Category:

The Marketplace

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.

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.

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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SEC set to change how investors elect board members

Gilbert Carrillo Executive Editor Loyola University Chicago School of Law, J.D. 2017   The Securities and Exchange Commission (SEC) is expected to propose new rules that would make it easier for shareholders to vote on board candidates nominated by investors, versus those pushed by the company’s management. What impact could this have on compliance departments? …
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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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Theranos: New Compliance Program Hopes to Save the Company

Gilbert Carrillo Executive Editor Loyola University Chicago School of Law, JD 2017 Edmund Tyrrell Associate Editor Loyola University Chicago School of Law, JD 2018   Theranos, the American health-tech and medical-lab-services company, recently hired two executives to oversee regulatory compliance standards. The executives were hired following Theranos receiving multiple sanctions from U.S. regulators about the …
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Mylan Medicaid Fraud Investigations

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   Mylan has already been under public scrutiny for increasing the price of its EpiPen allergy shots. Last week the State of West Virginia launched a Medicaid fraud investigation questioning Mylan’s price hike and compliance with drug rebate laws. Mylan Pharmaceuticals participates in …
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19 Ingredients, 2.2 Million Pounds of Product and $368.7 Million to Comply

Brittany Tomkies Executive Editor Loyola University Chicago School of Law, JD 2017   The Food and Drug Administration (FDA) issued a final rule on September 2, 2016 establishing that certain over-the-counter (OTC) consumer antiseptic wash products (i.e. antibacterial hand and body soaps) containing certain active ingredients can no longer be marketed as they are not generally …
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