Category:The Marketplace
A Changing Gray Market Post Lexmark
On May 30, 2017, the Supreme Court issued a decision in Impression Prods., Inc. v. Lexmark Int’l, Inc. finding 8-0 to disallow post-sale restrictions on goods, and 7-1 on the matter of international exhaustion. The Court’s holding reinforced the doctrine of international exhaustion for patents, finding that the first authorized sale exhausts the patent holder’s rights to block importation. In theory, one could now legally purchase pharmaceuticals overseas at cheaper prices and import them to the United States.
FDA Nutrition Facts Label: Will the New Administration Approve a Change?
On May 20, 2016 the Food and Drug Administration (FDA) announced a new nutrition facts label for packaged foods, the first significant makeover in twenty years. The new label reflects new scientific information regarding our diets; such as the link between diet and chronic diseases like obesity and heart disease. This new label comes after three years of negotiations and proposed improvements between the FDA, scientists, and lobbying groups. Those in favor of the changes have pointed out that the old nutrition fact labels had no information to help consumers determine if they were complying with the U.S. Dietary Guidelines’ recommendations and that the labels did not reflect the necessary nutrients per day. These changes affect manufacturers as well as consumers. Manufacturers are not only worried about having to reformulate their foods, but also having to reconsider their ability to make certain nutrient content claims in advertisements and on packaging. Companies will also have to consider additional costs associated with packaging design, development of new artwork, regulatory consultation and review to ensure label compliance, reconsideration of inconsistent advertising, and human costs associated with potential new operating procedures and training to ensure compliance with the new regulations. In response to complaints from manufacturers, consumer advocates are reminding the White House Administration to remember that the FDA’s mission is protect the health of the American people not the bottom line of manufacturers.
Spotify’s Settlements Rock the Music Scene: Artists Continue to Seek Compensation for Alleged Willful Copyright Infringement
It is no secret that streaming services have been a highly controversial issue in the entertainment industry in recent years. Artists from all over the world have been affected by the rise of music streaming; many believe it is no different than piracy. Nevertheless, Spotify is in fifty-eight countries, and the user base consists of over fifty million subscribers globally, with twelve and a half million paying subscribers. As Spotify has grown, questions have risen surrounding the rights that artists, producers, and writers have to their music that the public has access to through ‘streaming’. As technology advances, the music industry will continue to change. The recently filed lawsuits against Spotify show that this is an underdeveloped area of the law that needs to be explored. The decisions regarding Spotify’s streaming service and compliance with copyright laws will have major implications for not just Spotify, but the entire music industry.
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.
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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