Jason Drori

Jason Drori

K&L Gates LLP

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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

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