Daily Rules, Proposed Rules, and Notices of the Federal Government
On August 19, 2005, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Trinity Healthcare Corporation, d/b/a/ Oviedo Discount Pharmacy (Respondent) of Oviedo, Florida. The Order immediately suspended Respondent's Certificate of Registration, BT2863668, as a retail pharmacy, based on my preliminary finding that Respondent was filling large quantities of prescriptions for controlled substances that were issued through an internet site, iPharmacy.MD, by physicians who did not have a legitimate doctor-patient relationship with the individuals who ordered the drugs. See Show Cause Order at 5-10. Based on my preliminary finding that Respondent was "responsible for the diversion of large quantities of controlled substances," and that its participation in this scheme "invites the fraudulent procurement of controlled substances on a vast scale," I concluded that Respondent's continued registration pending these proceedings "would constitute an imminent danger to the public health and safety," and therefore immediately suspended its registration.
More specifically, the Show Cause Order alleged that Respondent was filling prescriptions for phentermine, a schedule IV controlled substance, which were issued to the customers of iPharmacy.MD by Richard Carino, a physician located in Port Richey, Florida.
The Show Cause Order also alleged that on May 6, 2004, DEA investigators conducted an inspection of Respondent during which they obtained its prescription records for the period January 1 through May 6, 2004.
Finally, the Show Cause Order alleged that on April 15, 2005, a DEA Special Agent (S/A) had accessed the iPharmacy.MD Web site, completed a questionnaire, and ordered 90 tablets of phentermine.
Respondent, through its counsel, requested a hearing. The matter was assigned to Administrative Law Judge (ALJ) Mary Ellen Bittner, who conducted a hearing on May 30 through June 2, 2006, in Arlington, Virginia. At the hearing, both parties called witnesses to testify and introduced documentary and/or demonstrative evidence. Following the hearing, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and argument.
On October 2, 2006, the ALJ issued her decision. In that decision, the ALJ concluded that Respondent's continued registration would be inconsistent with the public interest and recommended that I revoke Respondent's registration and deny any pending applications for renewal or modification. ALJ Dec. (hereinafter ALJ) at 32. Neither party filed exceptions.
On November 13, 2006, the ALJ forwarded the record to me for final agency action. Having carefully reviewed the record as a whole, I hereby issued this decision and final order. I adopt the ALJ's findings of fact and conclusions of law except as noted herein. Furthermore, while Respondent's registration expired on November 30, 2006, and Respondent did not submit a renewal application, I nonetheless conclude that this case is not moot.
Respondent is a corporation, which is owned and operated by Mr. Obi Enemchukwu, a pharmacist, and does business as Oviedo Discount Pharmacy in Oviedo, Florida. ALJ at 2; ALJ Ex. at 3. Respondent held DEA Certificate of Registration, BT2863668, which authorized it to dispense controlled substances in Schedules II through V, from September 1991 until the expiration of its registration on November 30, 2006. ALJ Ex. 3, at 1. Respondent last renewed its registration on October 24, 2003.
In April 2001, several years before the events at issue here, DEA published in the
More specifically, the guidance document advised that "[o]nly practitioners acting in the usual course of their professional practice may prescribe controlled substances. * * * A prescription not issued in the usual course of professional practice * * * is not considered valid. Both the practitioner and the pharmacy have a responsibility to ensure that only legitimate prescriptions are written and filled."
The guidance document also discussed the legality under existing law of prescribing controlled substances based on an on-line questionnaire. After noting DEA's regulation that a prescription for a controlled substance is not effective unless it is " 'issued for
Finally, the guidance document advised that "[s]ome internet pharmacy sites do not require that you have a prescription from your doctor[,]" but rather, "require the customer to complete a medical questionnaire," which then "will be reviewed by a doctor, and the drug will be prescribed and sent to you, if appropriate."
