On August 19, 2020, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Brenton D. Goodman, M.D. (hereinafter, Respondent) of Lafayette, Indiana. OSC, at 1. The OSC proposed the revocation of Respondent's Certificate of Registration No. FG7707409. It alleged that Respondent is without “authority to handle controlled substances in the State of Indiana, the state in which [Respondent is] registered with the DEA.” OSC, at 2 (citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that Respondent's Indiana medical license and Indiana controlled substances registration had both expired, leaving Respondent without authority to handle controlled substances in the State of Indiana. Id.
The OSC notified Respondent of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. (citing 21 CFR 1301.43). The OSC also notified Respondent of the opportunity to submit a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated September 22, 2020, Respondent timely requested a hearing. Hearing Request, at 1. According to the Hearing Request, Respondent denied that his Indiana medical license was expired and claimed that his Indiana controlled substance registration was in the administrative process of being renewed. Id. He further requested that the hearing be delayed “to afford Registrant a reasonable opportunity to be heard before the Indiana Board of Pharmacy” regarding the renewal of his Indiana controlled substance registration. Id.
The Hearing Request was filed on September 22, 2020. Order for Supplemental Briefing, at 1. I find that the Government's service of the OSC was adequate and that the Hearing Request was timely filed on September 22, 2020.
The Office of Administrative Law Judges put the matter on the docket and assigned it to Chief Administrative Law Judge John J. Mulrooney (hereinafter, the Chief ALJ). The Chief ALJ issued a Briefing Order, dated September 23, 2020, directing the parties to brief the Government's allegation that the Respondent lacked state authority and denying the Respondent's request for a stay. Order Granting Summary Disposition and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision dated January 13, 2021 (hereinafter, Recommended Decision or RD), at 2. The Government timely complied with the Briefing Order by filing a Motion for Summary Disposition (hereinafter, Government MSD) on October 8, 2020. Id. In its motion, the Government presented evidence that demonstrated that Respondent lacks authority to handle controlled substances in Indiana, the state in which he is registered with the DEA and argued that, therefore, DEA must revoke his registration. Government MSD, at 3. Respondent answered the Government MSD in a Response in Opposition to Government's Motion for Summary Disposition (hereinafter, Respondent's Response) in which Respondent argued that “certain procedural and substantive defects” of the Government's argument “cannot be ignored.” Respondent's Response, at 2-3. Specifically, Respondent argued that in the course of proceedings, the Government's theory of the case had changed such that Respondent was “deprived of due process guaranteed to him under the United States Constitution and the applicable statutes, rules and regulations.” Id. at 3. Additionally, Respondent objected to the Government's introduction of what Respondent claimed was “hearsay evidence that lacks appropriate foundation for authenticity.” Id. at 7. Finally, the Respondent argued that the Government had not demonstrated that he had had his medical license and controlled substance registration “suspended, revoked, or denied by competent State authority,” and argued that the limitation on his “access” to controlled substances did not limit his prescribing authority. Id. at 9.
On January 7, 2021, Respondent filed a “Belated Notice of Registrant's Current Status” (hereinafter, Status Update), which stated that the Indiana Board of Pharmacy had issued a Decision regarding Respondent's Indiana controlled substances registration and argued that the DEA proceeding was now moot. Status Update, at 1. The Status Update included a copy of the Board's Decision, which stated that it was “adopt[ing] the June 28, 2019 Medical Board Order.” Status Update Exhibit 1, at 1.
On January 13, 2021, the ALJ granted the Government MSD finding that because “the Respondent does not have authority as a practitioner in Indiana, there is no other fact of consequence for this tribunal to decide in order to determine whether or not he is entitled to hold a [DEA Certificate of Registration].” RD, at 7. The ALJ recommended that Respondent's DEA Certificate of Registration be revoked based on his lack of state authority. Id. By letter dated February 28, 2021, the ALJ certified and transmitted the record to me for final Agency action. In that letter, the ALJ advised that neither party filed exceptions.
I issue this Decision and Order based on the entire record before me. 21 CFR 1301.43(e). I make the following findings of fact.
Findings of Fact
Respondent's DEA Registration
Respondent is the holder of DEA Certificate of Registration No. FG7707409 at the registered address of 5165 McCarty Lane, Lafayette, IN 47905. Government MSD, Exhibit 1 (Certification of Registration Status), at 1. Pursuant to this registration, Respondent is authorized to dispense controlled substances in schedules II through V as a practitioner. Id. Respondent's registration expires on September 30, 2021. Id.
