Category:The Marketplace
Could Apple Dive into the Medical App and Device Market Sooner Than We Think and How Will This New Technology Be Regulated?
Amanda Plowman Executive Editor Loyola University Chicago School of Law JD 2017 Alexander Thompson Assistant Editor Loyola University School of Law JD 2018 Apple has had a longstanding interest in breaking into the healthcare industry. Recently, Apple has hired a Toronto physician to work on expanding its health apps and Aetna will now provide …
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Compliance in the Garment Industry: A Closer Look Into Bangladesh’s Factories
Compliance with labor laws is a major component of effectively and efficiently conducting business in the garment industry. Although there are a variety of areas, such as wage and hour compliance and disability compliance, human rights compliance issues are becoming increasingly prominent in recent times—especially in Bangladesh. The garment industry in Bangladesh came under international scrutiny in 2013 after the collapse of the Rana Plaza building, ultimately killing over 1,100 workers. This incident is considered to be one of the worst industrial disasters to ever occur and exposed many serious hazards that were occurring in Bangladeshi factories. Subsequently, some of the largest brands shifted to implement better conditions for workers.
Compliance Spotlight: Dominique Vittori, Abbott Laboratories
Dominique Vittori is a Regulatory Affairs Associate for Abbott Laboratories working within Abbott Diagnostics Division. Abbott Laboratories is a worldwide healthcare company that is most known for pharmaceutical development but eventually branched out to include medical devices, nutritional products and research-based drugs/pharmaceuticals. Ms. Vittori earned her Bachelor’s degree from the University of Illinois, where she majored Molecular and Cellular Biology. Ms. Vittori sought a career in compliance because of the opportunity to put her background and expertise in the sciences to use in a corporate setting, and has been most rewarded by the ability to see the tangible results of her work at Abbott Labs.
The following is an interview with Ms. Vittori where she gives an inside look into her daily life as a compliance professional.
History of Emergency Prescription Fulfillment Policies in the Wake of Hurricanes Harvey and Irma
In the midst of a natural disaster people gather their children and pets, try to locate a temporary home, and worry what situation they may come home to. The first things people think to grab have nothing to do with their prescription drugs. However, according to a study performed by the U.S. Department of Health and Human Services, from 2011-2014, 46.9% of the population was prescribed a drug in the last 30 days; prescription drugs are an important factor in many peoples’ lives. When portions of the population are displaced from their homes during a natural disaster, they often forget their pill bottles and/or prescriptions. Thankfully, following Hurricane Katrina, regulations were put in place to help people in these situations.
Guest Post: A Post-Regulatory Recipe for Economic Leadership
by William Devine, Guest Contributor
Apple has developed and distributed a curriculum that will teach students at 30 community colleges around the country to write code and create apps. What prompts this gift? A belief that we all bear responsibility for sustaining a functional economy. At a time when some corporate leaders and their legal teams focus on the perils of overregulation, the greatest regulatory risk an enterprise confronts may not be high compliance hurdles, but rather the possibility that regulators can’t keep the economy functioning well enough for the enterprise to do its most commercially inventive and societally valued work.
The Baxter Settlement and its Implications for FCA Liability
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 In January, Baxter Healthcare Corporation (“Baxter”) agreed to pay $18,158 million after the Department of Justice (DOJ) brought suit for violating the Food, Drug, and Cosmetic Act (FCDA) and the False Claims Act (FCA). The Baxter case is unique because it was …
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Pharmaceutical Representatives in Chicago Soon to be Subject to Strict Licensing Requirements
Kimberly Seay Associate Editor Loyola University Chicago School of Law, J.D. 2018 On November 16, 2016, the City Council approved an ordinance amending Chicago Municipal Code § 4-6-010(c)(30), which will require the licensing of all pharmaceutical sales representatives in order to endorse pharmaceuticals within city limits and is set to take effect July 1, …
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Federal Trade Commission: Who is Protecting Your Personal Information in the Digital Age
As our society evolves over to a more digital world, it is important to take a step back and review what we are putting online. Recently, data breaches have become a common occurrence in our day-to-day lives. In 2016, personal information from about 25 million Uber customers and drivers in the United States. The notorious website for individuals seeking extra marital affairs, Ashley Madison, has itself fallen victim to a data breach. The hacker dumped 9.7 gigabytes of data into/onto the dark web. The data released in the Ashley Madison breach included names, passwords, addresses, and telephone numbers of users who created an account on the site. When data breaches like these happen, the Federal Trade Commission (FTC) steps in to protect the United States consumers by investigating the source of data breaches and prosecuting hackers.
FDA Finalizes Enforcement Policy Against Vaping
Amid the epidemic levels of youth use of e-cigarettes, the U.S. Food and Drug Administration, released a policy on January 2, 2020, requiring enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. According to the policy, the FDA intends to prioritize enforcement against fruit and mint flavored, cartridge-based electronic nicotine delivery system (“ENDS”). The FDA looks to regulate all ENDS products that manufactures have failed to make safe for use, as well as any ENDS product marketed for use by minors. The 2019 National Youth Tobacco Survey (“NYTS”), a survey conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, shows approximately 1.6 million youths were using ENDS products frequently, with nearly one million using e-cigarettes daily. The FDA’s enforcement policy is not a “ban” on flavored cartridges. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considerations on how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.
Prescribing Online with COVID-19
COVID-19 has rapidly changed the healthcare field unlike anything has before. With the continued spread, healthcare providers have started to adopt telehealth as a way to access patients and continue to provide quality care, without breaking their self-isolation. One avenue that has long been closed off for physicians has been online prescribing, but COVID-19 appears to be changing even that.