At some date not specified in the record, but likely in the fall of 2003, Mr. Terry Butler, the owner and president of iPharmacy.MD (hereinafter iPharmacy) and Drug-storemd, called Mr. Enemchukwu to recruit his pharmacy to fill prescriptions for his business. Tr. 807-08, ALJ at 3. According to Mr. Enemchukwu, Mr. Butler told him that iPharmacy had a Web site "which would screen patients, and if they qualified * * * would refer them to physicians who wrote them prescriptions," and "that he would like [him] to fill these prescriptions and * * * send them to the patient." Tr. 808. In late December 2003, Mr. Enemchukwu met with Mr. Butler to discuss the proposed arrangement and asked him whether the physicians who would do the prescribing were qualified.
On January 7, 2004, Mr. Enemchukwu and Mr. Butler entered into a contract through their respective entities (Oviedo Discount Pharmacy and Drug-storemd). ALJ at 4, Gov. Ex. 95, at 1. Under the contract, Drug-storemd engaged Respondent "to provide medicinal products to Drug-storemd's customers." Gov. Ex. 95, at 1. Drug-storemd further agreed to provide to Respondent "[a]n electronic * * * prescription for medication, properly, legally, and ethically authorized by a licensed physician in good standing in Florida or any other relevant state." Gov. Ex. 95, at 3. Drug-storemd also agreed to pay Respondent $8.00 for each order filled and to reimburse Respondent for the cost of the drugs it dispensed.
The contract also included several provisions which Mr. Enemchukwu proposed as an addendum.
According to the record, Respondent was given a password which allowed it to access a webpage at the iPharmacy Web site and obtain a list of the prescriptions it was to fill.
On January 6, 2004, (even before the contract was apparently signed), Respondent began by filling fifteen prescriptions which were written by Dr. Richard Carino--a physician based in Port Richey, Florida, Gov. Ex. 15--and allocated to it by iPharmacy.
The Government's evidence established that early on in the arrangement (in early March 2004), it should have been obvious that many of Dr. Carino's "patients" resided in other States and thus were not likely to be patients at all. More specifically, the Government produced copies of controlled substance prescriptions, which showed that the "patients" resided in such far-flung places as Houston, Texas (Rx# 44122); Martinsville, Indiana (Rx# 44131); Dallas, Texas (Rx# 43947); Corbin, Kentucky (Rx# 43948); Woodward, Oklahoma (Rx# 43949); Cliffside Park, New Jersey (Rx# 43950); Cincinnati, Ohio (Rx# 43951); Hanahan and Greenville, South Carolina (Rx#s 44012 44016); Carver, Massachusetts (Rx# 44013); Pocono Lake, Pennsylvania (Rx# 44015); and Berwyn, Illinois (Rx# 43953).
Notwithstanding that many of the prescriptions were for persons who resided at a great distance from Port Richey, Florida (the location of Dr. Carino)--thus rendering it highly improbable that the patients were ever physically examined by Carino--Respondent proceeded to fill an ever increasing number of prescriptions issued by this physician. For example, on March 9, 2004, Respondent filled 82 prescriptions for controlled substances that were issued by Dr. Carino.
For some reason not established by the record, in late August/early September 2004, Respondent apparently stopped receiving prescriptions that were issued by Dr. Carino.
On September 10, 2004, Respondent filled 134 controlled substance prescriptions issued by Dr. Duncan for phentermine, phendimetrazine, benzphetamine, and diethylpropion.
With respect to these physicians, the Government introduced copies of the controlled substance prescriptions issued by them during the period April 20-26, 2005.
On July 19, 2005, DEA investigators executed a search warrant at Dr. Duncan's residence and interviewed him. Tr. 39-41. During the interview, Dr. Duncan stated that in September 2004, he had entered into a contract with iPharmacy.MD, under which he reviewed questionnaires submitted by iPharmacy's customers and either approved or did not approve a prescription for the drug (typically phentermine, but also including other stimulants which are controlled substances) requested by its customers. Tr. 45-47. More specifically, Duncan told investigators that he would approve the prescriptions if the person indicated that they had a Body Mass Index greater than thirty and indicated that they were in good health.
Duncan told investigators that he reviewed approximately 1100 questionnaires each week (for which he was paid $ 3.00 each).
