Inspections, Compliance, Enforcement, and Criminal Investigations
Canadian Discount Drugs 30-Jun-03
Public Health Service
|Rockville, MD 20857|
Jun 30, 2003
Via Fax and Federal Express
|C. Bradley Stevens
100 Denham Square
Peachtree City, GA 30269
1518 B Andrews Avenue
Ozark, AL 36360
|Dr. Russell L.Page, Jr.
Pharmaceutical Supply, Inc.
1009 Roy Parker Rd.
Ozark, AL 36360
Dr. Russell L. Page, Jr.
Vice President of Marketing
1518 B Andrews Avenue
Ozark, AL 36360 .
1518 B Andrews Avenue
Ozark, AL 36360
Dear Mr. Stevens, Mrs. Stevens, Dr. Page, and Mrs. Page:
The Food and Drug Administration (FDA) has learned that you, CanadianDiscountDrugs, and Ameri-Can Global Pharmaceutical Supply, Inc. (collectively, CanadianDiscountDrugs or you) are assisting United States consumers in obtaining prescription drugs from Canada. Specifically, consumers can use your fax machines, your computer equipment, or your Web site, canadiandiscountdrugs.com, to send U.S. prescriptions, credit card information, and paperwork (including a Customer Agreement & Order Form and a Health Profile) to Total Care Pharmacy in Calgary, Alberta, Canada. According to information provided by you, a Canadian physician reviews the prescription and customers medical history, and Canadian drugs are then shipped by Total Care Pharmacy directly to the U.S. consumer. As discussed in detail below, your actions violate the Federal Food, Drug and Cosmetic Act FD&C Act or Act), 21 U.S.C. 301 et seq. Your actions also present a significant risk to public health, and you mislead the public about the safety of the drugs obtained through CanadianDiscountDrugs.
Virtually every shipment of prescription drugs from Canadian pharmacies to consumers in the U.S. violates the Act. Even if a prescription drug is approved in the U.S., if the drug is also originally manufactured in the U.S., it is a violation of the Act for anyone other thanthe U.S. manufacturer to import the drug into the United States (21 U.S.C. 331(d)(1)). We believe that virtually all drugs imported into the U.S. from Canada by or for individual U.S. consumers also violate U.S. law for other reasons. Generally, such drugs are unapproved (21 U.S.C. 355), labeled incorrectly (21 U.S.C. 353(b)(2)), and/or dispensed without a valid prescription (21 U.S.C. 353(b)( 1)). Thus, their shipment into the U.S. from Canada violates the Act. See, e.g., 21 U.S.C. 331(a), (d), (t).
The reason that Canadian or other foreign versions of U.S. approved drugs are generally considered unapproved in the U.S. is that FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product, such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance. 21 C.F.R. 314.50. Frequently, drugs sold outside of the U.S. are not manufactured by a firm that has FDA approval for that drug. Moreover, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the U.S. approval, and thus it is considered to be unapproved. 21 U.S.C. 355.
In order to ensure compliance with the Act when they are involved in shipping prescription drugs to consumers in the U.S., businesses and individuals must ensure, among other things, that they only sell FDA-approved drugs that are made outside of the U.S. and that comply with the FDA approval in all respects, including manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance. 21 C.F.R. 314.50. They must also ensure that each drug meets all U.S. labeling requirements, including that it bears the FDA-approved labeling. 21 C.F.R. 201.100(c)(2). The drug must also be dispensed by a pharmacist pursuant to a valid prescription. 21 U.S.C. 353(b)(1).
Practically speaking, it is extremely unlikely that a pharmacy could ensure that all of the applicable legal requirements are met. Consequently, almost every time an individual or business ships a prescription drug from Canada to a U.S. consumer, the individual or business shipping the drug violates the FD&C Act. Moreover, individuals and businesses, such as CanadianDiscountDrugs and its responsible personnel that cause those shipments also violate the Act. 21 U.S.C. 3 331 (The following acts and the causing thereof are hereby prohibited.. .).
For your information, under FDAs Personal Importation policy, as a matter of enforcement discretion in certain defined circumstances, FDA allows consumers to import otherwise illegal drugs. However, this policy is non intended to allow importation of foreign versions of drugs of which there is a FDA-approved version. This is especially true when the foreign versions of such drugs are being commercialized to U.S. citizens through operations such as yours. Moreover, the policy simply describes the agencys enforcement priorities. It does not change the law, and it does not give a license to persons to import or export illegal drugs into the United States. See FDA Regulatory Procedures Manual, Chapter 9, Subchapter: Coverage of Personal Importations.
FDAs Public Health Concerns and Your Misleading Statements about Drug Safety
You also make misleading statements to consumers about the safety of the drugs purchased through CanadianDiscountDrugs and the legitimacy of your operation. A brochure which you distributed claimed that [a]ll medications offered are also approved by the U.S. Food and Drug Administration. The brochure also stated that Total Care Pharmacy was inspected by Health Canada at the request of the U.S. Food and Drug Administration. Canadiandiscountdrugscom purports to answer the question, How do I know prescription medications from Canada are of the same safety and quality as those in the United States? canadiandiscountdrugs.com also states that Total Care Pharmacy is one of the most respected Canadian pharmacies serving the U.S. market. These statements imply that your operation is legal and endorsed by the U.S. government, and that the drugs purchased through you are safe.
These statements are misleading. As discussed above, your operation is illegal. In addition, prescription drugs purchased from foreign countries generally are not FDA-approved, do not meet FDA standards, and are not the same as the drugs purchased in the United States. Drugs from foreign countries do not have the same assurance of safety as drugs actually regulated by the FDA. Because the medications are not subject to FDAs safety oversight, they could be outdated, contaminated, counterfeit or contain too much or too little of the active ingredient. In addition, foreign dispensers of drugs to American citizens may provide patients with incorrect medications, incorrect strengths, medicines that should not be used in people with certain conditions or with other medications, or medications without proper directions for use. These risks are exacerbated by the fact that many of the products you are soliciting United States consumers to buy are indicated for serious medical conditions (For example, on canadiandiscountdrugs.com. you offer prescription drugs indicated for use in treating cancer (tamoxifen), HIV (abacavir sulfate), and hypertension (irbesartan)). At least one of them presents risks that FDA has determined warrant special patient labeling (For example, on canadiandiscountdrug.com, you offer abacavir sulfate (Ziagen), a carbocylic nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV).
FDA is also very concerned about the importation of prescription drugs from Canada and other foreign countries because, in our experience, many drugs obtained from foreign sources that purport or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown quality. Recent examples of counterfeit products entering the U.S. marketplace also raise substantial safety questions about drugs from foreign countries.
Moreover, there is a possibility that drugs which come to U.S. consumers through Canada or purport to be from Canada may not actually be Canadian drugs. In short, drugs delivered to the American public from foreign countries may be very different from products approved by FDA and may not be safe and effective. For all of these reasons, FDA believes that operations such as yours expose the public to significant potential health risks.
This letter is not intended to identify all of the ways in which your activities violate United States law. It is your responsibility to ensure that you are in compliance with applicable legal requirements.
Please notify this office in writing within fifteen (15) working days of your receipt of this letter of the specific steps you will take to assure that your operations are in full compliance with United States law. Please address your correspondence to Mr. Melvin Szymanski, Compliance Officer, at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, HFD-310, 5600 Fishers Lane, Rockville, MD 20857. If you do not promptly correct your violations, FDA may take legal action without further notice. Possible actions include seizure and/or injunction. Further, federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of
David J. Horowitz, Esq.
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration