STATE OF FLORIDA = Ble DEPARTMENT OF HEALTH ea! DEPARTMENT OF HEALTH, oa through its BUREAU OF my PHARMACY SERVICES, te Petitioner, Case No: 03 USC 7 M wel (DOH: 01-04914) =} OMNIMED, INC., a Florida Corporation, G& tt MICHAEL BURMAN and DAVID BURMAN, n ‘ey individually, - ee) le ~~ oad ms 5 Respondents. ms wo i ADMINISTRATIVE COMPLAINT Notice is hereby provided that Petitioner, Department of Health, by and through its Bureau of Statewide Pharmaceutical Services (the bureau’), intends to impose against Respondents, Omnimed, Inc. (‘Omnimed”), a Florida Corporation, and Michael Burman and David Burman (the “Burman brothers’), individually an administrative fine in the amount of One Hundred Seven Thousand dollars ($107, 000), pursuant to section 499.066(3), Florida Statutes, and revoke the prescription drug wholesaler permit, permit number 22:01247, that authorizes Omnimed to operate as a prescription drug wholesaler in Florida. tn support of the intended final agency action the bureau states: (1) Petitioner, Department of Health (hereinafter “the Department’), through the Bureau of Statewide Pharmaceutical Services (“the Bureau’), 2818-A Mahan Drive, Tallahassee, Florida, 32308, is the state agency charged with implementing and enforcing the provisions of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (“the Act’). These duties include the regulation of the acquisition and distribution of prescription drugs in, into or from Florida as well as the permitting of establishments that engage in such activity. (2) Sections 499.01, and 499.012(3), Florida Statutes (“F.S.”), requires that, prior to operation as a prescription drug wholesaler in, into or from Florida, an establishment must first obtain from the department a permit for such activity. (3) Respondent, Omnimed, Inc. (‘Omnimed’), a Florida corporation, whose principle place of business currently is 6590 West Rogers Circle, Suite 6, Boca Raton, Palm Beach County, Florida 33487, is engaged in the business of wholesaling prescription drugs. However, at all times material to the allegations in this complaint, Omnimed's principle place of business was 8177 Glades Road, Suite 214, Boca Raton, Florida 33434. The department has permitted Omnimed as a prescription drug wholesaler under the Act, pursuant to permit number 22:01247 to engage in the wholesale distribution of prescription drugs in, into or from Florida until the permit expires on May 31, 2003, unless sooner suspended or revoked. (4) Respondent, Michael Burman is the president and sole corporate officer and owner of Omnimed. David Burman is his brother and works for Michael at Omnimed. The Burman brothers are the sole natural persons responsible for each of the actions alleged in this complaint. Alternatively, the corporate veil of Omnimed should be pierced in that Omnimed is the alter ego of the Burman brothers. (5) During the period July 2, 2001 through September 4, 2001 Respondents Omnimed and the Burman brothers violated sections 499.005 (1), (3) and (4), 499.006 (2) and (3), and 499.0121 (6)(d), F.S., and Fla. Admin Code Rule 64F-12.013 by purchasing for resale prescription drugs from Brazil-US Trading, LLC (‘Brazil UST’). [Subsequently, the department has suspended by Emergency Order Brazil UST’s prescription drug wholesaler permit]. The specific Brazil! UST invoices to Omnimed are 16008, 16049, 16050, 16051, 16053, 16055, 16060, 16063, 16067, 16072, 16075, 16081, 16085, 16086, 16092, 16107 and 16111, and accompanying Statements Identifying Pharmaceutical Sale (commonly referred to as a “pedigree paper’). Omnimed and the Burman brothers violated the subject statutes by making these purchases in that each of the pedigree papers that are required to accompany these prescription drug wholesale transactions was substantially deficient as follows. Section 499.0121(6)(d), in pertinent part, requires the following audit trail regarding the wholesale distribution of a prescription drug: “Each person who is engaged in the wholesale distribution of a prescription drug, and who is not an authorized distributor of record of such drug, must provide to each wholesale distributor of such drug before the sale is made to such wholesale distributor, a written statement identifying each previous sale of the drug. The written statement identifying all previous sales of such drug must accompany the drug for each wholesale distribution of the drug to a wholesale distributor. For purposes of this subsection, the term “authorized distributor of record” means those distributors with