The ALJ found that between January 2004 and April 2005, Respondent had purchased a total of 2,002,700 dosage units of phentermine which was comprised of 58,700 (15 mg.) tablets, 374,200 (30 mg.) tablets, and 1,569,800 (37.5 mg.) tablets. Gov. Ex. 57 98; ALJ at 21. On a monthly basis, Respondent thus purchased an average of approximately 125,168 tablets of the drug.
To demonstrate the excessiveness of these purchases, the Government obtained data regarding the dispensing of phentermine by forty Walgreens' stores in the metropolitan Orlando area during the period September 1, 2004, through July 30, 2005.
The Government also elicited testimony from several expert witnesses. The first of these was Dr. Carmen Catizone, a registered pharmacist and the Executive Director of the National Association of Boards of Pharmacy. Gov. Ex. 89. Dr. Catizone testified that "[a] valid prescription is one where the pharmacy or pharmacist has ascertained that there is a bona fide patient/doctor relationship, and the prescription is within the scope of practice * * * and * * * is legitimate for the patient, and the patient's condition, and does not contraindicate * * * with any other medications that the patient is taking." Tr. 479. Dr. Catizone further testified as to the State of Florida's regulations pertaining to the prescribing of weight loss drugs which include reviewing the patient's body mass index, conducting a physical examination,
Based upon his review of Respondent's prescription records, and more specifically, the records pertaining to Dr. Carino's prescribing,
On cross-examination, Dr. Catizone was asked a series of questions regarding how a pharmacist would know whether a prescription was suspicious and had not been issued for a legitimate medical purpose.
The Government also called to testify Dr. George J. Van Komen, the former President of The Federation of State Medical Boards of the United States and former Chairman of the State of Utah's Physicians Licensing Board. Gov. Ex. 88, at 3. Based upon his review of Respondent's prescription records, (compiled in Government Ex. 77), Dr. Van Komen concluded that Dr. Carino was engaged in "a rogue practice, because there is no way that a physician in a normal setting could see anywhere from fifty to a hundred patients, and appropriately and properly manage their weight." Tr. 602-03. After noting that Carino was writing prescriptions for patients located all over the country, Dr. Van Komen further testified that:
Finally, Dr. Van Komen testified that the manner in which Drs. Carino and Duncan were prescribing controlled substances over the Internet "was totally against any conceivable standard" of medical practice.
Mr. Enemchukwu testified that he stopped filling controlled substance prescriptions from iPharmacy in May 2005, after receiving various materials regarding Internet prescribing which were sent by the DEA Miami office in April 2005 including the 2001 guidance document.
Mr. Enemchukwu further claimed that he did not obtain knowledge that the iPharmacy prescriptions were not issued in the course of a legitimate patient-doctor relationship until "[i]n these proceedings."
Mr. Enemchukwu further testified that he was not familiar with regulations issued by the State of Florida governing the prescribing of obesity drugs.
Mr. Enemchukwu further maintained that "[p]harmacists are not mini-doctors," and what a pharmacist does "is completely separate from what the doctor does." Tr. 796. When asked on cross-examination how he would know that iPharmacy was "not a fly-by-night operation that [was] only interested in getting money?," Mr. Enemchukwu answered: "I was filling prescriptions that I believed were valid prescriptions, and prescribed by qualified physicians."
Notwithstanding that he was filling numerous prescriptions for phentermine which were issued by Dr. Carino, Mr. Enemchukwu admitted that he never spoke with Carino and never inquired in to whether he ran a diet practice.
Later, the Government asked Mr. Enemchukwu whether a physician could issue a legitimate prescription based solely on a questionnaire and without performing a physical examination.
Relatedly, Mr. Enemchukwu testified that the frequency of the prescriptions he was filling did not raise his suspicion even though none of the local physicians whose prescriptions he filled for walk-in customers prescribed at the rate of Dr. Carino.
Likewise, Mr. Enemchukwu testified that he had had only one conversation with Dr. Duncan, which was about a particular prescription, and that he never asked Duncan about his practice because it was "obvious" that he operated a diet practice.
