BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF RETIRED DETROIT POLICE SARGENT WALTER R. CLEMENT BS., MS., MBA., HOWARD ADELGLASS, MD., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“WE ARE PHYSICIANS, PHARMACISTS, DENTISTS TREATING PATIENTS IN NEED OF PAIN CARE WITH MEDICATIONS, NOT STREET DRUG DEALERS AND TRAFFICKERS”
STATEMENT
The question here is the Rule of Law. The most fundamental concept of our country, without it our society crumbles. This allows an agency to take anything they want unchecked based on their own manufactured rules and misinterpretation of laws, and medical procedures guidelines, creating their science and facts.
The great fear here is that the United States Drug Enforcement Administration (DEA) has operated unchecked as a rogue sub-agency of government operating outside the rule of law. Creating their own medical science (Auer deference), seizing property using the omnipotent authority of ill-gotten gain over the field of medicine and medical science.
Specifically, misidentifying the dosages and purposes of legally and medically prescribed FDA-approved Narcotic Analgesic medications, “having a useful and legitimate medical purpose,” to be illegitimate.
Congress determined Federal law enforcement agencies are unqualified to determine whether drugs “have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.” 21 U.S.C. § 801(1).
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: Richard A. Lawhern, Ph.D. DATED FEBRUARY 12, 2021
“ 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. 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 authorizes DEA-registered practitioners to do so, to treat patients according to his or her professional medical judgment under a standard of medical practice that is generally recognized and accepted in the United 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.”(1) ————————————
EXHIBIT 5-6F
1. (See exhibit 5-6F, Letter dated February 12, 2021, from Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, to Richard A. Lawhern, Ph.D. 3691 Nestling Lane Fort Mill, South Carolina 29708 lawhern@hotmail.com )
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Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: KEVIN NICHOLSON, RPH. DATED NOVEMBER 04, 2019
“The DEA lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine. The DEA DEA has not promulgated 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 may be prescribed on a single prescription on the duration of treatment intended with the prescribed controlled substance. The 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. This is outlined in the 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. {A copy is enclosed for your convenience.}” (2)(3)(4)
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EXHIBIT 5-4D
2. (See exhibit 5-4D, letter dated November 04, 2019, from Thomas W. Prevoznik, Deputy Assistant Administrator Diversion Control Division, to Kevin N. Nicholson, R.Ph., J.D.Vice President, Public Policy and Regulatory Affairs National Association of Chain Drug Stores1776 Wilson Boulevard Suite 200 Arlington, Virginia 22209)
DEA LETTER TO Congresswoman Grace Meng, Member of Congress Sixty District of New York, DATED DECEMBER 18, 2021
“As a Law Enforcement agency, DEA is not in a position to authorize or dictate what a doctor prescribes to a patient. DEA cannot grant waivers of any kind when it comes to the practice of medicine because no such waiver exists as the United States’ component body charged with the management of controlled substances and chemicals for scientific, medical research, and industrial applications; the DEA regulates the flow of control substances, not the practice of medicine. The changing prescribing practices of practitioners are derived by a shift to prescribe medicine consistent with guidance issued by the Center for Disease Control and Prevention, along with guidance and recommendations of state boards of medicine.”
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EXHIBIT 5-3C
3. (See exhibit 5-3c Congresswoman Grace Meng, Member of Congress Sixty District of New York, December 18, 2019).
Therefore, Congress did not leave it to DEA to perform one of its core CSA functions—the scheduling of controlled substances— without health care agency oversight and evaluation. See id. § 811(b) (“The Attorney General shall, before initiating proceedings . . . [to schedule or reschedule a drug] . . . request from the [HHS] Secretary a scientific and medical evaluation, . . . The recommendations of the Secretary to the Attorney General shall be binding . . . as to such scientific and medical matters.”).
However, Pharmacists and pharmacies also get contradictory guidance from federal health agencies and even the DEA, which often disagrees with the plaintiffs’ theory that pharmacists should interfere with a doctor’s individualized medical judgment.(ibid 4)(5)
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5. https://open.spotify.com/episode/2XcLGf4PCN0wNVLjxyAze6? si=EpDSJrvYTlCuiWwYqXUgWw
The decision in this case by this United States Court of Appeals for the District of Columbia will have far-reaching effects on the professions of Medicine, Dentistry, Nursing and other Mid-Level Practitioners and Pharmacist. The Appellant is a Pharmacist Not a Street Drug Dealer.
“It has clearly been decided by the #CDC, #DEA, #PROP, and some state governments that killing pain patients from complications of untreated or under-treated chronic, severe pain by denying adequate access to the only medicine which controls such pain is permissible even desirable”
FACTUAL BACKGROUND
On August 29, 2019, in the city of Tampa, Florida, Hillsborough County, Pronto Pharmacy 86 FR 647,14 (2021) was raided by DEA agents. Norman Clement was acting in the capacity of a licensed’s pharmacist and authorized. Whereby a Pharmacist is a person who is professionally qualified to prepare and dispense medicinal drugs. This definition and is a statute within the Florida Administrative Code & Florida Administrative Register.
In this and other cases, DEA Diversion Investigator using a subjective standard rather than an objective standard of proof “beyond the reasonable doubt,” who is “authorized” established Supreme Court 9-0 Ruan-Khan vs the United States could not be met to establish criminal negligence. And falsely established diversion based solely on the use of googles maps and performed absolutely no follow-up investigation as found in Wheatland Pharmacy, 78 FR 69441, 69445 (2013) to establish diversion or evidence that any patients had diverted any prescription medication filled by a pharmacist from Pronto Pharmacy LLC (see Decision and Order, Fed. Reg.86 FR 64714 (2021). Importantly, in Ruan v. the United States holding that “§841(a)(1) and § 1306.04(a) require the government to provide that a practitioner-defendant either: (1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.”
1. UNITED STATES DISMISSED INDICTMENT CASE NO. 1:19-CR-81 JUDGE McFARLAND
This matter is before the Court on the Unopposed Motion to Dismiss the Superseding Information and OriginalIndictment (Doc.150), as against Defendant James Barclay. Also before the Court is a letter submitted by Defendant Barclay(see exhibit 5.1A). Prosecutors had alleged in a 2019 indictment that Springboro, Ohio-based Miami-Luken, James Barclay, and others failed to guard against the illegal diversion of opioid pills in five states, including West Virginia. Prosecutors in this case elected to dismiss all defendants(s) charges in this case as they felt the standard of proof “beyond the reasonable doubt,” who is “authorized” established Supreme Court 9-0 Ruan-Khan vs the United States could not be met to establish criminal negligence. It is based upon a fundamentally untenable procedure, whereby “the DEA Administrator created its own “changed circumstance” by “quashing” an Order that already had been determined by this Court to be valid and enforceable, rather than either choosing to comply with this Court’s Order or to file a further appeal.
____________________________________________
EXHIBIT 5-1A
(see exhibit 5.1A by Defendant Barclay)
Further, Prosecutors feared an Appeal to a higher Court and therefore left open the fact the DEA Administrator acted beyond the authority to develop regulations to monitor and control provider registration for prescribing and dispensing controlled substances. 21 U.S.C. § 823(f); 21 U.S.C. 824(a); Gonzales, 546 U.S. at 262 (observing “Sections 823(f) and 824(a) explicitly grant the Attorney General the authority to register and deregister physicians…”).
“It is entirely possible that an appellate court would view the issues differently than previously determined by this Court. However, the key here is that review of this Court’s Orders is appropriate only by an appellate court. An agency that has been directed to comply with a district court’s order has no authority to disregard it through use of a procedural end-run simply.”
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EXHIBIT 5-5E
(see exhibit 5-5E pages 8 thru 10), Federal regulations do not define the term legitimate medical purpose nor do they set forth the standards of medical practice.
Thus we have based our argument here that the DEA Administrator has attained “omnipotent powers” not granted by Congress and has been wrongfully exercising the use of their ill-attained authority to regulate the practice of medicine by criminalizing good faith medical mistakes being able to move the goal post backward and forward. See 21 U.S.C. § 903. and act as the Federal equivalent of a state medical board overseeing the general practice of medicine while they have lacked the authority to issue guidelines that constitute advice relating to the general practice of medicine.”…dictating what a doctor prescribes to a patient, promulgating regulations regarding the treatment of pain, imposing a specific quantitative minimum or maximum limit (90MME) on the amount of medication that may be prescribed on a single prescription on the duration of treatment intended with the prescribed controlled substance, simply “The DEA lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.” ibid (2)
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(See exhibit 5-4D, letter dated November 04, 2019, from Thomas W. Prevoznik, Deputy Assistant Administrator Diversion Control Division, to Kevin N. Nicholson, R.Ph., J.D.Vice President, Public Policy and Regulatory Affairs National Association of Chain Drug Stores).
