Category:

Drugs & Devices

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.

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.

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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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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Big Pharma Scorecard Encouraging Greater Clinical Trial Transparency

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   Bioethics International (BEI), a non-profit organization, is working to improve transparency and ethics in healthcare delivery and innovation by holding pharmaceutical companies accountable for compliance with the Food and Drug Administration Amendments Act (FDAAA). Many people do not trust drug companies, believing …
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