Barbara Brewitt Fined for Illegally
and Marketing "Homeopathic" Drugs
Stephen Barrett, M.D.
Barbara Brewitt, Ph.D. has been fined for illegally manufacturing and selling homeopathic "healthy aging" drugs through her company Biomed Comm, Inc. The health law judge's order (shown below) concluded:
- Brewitt and Biomed Comm were not licensed to manufacture or sell drugs.
- Over a 5-year period, Brewitt falsely represented herself as a medical doctor more than 20 times to a Seattle-based pharmacy in order to obtain Norditropin, a growth hormone drug used in Biomed Comm's manufacturing process.
- Brewitt's products were promoted for treating Alzheimer’s disease, autism, cancer, menopausal symptoms, attention deficit hyperactivity disorder (ADHD), and HIV/AIDS and about 50 other conditions. Many callers to her company were advised what to take for their conditions.
- Inspections of her manufacturing facility revealed multiple law violations. On one occasion, Brewitt hid materials in her car that she did not want the inspector to see.
Concluding that Brewitt had "systematically avoided compliance with laws regulating the manufacture and sale of drugs," the judge ordered the maximum $1000-per-day penalty for (a) 315 days of unlicensed drug sales, (b) 37 days of unlicensed manufacturing, and (c) 63 days of unlicensed practice of medicine—a total of $415,000.
In a parallel action, another health law judge denied Biomed Comm's application for a license to manufacture drugs and prohibited it from reapplying for a 10-year period. The judge's order concluded that Brewer had engaged in dishonesty, misrepresentation, and unprofessional conduct.
The Department of Health's investigation was triggered by a complaint from a former employee who stated that Brewitt herself mixed many of the products in her own kitchen as she chanted over a crystal bowl. The department obtained a temporary restraining order in February 2006.
Brewitt appealed both orders. The courts ultimately dismissed the charge of practicing without a license, upheld the illegal manufacturing charge, and said that penalty should be between $157,000 and $315,000. Brewitt died in 2009.
STATE OF WASHINGTON
DEPARTMENT OF HEALTH
ADJUDICATIVE SERVICE UNIT
In the Matter of the Unlicensed Practice
BARBARA BREWITT, individually and
FINDINGS OF FACT,
Respondent, Barbara Brewitt, dba Biomed Comm, Inc., by
Law Offices of Robert N. Meals, P.L.L.C., per
Robert N. Meals, Attorney at Law
Department of Health Unlicensed Practice Program, by
Office of the Attorney General, per
Dorothy H. Jaffe and Alice M. Blado, Assistants Attorney General
PRESIDING OFFICER: Zimmie Caner, Health Law Judge
The Presiding Officer, on behalf of the Secretary of the Department of Health· convened a hearing on February 6-8, 2007. This order addresses the allegations set forth in the Amended Notice of Intent to Issue Cease and Desist, and orders the Respondent to permanently1 cease and desist and to pay a fine.
1A temporary cease and desist order was issued on February 3, 2006.
1. Did the Respondent engage in the:
A. Unlicensed manufacturing of drug products in violation of RCW 18.71.021?
B. Unlicensed selling of drug products in violation of RCW 18.71.044(2) (shopkeeper's registration) and in violation of RCW 18.64.046(1) (wholesaler's license)?
C. Unlicensed practice of medicine in violation of RCW 18.71.021?
2. Did the Respondent use the title of medical doctor or initials M.D., or use "other fraud, deceit, misrepresentation, or subterfuge" to obtain a legend drug in violation of RCW 69.41.020?
3. If the Respondent engaged in unlicensed practice of a business or profession for which a licensed is required, what is the appropriate fine under RCW 18.130.180(3)?
SUMMARY OF THE PROCEEDING
The Presiding Officer, on behalf of the Secretary of the Department of Health (Secretary), and the Board of Pharmacy (Board) convened a joint hearing on February 6-8, 2007, pursuant to a partial order of consolidation. At the close of the hearing, the Board deliberated separately from the Presiding Officer. This order, issued on behalf of the Secretary, addresses the allegations set forth in the Amended Notice of Intent to Issue Cease and Desist. The Board will issue its own order addressing the allegations set forth in the Amended Statement of Charges with Intent to Deny regarding the Respondent's application for drug manufacturer's license.
During the hearing, the Department presented the testimony of Debra A. Smith; Roberta Richards; Terry Greiling; John B. Syverud; Jeremy Adler; Scott Byhre; Marie Brown; Kelly McLean; Beth McDonald, M.D.; and Stan Jeppersen.
Barbara Brewitt, Ph.D. (Respondent), testified on her own behalf.
The following exhibits were admitted at hearing:
Exhibit P-1: The Respondent's August 29, 2005 Wholesaler/Manufacturing Application.
Exhibit P-2: Kelly McLean's October 14, 2005 Inspection Report. Exhibit P-3: The Respondent's October 24, 2005 letter to the Board of Pharmacy (Board).
Exhibit P-4: The Respondent's October 26, 2005 letter to the Board of Pharmacy.
Exhibit P-5: Board of Pharmacy's October 26, 205 letter to the Respondent. Exhibit P-6: Jeremy Adler's employment agreement with the Respondent. Exhibit P-7: E-mail correspondence between various Biomed staff.
Exhibit P-8: November 22, 2005 Certificates of Dilution Preparation.
Exhibit P-9: November 9, 2005 Certificate of Source Content, with attached e-mail correspondence.
