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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993-0002 |
TO: Mr. Larry Burstein
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(f), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 321(g), 321(p), 331(a), 331(d), 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)].
Many products offered for sale on your websites are indicated to treat serious medical conditions for which supervision by a licensed healthcare practitioner is necessary to ensure safe and effective use. Some of these medical conditions include invasive breast cancer, obesity, and mental health disorders. Examples of violative products offered for sale on your firm’s websites include “Generic Nolvadex” and “Generic Meridia.” Your websites claim that “Generic Nolvadex” is “used for treating breast cancer that has spread to other sites in the body” and that, “[i]t is used in women who are at high risk for breast cancer and in women with DCIS to decrease the risk of developing breast cancer.” While there are FDA-approved generic versions of FDA-approved Nolvadex, there is no FDA-approved drug application for “Generic Nolvadex,” and as such, “Generic Nolvadex” is an unapproved new drug product. Furthermore, FDA requires that Nolvadex, as well as its approved generics, be accompanied by a black box warning, the highest level of FDA-required warnings, indicating that the drug carries a significant risk of serious or even life-threatening adverse events. The black box warning is directed to women with DCIS and women at high risk for breast cancer, warning them about the serious adverse events reported in association with use of the product, such as malignancies, stroke, and pulmonary embolism. The “Generic Nolvadex” product you offer for sale on your website contains no such black box warning, which places consumers at risk, and may prevent individuals from receiving appropriate and effective treatment.
Another example of an unapproved new drug product your websites offer is “Generic Meridia,” which is intended to treat obesity. Meridia was approved for use in the U.S. in 1997 for weight loss and maintenance of weight loss in obese people, but was withdrawn from the U.S. market in 2010 due to clinical trial data indicating an increased risk of heart attack and stroke.
In an FDA Safety Alert in 2010, the Agency recommended physicians stop prescribing Meridia to their patients and for patients to stop taking this medication due to severe adverse events associated with use of the product.
“Generic Nolvadex” and “Generic Meridia” are subject to regulation as drugs under Section 201(g) of the FD&C Act because they are intended for use in the diagnosis, cure, mitigation treatment, or prevention of disease. 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. Because there are no approved applications in effect for these products, they are unapproved new drugs. 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 prescription drug products for sale, such as “Generic Valium” and “Generic Xanax.” These products claim to be FDA-approved generic versions of the FDA-approved brand name products, Valium and Xanax. While there are FDA-approved generic versions of Xanax and Valium, “Generic Valium” and “Generic Xanax” are not the names of FDA-approved products. It is particularly concerning that these products are available for purchase without a prescription on your websites because the FDA-approved Valium and Xanax are controlled drug substances with the potential for abuse and dependency. In fact, there have been life-threatening adverse events reported as a direct consequence of physical dependence on Xanax, such as seizure. There have also been adverse events reported in association with the use of Valium, such as an increased risk of heart defects and other developmental abnormalities in pregnant women and, when used in combination with other products to treat convulsive disorders, the abrupt withdrawal of Valium has been associated with a temporary increase in the frequency and/or severity of seizures. Prescription drug products (including controlled drug substances), 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 and can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs under section 503(b)(1)(B)(i) of the FD&C Act [21 U.S.C. § 353(b)(1)(i)]. When prescribing a prescription drug, a physician provides guidance to their patient to assure safe and effective use of the product. For example, proper dose administration of Xanax is necessary for the drug to be effective in the management of panic disorder, especially given the risk of dependence. Therefore, your offering these prescription drug products without requiring a prescription jeopardizes patient safety and misbrands the drug products under section 503(b)(1)(B)(iii) of the FD&C Act [21 U.S.C. § 353(b)(1)(B)(iii)].
“Generic Valium” and “Generic Xanax” are also misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because they fail to bear adequate directions for their respective intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in 503(b)(1)(A) of the Act, can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Furthermore, your websites offer unapproved Accutane (isotretinoin) for sale. FDA approved the new drug application (NDA) for Accutane in 1982, but withdrew the approval via a Federal Register Notice effective November 22, 2010. [21 U.S.C. § 355(a)]. The introduction or delivery for introduction into interstate commerce of unapproved drug products violates sections 301(d) and 505(a) [21 U.S.C. § § 331(d) and 355(a)] of the FD&C Act. As a result, the Accutane product offered for sale on your websites is unapproved within the meaning of section 505(a) of the FD&C Act
Moreover, your websites offer for sale misbranded drugs containing isotretinoin. Although isotretinoin is legally marketed under other approved applications, FDA-approved drugs containing isotretinoin are available in the United States only pursuant to a restricted distribution program called a Risk Evaluation Mitigation Strategy (REMS). The REMS is intended to prevent fetal exposure to isotretinoin and inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions. If these products are not taken under the close supervision of a healthcare professional and pharmacist, they can be potentially dangerous prescription drugs. Because isotretinoin has serious risks, the REMS requires, among other things, that patients, prescribers, and pharmacies/pharmacists register with the iPLEDGE program for patients to receive this medication. Patients taking drugs containing isotretinoin are placed at risk when these safety controls are bypassed. To offer isotretinoin for sale without the above-mentioned safety controls misbrands the product as it is false and misleading to the consumer and is potentially dangerous to health because it lacks adequate warnings against use per sections 502(a) of the FD&C Act and 502(f)(2) of the FD&C Act, respectively.
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