The Status of Respondent's State License
At the time DEA issued its OSC, Respondent's Indiana medical license and Indiana controlled substances registration were both expired. MSD, at 3. Respondent has since renewed his state medical license; however, under the terms of a previous order, Respondent's medical license is on indefinite probation. Id. Specifically, the Government submitted as evidence an Order issued by the Indiana Medical Board on June 28, 2019, which placed Respondent's Indiana medical license on indefinite probation and included a provision that prohibited Respondent from having “access to Schedules I through V Controlled Substances, except for medications prescribed to him by a treating physician for Respondent's recovery or medical needs” for the first two years of probation. MSD, Exhibit 4 (Indiana Medical Board Order), at 3. Respondent further submitted evidence that the Indiana Board of Pharmacy had adopted the Indiana Medical Board Order, which included all of the provisions of his probation, including the same restriction on access to controlled substances. Status Update, Exhibit 1, at 1.
Respondent notes that the Government added to its foundation for revocation the fact that Respondent's medical license is currently on probation after the OSC was issued, and argues that the addition of this fact at this stage impeded Respondent's Constitutional right to due process of law. Respondent's Response, at 3-6. Although it is noted that the Indiana Medical Board's Order was in effect at the time of the issuance of the OSC, the status of Respondent's medical license and controlled substances registration at the time was expired, and it was the intervening act of Respondent on or about September 14, 2020, to renew his controlled substances registration, following the issuance of the OSC, that changed his status. See Respondent's Response, Exhibit (Respondent's Affidavit), at 1. The agency has frequently determined that an OSC does not need to be amended to account for loss of state authority grounds. See e.g., Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016). Furthermore, by virtue of Respondent's arguments in his response, I find that Respondent has had an opportunity to contest both the legal and factual predicates of the Government's case. See e.g., Duane v. Dep't of Defense, 275 F.3d 988, 993-96 (10th Cir. 2002); Abercrombie v. Clarke, 920 F.2d 1351, 1360 (7th Cir. 1990), cert. denied, 502 U.S. 809, 112 S.Ct. 52, 116 L.Ed.2d 29 (1991))(“Absent evidence that a party is misled by an administrative complaint, resulting in `prejudicial error,' we shall not reverse.”)
It is noted that, although Respondent challenges some of the Government's supporting documentation, he does not appear to challenge the legitimacy or text of this Order, which is the primary document in the Government's evidence on which I am relying in this decision. See Respondent's Response, at 3 and Respondent's Affidavit.
According to Indiana's online records, of which I take official notice, both Respondent's Indiana medical license and Indiana controlled substances registration are listed as on indefinite probation. http://www.mylicense.in.gov/everification (last visited date of signature of this Order).
Under the Administrative Procedure Act, an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” United States Department of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), “[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.” Accordingly, Respondent may dispute my finding by filing a properly supported motion for reconsideration of findings of fact within fifteen calendar days of the date of this Order. Any such motion and response shall be filed and served by email to the other party and to Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.usdoj.gov.
Accordingly, I find that Respondent is currently restricted from access to controlled substances in Indiana, the state in which Respondent is registered with the DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA) “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. See, e.g., James L. Hooper, M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978).
This rule derives from the text of two provisions of the CSA. First, Congress defined the term “practitioner” to mean “a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . . , to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice.” 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that “[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the state in which he practices. See, e.g., James L. Hooper, 76 FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43 FR at 27,617.
I reject the Respondent's arguments related to the distinction between expiration and suspension or revocation of the registrant's state authority as inconsistent with long-established DEA decisions, including the case to which he cited in support of his argument. See William D. Levitt, 64 FR 49,822, 49,823 (1999) (because “state authorization was clearly intended to be a prerequisite to DEA registration, Congress could not have intended for DEA to maintain a registration if a registrant is no longer authorized by the state in which he practices to handle controlled substances due to the expiration of his state license.”) Additionally, Respondent's argument is irrelevant, because the facts on the record here demonstrate that both the Pharmacy Board and the Medical Board of Indiana placed a restriction on Respondent's access to controlled substances.