Exhibit P-10: Marie Brown's September 28, 2005 letter to Jeremy Adler, and September 28, 2005 e-mail correspondence between Marie Brown, Scott Byhre, and Jeremy Adler.
Exhibit P-11: Inventory, repackaging, and sale summaries.
Exhibit P-12: Kelly McLean's December 15, 2005 inspection report with attachments.
Exhibit P-13: Production/manufacturing notes.
Exhibit P-14: Work Instructions for Private Label Customers.
Exhibit P-15: The Respondent's Log Book containing manufacturing notes and formulas.
Exhibit P-16: Copy of Walgreen's website that lists the Respondent's products for sale.
Exhibit P-17: "Local Firms Bite into New Chocolate Market", Puget Sound Business Journal, October 10, 2005.
Exhibit P-18: "Brewitt Forges Ahead with a New Kind of Medicine", Puget Sound Business Journal, March 3, 2006.
Exhibit P-19: The Respondent's "Medicine Use Table".
Exhibit P-20: 2005 article entitled "Interview with Barbara Brewitt: The Fundamental Role of Cell Signaling in Healing and Relevance to Autism".
Exhibit P-21: Copies of documents from www.biomedcomm.com. Exhibit P-22: The Respondent's advertising material.
Exhibit P-23: The Respondent's product packaging material.
Exhibit P-24: The Respondent's literature claiming its effectiveness in treating HIV/AIDS.
Exhibit P-25: The Respondent's "Basic Protocol Guideline for Autism".
Exhibit P-26: The Respondent's article entitled "The Scientific Logic of Using Homeopathic Recombinant FGF-2 for Autism Augmented with Homeopathic IFG-1, PDGFbb, and TGRb Growth Factors, A Brief Overview".
Exhibit P-27: Photographs of a Biomed shipment to Costco.
Exhibit P-28: FDA Compliance Policy Guide 7132.5, Section 400.400 "Conditions Under Which Homeopathic Drugs May Be Marketed".
Exhibit P-29: Photographs of the Respondent's Woodinville site. Exhibit P-30: Ballard Plaza Pharmacy prescription records. Exhibit P-31: Elizabeth McDonald's curriculum vitae.
Exhibit P-32: Dolisos America Production Control Sheet.
Exhibit P-33: One plastic bag containing five tablets, three imprinted as CSE 20 and two imprinted as HhGH.
Exhibit P-34: One #90-count empty bottle of Naturally hGH. Exhibit P-35: Two 60 ml bottles of CSE 7.
Exhibit P-36: One Cocoa Bliss chocolate bear.
Exhibit P-37: Two bottles of EASE chewable tablets and two #90-count bottles of IGF-1 chewable tablets.
Exhibit P-38: Packaged box of Athletic Edge. Exhibit P-39: Two 60 ml bottles.
Exhibit P-40: One box of the Respondent's products that contains one Athletic Edge #180-count bottle with seal, one Naturally hGH #90-count bottle in box, one unlabeled bottle, one Cocoa Bliss chocolate bear, and one package of #90-count Naturally hGH chewable tablets with no lot number.
Exhibit P-41: The Respondent's October 10, 2000 letter to the Homeopathic Pharmacopoeia Convention of the United States regarding the proving of Insulin-like growth factor-1 (IGF- 1) and recombinant human growth hormone (rhGH).
Exhibit P-42: The Respondent's March 24, 2001 letter to the Homeopathic Pharmacopoeia Convention of the United States stating monograph.
Exhibit P-43: The Respondent's April 18, 2001 letter to the Homeopathic Pharmacopoeia Convention of the United States.
Exhibit P-44: Homeopathic Pharmacopoeia Convention of the United States' June 4, 2001 letter to the Respondent.
Exhibit P-45: Spreadsheet entitled "Biomed Yearly Totals Summary".
Exhibit P-46: Spreadsheet entitled "Biomed Daily Totals Summary".
Exhibit P-47: Spreadsheet entitled "Biomed Daily Sales Total- 2003".
Exhibit P-48: Spreadsheet entitled "Biomed Daily Sales Total- 2004".
Exhibit P-49: Spreadsheet entitled "Biomed Daily Sales Total- 2005".
Exhibit P-50: Spreadsheet entitled "Biomed Daily Sales Total - 2006".
Exhibit R-1: The Respondent's curriculum vitae.
Exhibit R-2: The Respondent's business cards.
Exhibit R-3: Biomed's May 1, 1996 certificate of incorporation.
Exhibit R-4: Biomed's Initial Annual Report dated June 1, 1996.
Exhibit R-5: Biomed's May 30,1997 License Renewal & Annual Report,.
Exhibit R-6: Biomed Master Business Licenses for 1998 through 2006.
Exhibit R-7: Document entitled "About Biomed-Company Profile".
Exhibit R-8: Amino Acid Sequence, illustrating biological structure of human growth hormone and insulin-like growth factor.
Exhibit R-9: Medical Veritas 2005 article entitled "Interview with Barbara Brewitt: The Fundamental Role of Cell Signaling in Healing and Relevance to Autism".
Exhibit R-10: July 7, 2006 letter from Gary Goldman of Medical Veritas to the Respondent.
Exhibit R-25: Pharmaceutical Manufacturer Inspection Report dated November 25, 2005.
Exhibit R-26: Final submission and response to inspection issues-February 2006. Exhibit R-27: Photographs of Biomed's Woodinville facility.
