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Big Mountain Drugs 04/02/2013

Big Mountain Drugs - 02/04/2013

Big Mountain Drugs

United States

Issuing Office:
Center for Drug Evaluation and Research

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Silver Spring, MD  20993-0002 


TO:                 Mr. Mohammed Hassan, Pharmacy Manager
                        202A, 8322-130th Street
                        Surrey, British Columbia, Canada V3W 8J9
FROM:           United States Food and Drug Administration
                        Center for Drug Evaluation and Research
                        Office of Compliance
                        Office of Drug Security, Integrity and Recalls
                        Division of Supply Chain Integrity
RE:                 Internet Marketing of an Unapproved and Misbranded Drug
DATE:           February 4, 2013
The United States Food and Drug Administration (FDA) reviewed your websites, www.bigmountaindrugs.com, and www.buypirfenidone.com, on October 24, 2012 and October 26, 2012, respectively, and websites www.bestbuyrx.com and www.drugworldcanada.com on January 8, 2013. We have determined that www.bigmountaindrugs.com, www.bestbuyrx.com, and www.drugworldcanada.com  offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites offer a misbranded and unapproved new drug for sale 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 under 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 marketing violative drug products to United States consumers.
Unapproved New Drug
Pirfenidone is offered for sale on www.bigmountaindrugs.com, www.bestbuyrx.com, and www.drugworldcanada.com as a generic drug and/or under the brand name Pirfenex. Pirfenidone is also available in some markets under the brand name Esbriet.
Pirfenidone is a drug within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or it is intended to affect the structure or function of the body. Moreover, pirfenidone appears to be 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 for its labeled use. Examples of some of the claims on the www.bigmountaindrugs.com website that establish pirfenidone as a drug include:
  • “[I]s used to relieve some of the symptoms of idiopathic pulmonary fibrosis (IPF).”
  • “[H]elps to slow down the process of fibrosis and also reduces inflammation.”
  • “[S]lows tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor, platelet-derived growth factor, and transforming growth factor beta 1.”
Examples of some of the claims on the www.buypirfenidone.com website include:
  • “Esbriet is an anti-chronic lung disease drug used against a form of chronic progressive lung disease. It gives hope to sufferers of IPF…Esbriet is a novel anti-fibrotic drug which through clinical trials has shown to slow down progress of the terminal disease and stabilize lung function.”
  • “The recent availability of Pirfenidone, Esbriet, under the brand name Pirfenex, an anti-fibrotic and anti-inflammatory agent available in an oral tablet form of 200 mg. Esbriet is the first and only approved drug improves [sic] progress free survival in IPF patients by 30%.”
  • “Although Esbriet, a groundbreaking IPF drug, is still being reviewed by the FDA, American consumers can buy it online from Canada.”
  • “Pirfenidone works by inhibiting the synthesis of TGF-Beta, which decreases the pulmonary fibrosis symptoms seen in the liver, lungs and kidneys. Pirfenidone has also been seen to hinder the synthesis of TNF-Alpha, which affects the swelling that has already occurred.
In addition, videos on YouTube, uploaded on December 22, 2011 by “bigmountaindrugs,” and on www.buypirfenidone.com claim: “Pirfenidone is used to treat idiopathic pulmonary fibrosis.”
Although pirfenidone is approved in Canada under the brand name Esbriet, there is no approved application pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for this drug product. Accordingly, its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which is prohibited under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].
Misbranded Drug
Because pirfenidone is intended for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for it so that a layman can use this product safely for its intended use. Consequently, its labeling fails to bear adequate directions for its intended use, causing it to be misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because pirfenidone lacks a required approved application, it is not exempt from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as described in Title 21 of the Code of Federal Regulations (21 CFR) § 201.115. The introduction or delivery for introduction into interstate commerce of a misbranded drug product is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].
FDA is taking action against your firm 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, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.  FDA-regulated drugs offer protections that include rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. must be licensed by the states. Unapproved new drugs delivered to the American public 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 law. It is your responsibility to ensure that all drug products marketed by your firm are in compliance with 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 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.
Thomas Christl, Office Director (Acting)
Office of Drug Security, Integrity and Recalls
Office of Compliance
Center for Drug Evaluation and Research