Oct 11 2005 15:06 1 OCT-11-2885 15:19 = AHA _ STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Vv. CASE NO. 2005-00194 ALAM L. BERKE, M.D., RESPONDENT. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Alam L. Berke, M.D., and in support thereof alleges: 1. Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed physician within the State of Florida, having been issued license number ME 25052. I DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke,. Alam AC; 05-00194.doc Oct 11 2005 15:06 OCT-11-2085 15:19 AHCA x a 3. Respondent’s address of record is 18100 N.E. 19 Avenue, Miami, Florida 33162-1606, however her current address is believed to be 1400 N.E. Miami Gardens Drive, Suite 202, North Miami Beach, Florida 33179. 4, Botox®, which contains Botulinum Toxin Type A, is a legend drug, which requires a physician’s prescription for use or administration. Botulinum Toxin Type A is a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g)(1)(B) and (C), intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, or to affect the structure or the function of the body of man, and biologic, as defined in section 361(i) of the Public Health Service Act, 42 U.S.C. § 262, and Section 499.003(17)(b) and (c), Florida. Statutes (2003)(2004). On December 9, 1991, the FDA approved BOTOX®, a Botulinum Toxin Type A drug manufactured by Allergan of Irvine, California, for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia and the treatment of strabismus and blepharospasm associated with dystonia. On April 12, 2002, the FDA approved a supplement to the 2 DOH v. Alam L Berke, M.D.; DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:07 OCT-11-2085 15:19 AHCA : o an Botulinum Toxin Type A license application for treatment of glabellular lines, commonly referred to as wrinkles. Under this approval, Botulinum Toxin Type A is marketed and labeled for this new indication as BOTOX® and BOTOX®COSMETIC manufactured by Allergan. No other ‘manufacturers have been approved by the FDA to produce or distribute Botulinum Toxin Type A as a drug in the United States. 5. Botulinum Toxin Type A is a neurotoxin produced by the Clostridium botulinum bacterium, the same bacterium that causes botulism. Abuse or overdose of Botulinum Toxin Type A can cause botulism. 6. Botulism is a muscle-paralyzing disease caused by a toxin made by a bacterium called Clostridium botulinum. Once. in the body, the toxin binds to nerve endings at the point where the nerves join muscles. This prevents the nerves from signaling the muscles to contract. The result is weakness and paralysis that descends from the cranium down, affecting, among other things, the muscles that regulate breathing. Respiratory dysfunction often follows from the respiratory paralysis. Recovery can be extremely slow. Assuming the patient receives proper care to ensure 3 DOH v. Ajam L. Berke, M.D.; DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLTS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:07 OCT-11-2885 15:28 AHCA ros continued breathing, recovery occurs only when the affected nerves grow new endings, a process that can take several months, although the length of time varies greatly from case to case. In rare cases, botulism can be fatal. | 7. Onor about December 1, 2004, while investigating the genesis of four cases of botulism that had drawn national attention, the FDA executed a search warrant on Advanced Integrated Medical Center, inc., (Advanced Integrated). Pursuant to the warrant, the FDA seized advertisements from Toxin Research International, Inc. (TRI), which advertised Botulinum Neurotoxin Type A for sale at a price of $1,250.00 for one 500-unit vial or $2,000.00 for two 500-unit vials. The advertisement included a notation under the TRI logo, which read, “For Research Purposes Only Not for Human Use.” 8. On or about December 29, 2004, the Department received communication from the FDA that it had executed a search. warrant on TRI, P.O. Box 89357, Tucson, Arizona, a company advertising and distributing “Stabilized Botulinum Neurotoxin Type A” to physicians around the country. DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 7:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:07 OCT-11-2885 15:28 AHCA 9, TRI does not have a permit to operate as a prescription drug manufacturer, pharmacy, prescription drug distributor, or pharmaceutical wholesaler in Florida. 