Exhibit R-66: December 17, 1998 Letter from Edward Miracco to the Respondent.
Exhibit R-67: Biomed Purchase Order No. 219, dated August 17, 2004.
Exhibit R-68: Excerpts from HPRS: Cholinum; DNA; Embryo; Fomalinium; Hippozaeinum; Histaminum; Hyupothalmus; Oophorinum; Opium; Orchitinum; Ovi Gallinae Pellcula; Pancreatinum; Proteus; Psorinum; Pyrogenium; Throidinum; and Torula Cerevsia.
I. FINDINGS OF FACT
1.1 Barbara Brewitt, PhD. is the founder, Chief Executive Officer, and Chief Scientific Officer of Biomed Comm, Inc. (Biomed). Barbara Brewitt, Ph.D. individually and doing business as Biomed (Respondent) manufactured and sold drugs in the state of Washington without a drug manufacture license, a wholesaler license, and a shopkeeper registration.
Unlicensed Practice of Medicine
1.2 The Respondent has a doctoral degree (Ph.D.) in the field of biological structure. She has never possessed a medical degree (M.D.). Despite this fact, the Respondent falsely claimed, directly and indirectly, to be a medical doctor on numerous occasions to obtain legend drugs, promote her homeopathic drugs, and diagnose and recommend treatment with one or more of her homeopathic drugs to customers.
1.3 From August 2000 through October 2005, the Respondent falsely represented herself as a medical doctor, directly and indirectly, through her Biomed staff to obtain legend drugs from Ballard Pharmacy. Through this deception, the Respondent obtained 23 prescriptions of Norditropin and two prescriptions of Insulin that may only be prescribed by medical physicians.2 The Respondent used the Norditropin and Insulin as ingredients (source products) in the manufacturing of her homeopathic drugs.
2Exhibit 30 (There are exceptions that do not apply to the facts at hand.)
1.4 The Respondent's denial of any misrepresentation of her credentials to Ballard Pharmacy is not credible in light of the overwhelming evidence to the contrary. The Respondent directly called in the prescriptions and directed her staff to call in the prescriptions claiming that the Respondent was a medical doctor. The Respondent picked up the prescriptions of Norditropin and/or Insulin from Ballard Pharmacy on at least four occasions. Even when the Respondent did not pick up the prescriptions from Ballard Pharmacy, she handled the drugs when she manufactured the dilutions for the homeopathic drugs, or when she delivered the drugs from Ballard Pharmacy to a University of Washington lab where a graduate student made the dilutions under the Respondent's directions. The Respondent's manufacturing log3 clearly indicates that she reviewed the prescription labels, since she recorded the lot number and expiration date that Ballard Pharmacy noted on the medications' labels along with the Respondent's name as "Barbara Brewitt, M.D." The Respondent was also provided with receipts and invoices that listed her as an M.D.
1.5 The Respondent's deceptive prescription practice only ended after the Department of Health investigator confronted the Respondent with questions regarding the Norditropin and Insulin prescriptions. The Respondent told the investigator that an Arizona physician, Dr. Gary Gordon, wrote prescriptions for Insulin and Norditropin that were filled at Ballard Pharmacy.4 Ballard Pharmacy records indicate the Respondent was the "prescribing physician", and the investigator found no evidence of a Dr. Gary Gordon in Arizona. The pharmacist who took the Respondent's original prescription told the Department of Health investigator that the Respondent called in that prescription and stated that she was a medical doctor.
4Exhibit 12 at page 3.
1.6 The Respondent ordered the Norditropin and Insulin on an "office use" only basis. Ballard Pharmacy filled these prescriptions accordingly, noting "for clinic use only". Therefore, these drugs were to be administered by injection to patients in a medical physician's office. Norditropin and Insulin are injectable drugs, and therefore, the safety and efficacy of oral administration is unknown. The Respondent obviously had no intention of administering these drugs to patients in an office. She intended to use them in the manufacturing of homeopathic medications, which customers orally consumed pursuant to the instructions on the Biomed drug labels.
1.7 On occasion, there may have been an honest misunderstanding with the title of "Dr. Brewitt" that the Respondent is an M.D., not a Ph.D. But, there is an abundance of evidence demonstrating the Respondent deliberately and repeatedly used "M.D." to obtain drugs she did not have the authority to obtain, to promote Biomed's homeopathic products, and to provide medical advice to customers over the telephone. The Respondent misled staff and customers as to her qualifications. The Respondent's Biomed website listed the Respondent as an "M.D." as well as a "Ph.D." The Respondent inserted literature with products that listed the Respondent as an "M.D."5
5Exhibit 15. Exhibit 21 and Marie Brown's testimony
1.8 The Respondent instructed Biomed staff to answer customers' questions recommending specific Biomed drugs to treat certain conditions, diseases, and/or symptoms. As a result, staff regularly advised callers to use specific Biomed drugs by referring to the "Medicine Use Table"6 that the Respondent prepared. This three-page reference guide recommends specific Biomed drugs for approximately 58 conditions, symptoms, and diseases such as acne, Alzheimer's, anxiety, arthritis, autism, breast cancer, back pain, bone morrow transplant, diabetes, hepatitis, hip replacement, lymphoma, and multiple sclerosis. If the staff could not answer a customer's questions with the "Medicine Use Table", the staff would refer the customer to the Respondent. Marie Brown, Biomed's Operations Manager from April 2005 to January 2006, handled these types of customer questions. Marie Brown regularly referred customers to the Respondent when Ms. Brown could not answer the questions with the help of the "Medicine Use Table." Until the Department of Health inspectors discovered the Respondent's deceptive prescription practice with Ballard Pharmacy, the Respondent lead Marie Brown to believe she was a medical doctor (M.D.). Therefore, these customers fell under the same deception; they were receiving advice from a medical doctor.7 The Respondent regularly talked to customers who called in for help determining what Biomed drugs would help them treat a disease, condition, and/or symptom. Through these conversations with customers, the Respondent diagnosed the customer's underlying condition and recommended Biomed drug(s), dosage, frequency, and duration that the customer should use the Biomed drug(s) to treat the customer's disease, injury, pain, or other condition, physical or mental.