(see exhibit 5-5E, pages 8 thru 10)
RULE
The Controlled Substances Act (CSA) is a closed regulatory system enacted by Congress, making it unlawful to manufacture, distribute, dispense, or possess any controlled substance, except in a manner authorized by the Act. 21 U.S.C. § 801 et seq.; Jones Total Health Care Pharmacy, LLC v. Drug Enf’t Admin., 881 F.3d 823, 827, 830 (11th Cir. 2018) (quoting Gonzales v. Raich, 545 U.S. 1, 13 (2005)). The Act entrusts the Attorney General with authority to develop regulations to monitor and control provider registration for prescribing and dispensing controlled substances. 21 U.S.C. § 823(f); 21 U.S.C. 824(a); Gonzales, 546 U.S. at 262 (observing “Sections 823(f) and 824(a) explicitly grant the Attorney General the authority to register and deregister physicians . . . ”). The Attorney General has delegated this authority to the Drug Enforcement Administration (DEA) Administrator, under which the Administrator has developed regulations to oversee provider registration. 21 U.S.C. § 871; Gonzales, 546 U.S. at 262; Final Rule: Redelegation of Functions; Delegation of Authority to Drug Enforcement Administration Official, 75 Fed. Reg. 4982 (Feb. 1, 2010).
ANALYSIS
Congress, therefore, did not even leave it to DEA to perform one of its core CSA functions—the scheduling of controlled substances— without health care agency oversight and evaluation. See id. § 811(b) (“The Attorney General shall, before initiating proceedings . . . [to schedule or reschedule a drug] . . . request from the [HHS] Secretary a scientific and medical evaluation, . . . The recommendations of the Secretary to the Attorney General shall be binding . . . as to such scientific and medical matters.”).
Pronto Pharmacy LLC; see Decision and Order, Fed. Reg.86 FR 64714 (2021) the discretion of the DEA Administrative Court was not justified by the evidence and was based exclusively on speculation. No finding of actual drug diversion was proven or found. No manufacturing of drugs occurred or proved beyond the reasonable doubt that both Pronto Pharmacy, its owner Norman J Clement subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.”
CONCLUSION
Doctors are not Street Drug Dealers in White Coats.
- Illegal street drugs are not of identical, fungible, potency, or carry equivalent degrees of fatal diversion and addiction risks to DEA-Scheduled, FDA- supervised, and controlled prescription drugs. The purity, doses, chemical structure, bioequivalence, and /or means of intake of illegal street drugs versus DEA – scheduled / FDA- supervised medications are different. Street drugs and prescription drugs are not equivalent.
- Illegal street drugs and DEA-Scheduled, FDA- supervised medications require different registered users. Doctors and pharmacist register with the DEA. Street drug dealers register with the Mexican / Columbian / or Russian Drug Cartels.
- Illegal Street Drugs dealers and the DEA Registrant doctor are not equivalent. The doctors prescribe DEA-Scheduled, FDA- Supervised medications with “intent to treat”. On the other hand, street drug dealers act in furtherance of supremacy in the international illicit drug market.
- Doctors receive formal education from accredited schools of graduate education. Illegal street drug dealers receive informal education from the jails, the streets, and the Mexican / Columbian / Russian Drug Cartels.
- Doctors settle disputes with patients in the court system. On the other hand, drug dealers settle disputes via gang fights while using deadly weapons. The weapons are used with intent to kill, intent to cause grievous body harm or felony murder.
- In conclusion, the education, experience, conduct, and registration of DEA-registered doctors and street drug dealers are not the same.
- Doctors and pharmacists are not drug dealers in white coats.
2. THE DEA COURT OF THE KANGAROO IS NOT INTERESTED IN FINDING THE TRUTH
An Administrative Law Judge has the power to receive evidence and issue subpoenas to compel witnesses’ attendance and produce materials “necessary” for the hearing. See 21 C.F.R. §1316.52(d). However, DEA administrative revocation hearings do not include the type of discovery process that is available to civil litigants in this Court and are prevented from presenting witnesses such as the prescribing practitioners. As is found in Suntree Phar- macy and Suntree Medical Equipment, LLC; Decision and Order, 85 Fed. Reg. at 73776-77.
On Petition for a Writ of Certiorari to the US Supreme Court at no point did the Acting Administrator determine the legitimacy of the underlying controlled substance prescriptions that Suntree Pharmacy filled, nor did any qualified healthcare professional comment on whether the prescriptions were issued for a legitimate medical purpose. Id. at 73774-75.
The Acting Administrator also never heard testimony from any patients and prevented testimony from the physicians who prescribed the controlled substances Suntree Pharmacy filled. Id. at 73754. Instead, the Acting Administrator simply relied on “red flags” identified by Dr. Gordon, a clinical hospice pharmacist for ProCare RX, working from home as a consultant (i.e., not a retail pharmacist), and used these “red flags” as a proxy to conclude the prescriptions were illegitimate. Id. at 73754, 73774-75; R. 6 at 21; See Br. at 15-20 (describing in detail Dr. Gordon’s testimony). To this day, the DEA has never followed up with or penalized the medical providers who prescribed these “illegitimate” controlled substances that Sun- tree Pharmacy filled.
In both the cases of Pronto Pharmacy and James Barclay et al. are similarly situated, Dr. Donald Sullivan professor at the Ohio State University College of Pharmacy working from home, was used as the Pharmacy Expert consultant and used “red flags” as a proxy to conclude the prescriptions were ‘illegitimate.’ (See Decision and Order, Fed. Reg.86 FR 64714 (2021) id. at https://www.federalregister.gov/d/2021-25133/p-87)
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The owner of Suntree Pharmacy is both a pharmacist and a licensed practicing Attorney. Suntree Medical LLC was a separate closed-door pharmacy that did not dispense retail prescriptions. Suntree Medical had a separate DEA registration and was not in any way engaged in the conduct in the Order to Show Cause.
In a letter to the court, Honorable James McFarland, Mr. Barclay said he had;
“ repeatedly contacted the U.S. Drug Enforcement Administration for guidance about opioid orders, and either received no response or was told that whether to fill an order was purely a “business decision.” He also said;
“ the DEA had proof from the beginning of its investigation that Barclay lacked any authority to cancel orders personally. “I was indicted because the DEA failed to do their job, and the government needed a scapegoat after the publicity of the opioid problems in West Virginia,” Plaintiff Miami-Luken is a Dayton, Ohio, pharmaceutical wholesaler with a DEA registration that permits it to operate its business.
For nearly a decade, 3 Plaintiff has been under DEA scrutiny for “facilitat[ing] the diversion of significant quantities of the highly addictive pain killers, oxycodone and hydrocodone.” The Court took judicial notice of the fact that the referenced prescription drugs are among a class of opioids that have been commonly recognized as contributing to an ongoing opioid crisis in the United States. Over the course of its investigation, the DEA has issued numerous investigatory subpoenas to Miami-Luken, requiring the production of documents to DEA investigators, primarily in the Cincinnati, Ohio office.
RULE
Supreme Court 9-0 Ruan-Khan vs United States could not be met to establish criminal negligence. And falsely established diversion based solely on the use of googles maps and performed absolutely no investigation in Ruan v. United States, holding that “§841(a)(1) and § 1306.04(a) requires the government to provide that a practitioner-defendant either: (1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice.” Going strictly by “pill,” numbers is not enough to support a prosecution.
ANALYSIS
The DEA conducts administrative, civil, and criminal proceedings. Among the administrative tools that the DEA has employed to combat the opioid crisis are immediate suspension orders and revocation orders. The issues are of first impression in the Sixth Circuit (if not nationally), and both parties stress the far-reaching impact of their dispute in the broader context of DEA’s continuing efforts to curb the opioid epidemic.“[T]he stakes are high; on the line is not merely DEA’s one-time compliance with an adjudicatory subpoena, but rather the effective functionality of the administrative process for revoking and suspending the registrations of entities that illegally import, manufacture, distribute, or dispense controlled substances.”