10. In a statement to FDA investigators, Chad Livdahl, principal owner, operator, and president of TRI, said that TRI is not registered with the FDA and has not filed a New Drug Application for its product or an application for approval as an Investigational New Drug because the Stabilized Botulinum Toxin Type A is marketed “for research purposes only, not for human use.” 11. During the execution of the search warrant, the FDA recovered files from TRI computers containing invoices of purchasers of the Stabilized Botulinum Neurotoxin Type A. Respondent was among these purchasers, with the following purchase: Date of Product Quantity Price Invoice jo 6/21/2004 Stabilized 1 vial $1,195.00 Botulinum Neurotoxin Type A: 500 TU (5.0 ng) The invoice Respondent received stated, “For research purposes only, not 3 DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 J:\P5U\Medical\PAULA WILLTS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:08 OCT-11-2885 15:28 AHCA rom for human use.” In addition, the standard label on the vials from TRI indicated, “For research purposes only. Not for human use.” 12. Because Botulinum Neurotoxin Type A is the active ingredient in Botox®, and because Botox® is the only FDA approved form of the Botulinum Toxin Type A, on or about January 6, 2005, investigators from the Department inspected Respondent’s office to ascertain how Respondent was using the Stabilized Botulinum Neurotoxin Type A. 13. When investigators interviewed Respondent, she stated that she ordered the Stabilized Botulinum Neurotoxin Type A and when the vials arrived she diluted (re-constituted) the Stabilized Botulinum Neurotoxin Type A and put it in individual syringes to freeze it as instructed by TRI. 14. Respondent stated that the Stabilized Botulinum Neurotoxin Type A would not freeze and that she immediately destroyed the syringes by disposing of them in a biohazard waste container in her office. 15. Respondent stated that she had never used the product on patients. 6 DOH v. Alam L. Berke, M.D.7 DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:08 OCT-11-2085 15:21 AHCA a, _ 16. On or about January 6, 2005, when interviewed, Respondent had no remaining Stabilized Botulinum Toxin Type A from TRI, in her office. 17. By her admission, Respondent ordered and/or purchased a non-FDA approved neurotoxin from an unlicensed source, received it, held it, and then disposed of it. 18. Chapter 499, Florida Statutes, is called the Florida Drug and Cosmetic Act. According to Section 499.002, Florida Statutes (2003)(2004), the purpose of the act is to: (1) Safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics. (2) Provide uniform legislation to be administered so far as practicable in conformity with the provisions of, and regulations issued under the authority of, the Federal Food, Drug, and Cosmetic Act. and that portion of the Federal Trade Commission Act which expressly prohibits the false advertisement of drugs, devices, and cosmetics. (3) Promote thereby uniformity of such state and federal laws, and their “administration and enforcement, throughout the United States. 7 DOH vy. Alam L. Berke, M.D.; DOH Case No, 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:08 OCT-11-2665 15:21 AHCA oo _ 19. Administering or dispensing an unapproved drug is inherently dangerous as there is no mechanism for inspection or verification of product contents, efficacy, or safety. Similarly, purchasing drugs from an unlicensed source is inherently dangerous as there is no mechanism for quality assurance. Qutside of the parameters of lawful regulatory processes, there is no mechanism to ascertain whether a product is safe and effective, or adulterated and hazardous. Members of the public cannot protect themselves from such dangers as hidden defects in pharmaceutical products. 20. FDA approval is critical to establish the safety and efficacy of a new drug. Biologic products, such as the botulinum toxin at issue herein, must be approved by the FDA by a biologic license application (“BLA’). 