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31 Health Law. 1 (2018-2019)
Internet Pharmacies: Trends, Opportunities, and Risks

handle is hein.journals/healaw31 and id is 133 raw text is: H IEALTH H LAWYER Internet Pharmacies: Trends, Opportunities, and Risks.......... 1 Chair's Column...................... 2 Employment-Based Legal and Policy Solutions for Female Victims of Intimate Partner Violence................. 17 Section News...................... 28 Changes in Ownership: Medicare Rules and Other Issues ................................. 30 Honoring Member Commitment Recognition List......................38 Section Calendar.......Back Cover INTERNET PHARMACIES: TRENDS, OPPORTUNITIES, AND RISKS Libby L. Baney, Esq. Faegre Baker Daniels Washington, DC Niamh M. Lewis, Esq. Circle 3 Law LLC Lake Oswego, OR Introduction As tech-savvy consumers become increasingly comfortable obtaining healthcare via electronic means, crim- inal enterprises seek to capitalize on these new technologies and prey on consumers. In the world of e-health, nowhere is criminal action more prev- alent than in the Internet pharmacy market. Although many U.S.-based brick-and-mortar pharmacies offer legitimate online platforms that com- ply with state and federal law, rogue actors abound. Most operate from abroad as part of massive pharmacy networks comprised of thousands of Web sites; these illegal Internet phar- macy networks ship unapproved, mis- branded, and adulterated prescription drugs into the United States, often without requiring a valid prescription and without appropriate pharmacy licensure. At a minimum, these illicit pharmacies violate the Federal Food, Drug, and Cosmetic Act (FDCA)' and state pharmacy laws; however, they often violate other laws, includ- ing those related to the practice of medicine, controlled substances, fraud, money laundering, and intellectual property rights. This article provides an overview of state and federal laws governing Internet pharmacies; a description of the issues surrounding Canadian Internet pharmacies; a synopsis of state, federal, international, and pri- vate sector enforcement activities involving illegal online drug sellers; and a summary of next steps required to address this pervasive issue. Current Statistics According to industry experts, there are roughly 30,000 to 35,000 active Internet pharmacies, of which only four percent comply with applica- ble laws.2 Of the remaining 96 percent that operate illegally, 92 percent overtly violate the law; for example, many sell unapproved prescription drugs without requiring a prescription.3 A 2018 report by the National Asso- ciation of Boards of Pharmacy (NABP) found that 54 percent of the online drug sellers analyzed offered controlled substances, and 40 percent offered oxycodone, Percocet, Xanax, or Norco, which are frequently coun- terfeited with fentanyl.4 This puts mil- lions of Americans at risk of receiving dangerous counterfeit or otherwise illegal and unsafe medications, often continued on page 3 Volume 31, Number 5, June 2019