This article was published in the Health, Life Sciences, and Product Liability sections of Law360 on October 17, 2013, under the title, “Misbranded Drugs — A Danger to Physicians and Patients.” © Copyright 2013, Portfolio Media, Inc., publisher of Law360.
Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise of monetary savings for themselves and their patients, but they pose dangers. The Internet and unsolicited fax communications are the route to market for many “misbranded” – known more commonly as counterfeit – medications. “Misbranded” can mean a variety of things under federal law, including drugs that are imported from sources that have not registered with the Secretary of Health and Human Services.1 These unregistered – or unauthorized – companies often base their operations in foreign countries far beyond the protection of the U.S. Food and Drug Administration (FDA). When a physician purchases misbranded medications from unauthorized suppliers, he subjects himself to potential criminal fines and imprisonment – and, equally troubling, he may risk his patients’ safety.
The last 12 months have seen a surge in FDA investigations of foreign distributors and purchasers of counterfeit medications. On June 7, 2013, the FDA announced the seizure of 9,600 online pharmacies selling illegal, unapproved medications. As part of this sting, the FDA, along with international law enforcement, confiscated $41,104,386 worth of illegal product from foreign distributors2 and, worldwide, placed more than 200 individuals under arrest or under further investigation for a range of offenses.3
The FDA has also focused its attention on physicians who purchase from unauthorized distributors. One recent example involves Botox. From 2012 through 2013, Canadian distributors, not registered to sell medication in the United States, sold unapproved formulations of Botox to American physicians at bargain prices.4 The FDA notified more than 350 physicians that they had purchased Botox from an unregistered distributor and were in violation of the Federal Food Drug and Cosmetic Act (FDCA).5 According to the FDA, these medications posed risks to patient safety because they could lack necessary FDA warnings, contain ineffective or unknown ingredients, or could be improperly manufactured and shipped.6 Another recent example involves Avastin, an injectable medication used to treat cancer. Beginning in February 2012, the FDA investigated unlicensed Internet sellers of Avastin and found that Avastin purchased from these unauthorized distributors either contained the wrong active ingredient or contained no active ingredient at all, depriving cancer patients of critical treatment.7 In some cases, physicians were being sold Altuzan – an unapproved, Turkish form of the medication. The FDA sent a letter to medical practices that had purchased the counterfeit Avastin, warned them of the risk to patients and that the purchase of these medications may violate the FDCA.8
Medications or treatments brought into the United States from unregistered foreign distributors are considered misbranded under the FDCA. The consequences for purchasing misbranded pharmaceuticals can be serious. Violators may face criminal prosecution with a resulting maximum penalty of a one-year prison term, a $1,000 fine or both; penalties increase with repeated offenses.9 Ramifications extend beyond criminal prosecutions. Purchasing physicians face losing their medical licenses, professional reputations, and potential lawsuits by patients.
Physicians who choose not to purchase directly from manufacturers need to watch for the red flags misbranded medications often carry. Physicians should:
By taking these steps, physicians can reduce the likelihood that they are purchasing illegal medications.
1 21 USC §§ 333(a), 352(o) (2012).
2 See Press Release, FDA, FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies (June 27, 2013) (available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358794.htm).
3 See Press Release, Interpol, International operation targets online sales of illicit medicines (June 27, 2013) (available at http://www.interpol.int/News-and-media/News-media-releases/2013/PR077).
5 See Letter from FDA to Practitioners re: Purchasing Unapproved Medications from Foreign or Unlicensed Suppliers Could Result in Serious Harm to Patients (Nov. 30, 2012) (available at http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm).
7 See Press Release, FDA, FDA sends letters to 19 medical practices about counterfeit products and other unapproved cancer medicines (Feb. 14, 2012) (available at http://www.fda.gov/drugs/drugsafety/ucm291960.htm).
8 See, e.g., Letter from FDA to Paul D. Raymond (physician) re: Purchasing Medications from Foreign or Unlicensed Suppliers Could Result in Serious Harm to Patients (June 28, 2012) (available at http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM311165.pdf).
9 21 USC 333(a) (2012); U.S. v. Micheltree, 940 F.2d 1349 (10th Cir. 1991).
Yvonne M. McKenzie and Colleen C. Kelly
The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.