7Since the Respondent regularly spoke with customers during Ms. Brown's employment with Biomed (approximately 10 months), it would be reasonable to conclude that the Respondent advised customers at lease one time a week what Biomed drug(s) should be used for their condition/disease.
Promotion of Biomed Products as Drugs
1.9 The Respondent's promotional material states that Biomed "sells small proteins that tell aging body to begin making and repairing cells, a process that sparks rejuvenation".8 Pursuant to homeopathic principles,9 the Respondent used human growth hormones (hGH) as the source product that was significantly diluted and used in the manufacture of her homeopathic drugs. As the Respondent explains on the Biomed website:
What is human growth hormone (hGH)? HGH is a signaling protein with a specific shape, comprised of 191 amino acids in a unique sequence. Secreted by pituitary, immune, fat and bone cells, hGH promotes growth, regulates the heart and metabolism, and coordinates psychological and physical health. HGH levels decrease significantly with age.
What organs respond best to hGH? HGH predictable affects the liver, intestines, skin, Islets of Langerhans, prostate and uterus (hormonal). Additionally, hGH targets the heart, brain, eyes, and specific immune cells (nervous and immune). All of these organs decline in health during the aging process. Organs actually shrink in size during the aging process. It is well documented that hGH stimulates organs to return to their original, youthful sizes.10
8Exhibit 21, page 3.
9The practice of homeopathy is rooted on the principle that disease symptoms can be cured by small doses of substances which produce similar symptoms in healthy people. Exhibit 28 page 1.
10Exhibit 21, page 5.
1.10 In addition, the Respondent promoted and packaged Biomed's homeopathic11 medicines as drugs that mitigate disease symptoms, treat the underlying disease, and affect the structure and function of the human body. The Respondent's web site and drug packaging/labels12 lists the beneficial affects of the approximately 20 Biomed drugs. For example, on Biomed's website, packaging and labels state "Naturally hGH" burns fat, increases lean muscle, increases energy, improves sleep, and reduces nervousness. The Naturally hGH packaging recommends that the customer "Also try: Endurance Plus, Athletic Edge, and Natural Menopause Relief'. Some of Biomed's listed beneficial effects of these drugs include: improves memory and focus; increases muscle mass, energy, strength, endurance and libido; burns fat; controls appetite; regulates sleep; and relieves symptoms of PMS and menopause.13 Biomed's website recommends its additional drugs for a wide variety of beneficial affects such as prevention of liver and kidney fatigue, pain reduction, reduction of skin irritations, and inflammation due to minor injuries.14
11The term 'homeopathy' is derived from the Greek words homeo (similar) and pathos (suffering or disease). Exhibit 28 (FDA Compliance Policy Guide 7132 Section 400.400 "Conditions under which Homeopathic Drugs May be Marketed").
12Biomed's product labels often use the term "drug facts" to describe effect of the product.
13Exhibits 21, 28, 40
14 Exhibit 21 page 15 (Biomed's "CSE 3 Anti-Inflammatory").
Unlicensed Sales of Homeopathic Medications (Drugs)
1.11 The Respondent sold homeopathic drugs for a number of years, commencing some time after May 1996, when R&D Systems shipped its first order of human growth hormone to the Respondent. The Respondent sold drugs manufactured under her direction by a third party drug manufacturer, Dolisos America, as well as drugs partially or fully manufactured by the Respondent. The record clearly indicates that the Respondent sold drugs to individuals and corporations/stores. The Respondent sold drugs directly to customers over the internet, the telephone, and through retail markets in Washington, the United States, and internationally. The sales records that were not lost or destroyed clearly indicate that the Respondent sold drugs on at least 315 days during 2003, 2004, 2005, and 2006.15
Unlicensed Manufacturing of Drugs
1.12 From approximately June 2001 through February 2006, when the Temporary Cease and Desist Order was issued, the Respondent manufactured her homeopathic drugs in whole or in part.16 The Respondent claimed on Biomed's website, printed literature, and on product packaging and labels that Biomed drugs were manufactured under the "strict guidelines of the Homeopathic Pharmacopoeia",18 and pursuant to the "Good Manufacturing Practices".18 Biomed drugs were not official homeopathic medicines recognized in the official United States Pharmacopoeia or in the official Homeopathic Pharmacopoeia of the United States (HPUS).19 Under the Respondent's direction and control, Biomed's drugs were not manufactured pursuant to "Good Manufacturing Practices" or within the "strict guidelines of the "Homeopathic Pharmacopoeia". The Respondent's failure to comply with good manufacturing procedures created a risk of harm; that its drugs could harm consumers.
16The Department submitted evidence of specific drug manufacturing activity by the Respondent or others under her supervision on at least 37 days.