CONCLUSION
As in Pronto Pharmacy LLC, Tampa Florida, Sun Tree Pharmacy, and Jame Barclay et al., all control medications ordered were legitimate, compounded, distributed, or dispensed by 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. This is outlined in the 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.
ARGUMENT
The regulation at the heart of this case, 21 C.F.R. § 1306.04(a), provides: “A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”
Leo Beletsky of Northeastern calls for the government crackdown on prescribers getting low-hanging fruit. “The DEA measures success based on the number of arrests and prosecutions. Doctors are minor players. The DEA convicted two hundred sixty-three physicians on charges between 2003-2017, and over 3000 were forced to surrender their licenses. They create their targets. Who is the biggest prescriber in a region, state, and nationwide? They are investigated. Who does the most procedures? They use ‘flags’ like distance traveled, forgetting that by disincentivizing and terrorizing prescribers, there is no one left to prescribe, and patients must travel farther for the same services. The flags created during the pill mill era are now self-perpetuating. If you mine data enough, you might find something, and law enforcement can access data without individualized suspicion, probable cause, or any judicial review.
“Numbers alone can’t determine whether a crime has been committed: The ‘normal’ amount of opioid prescribing for a physician treating pain or addiction will inevitably be much higher than the average for all doctors or the typical amount in most other specialties.”
For the foregoing reasons, Auer deference is inappropriate and § 1306.04(a) should be interpreted in a way that is consistent with Congress’ intent in enacting the CSA, while also allowing adequate notice to pharmacists and pharmacies of when a violation of the regulation occurs. As such, the regulation should be interpreted as requiring a qualified professional with medical expertise to determine whether a prescription was issued for a legitimate medical purpose. The Acting DEA Administrator’s decision finding Suntree Pharmacy violated § 1306.04(a), thereby revoking its registration, should therefore be reversed.
In the
Supreme Court of the United States
SUNTREE PHARMACY AND SUNTREE MEDICAL EQUIPMENT, LLC,
v.
DRUG ENFORCEMENT ADMINISTRATION,
Petitioners,
Respondent.
On Petition for a Writ of Certiorari to the United States Court of Appeals for the Eleventh Circuit
PETITION FOR A WRIT OF CERTIORARI
AUGUST 3, 2022 SUPREME COURT PRESS
RONALD W. CHAPMAN II
COUNSEL OF RECORD
CHAPMAN LAW GROUP
1441 W. LONG LAKE RD., STE. 310 TROY, MI 48098
(248) 644-6326 RWCHAPMAN@CHAPMANLAWGROUP.COM
MATTHEW J. PELCOWITZ
CHAPMAN LAW GROUP
701 WATERFORD WAY, STE. 340
MIAMI, FL 33126
(305) 712-7177 MPELCOWITZ@CHAPMANLAWGROUP.COM
COUNSEL FOR PETITIONERS
♦ (888) 958-5705 ♦ BOSTON, MASSACHUSETTS
The DEA’s Interpretation of § 1306.04(a) Is Not Entitled to Auer Deference Because It Is Not Supported by “Clear Congressional Authorization” in the CSA.
The Court’s recent decision in West Virginia v. EPA reminds us that oftentimes an agency must point to “clear congressional authorization” for the authority it claims. No. 20-1530 (2022) (slip op. at 17-19). In “extraordinary cases”, those in which “history and the breadth of the authority that [the agency] has asserted, and the economic and political significance of that assertion, provide a reason to hesitate before concluding that Congress meant to confer such authority”, prec- edent advises that an agency must point to “clear con- gressional authorization” for the authority it claims. Id. at 17 (quotations and citation omitted). The DEA’s interpretation of § 1306.04(a) is clearly an “extraordinary case” given the Court’s findings in Gonzales, 546 U.S. at 265-66.
