By Joseph Gregorio
On March 3, 2014, the FDA announced proposed changes to its nutrition facts panel (“NFP”). Of the several proposed modifications, the addition of an “added sugars” label may be the most controversial. The proposed “added sugars” label would be indented below the already standard “sugar” section, a subsection of the “carbohydrates” information. The FDA accepted comments on the proposed rule until June 2, and comments regarding information collection issues until August 2. There were several parties who provided comments, strongly opposing the “added sugars” label.
By Hillary Cook
In July 2014, two United States Circuit Court of Appeals ruled on the issue of whether the tax credit promulgated by the Internal Revenue Service (“IRS”) within the Patient Protection and Affordable Care Act (“ACA”) is applicable to health insurance purchased by individuals on federally-facilitated health insurance exchanges established in the absence of state run health insurance exchanges. The United States Court of Appeals for the District of Columbia held health insurance purchased on a federally-facilitated exchange established in the absence of a state run exchange is ineligible for the IRS tax credits pursuant to ACA. Hours after the decision from the D.C. Circuit Court of Appeals, the Fourth Circuit Court of Appeals ruled in the reverse, affirming the lower court’s decision to uphold the IRS rule authorizing tax credits to individuals who enroll in health insurance programs on both state-run and federally-facilitated health benefit exchanges valid.
By Vaughn Bentley
The Food and Drug Administration (“FDA”) recently released a draft guidance for pharmaceutical companies looking to advertise on Twitter, Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. The guidance makes it illegal to advertise only positive benefits of drugs on social media without having a negative effect in the same posting. Since the release of the guidance in the June of 2014, the pharmaceutical companies have responded with a chorus of objections and outcry. One of the more interesting objections the pharmaceutical industry has raised is that the draft guidance is unconstitutional.
By Jennifer Chow
Earlier in 2014, Cable News Network (“CNN”) issued a series of articles on the extended delays for United States veterans to be seen in the Veterans Affairs health care system. CNN boldly stated that hospital delays were “killing war veterans.” That following April, CNN broke the news that United States veterans were not only dying as they waited for health care appointments, but secret waiting lists and falsified records were also being utilized to hide the thousands of veterans forced to wait months to see a physician. The breaking news launched multiple federal investigations, including an internal investigation by Veterans Affairs (“VA”), as well as investigations by Veterans Affairs Office of the Inspector General, the Justice Department and the Federal Bureau of Investigations. As the year comes to a close, this article examines the progress, or lack thereof, of the Veterans Affairs Administration and addresses what the future of health care looks like for our war heroes.
By Sydney Mayer
In September 2014, CVS and Caremark, CVS Health’s pharmacy benefits manager, became the first major pharmaceutical chain to ban tobacco sales in all of its 7,700 stores. The company is moving forward with a plan to“improve public health and generate goodwill” among its customers. However, while their commitment to remove tobacco products from its shelves is admirable and a step in the right direction against cigarettes and other addictive products, CVS sacrificed a reported $2 billion in annual tobacco sales for this initiative. In an attempt to compensate for their financial damages, beginning in 2015, Caremark will require certain customers to pay an extra co-payment on any prescription filled at a pharmacy that sells tobacco products. The co-payment could be as high as $15 for some customers. Caremark currently works with Walgreens, Rite Aid, Target, Kroger, and CVS as a pharmaceutical benefits manager, responsible for processing and paying prescription drug claims. Of those, only CVS and Target are tobacco-free. With a start date of January 1, 2015, employers and Caremark-managed pharmacies would have the option of joining the tobacco-free network, and any of its customers that fill at a pharmacy not in the network would have to pay the additional co-payment. This action is meant to encourage other pharmacies in the Caremark network to join the tobacco-free network and ban tobacco sales in their store. Furthermore, CVS hopes that this initiative will drive business in their direction; individuals who do not want to pay an extra co-payment will leave their tobacco-selling pharmacy and come to CVS. The additional co-payment appears to be the answer to CVS’s financial losses since pulling tobacco-products from its shelves...
By Azeema Akram *
On October 17, 2014, the Illinois Supreme Court upheld the constitutionality of a law that requires the Department of Financial and Professional Regulation (the “Department”) to permanently revoke the licenses of health-care workers convicted of sex-related crimes or crimes relating to battery of patients. The Court affirmed the decision of the appellate court, which affirmed the circuit court’s judgment to dismiss the plaintiffs’ complaints against the Department for permanently revoking their licenses.[i]
By Sutapa Adhikari
On November 18, 2014, DePaul’s Health Law Institute welcomed members of the Wolters Kluwer Health Law editorial team, Anthony Nguyen, J.D. and Danielle Capilla, J.D., who gave a lecture on generic drug liability litigation. The lecture helped attendees gain a better understanding of the current implications of generic drug liability litigation and established a platform for future discussion.
By Brian King
Earlier this month, Mallinckrodt, Inc. (“Mallinckrodt”), a generic drug manufacturer, filed a complaint in the U.S. District Court for the District of Maryland challenging the U.S. Food and Drug Administration’s (“FDA”) decision to downgrade the Therapeutic Equivalence (“TE”) index of one of its primary products, generic CONCERTA, from “AB” to “BX.”  Although the FDA approved the company’s generic drug in 2012, its TE rating was downgraded after the FDA issued a revised Abbreviated New Drug Application (“ANDA”) bioequivalence guidance in early November.  Based on an analysis of adverse event reports and reexamination of previously submitted data, the FDA raised concerns that the generic drug may not produce the same therapeutic benefits as brand-name CONCERTA, and has required that the drug company either confirm bioequivalence of their product under the revised standards within six months, or agree to voluntary market withdrawal. 
By Haley Guion
On October 28, Alane Repa, RN, BSN, MS, JD, presented to law students and legal and medical professionals the status of current laws on informed consent and refusal in the United States.
By Meagan Pagels
On October 6, 2014, the Centers for Medicare & Medicaid Services (“CMS”) announced an initiative set to improve transparency and accountability in nursing homes.[i] Commencing January 2015, CMS will make significant changes to the Nursing Home Five-Star Quality Rating System, which is the current system in place to “rate” nursing homes that receive Medicare funding.[ii] This rating system was implemented by CMS in December of 2008 and applies in all fifty states and Washington, D.C.[iii] Each facility receives a certain number of stars in specific categories, including state health inspections, time nurses spend with patients, and the overall quality of medical care.[iv] Five-star facilities are rated the best, while one-star facilities are said to be the worst.[v] In addition to compelling nursing homes to strive for best care practice, the rating system was developed to aid consumers and their families in choosing a nursing home best suited for their needs.