17Exhibit 21, page 1.
18Exhibit 21, pages 12-18. FDA regulations require that homeopathic drug products be manufactured in conformance with current good manufacturing practices. 21 USC Section 501 (a)(2)(B) and 21 CFR 211 (except requirements regarding expiration dates 21 CFR 211.137 and testing/release for distribution
19The Respondent unsuccessfully attempted to have her homeopathic medicine(s) recognized by the Homeopathic Pharmacopoeia of the United States (HPUS). Exhibits 41-44. HPUS is a compilation of standards for source, composition, and preparation of homeopathic drugs. HPUS contains monographs of drug ingredients used in homeopathic treatment. HPUS is recognized as an official compendium under 21 USC 201 U) of the federal Food, Drug and Cosmetic Act. 21 CFR 211.165).
1.13 The Respondent failed to comply with numerous safety standards pursuant to good manufacturing practices20 Some of those failures include:
A. Use of source products that are not safe for human consumption (manufacturer's certificate of analysis states the product is for research only; not for human use);21
B. Use of source products that contain bovine serum albumin22 (creating a risk that consumers may contract mad cow disease);
C. Use of source products that had not been tested for oral consumption;23
D. Failure to consistently list source of materials in the manufacturing process so the source materials may be tracked in case customers have an adverse reaction and a product recall is warranted;24
E. Failure to maintain records regarding complaints and adverse effects (the Respondent and her staff regularly discussed complaints/adverse effects with customers over the telephone);25
F. Failure to adopt policies and procedures for documenting and reporting of adverse reactions to Biomed drugs;26
G. Failure to properly quarantine returned Biomed drugs;
H. Repackaging quarantined returned drugs for resale;
I. Failure to properly identify and track drug batches with lot numbers and a tracking system;
J. Failure to properly test sample batches in the manufacturing process;
K. Failure to use standard formulas when mixing new batches;27
L. Failure to have policies and procedures for batch failures;
M. Failure to have provisions for testing stability of finished products;
N. Failure to utilize different identifying dies for different medication tables (Biomed used same identifying die for Athletic Edge and CSE 200 tablets);
O. Failure to provide temperature and humidity control system that protects products in the manufacturing process; and
P. Failure to provide an adequate potable water supply.
20Exhibits 2, 12, and 15.
21Exhibit 12, pages 7-15 through 7-71. These source products from R&D systems were not tested for human consumption, a very costly process that is required by the FDA. Therefore, this product is cheaper than the Norditropin (growth hormone) that the Respondent purchased through Ballard pharmacy.
22Exhibit 12, pages 7-17 and 7-18.
23Norditropin and Insulin were tested and determined safe and effective for human use by injection. No evidence was presented indicating that oral administration of these drugs was tested for efficacy and safety.
24For example see page 28 of the Respondent's "log book" in which she noted her manufacturing of medication batches. Exhibit 15.
25For example, one customer called and complained that a Biomed product caused cardiac problems that required medical treatment in an emergency room. The Respondent spoke to this customer and failed to record and report this adverse effect.
26Exhibit 2. 27Exhibit 15 and Respondent's testimony.
27Exhibit 15 and Respondent's testimony.
1.14 From approximately June 2001 through June 2002, the Respondent initially limited her manufacturing activity to diluting the source material with sterile water. On at least 11 days, the Respondent or someone else under her direction conducted the first stage of the manufacturing process, diluting the source material. She then shipped the dilution to Dolisos America, a third party drug manufacturer to finish making Biomed's drugs.28 During this time period, Dolisos also received the Norditropin source product in undiluted form, and made the dilutions and the final Biomed drugs pursuant to the Respondent's instructions.
1.15 The Respondent obtained the source material through her Ballard Pharmacy prescriptions (Norditropin and Insulin). From May 1996 through July 2004, the Respondent also obtained less costly source material from R&D Systems (Recombinant Human Growth Hormone FGF, IGF, GM-CSF, TGF, and PDGF-BB). R & D Systems stopped supplying the human growth hormone as soon as it learned that the Respondent was using the material for human consumption. For each R&D System's shipment, Biomed received documentation describing the contents, source, and purity of the product. Each delivery contained a written warning "FOR RESEARCH ONLY, NOT FOR USE IN DIAGNOSTIC PROCEDURES" or warned that the product was "FOR RESEARCH USE ONLY. NOT FOR USE IN HUMANS."29 Despite these warnings, the Respondent directed that these products be used as ingredients in Biomed drugs. The Respondent only stopped using these products when the R&D Systems refused to supply the products.
29Exhibit 12, pages 7-14 through 7-19.
1.16 Starting in approximately September 2005, the Respondent started manufacturing Biomed drugs from start to finish. On at least 14 days, the Respondent or someone else under her direction engaged in one or more manufacturing activities from mixing dilutions to the bottle labeling and sealing stages.30 Under the Respondent's direction, Biomed continued in its failure to comply with good manufacturing practices. The Respondent's manufacturing activities included the repackaging of returned/quarantined Biomed products and repackaging of unsold Biomed products to fill specific orders. The manufacturing activity occurred in the Respondent's home where the Respondent and other individuals under her direction manufactured dilution batches and Coco Bliss Bears31. The Bear formula included a Biomed product that contained hGH source material, and therefore, the Coco Bliss Bears are drugs. The manufacturing process also occurred in Biomed's Woodinville manufacturing space. The Respondent's home and the Woodinville manufacturing space did not comply with good manufacturing practices. The Respondent was aware of her failure to comply with manufacturing regulations and licensing requirements. The Respondent and her staff at her direction, hid items that indicated drug manufacturing and sales activities when Department of Health investigators inspected Biomed's Woodinville and Nickerson offices.32
30Respondent's manufacturing log (Exhibit 15), manufacturing notes (Exhibit 13), Biomed emails (Exhibit 7) and Biomed staff testimony (Marie Brown and Jeremy Adler).