21. Without FDA approval, then, there is no assurance that the product has been appropriately tested for use on humans, or that the manufacturing process conforms to current good manufacturing practices. The purity, potency, stability, and sterility characteristics of the product may vary batch by batch. DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Barke, Alam AC; 05-00194.doc OCT-11-2085 15:21 AHCA oo Oct 11 2005 15:08 _" 22. As stated in Section 499.002(1), Florida Statutes (2003 (2004), Chapter 499, Florida Statutes, is a public welfare statute, The regulatory provisions of the Florida Food and Drug Act under Chapter 499, Florida Statutes (2003)(2004), and the Federal Food, Drug, and Cosmetic Act under 21 U.S.C. § 301, et seq., are strict liability statutes. 23. While doctors cannot be guarantors of the safety or efficacy of drugs they administer, inject, or dispense to their patients, doctors have a statutory or legal obligation to their patients to abide by the laws regulating the distribution of those drugs. 24. The FDA approval status of a drug is readily ascertainable to a physician. Upon approval of a drug, the FDA adds the drug. to its published list of approved products, and that list is available to the public. Similarly, through the exercise of due diligence, a doctor can ascertain whether an entity is licensed to manufacture or distribute a drug in the State of Florida. Thus, an exercise of due diligence would have revealed that the TRI product described herein was not FDA approved, or even pending approval, and that TRI was not a licensed pharmaceutical wholesaler, pharmacy, or distributor. 9 DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 2:\PSU\Medical\PAUILA WILLIS\Madicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:09 OCT-11-2085 15:21 AHCA aos ame 25. Under the strict liability regulatory provisions of the Federal Food, Drug, and Cosmetic Act, and the Florida Food and Drug Act, it is the affirmative duty of a doctor to know whether a drug is FDA approved and to know that the source from which he or she obtained the drug is licensed to distribute the drug to him or her prior to, and as a condition of, administering, injecting, or distributing that drug to a patient. 26. Section 499.003(17), Florida Statutes (2003)(2004), defines “drug” as an article that is: (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications; (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals; (c) Intended to affect the structure or any function of the body of humans or other animals; or (d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), but does not include devices or their components, parts, or accessories. The definition of “drug” under 21 U.S.C. § 321 is the same in all material respects. | 10 DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 2:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.dec Oct 11 2005 15:09 OCT-11-20@5 15:22 AHCA P.12 . — om 27. Because Stabilized Botulinum Neurotoxin Type A is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals, or to affect the structure or the function of the body of humans or other animals, it is a drug within the meaning of Section 499,003(17), Florida Statutes (2003)(2004), and 21 US.C.-§ 321. 28. Botulinum Toxin Type A is a “legend drug” under Florida law. 29. The Stabilized Botulinum Neurotoxin Type A that Respondent purchased from TRI does not have an approved and effective application under Section 505 of the Federal Food, Drug, and Cosmetic Act, and is a “new drug” under Section 499.023, Florida Statutes (2003)(2004), and under 21 U.S.C. § 355. COUNT ONE 30. Petitioner realleges and incorporates paragraphs one (1) through twenty-nine (29) as if fully set forth herein. 31. Section 458.331(1)(g), Florida Statutes (2003)(2004), subjects a doctor to discipline for “[flailing to perform any statutory or legal obligation placed upon a licensed physician.” : Ml DOH v, Alam L. Berke, M.D.; DOH Case Ne. 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:09 OCT-11-2085 15:22 AHCA —, 32, Under Section 499.006(10), Florida Statutes (2003)(2004), a drug or device is deemed to be adulterated if it is a legend drug that has been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so. 33. Under Section 499.005(3), Florida Statutes (2003)(2004), it is unlawful to perform or cause the performance of the following acts: The receipt of any drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of such drug, device, or cosmetic, for pay or otherwise. 34. Section 499.005(3), Florida Statutes (2003)(2004), places a statutory or legal obligation upon Respondent. 