmacy is allowed to participate in nor does
DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.
Dr. Sullivan will testify that patients willing to pay such extremely inflated prices in cash for controlled substances are a potential red flag for abuse or diversion because customers taking prescriptions for legitimate medical needs would not pay such extreme prices for medication that can be purchased elsewhere for a fraction of the amount.
Dr. Sullivan will testify that Respondent nevertheless repeatedly dispensed controlled substances to such cash-paying patients without resolving or addressing this red flag.
Pronto Pharmacy is a specialty compounding Pharmacy and has been for 10 years. Pronto Pharmacy compounds Oxydone, Hydromorphone capsule as well as other pain medications, based on a history of a physician-patient relationship.
DEA has conspired to engage in interferences of interstate/intrastate commerce based on enforcing laws that have never existed such as distance travel. This was done by voiding the legitimacy of a person’s right to seek medical care and the pharmacy’s legal authority to dispense medical services.
Dr. Sullivan will testify that a compounded capsule form of a controlled substance poses a heightened risk of abuse and/or diversion because capsules can more easily be converted into an injectable form (a preferred method of abuse) than a tablet can. As a result, a controlled substance should not be compounded when there is a commercially available alternative that poses a lower risk of abuse and/or diversion.
“..I have reviewed the pertinent materials that were provided regarding the testimony of Dr. Sullivan. It is clear to me that he has a basic flaw in his thinking regarding the Doctor – Pharmacist relationship. .”
However
“Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice. It is up to each DEA-registered practitioner authorized by DEA to do so, to treat patients according to his or her professional medical judgment in accordance with a standard of medical practice that is generally recognized and accepted in the United States.”
Dr. Sullivan will testify that both oxycodone 30 mg and hydromorphone 8 mg tablets are readily available from multiple commercial suppliers. As a result, Dr. Sullivan will testify that Respondent was not legitimately “compounding” these medications consistent with the standard of practice at a retail pharmacy.
“DEA has consistently emphasized and supported the prescriptive authority of an individual practitioner under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards as outlined in DEA’s policy statement published in the Federal Register (FR) on September 6, 2006, titled, Dispensing Controlled Substances for the Treatment of Pain. 71 FR 52716.?
THE NARRATIVE OF THE DEA IS FALSE AND ITS TIME TO ABOLISH THE DEA
The prime motivation of the DEA appears to be the false assumption that any prescribed opioid pain medication can worsen the “opioid crisis” that we now know is caused predominantly by illegal flooding of illicit Chinese fentanyl and heroin overdose deaths. A review of statistical trends shows that this “crisis” has been present since 1970 and that the trajectory of overdose deaths was well established in numerous studies and was not affected by the entry of novel medications like OxyContin.
Healthcare is a right – a right of access, much like the right of access to information and court documents. To deny access is to deny justice,
Lawmakers must understand that the DEA regulates the entire legal opioid market and that if prescription opioids were fueling the crisis then the government themselves would be liable and responsible for the increase in overdose deaths. Although prescribing of opiates has decreased in the past few years there has been a vast acceleration of overdoses proving that prescription opiates do not have a causal effect on overdoses.
Lawmakers also ignore the costs of all alternative therapies. The high costs of physical therapy, topical medications, hypnosis, massage therapy, and behavioral modification, prohibits patients from engaging in these therapies. Nothing is free and there is always a cost and thus many of the 8 million US citizens who currently benefit from opiate therapy cannot work or engage in a meaningful life.
“drug cops with no formal medical training search for “red flags”
THE UNITED STATES DRUG ENFORCEMENT ADMINISTRATION IS A CRIMINAL ENTERPRISE OF FEDERAL GOVERNMENT CONGRESS MUST BE ABOLISHED
These haphazard policies have had a chilling effect on the compassionate delivery of medical treatment by reducing the ability of pharmacies to maintain the needed supply of well-established pain medications for the people who need them the most.
Most importantly they have forced millions of people to taper off of one or more of the necessary medications that allow them to engage in life and enjoy their families. These unsupervised law enforcement actions have left patients with uncontrolled and excruciating pain as no scientific or medical literature justifies opioid tapering once a patient’s painful condition is stabilized successfully.
Cato Institute Congresswoman Bonnie Watson Colemen
Rep. Bonnie Watson Coleman
(D-NJ)
Mr. President End the War on Drugs
Mr. President Sir,
How many thousands of American daughters and sons are we willing to subject to this War on Drugs. Already we have children whose great grandparents were subject to the abuses of the DEA’s drug war.
After 50 years and trillions of dollars spent and wasted. 3 million of our people are housed in prisons, families destroyed, neighborhoods in every city, town, village decimated and with no reasonable expectation of a different outcome we should end this war and begin a clinical war of treatment. Seek to abolish the DEA in 2 years. We’ve known for a very long time that building more prisons is not the answer.
We are now criminalizing medical care, incarcerating our licensed healthcare practitioners which is further undermining our healthcare delivery in the time of a pandemic; where we have enormous shortages of hospital care and healthcare workers. People with chronic intractable diseases such as sickle cell anemia, terminal cancers, are made to suffer needlessly.
We ask you to put an end to the war on drugs. Move to change enforcement to treatment and some of that treatment will be lifelong. Getting Help is the answer and treating all seeking treatment with dignity and respect.
FOR NOW, YOU ARE WITHIN
THE NORMS
Endnote
- Letter From Thomas Prevoznik Deputy Assitant Administrator Diversion Control Division to Richard Lawhern Ph.D. July 15, 2019