31Joy Laughter helped the Respondent manufacture Coco Bliss Bears on October 2,3, and 4, 2005.
32For example, the Respondent asked Jeremy Adler to hide dilution manufacturing supplies/materials, and Marie Brown to hide the manufacturing log book from Department investigators. Exhibit 15
1.17 The Respondent denied that she instructed her staff to hide evidence of drug manufacturing and drug sales. Her denial is not credible. Marie Brown's and Jeremy Adler's testimony was credible because it was consistent and supported by Biomed's records. The Respondent's testimony was inconsistent with the records and upon close cross-examination she admitted many activities she initially denied in earlier testimony (i.e., use of source products that contain bovine serum albumin).33 The Respondent's credibility is further eroded by her false adverting and false statement in media releases that her medicines "meet all regulations",34 do not contain "bovine substances", and are manufactured pursuant to "Good Manufacturing Procedures".35
33Bovine materials in source products create a risk of mad cow disease, even though that risk is small due to the manufacturing dilution process of the source product. The source product used by the Respondent that contained bovine material was clearly marked "FOR RESEARCH USE ONLY, NOT FOR USE IN DIAGNOSTIC PROCEDURES." Exhibit 12, pages 7-17 and 7-18 (R&D Systems description of the recombinant Human FGF source materials provided on 12/10/97 and 3/2/99 that the Respondent ordered for manufacturing of various homeopathic medicines).
34Exhibit 21, page 2 (2/7/06 press release).
35Exhibit 21, pages 12-17 (Biomed's website list of products).
1.18 The Respondent is a highly educated individual who has decided that she may ignore the laws that regulate the manufacturing and sale of homeopathic drugs. She claimed ignorance as a defense, even though it is not a valid defense. Even if ignorance is a valid defense, her ignorance claim is not credible. Her employees contradict her claims of ignorance. The Respondent ignored warnings of her employees. Marie Brown and Jeremy Alder researched what licenses were required. Ms. Brown told the Respondent that Biomed needed five to six licenses, such as drug manufacturing, shopkeeper, wholesaler, and exporter licenses. Marie Brown also provided the Respondent with written materials from the Department of Health regarding the required licenses. The Respondent told Marie Brown not to worry; that she can manufacture the products in her bathtub and no one can stop her. Jeremy Adler, who was hired by The Respondent to setup and oversee the manufacture of Biomed's homeopathic medications, gave the Respondent similar warnings. Despite these warnings, the Respondent continued to manufacture Biomed's homeopathic drugs and hid evidence of drug manufacturing and sales from Department of Health inspectors.
II. CONCLUSIONS OF LAW
2.1 The Secretary has jurisdiction over the Respondent's unlicensed practice of medicine and unlicensed manufacturing and selling of drugs in the state of Washington.
2.2 The Secretary is authorized under RCW 18.130.190(3) to issue a permanent cease and desist order and to assess a civil fine for Respondent's unlicensed practice of medicine, manufacturing of drugs, and selling of drugs. The Respondent argues that under the law defining drugs and practice of medicine that the Respondent did not engage in any activity that required licensure. The laws defining the practice of medicine and drug manufacturing clearly indicate that the Respondent illegally engaged in such activities.
Definition of Drug
2.3 The Respondent argues that her homeopathic products are not "drugs" as defined in RCW 18.64.011 (3) because these products only contain a "spec" of protein and, therefore, is not a "substance". The Washington Legislature did not limit the size of the "substance" in its definition of drug and, therefore, the small amount of protein contained in the Respondent's products does not preclude her products from falling under the definition of drug. The Legislature clearly defines drug as:
(a) Articles recognized in the official United States pharmacopoeia or the official homeopathic pharmacopoeia of the United States;
(b) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
(c) Substances (other than food) intended to affect the structure or any function of the body of man or other animals; or
(d) Substances intended for the use as a component of any substances specified in (a), (b), or (c) of this subsection, but not including devices or their component parts or accessories.
2.4 The Federal Legislature similarly defined "drug" in the Federal Food, Drug and Cosmetic Act (Act):
(A) Articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) Articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) Articles intended for use as a component of any article specified in (A), (B), or (C).
21 USC sec. 321(g)(1).
2.5 Since the Respondent's products are not recognized in the official United States Pharmacopoeia or the official Homeopathic Pharmacopoeia of the United States, the question is whether the Respondent's products are intended for the mitigation and/or treatment of disease or used to affect the structure or function of the human body. Washington courts have not interpreted the RCW 18.64.011 (3) definition of drug. In light of the similarities in the federal and state definitions of "drug", federal cases interpreting the federal Act's definition of "drug" should" be used as guidance in the interpretation of the RCW 18.64.011 (3) definition of drug. To answer the question regarding a product's intended use, federal courts have repeatedly turned to promotional material, advertising, and product labeling.
