- RX Partners
- Issuing Office:
- Center for Drug Evaluation and Research
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993-0002 |
TO: Ms. Jessica Eagloff and Mr. Vitaly Petrov
FROM: The United States Food and Drug Administration
RE: Notice of Unlawful Sale of Unapproved and Misbranded Drug Products to
United States consumers over the Internet
DATE: June 8th, 2015
The United States Food and Drug Administration (FDA) recently reviewed your websites (listed in the table at the bottom of this letter) and determined that your websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved new drugs and misbranded drugs for sale in violation of sections 301(a), 301(d), 502(a), 502(f), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 352(a), 352(f), 353(b), and 355(a)]. FDA requests that you immediately cease marketing violative drug products to United States consumers.
Unapproved New Drugs
As labeled, certain products offered for sale through your websites are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These products, as marketed through your websites, are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act [21 U.S.C §§ 355(a) and 331(d)].
Examples of unapproved drug products offered for sale on your websites include “Generic Truvada” and “Generic Advair Diskus.” While there are FDA-approved brand drug products with the names Truvada and Advair Diskus, there are no FDA-approved generic versions of these products. Consequently, the websites offering these products for sale mislead consumers into believing these are FDA-approved drug products.This is particularly concerning, considering that both FDA-approved Truvada and Advair Diskus have a black box warning, the highest level of FDA-required warnings, indicating that these drugs carry significant risks of serious or even life-threatening adverse effects.
For example, the black box warning for Truvada warns patients about serious, life threatening and sometimes fatal, adverse events such as liver toxicity issues reported in association with use of the product. Treatment with Truvada should be guided by laboratory tests and treatment history. When consumers purchase “Generic Truvada” from your websites, neither of these guidelines are appropriately considered by a licensed practitioner in order to prevent the potential for drug resistance and ineffective treatment.
The black box warning for Advair Diskus warns patients that one of the active ingredients in the product increases the risk of asthma-related deaths and states that physicians should only prescribe Advair Diskus when the patient’s asthma cannot be adequately controlled by a long-term asthma control medication. By offering Generic Advair Diskus without a prescription and its accompanying black box warning your firm exposes consumers to serious adverse events, including death.
Your websites make claims for both Generic Truvada and Generic Advair Diskus that cause these products to be subject to regulation as drugs under Section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. One such drug claim your websites make for Generic Truvada states that this product “…[is] [an] antiviral drug that work[s] by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.” An example of a drug claim your websites make for Generic Advair Diskus states that it “…is used for long-term treatment of asthma and chronic obstructive pulmonary disease (COPD) in certain patients.” These products, as marketed through your websites, are new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Furthermore, these products are unapproved new drugs because there are no approved applications in effect for these products. Your introduction or delivery for introduction of these unapproved new drug products into the United States violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. § § 331(d) and 355(a)].
Additionally, your websites offer unapproved versions of prescription drug products for sale, such as “Generic Depakote.” While there are FDA-approved generic versions of the FDA-approved brand name product, Depakote, “Generic Depakote” is not the name of an FDA-approved product. Depakote, as well as the approved generics for the brand name product, is indicated for the treatment of epilepsy, migraines, and manic episodes associated with bipolar disorder. Depakote has a narrow therapeutic index, which means that the drug product is only safe and effective for use at a specific dose and strength. If the product contains too little or too much of the active ingredient or is administered at an improper dose, it may render the treatment ineffective. Furthermore, Depakote has a black box warning alerting patients to serious adverse events reported in association with use of the product, such as liver failure resulting in death, increased risk of developing fatal liver toxicity in children under the age of 2, severe birth defects in pregnant women, and life-threatening pancreatitis in both children and adults.
Prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. However, your websites offer “Generic Depakote,” an unapproved drug product, for sale to U.S. consumers without requiring a prescription, jeopardizing patient safety and misbranding the drug product under section 503(b)(1)(B)(iii) of the FD&C Act [21 U.S.C. § 353(b)(1)(B)(iii)]. Prescription drugs, as defined by 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner. In addition, because the aforementioned drug is intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for its intended use. Consequently, “Generic Depakote” is further misbranded because the labeling for this product fails to bear adequate directions for intended use, causing it to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)].
FDA is taking this action against your firm because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight, and in many cases, drugs that have circumvented regulatory safeguards have been shown to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
This letter is not intended to identify all of the ways in which your activities might be in violation of law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to correct the violations noted above as well as any other violations of the FD&C Act (which would include the offer for sale of all unapproved and/or misbranded drug products by your websites, not just the products noted above),. Failure to correct these violations immediately may result in regulatory action.
Please notify this office in writing within 10 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence.
If the corrective action(s) cannot be completed within 10 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response and any other inquiries concerning this letter should be sent to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Table of Websites:
Office of Drug, Security, Integrity, and Recalls
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration