Federal Register - December 8, 2021
Versione di testo Cosa è?Dateas è un sito indipendente non affiliato a entità governative. La fonte dei documenti PDF che pubblichiamo qui è l'entità governativa indicata in ciascuno di essi. Le versioni in testo sono trascrizioni che realizziamo per facilitare l'accesso e la ricerca di informazioni, ma possono contenere errori o non essere complete.
Source: Federal Register
jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices when she was issuing prescriptions while her license was expired, Respondent stated that due to personal family issues, she wasnt even thinking about the CDS license since she knew she had just gotten it renewed in the early part of the year 2017. Id. Respondent again stated that she did not realize her license was expired, and that as soon as she was notified in early 2018 that the license was expired, she immediately got it renewed. Id. Respondent did not offer an explanation as to the third period when she was issuing prescriptions while her license was expired. Id.
Respondent noted that she has practiced medicine in Louisiana for 20
years, she has never had a problem with her CDS license, her medical license has never expired, and her DEA license has never expired. Id. Respondent stated that her misconduct was unintentional and that because she was commuting and not in the office every day, she missed the renewal dates. Id.
Respondent also noted that she was under horrible levels of stress and apologized for the license having expired, stating that it would never happen again. Respondent concluded her letter by describing corrective action that she had taken, specifically that she had logged the expiration date in several places, even on her personal cell phone and that she was renewing on the date that she receives the renewal letter. Id. Respondent also stated that she had already completed the most recent renewal in July 2019. Id.
Finally, Respondent stated that she was not waving sic her right to a hearing and that if the DEA wished to pursue the matter after her explanation, she still would like to come to a hearing. Id.
As for Respondents failure to comply with the Order for Prehearing Statements that led to the termination of the proceedings without a hearing, Respondent offered some explanation in her subsequent emails to the Tribunal, in which she requested that the proceedings be reopened. See ALJX 13
17. Specifically, Respondent stated that she did not realize that she had to provide additional documents, noting that she did not have a lawyer and was unfamiliar with the course of the proceedings. ALJX 17.
I do not find this explanation regarding her noncompliance with the proceedings to be persuasive. As the ALJ noted in the Order Denying Respondents Request to Reopen These Proceedings, the Respondent was given clear instructions in the Order for Prehearing Statements to file a Prehearing Statement, as well as the
VerDate Sep<11>2014
16:53 Dec 07, 2021
Jkt 256001
logistics and deadlines for doing so.
RFAAX F, at 23; see also ALJX 5.
Further, the Respondents argument that she does not have a lawyer and is not familiar with these proceedings does not provide sufficient cause for her failure to file a Prehearing Statement.
RFAAX F, at 3; see also ALJX 17. There was also ample evidence that the instructions to provide a telephone number were clear and that the date to file a prehearing statement was clear.
See ALJX 5, at 24. Respondent also was in receipt of the Governments Prehearing Statement, so it would be difficult for her to credibly argue ignorance as to what a prehearing statement was. See ALJX 6 Email:
Governments Pre-Hearing Statement.
Respondents statements in her hearing request notably do not refute the allegations in the OSC; therefore, I find that the facts in the record remain uncontested.
C. Analysis Under Section 304 of the CSA, a registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts that would render his or her registration under section 823 of this title inconsistent with the public interest as determined by such section.
21 U.S.C. 824a4. In the case of a practitioner, defined in 21 U.S.C.
80221 to include a physician, Congress directed the Attorney General to consider the following factors in making the public interest determination:
1 The recommendation of the appropriate State licensing board or professional disciplinary authority.
2 The applicants experience in dispensing, or conducting research with respect to controlled substances.
3 The applicants conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
4 Compliance with applicable State, Federal, or local laws relating to controlled substances.
5 Such other conduct which may threaten the public health and safety. 21
U.S.C. 823f.
The DEA considers these public interest factors in the disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230
2003. Each factor is weighed on a caseby-case basis. Morall v. Drug Enft Admin., 412 F.3d 165, 17374 D.C. Cir.
2005. Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 1993. Thus, there is no need to enter findings on
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
69683
each of the factors. Hoxie v. Drug Enft Admin., 419 F.3d 477, 482 6th Cir.
2005. Furthermore, there is no requirement to consider a factor in any given level of detail. Trawick v. Drug Enft Admin., 861 F.2d 72, 7677 4th Cir. 1988. The balancing of the public interest factors is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest. . . . Jayam Krishna-Iyer, M.D., 74 FR 459, 462 2009. When deciding whether registration is in the public interest, the DEA must consider the totality of the circumstances. See generally Joseph Gaudio, M.D., 74 FR
10083, 1009495 2009 basing sanction on all evidence on record.
The Government has the burden of proving that the requirements for revocation of a DEA registration in 21
U.S.C. 824a are satisfied. 21 CFR
1301.44e. When the Government has met its prima facie case, the burden then shifts to the Respondent to show that revoking registration would not be appropriate, given the totality of the facts and circumstances on the record.
Med. Shoppe-Jonesborough, 73 FR 364, 387 2008.
While I have considered all of the public interest factors,3 the Governments case invoking the public interest factors of 21 U.S.C. 823f seeks revocation of Respondents registration based solely under Public Interest Factors Two and Four. I find that the Governments evidence with respect to Factors Two and Four satisfies its prima 3 As to Factor One, there is no evidence in the record of any recommendation from Respondents state licensing board or professional disciplinary authority. 21 U.S.C. 823f1. The fact that the record contains no evidence of a recommendation by a state licensing board does not weigh for or against a determination as to whether continuation of Respondents DEA certification is consistent with the public interest. Roni Dreszer, M.D., 76 FR
19434, 19444 2011.
As to Factor Three, there is no evidence in the record that Respondent has been convicted of an offense under either federal or state law relating to the manufacture, distribution, or dispensing of controlled substances. 21 U.S.C. 823f3.
However, as Agency cases have noted, there are a number of reasons why a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, M.D., 75 FR
49956, 49973 2010. Agency cases have therefore found that the absence of such a conviction is of considerably less consequence in the public interest inquiry and is therefore not dispositive. Id.
As to Factor Five, the Governments allegations fit squarely within the parameters of Factors Two and Four and do not raise other conduct which may threaten the public health and safety. 21
U.S.C. 823f5. Accordingly, Factor Five does not weigh for or against Respondent.
E:FRFM08DEN1.SGM
08DEN1