whom the manufacturer has established an ongoing relationship to distribute the manufacturer’s products.” (Emphasis supplied.) Each of the pedigree papers that Brazil UST supplied to Omnimed and the Burman brothers prior to the sale of prescription drugs noted on the invoices listed in this paragraph did not contain all previous sales of the subject prescription drugs. These pedigree papers did not trace the previous sales either (a) back to the drug's manufacturer [department's interpretation], or (b) back to an authorized distributor of record of such drug [industry interpretation of the quoted statute]. In addition these pedigree papers did not disclose the information required by Fla. Admin. Code Rule 64F-12.012(3), in particular the name of the drug, the manufacturer, the dosage form, the strength, the container size, and quantity by lot number. As a consequence Omnimed and the Burman brothers purchased prescription drugs through the subject transactions, such that the drugs are adulterated, or alternatively, are likely to have been held for sale in a manner rendering the drugs unfit for human use. Accordingly, Omnimed and the Burman brothers should not have made these purchases, see Fla. Admin. Code Rules 64F-12.012(3) and 64F-12.013 (5). (6) During the period July 2, 2001 through September 4, 2001 Respondents Omnimed and the Burman brothers violated sections 499.005 (1), (3) and (4), 499.006 (2) and (3), and 499.0121 (6)(d), F.S. by selling prescription drugs that were adulterated or otherwise unfit for human use, as more fully described and identified in the previous paragraph. Respondents documented these sales through Omnimed invoices and pedigree papers that also did not trace all previous sales back to the drug manufacturer or an authorized distributor of record of that drug. The subject invoices with accompanying pedigree papers are Omnimed invoices: 100 through 117, and 119 through 121. (7) During the period October 1, 2001 though December 4, 2001 Respondents Omnimed and the Burman brothers also purchased for resale prescription drugs from BTC Wholesale, LLC (“BTC”), 3501 West Vine Street, Suite #264, Kissimmee, Florida, which is no longer permitted as a prescription drug wholesaler by the department. The specific BTC invoices to Omnimed are 1718, 1721, 1725, 1753, 1765, 1792, 1801, 1803, 1822, 1825, and 1827, together with accompanying pedigree papers and Omnimed Purchase Orders. Omnimed and the Burman brothers violated sections 499.005(1), (3), (4), and (14), 499.006 (2) and (3), and 499.0121 (6)(d), F.S. and Fla. Admin Code Rule 64F-12.013 by making these purchases as follows. The pedigree paper accompanying each of these purchases were false in that Omnimed and the Burman brothers actually purchased each of the subject prescription drugs from sources that do not have a Florida prescription drug wholesaler permit, and are not the Florida manufacturer of the drug. These sources, therefore, are not authorized to sell or otherwise distribute prescription drugs in, into or from Florida. Respondents thereby purchased prescription drugs that are adulterated or otherwise unfit for human use. These sources include Michael Carlow at his personal residence in Weston, Florida, who obtained the drugs from unknown sources. (8) Omnimed and the Burman brothers further violated sections 499.005(1), (3), and (4), 499.006 (2) and (3), and 499.0121 (6)(d), F.S. by holding for sale or selling or otherwise distributing some or all of the prescription drugs that were adulterated or otherwise unfit for human use, as more fully described and identified in the previous paragraph. (9) Respondents, Omnimed and the Burman brothers also purchased and resold Panglobulin that is either adulterated or unfit for human use in violation of sections 499.005(1), (3), (4), and (14), 499.006 (2) and (3), and 499.0121 (6)(d), F.S. and Fla. Admin Code Rule 64F- 12.013 as follows. Respondents purchased Panglobulin from Brazil UST on February 15, 2002. Respondents should have declined to make this purchase in that the pedigree paper indicated that Brazil UST had purchased this prescription drug, used to treat persons with severely compromised immune systems, from A. & J. Trading, LLC (“A&J”) of Charlotte, NC. A&J is an out of state prescription drug wholesaler that does not have a permit to distribute prescription drugs into Florida. Respondents should also have declined to make this purchase in that the pedigree indicates that A&J purchased this prescription drug supposedly from an authorized distributor of record at Miami that is not even permitted to wholesale prescription drugs in, into or from Florida. On resale Respondents compound these violations by listing the unpermitted authorized distributor by a different name and with an address in Tampa, Florida. Not only has the department not permitted either establishment to wholesale prescription drugs, but also the manufacturer of Panglobulin has not sold that drug to either establishment. (10) As an additional aggravating factor for assessing administrative penalties against Respondents, Respondents failure to develop procedures consistent with Rule 64F-12.0013(5) to assess whether to purchase a prescription drug resulted in Respondents purchasing and reselling prescription drugs in the wholesale market that are adulterated or unfit for human use. Respondents should not have made these purchases in that Respondents knew or should have known that each of the supporting pedigree papers is false, and does not disclose the actual audit trail of these prescription drugs from the manufacturer or its authorized distributor of record through other permitted prescription drug wholesalers to Omnimed. These transactions are documented by BTC sales invoices and pedigree papers to Omnimed [BTC invoices 1718, 1721, 1725, 1753, 1765, 1792, 1801, 1803, 1822, 1825 and 1827. These transactions also include and are documented by Omnimed sales invoices OMN!-203B, 207A, 206, 208, 211, and 211A, and related Omnimed pedigree papers, purchase orders and invoices of purchase. Respondents thereby violated section 499.005(23), F. S. for each of these transactions. (11) Respondents are a danger to the public health, safety and welfare and have demonstrated an unwillingness to abide by the Laws of the State of Florida that pertain to the regulation of the wholesale distribution of prescription drugs in that: (a) Respondents knowingly purchased or otherwise acquired and distributed hundreds of thousands of dollars worth of prescription drugs that are adulterated or unfit for human use on numerous occasions as set forth in this complaint, (b) Respondents through pedigree papers, are misrepresenting the source of prescription drugs to Omnimed's customers and to the department, (c) Respondents do not comply with Fla. Admin. Code R. 64F-12.013(5), requiring a purchasing wholesaler to examine the transaction in its entirety when making purchases of prescription drugs, and consequently have purchased hundreds of thousands of dollars worth of prescription drugs that are adulterated or unfit for human use. (12) The violations of Chapter 499, F.S., by Omnimed and the Burman brothers as set forth in this complaint constitute sufficient grounds for the department to revoke Omnimed’s prescription drug wholesaler permit and impose an administrative fine of One Hundred Seven Thousand dollars ($107,000) or impose any other penalty authorized by Chapter 499, F.S. and Chapter 64F-12, Florida Administrative Code against the Respondents. (13) Rule 64F-12.024 (4), Florida Administrative Code sets the range of the penalty for violations of the Florida Drug and Cosmetic Act, Chapter 499, F.S. Pursuant to that rule the bureau intends to impose the fines and action as noted. (a) The rule authorizes a fine for activity includes purchase or sale] with an adulterated prescription drug, or drug that is otherwise unfit for human use or distribution violating section 499.005 (1), (3) and (4), F.S., ranging from $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. This is the violation alleged regarding the 51 transactions of the Respondents in paragraphs (5), (6), (7), and (9) for which the bureau intends to fine Respondents $102,000 as follows: $2000 for each of the 51 transactions alleged in these paragraphs and revocation of the permit 22:01247. (b) The rule authorizes a fine for activity [includes purchase or sale} with an adulterated prescription drug, or drug that is otherwise unfit for human use or distribution violating section 499.005 (1), (3) and (4), F.S., ranging from $250 - $5,000 per violation per day and suspension or revocation of the permit with a fine. For the sale and holding for sale of such drugs alleged in paragraph (8) the bureau intends to impose on the Respondents a fine of $5,000 total, and revocation of permit 22:01247. The bureau reserves the right to increase the amount of this fine based on records and other evidence revealed in pre-hearing discovery. (c) The intended fines listed above within this paragraph are enhanced based on the aggravating circumstances alleged in paragraph (10) of this complaint, including Respondents violation of section 499.005(23). (14) Section 499.067(1), F.S., authorizes the department to deny, suspend, or revoke a permit if it finds that there has been a substantial failure to comply with ss. 499.001-499.081 or chapter 465, chapter 893, or chapter 501, or the rules adopted under any of those sections or chapters. In addition, s. 499.067(3)(c), F.S., authorizes the department to deny, suspend or revoke a permit if the permittee has violated any provisions of ss. 499.001-499.081 or rules adopted under those sections. The violations alleged in this complaint evidence a substantial failure to comply and are substantial violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (15) You have the right to request an administrative hearing pursuant to sections 420,569 and 120.57, F.S., if you wish to challenge the imposition of the administrative fine and the intended agency action to revoke permit 22:01231. Such proceedings are governed by sections 420.569 and 120.57, F.S., and Rules 28-106 and 28-107, Florida Administrative Code. Request for a hearing, forma! or informal, must comply with Rule 28-107.004, Florida Administrative Code. (16) A petition for administrative hearing must be in writing and must be received by the Agency Clerk for the Department, within twenty-one (21) days from the receipt of this complaint. The address of the Agency Clerk is 4052 Bald Cypress Way, BIN # A02, Tallahassee FL 32399- 1703, The Agency Clerk’s facsimile number is 850-410-1448. (a) Mediation is not available as an alternative remedy. (b) Your failure to submit a petition for hearing within 21 days from receipt of this complaint will constitute a waiver of your right to an administrative hearing, under Florida Administrative Code Rule 28-106.111 and this complaint shall become a "final order". (c) Should this complaint become a final order, a party who is adversely affected by it is entitled to judicial review pursuant to section 420.68, Fla. Stat. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings may be commenced by filing one copy of a Notice of Appeal! with the Agency Clerk of the Department of Health and a second copy, accompanied by the filing fees required by law, with the Court of Appeal in the appropriate District Court. The notice must be filed within 30 days of rendition of the final order. (17) The undersigned certifies that a true copy of this administrative complaint was sent by U.S. Certified Mail, Return Receipt Requested, to Michael Burman, individually and as President of Omnimed, Inc., 6590 West Rogers Circle, Suite 6, Boca Raton, Florida 33487and to David Burman at this same address this ZO th day of October, 2002. Copy also furnished to: Robert P. Daniti, Senior Attorney Department of Health 4052 Bald Cypress Way, Bin AO2 Tallahassee, Florida 32399-1703 Telephone (850) 245-4005 Facsimile (850) 413 8743 Florida Bar No. 191599 Pharmaceutical Services 2818-A Mahan Drive. Tallahassee, Florida 32308 Telephone: (850) 922-5190 Complete items 1, 2, and 3. Also complete’ item 4 if Restricted Delivery is desired. -—-— ™ Print your name and address on the reverse so that we can return the card to you. m@ Attach this card to the back of the mailpiece, or on the front if space permits. } 1, Article Addressed to: AIC {] No lf YES, enter delivery address below: Michael Burman, President ‘Omnimed, Inc. 6590 West Rogers Circle, Suite 6 : Boca Raton, Florida 33487 3, Ser ‘ice Type Certified Mail © Express Mail ( Registered i Return Receipt for Merchandise O Insured Mail © C.0.D. Pa Restricted Delivery? (Extra Fee) O Yes 2. Article r (Copy fram service 000 1610 Oa 102595-00-M-0952 PS-Form 3811, July 1999, | SENDER: COMPLETE THIS SECTION ™ Complete items 4-2; and 3, Also complete item 4 if Restricted-t%éivery is desired. m@ Print your name and address on the reverse so that we can return the card to you. & Attach this card to the back of the mailpiece, or on the front if space permits. Agent © Addressee _, ) Mindy addresdgifferent from item 1? [1 Yes If YES, enter delivery address below: No t 1. Article Addressed to: C David Burman Omnimed, Inc. ; 6590 West Rogers Circle, Suite 6 , Baca Raton, For! Florida 33487 ieee on | 3. Service Type Om Certified Mail 1 Express Mail ! Ta CE registred CO Return Receipt for Merchandise 0 Insured Mail O co. i . {I'4. Restricted Delivery? (Extra Fee) C1 Yes Me, ! Pg Form 3811, July 1999 Domestic Return Receipt : j 1025@5-00-M-0952

Docket for Case No: 02-004567