Latest Publications

Share:

OIG Urges Additional Oversight to Combat Medicare Part D Fraud

Fraud, waste, and abuse in the Medicare Part D prescription drug program continue to threaten the integrity of the program and pose challenges to the federal agencies charged with its administration and oversight. Earlier...more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Recent Supreme Court Decision on “Truth-in-Labeling” Has Far-Reaching Implications

On April 28, 2014, we reported on the United States Supreme Court’s involvement in the juice-labeling lawsuit between POM Wonderful LLC (“POM”) and Coca-Cola (“Coke”). In POM Wonderful LLC v. Coca-Cola Co. (“POM”), POM sued...more

Supreme Court to Untie Regulatory Knot in Juice Labeling Dispute

Hearing oral arguments on April 21, 2014, the United States Supreme Court has waded into the contentious world of food labeling in the case of Pom Wonderful LLC v. Coca-Cola Co. While the facts of Pom may present a...more

OIG Reveals Pervasive Problems in Federal Drug Discounting Program

The 340B drug pricing program was created by Congress in 1992 to make prescription medicines more available to low-income and indigent patient populations. The program has been, and likely will continue to be, fertile ground...more

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

Manufacturers Face Potential Roadblock to Early Challenges to Biologic Drug Patents

Biologic drugs have become increasingly popular in recent years, and now serve as standard treatment options for diseases such as diabetes, anemia, cancer, hepatitis, and multiple sclerosis. Biologics are a class of drugs or...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

The FDA’s Latest One-Two Punch to Combat Drug Shortages

On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more

9 Results
/
View per page
Page: of 1

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!