FDA WARNING_LETTER - Big Mountain Drugs - January 08, 2013

The FDA issued a Warning Letter after reviewing websites www.bigmountaindrugs.com, www.buypirfenidone.com, www.bestbuyrx.com, and www.drugworldcanada.com between October 2012 and January 2013. The FDA determined that www.bigmountaindrugs.com, www.bestbuyrx.com, and www.drugworldcanada.com offer products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, the websites offer Pirfenidone (marketed as generic, Pirfenex, or Esbriet) for sale, which is an unapproved new drug and a misbranded drug. Pirfenidone is considered a "new drug" under section 201(p) of the FD&C Act because it is not generally recognized as safe and effective for its labeled uses, such as treating idiopathic pulmonary fibrosis (IPF) and slowing fibrosis/inflammation. Claims on the websites and YouTube videos establish its drug intent.

Since no approved application pursuant to section 505 of the FD&C Act is in effect for Pirfenidone, its introduction into interstate commerce violates section 505(a) and is prohibited under section 301(d). Furthermore, Pirfenidone is misbranded under section 502(f)(1) because it is intended for conditions not amenable to self-diagnosis/treatment,