The United States Food and Drug Administration (FDA) recently learned that your pharmacy located at 239 S.E. Marine Drive, Vancouver, B.C. V5X 2S4, offers clobazam for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, your pharmacy is promoting a misbranded and unapproved new drug product in violation of sections 502(f) and 505(a) of the FD&C Act [21 U.S.C. §§ 352(f) and 355(a)], which are prohibited acts pursuant to sections 301(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 331(a) and 331(d)], respectively. We request that you immediately cease promotion of this violative drug product to United States patients and healthcare professionals.

 

 

Clobazam is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Clobazam also is a new drug within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective when used as labeled. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)].

 

It has been brought to our attention that your firm has sent letters to U.S. patients and physicians advertising your continued ability to supply them with the Canadian version of clobazam even after FDA approval of Lundbeck’s ONFI Tablets on October 21, 2011. The letter to patients states:

 

“Your doctor is authorized to prescribe this medication solely for LENNOX-GASTAUT SYNDROME. Should you or your child have any other syndrome, your doctor cannot prescribe legally in America but you will still be able to receive your Clobazam from our pharmacy in Canada.”

 

Similarly, the letter to physicians states:

 

“Physicians are authorized to prescribe Clobazam (ONFI) solely for patients with LENNOX-GASTAUT SYNDROME…We hope to continue to provide to your non-Lennox-Gastaut Syndrome patients high quality medicine at a low price.”

 

FDA-approved drugs are manufacturer- and product-specific and adhere to requirements, such as those regarding formulation, active ingredient specifications, current good manufacturing practices, and labeling. No approved application pursuant to section 505 of the FD&C Act is in effect for any clobazam drug product other than ONFI. Accordingly, the introduction or delivery for introduction of any other clobazam drug product, including the clobazam drug product you are offering from your pharmacy in Canada, violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] and is prohibited under section 301(d) of the FD&C Act [21 U.S.C. §331(d)].

 

 

Clobazam is a controlled substance and can be a potentially dangerous prescription drug product if not taken under the close supervision of a healthcare professional or pharmacist. Some of the most serious risks associated with clobazam include abuse or misuse leading to physical dependence, withdrawal symptoms if the drug is abruptly discontinued, and suicidal ideation. To mitigate these risks, ONFI must be dispensed with an FDA-approved Medication Guide. This safety measure is bypassed when the drug product is purchased over the Internet, thereby placing United States patients at risk. The clobazam drug product offered for sale by your pharmacy is misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] in that the labeling for the drug fails to bear adequate directions for use. The introduction or delivery for introduction into interstate commerce of a misbranded drug product is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

 

FDA is sending this letter because of the inherent risk in buying misbranded and unapproved new drugs. Unapproved new drugs may not have the same assurance of safety, efficacy, and quality as drugs subject to FDA oversight. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the States. Unapproved new drugs delivered to the American public by pharmacies that are not licensed in the U.S. may not be safe and effective.

 

This letter is not intended to identify all of the ways in which your activities might be in violation of the law. It is your responsibility to ensure that all products marketed by your pharmacy are in compliance with the FD&C Act and its implementing regulations.  You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in FDA regulatory enforcement action, including but not limited to, seizure or injunction, without further notice.

 

Please notify this office in writing within 15 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 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to DrugSupplyChainIntegrity@fda.hhs.gov. Please direct any inquiries concerning this letter to Eleni Anagnostiadis, Acting Deputy Director for the Division of Supply Chain Integrity at the above address.

 

Sincerely,

/s/

Thomas Christl, Office Director (Acting)

Office of Drug Security, Integrity and Recalls

Office of Compliance

Center for Drug Evaluation and Research