35. Respondent received a drug (the unapproved TRI product, Stabilized Botulinum Neurotoxin Type A) that had been adulterated because it had been purchased, held, sold, or distributed by a person not authorized under federal or state law to do so (TRI). 36. Based on the foregoing, Respondent violated Section 499.005(3), Florida Statutes (2003)(2004), and, consequently, Section 458.331(1)(g), Florida Statutes (2003)(2004), by receiving a drug (the unapproved TRI product, Stabilized Botulinum Neurotoxin Type A) that had 12 DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:10 OCT-11-2085 15:22 AHCA oot been adulterated because it had been purchased, held, sold, or distributed by a person not authorized under federal or state law to do so (TRI). COUNT TWO 37. Petitioner realleges and incorporates paragraphs one (1) through twenty-nine (29) and paragraphs thirty-two (32) and thirty-three (33) as if fully set forth in this count. 38, Section 499.005(14), Florida Statutes (2003)(2004), makes unlawful: The purchase or receipt of a legend drug from a person that is not authorized under this chapter to distribute legend drugs to that purchaser or recipient. 39, Section 499:005(14), Florida Statutes (2003)(2004), places a statutory or legal obligation upon Respondent to refrain from purchasing or receiving a legend drug from a person that is not authorized under Chapter 499 to distribute a legend drug to her. 40, Respondent purchased and received a legend drug (the unapproved Stabilized Botulinum Neurotoxin Type A) from TRI, an entity not licensed in Florida to distribute legend drugs. 13 DOH v. Alam L. Berke, M.D.; OOH Case No. 2005-00194 :\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194.doc Oct 11 2005 15:10 OCT-11-2085 15:23 AHCA oo oo" 41. Based on the foregoing, Respondent violated Section 499.005(14), Florida Statutes (2003)(2004), and consequently Section 458.331(1)(g), Florida Statutes (2003)(2004), when she purchased and received a legend drug (the unapproved Stabilized Botulinum Neurotoxin Type A) from TRI, an entity not licensed in Florida to distribute legend drugs. COUNT THREE 42. Petitioner realleges and incorporates paragraphs one (1) through twenty-nine (29) and paragraph thirty-four (34) as if fully set forth in this count. 43, Under Section 499.005(12), Florida Statutes (2003)(2004), it is unlawful to perform or cause the performance of the following acts: The possession of any drug in violation of ss. 499.001-499.081. 44. Section 499.005(12), Florida Statutes (2003)(2004), places a statutory or legal obligation upon Respondent. 45, Respondent possessed an unapproved drug (the unapproved Stabilized Botulinum Neurotoxin Type A) from an unapproved source (TRI) 14 DOH v, Alarm L. Berke, M.D.; DOH Case No, 2005-00194 3:\PSU\Medical\PAULA WILLIS\Madicing Cases\Berke, Alam; 2005-00194\Berke, Alarn AC; 05-00194.doc Oct 11 2005 15:10 OCT-11-2085 15:23 . AHCA rom in violation of Sections 499.006(10), 499.005(3), and 499.005(14), Florida © Statutes (2003)(2004). 46. Based on the foregoing, Respondent violated Section 499.005(12), Florida Statutes (2003)(2004), and consequently Section 458.331(1)(g), Florida Statutes (2003)(2004), when she possessed an unapproved drug (the unapproved Stabilized Botulinum Neurotoxin Type A) from an unapproved source (TRI) in violation of Sections 499.006(10), 499.005(3), and 499.005(14), Florida Statutes (2003)(2004). WHEREFORE, the Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. 15 DOH v. Alam L. Berke, M.D.; DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLIS\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AG; 05-00194.dec Oct 11 2005 15:10 OCT-11-2085 15:23 AHCA SIGNED this ___>7_ day of Crh , 2005. John ©. Agwunobi, M.D., M.B.A., M.P.H. Secretary, Department of Health 727 7 Paula A. Willis FILED Assistant General Counsel DEPARTMENT OF HEALTH DOH Prosecution Services. Unit DEPUTY CLERK 4052 Bald Cypress Way, Bin C-65 otek Nites Colman Tallahassee, FL 32399-3265 DATE ___ @- 28-25 _ Florida Bar #0746241 (850) 414-8126 (850) 488-7723 FAX PAW/sw Fa Reviewed and approved by:: “8 (initials) o) wf oS (date) PCPizune 24, 2005 PCP Members: m-sanri, Ondra, Dyches - NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. 16 DOH v. Alam L, Berke, M.0.; DOH Case No. 2005-00194 J:\PSU\Medical\PAULA WILLI5\Medicine Cases\Berke, Alam; 2005-00194\Berke, Alam AC; 05-00194,doc

Docket for Case No: 05-003721PL