2.6 The United States Supreme Court emphasized that the Act's definition of "drug" should be given "liberal construction that is consistent with the Act's overriding purpose to protect the pubic health". United States v. An Article of Drug . . . Bacto-Unidisk, 394 US 784, 798 (1969). Washington's legislation regarding the manufacture and sale of drugs have the same overriding goal, to protect the public health. The definition of "drug" is broadly interpreted to include homeopathic products that have an intended use is to treat human diseases. Meserey v. United States, 447 F Supp 548, 553 (D.C. Nev. 1977). Dr. Meserey argued, as the Respondent argues in the case at hand, that his homeopathic products are not "drugs" because they are completely harmless to anyone in any condition and in any dosage. Id. The court disagreed with this narrow definition of "drug". As the court held:
This argument, even if true, will not preclude a finding that his remedies are "drugs" within the meaning of the Act. Regardless of the actual physical effect of the product, once it is established that its intended use brings it within the drug definition, it will be deemed a drug for purposes of the Act.
Id (emphasis added). The intended/advertised use is the controlling question, even when product fails to have the claimed/advertised affect.36 The Respondent's "Medical Use Table", literature, website, and product labeling/packaging clearly demonstrate that the intended use of her homeopathic products is to mitigate/prevent disease, and affect the structure of the human body. Therefore, the Respondent's products fall within RCW 19.108.011 (3) definition of "drug".
36For example, see: United States v. An Article of Drug Consisting of 250 Jar, Etc, of US Fancy Pure Honey, 218 F Supp 208, 211 (DC Mich. 1963) (honey's intended use as a "drug"); United States v. Hohensee, 2234 R 2d 362, 370 (3d Cir. 1957) (peppermint tea leaves); and Meza v. Southern California Physicians Insurance Exchange, 73 Cal Rptr 2d 91 (1998).
Manufacture and Sale of Drugs
2.7 The Respondent was a manufacturer within the meaning of RCW 18.64.011(21) that defines a manufacturer as "a person, corporation, or other entity engaged in the manufacture of drugs." The Respondent's manufacturing activities fall within the scope of "manufacture" as defined in RCW 18.64.011 (20):
"Manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance or device or the packaging or repackaging of such substance or device, or the labeling37 or relabeling of the commercial container of such substance or device, but does not include the activities of a practitioner who, as an incident to his or her administration or dispensing such substance or device in the course of his or her professional practice, prepares, compounds, packages, or labels such substance or device.
RCW 18.64.011 (20)
37RCW 18.64.011 (22) defines "labeling" as "the process of preparing and affixing a label to any drug or device container. The label must include all information required by current federal and state law and pharmacy rules."
2.8 The Department proved with clear and convincing evidence that the Respondent manufactured drugs without a license in violation of RCW 18.64.045. The Legislature requires a manufacturer's license to be obtained prior to commencing the manufacturing process:
1) The owner of each and every place of business which manufactures drugs shall pay a license fee to be determined by the secretary, and thereafter, on or before a date to be determined by the secretary, a fee to be determined by the secretary as provided in RCW 43.70.250 and 43.70.280, for which the owner shall receive a license of location from the department, which shall entitle the owner to manufacture drugs at the location specified for the period ending on a date to be determined by the secretary, and each such owner shall at the time of payment of such fee file with the department, on a blank therefore provided, a declaration of ownership and location, which declaration of ownership and location so filed as aforesaid shall be deemed presumptive evidence of the ownership of such place of business mentioned therein. It shall be the duty of the owner to notify immediately the department of any change of location or ownership and to keep the license of location or the renewal thereof properly exhibited in such place of business.
2.9 The Department proved with clear and convincing evidence that the Respondent sold drugs without a shopkeeper registration in violation of RCW 18.64.044 that states in part:
(2) Every shopkeeper not a licensed pharmacist, desiring to secure the benefits and privileges of this section, is hereby required to register as a shopkeeper through the master license system, and he or she shall pay the fee determined by the secretary for registration, and on a date to be determined by the secretary thereafter the fee determined by the secretary for renewal of the registration; and shall at all times keep said registration or the current renewal thereof conspicuously exposed in the location to which it applies. In event such shopkeeper's registration is not renewed by the master license expiration date, no renewal or new registration shall be issued except upon payment of the registration renewal fee and the master license delinquency fee under chapter 19.02 RCW. This registration fee shall not authorize the sale of legend drugs or controlled substances.
2.10 The Department proved with clear and convincing evidence that the Respondent sold drugs without a wholesaler38 license in violation of RCW 18.64.046 that states in part:
(1) The owner of each place of business which sells legend drugs and nonprescription drugs, or nonprescription drugs at wholesale shall pay a license fee to be determined by the secretary, and thereafter, on or before a date to be determined by the secretary as provided in RCW 43.70.250 and 43.70.280, a like fee to be determined by the secretary, for which the owner shall receive a license of location from the department, which shall entitle such owner to either sell legend drugs and nonprescription drugs or nonprescription drugs at wholesale at the location specified for the period ending on a date to be determined by the secretary, and each such owner shall at the time of payment of such fee file with the department, on a blank therefore provided, a declaration of ownership and location, which declaration of ownership and location so filed as aforesaid shall be deemed presumptive evidence of the ownership of such place of business mentioned therein. It shall be the duty of the owner to notify immediately the department of any change of location and ownership and to keep the license of location or the renewal thereof properly exhibited in such place of business.
38Wholesaler means a corporation, individual, or other entity which buys drugs for resale and distribution to corporations, individuals, or other entities other than customers. RCW 18.64.011 (19).
Practice of Medicine
2.11 The Department proved with clear and convincing evidence that the Respondent did engage in the unlicensed "practice of medicine" as defined in RCW 18.71.011 that states in part:
A person is practicing medicine if he (or she) does one or more of the following:
(1) Offers or undertakes to diagnose, cure, advise or prescribe for any human disease, ailment, injury, infirmity, deformity, pain or other condition, physical or mental, real or imaginary, by any means or instrumentality; . . .
(4) Uses on cards, book, papers, signs or other written or printed means of giving information to the public, in the conduct of any occupation or profession pertaining to the diagnosis or treatment of human disease or conditions the designation "doctor of medicine", "physician", "surgeon", "m.d." or any combination thereof unless such designation additionally contains the description of another branch of healing arts for which a person has a license: PROVIDED HOWEVER, That a person licensed under this chapter shall not engage in the practice of medicine and drug manufacturing as defined in RCW 18. 25.005.
2.12 RCW 18.71.021 prohibits any person from practicing medicine or representing "himself or herself as practicing medicine without first having a valid license to do so." The Department proved with clear and convincing evidence that the Respondent practiced medicine in violation of RCW 18.71.021.
2.13 RCW 69.41.020(1 )(a) prohibits a person from obtaining or attempting to obtain a legend drug by "fraud, deceit, misrepresentation, or subterfuge ... " The Respondent obtained legend drugs from Ballard Pharmacy by fraud, deceit, and misrepresentation in violation of RCW 69.41.020(1). RCW 69.41.020(4) also prohibits a person from falsely assuming a title of, or representing oneself as, any practitioner for purposes of obtaining a legend drug. The Respondent's false assumption of a medical physician title and/or the use of the initials M.D. to obtain the legend drugs from Ballard Pharmacy constitutes a violation of RCW 69.41.020(1) and (4).The Department proved with clear and convincing evidence that the Respondent obtained legend drugs from Ballard Pharmacy in violation of RCW 69.41.020(1 )(a) and (4).
2.14 Pursuant to RCW 18.230.190(3), the Secretary has the authority to issue a cease and desist order and assess a fine for the unlicensed practice of a profession or a business for which a license is required by the chapters specified in RCW 18.130.040 . RCW 18.130.040 lists the chapters related to the practice of medicine (chapter 18.71 RCW) and manufacturing and selling of drugs (chapter 18.64 RCW). Therefore, in the case at hand, the secretary has the authority to impose:
... a civil fine in an amount not exceeding one thousand dollars for each day upon which the person engaged in unlicensed practice of a business or profession for which a license is required by one or more or the chapters specified in RCW 18.130.040. The proceeds of such fines shall be deposited to the health professions account.
RCW 18.130.190(3) (emphasis added). The full $1,000 per day fine is warranted in light of the aggravating factors. The Respondent systematically avoided compliance with laws regulating the manufacture and .sale of drugs. For example, the Respondent used source products not deemed safe for human use, hid drug manufacturing evidence from investigators, and failed to record and report adverse effects of her drugs.
2.15 Clear and convincing evidence was submitted to support a $1,000 per day fine for: (1) 315 days of unlicensed sales of drugs to individuals and businesses (as a shopkeeper and/or wholesaler); (2) 37 days of unlicensed manufacturing of drugs; and (3) 63 days of unlicensed practice of medicine. Therefore, the Respondent should be assessed a civil fine in the amount of $415,000.
The Respondent, individually and dba Biomed Comm, Inc., shall:
3.1 Cease and desist from the practice of medicine, drug manufacturing, sale of drugs as a shopkeeper, and sale of drugs as a wholesaler, without the requisite licenses.
3.2 Pay a civil fine in the amount of $415,000 that shall be deposited to the health professions account.
Dated this 19th of April, 2007.
ZIMMIE CANER, Health Law Judge
| RCW 18.64.044
NOTICE TO PARTIES
This order is subject to the reporting requirements of RCW 18.130.110, Section 1128E of the Social Security Act, and any other applicable interstate/national reporting requirements. If adverse action is taken, it must be reported to the Healthcare Integrity Protection Data Bank.
Either Party may file a petition for reconsideration. RCW 34.05.461(3); 34.05.470. The petition must be filed within 10 days of service of this Order with:
Adjudicative Service Unit
PO Box 47879 Olympia,
and a copy must be sent to:
Unlicensed Practice Program
PO Box 7867
Olympia, WA 98504-7867
The petition must state the specific grounds upon which reconsideration is requested and the relief requested. The petition for reconsideration is considered denied 20 days after the petition is filed if the Adjudicative Clerk Office has not responded to the petition or served written notice of the date by which action will be taken on the petition.
A petition for judicial review must be filed and served within 30 days after service of this order. RCW 34.05.542. The procedures are identified in chapter 34.05
RCW, Part V, Judicial Review and Civil Enforcement. A petition for reconsideration is not required before seeking judicial review. If a petition for reconsideration is filed, however, the 30-day period will begin to run upon the resolution of that petition. RCW 34.05.470(3).
The order remains in effect even if a petition for reconsideration or petition for review is filed. "Filing" means actual receipt of the document by the Adjudicative Service Unit. RCW 34.05.010(6). This Order was "served" upon you on the day it was deposited in the United States mail. RCW 34.05.010(19).
This page was revised on February 18, 2012.