Respondent makes two primary arguments related to the Indiana Board of Medicine's Order: (1) That the Indiana Board of Medicine has no authority to restrict Respondent's prescribing, Respondent's Response, at 9-10; and (2) that the term “access” in the Indiana Board of Medicine Order was “in reference to controlled substances that Affiant would be in possession of for personal use,” Respondent's Response, Respondent's Affidavit, at 2. In regard to the first argument, Respondent submitted evidence that the Indiana Board of Pharmacy had adopted the same terms of probation; and therefore, I find this argument to be mooted because the entity that Respondent claimed had the appropriate jurisdiction has now acted. See Status Update, Exhibit 1, at 1. Further, I agree with the Chief ALJ's finding that Respondent's interpretation of the Indiana Board of Medicine's restrictions on his “access” to controlled substances as permitting him to continue to prescribe controlled substances contradicts the plain language of such terms. RD, at 5 (citing Respondent's Response, at 3, 6, 9). The Board's Order states that Respondent shall not have “access to Schedules I through V Controlled Substances, except for medications prescribed to him by a treating physician for Respondent's recovery or medical needs.” MSD, Exhibit 4, at 3.
The plain language of this provision makes the drafters' intent crystal clear: the limitations regarding his access to controlled substances do not apply to controlled medications prescribed for his benefit, but apply to any controlled substances he may encounter outside that scenario (to wit, medications that he might have occasion to prescribe or administer). Thus, the Respondent's position that the [Indiana Medical Board] used the term “access” in that clause only to describe controlled medications that might come “in[to his] possession [ ] for personal use” makes no sense, because the plain language of that clause already addresses drugs prescribed for his treatment. A contrary interpretation would indulge the unlikely supposition that the [Indiana Medical Board] was making a provision designed to regulate controlled substances he possesses without a prescription (i.e., abuse them).
I find that the Chief ALJ's reading is further bolstered by the additional terms of the Indiana Medical Board's Order, which state that once the initial two year probation period has ended and Respondent has met certain conditions, his medical license will be then be subject to a “subsequent probation,” which includes that “Respondent shall submit Quarterly Reports and Inspect Reports for both himself as a patient and as a prescribing physician for this Board's review.” MSD, Exhibit 4, at 6. If the Indiana Medical Board intended for Respondent to be able to prescribe under the restricted access provision in the first two years of his probation, it would make little sense for the terms to have omitted a similar provision requiring such reports on his prescribing. The fact that the reporting provision appears as the probation becomes more lenient, further demonstrates that the Indiana Medical Board did not intend for Respondent to be able to prescribe for the beginning two years of probation.
Furthermore, because “the controlling question” in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a practitioner's registration “is currently authorized to handle controlled substances in the state,” Hooper, 76 FR at 71,371 (quoting Anne Lazar Thorn, 62 FR 12,847, 12,848 (1997)), the Agency has also long held that revocation is warranted even where a practitioner is still challenging the underlying action or where the state action is temporary. Kambiz Haghighi, M.D., 85 FR 5989 (2020); Bourne Pharmacy, 72 FR 18,273, 18,274 (2007); Wingfield Drugs, 52 FR 27,070, 27,071 (1987). Thus, it is of no consequence that the action is temporary. What is consequential is my finding that Respondent is not currently authorized to dispense controlled substances in Indiana, the state in which he is registered.
According to Indiana statute, “[e]very person who dispenses or proposes to dispense any controlled substance within Indiana must have a registration issued by the [Indiana Board of Pharmacy] in accordance with the board's rules.” Ind. Code § 35-48-3-3(b) (2021). “Dispense” means “to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner and includes the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.” Ind. Code § 35-28-1-12 (2021).
Additionally, as discussed herein, there is direct evidence on the record that the terms of Respondent's probation explicitly prohibit him from access to controlled substances in Indiana. See Status Update, Exhibit 1, at 1; see also MSD, Exhibit 4.
Here, the undisputed evidence in the record is that Respondent currently lacks authority to dispense controlled substances in Indiana. As already discussed, a physician must hold a controlled substances registration to dispense a controlled substance in Indiana. Thus, because Respondent lacks authority to handle controlled substances in Indiana, Respondent is not eligible to maintain a DEA registration. Accordingly, I will order that Respondent's DEA registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. FG7707409 issued to Brenton D. Goodman. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application of Brenton D. Goodman to renew or modify this registration, as well as any other application of Brenton D. Goodman, for additional registration in Indiana. This Order is effective May 3, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-06801 Filed 4-1-21; 8:45 am]
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