Jason Drori

Jason Drori

K&L Gates LLP

Contact  |  View Bio  |  RSS

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

7/1/2015 - Controlled Substances Medicare Medicare Part D OIG Physician Medicare Reimbursements Prescription Drugs

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

2/3/2015 - ANDA Failure To Warn FDA Generic Drugs Labeling Pharmaceutical Pharmaceutical Manufacturers PLIVA v Mensing Preemption SCOTUS

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

6/16/2014 - Advertising Coca Cola FDA FDCA Food Labeling Lanham Act NLEA POM Wonderful POM Wonderful v Coca Cola SCOTUS

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

4/29/2014 - Coca Cola FDA Food Labeling POM Wonderful SCOTUS

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

2/17/2014 - 340B HHS HRSA OIG Pharmaceutical Prescription Drugs

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

1/20/2014 - DQSA Drug Compounding Drug Safety Enforcement FDA FDCA Generic Drugs Pharmaceutical Pharmacies Prescription Drugs

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

11/22/2013 - Biologics Drug Manufacturers FDA Patents Pharmaceutical

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

11/18/2013 - ANDA Failure To Warn FDA Generic Drugs Labeling Mensing Pharmaceutical Wyeth

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

11/7/2013 - Drug Manufacturers FDA FDASIA FDCA Pharmaceutical Prescription Drugs

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 to create your digest using LinkedIn*

*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.
×