The ALJ specifically declined to credit Mr. Enemchukwu's testimony that he believed that the prescriptions he filled for iPharmacy were issued by its physicians pursuant to a legitimate doctor-patient relationship and that he had no reason to believe to the contrary.
I adopt both of the ALJ's findings. With respect to the finding that Mr. Enemchukwu's testimony (that he had no reason to believe that the iPharmacy prescriptions were invalid) was disingenuous, the ALJ personally observed Mr. Enemchukwu's testimony and was in the best position to evaluate his credibility on this issue of historical fact.
Indeed, Mr. Enemchukwu's testimony is implausible. As found above, early on in Trinity's relationship with iPharmacy it was apparent that the prescriptions were illegal. Even under Respondent's theory that it would be possible for a physician using four physician assistants to write over one hundred valid prescriptions a day, as early as May 26, 2004, Respondent filled, on a single day, 182 prescriptions for controlled substances issued by Carino. And by July 30, 2004, Respondent filled, on a single day, 337 prescriptions issued by this same doctor. Moreover, the prescriptions were for "patients" located throughout the United States. Notwithstanding this information, Mr. Enemchukwu made no inquiry as to the legitimacy of Carino's prescriptions. Nor did Mr. Enemchukwu inquire as to the legitimacy of Dr. Duncan's prescriptions.
Substantial evidence thus supports the conclusion that Mr. Enemchukwu knew early on in his company's relationship with iPharmacy that the prescriptions were not the result of a legitimate doctor-patient relationship. I therefore also adopt the ALJ's further finding that Mr. Enemchukwu knew that the iPharmacy prescriptions were invalid. Relatedly, I reject as disingenuous Mr. Enemchukwu's testimony that he did not recognize that the prescriptions were illegal until this proceeding.
At the outset, this case presents the question as to whether this proceeding is now moot. As found above, Respondent's registration expired on November 30, 2006 (shortly after the record was forwarded to me), and Respondent has not submitted a renewal application. Therefore, Respondent no longer has a registration and there is no application to either grant or deny.
This proceeding began, however, with the immediate suspension of Respondent's registration. As
It is indisputable that an immediate suspension harms a registrant's reputation. Moreover, were Respondent to apply for a new DEA registration in the future, it would be required to disclose the suspension.
Besides these collateral consequences, I note that neither party has moved to dismiss the proceeding as moot. Moreover, given the resources that both the Government and Respondent have invested in this proceeding, it makes little sense to dismiss this case without issuing a ruling on the merits even if that ruling is limited to assessing whether the suspension of Respondent's registration was warranted under section 304(a), 21 U.S.C. 824(a). I therefore conclude that this case is not moot.
Section 304(a) of the Controlled Substance Act provides that "[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 as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section." 21 U.S.C. 824(a). Section 304(d) further provides that "[t]he Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety." 21 U.S.C. 824(d).
In determining the public interest, the Act directs that the Attorney General consider the following factors:
"[T]hese factors are * * * considered in the disjunctive."
As explained above, under DEA's regulation, a prescription for a controlled substance is unlawful unless it has been "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." 21 CFR 1306.04(a). While "[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, * * * a corresponding responsibility rests with the pharmacist who fills the prescription."
DEA has consistently interpreted this provision as prohibiting a pharmacist from filling a prescription for controlled substances when he either "knows or has reason to know that the prescription was not written for a legitimate medical purpose."
Respondent concedes that the iPharmacy prescriptions were not legitimate.
The Government did, however, prove that it was more likely than not that Respondent knew that these prescriptions were illegitimate.
As recognized in other cases, the sheer volume of prescriptions thus establishes that it more likely than not that Respondent's owner knew that the prescriptions were illegitimate and intentionally ignored this.
I thus conclude that Respondent is responsible for the dispensing of more than 43,000 illegal prescriptions and the diversion of more than two million dosage units of various controlled substances. Not only is this a violation of federal law,
Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 28 CFR 0.100(b) 0.104, the order of immediate suspension of DEA Certificate of Registration, BT2863668, issued to Trinity Health Care Corporation, d/b/a/ Oviedo Discount Pharmacy, is hereby affirmed.