There, the Court held the Attorney General exceed- ed the authority granted to him under the CSA when he tried to make medical judgments regarding assisted suicide. Id. at 262 (observing “the Attorney General claims extraordinary authority.”). The Court found that Congress limited the Attorney General’s authority to registering physicians to prescribe controlled substances and scheduling drugs, but that by making medical judgments, the Attorney General declared an entire class of activity (i.e., assisted suicide) as outside the course of professional practice (i.e., not medically legitimate), and therefore, a criminal violation of the CSA. Id. Moving forward, the Gonzales decision rein- forced that the Attorney General did not have the “extraordinary authority” he claimed, and that he could not determine what classes of activity were criminal violations of the CSA.
In this case, the DEA tries to claim this “extraor- dinary authority” the Attorney General declared inGonzales, 546 U.S. at 262, 265-66. That is, as discussed, the DEA’s interpretation of § 1306.04(a) has allowed the DEA Administrator to declare an entire class of activity (i.e., filling (i.e., dispensing under § 841(a)) a prescription for a controlled substance with unresolved “red flags” whether or not the prescription was issued for a legitimate medical purpose) as outside the course of professional practice, and therefore, a criminal violation of the CSA.12 See Holiday CVS, LLC, 77 Fed.
12 As discussed, due process under the U.S. Constitution requires a qualified professional with medical expertise to determine whether a prescription was not issued for a legitimate medical
Reg. at 62341; Suntree Pharmacy and Suntree Medical Equipment, LLC; Decision and Order, 85 Fed. Reg. at 73774-75; 21 U.S.C. § 841(a); see also H.R. Rep No. R45948, at 17. However, the DEA Administrator draws his authority under the CSA from the Attorney General. 21 U.S.C. § 871; See Final Rule: Redelegation of Functions; Delegation of Authority to Drug Enforce- ment Administration Official, 75 Fed. Reg. at 4982-83. The Administrator, therefore cannot have any greater authority than the Attorney General does under the Act. The fact that the Administrator has nonetheless claimed such “extraordinary authority” represents an “extraordinary case” where the breadth of the authority the DEA has claimed should provide the Court reason to hesitate before concluding that Congress meant to confer the DEA with such authority. West Virginia, No. 20-1530 (slip op. at 17-19).
Given this is an “extraordinary case”, the DEA must point to “clear congressional authorization” for the authority it claims under its interpretation of § 1306.04(a). Id. Nowhere in the CSA does it authorize the Attorney General or the DEA Administrator to determine what classes of activity qualify as criminal violations of the Act. See 21 U.S.C. § 801 et seq.; Gonzales, 546 U.S. at 262; Federal Maritime Comm’n v. Seatrain Lines, Inc., 411 U.S. 726, 744 (1973). This lack of “clear congressional authorization” further
purpose outside the course of professional practice to sustain a conviction under the CSA. See Ruan, 597 U.S. ___ (slip op. at 1- 3) (citing 21 U.S.C. § 841(a)); see In re Winship, 397 U.S. at 364; Christoffel, 338 U.S. at 89.; see also Gonzales, 546 U.S. at 266 (“the structure of the CSA [] convey[s] [Congress’] unwillingness to cede medical judgments to an executive official [Attorney General] who lacks medical expertise.”).
supports that the Acting DEA Administrator’s interpre- tation of § 1306.04(a) is not entitled to Auer deference given an independent inquiry into the character and context of the DEA’s interpretation does not entitle it to controlling weight. Kisor, 139 S. Ct. at 2415-16 (observing “ . . . we give Auer deference because we pre- sume, for a set of reasons relating to the comparative attributes of courts and agencies, that Congress would have wanted us to.” (citation omitted)).
For the foregoing reasons, Auer deference is inappropriate and § 1306.04(a) should be interpreted in a way that is consistent with the authority Congress granted to the Attorney General—and by extension the DEA—under the CSA. Because this authority is limited to deregistering physicians and scheduling drugs—and not declaring an entire class of activity unlawful—a qualified professional with medical exper- tise must determine the underlying legitimacy of prescriptions a pharmacist or pharmacy filled under § 1306.04(a). Therefore, the then-Acting DEA Adminis- trator’s decision finding Suntree Pharmacy violated § 1306.04(a), thereby revoking its registration, should be reversed.
FOR NOW, YOU ARE WITHIN
THE NORMS
REFERENCE:
BRIEF SUBMITTED US COURT OF APPEALS DISTRICT OF COLUMBIA 9/20.//2022
VIOLATION OF CFR 42-1395,,,MW