James Matthews

James Matthews

K&L Gates LLP

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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

Supreme Court Applies Rule of Reason in Antitrust Challenges to Reverse-Payment Patent Settlements

One of the most controversial antitrust issues for the pharmaceutical industry during the last decade has been the treatment of patent settlements in which a patent-holding branded manufacturer made payments to its generic...more

6/24/2013 - Actavis Inc. FTC FTC v Actavis Generic Drugs Hatch-Waxman Patents Pharmaceutical Prescription Drugs Reverse Payment Settlement Agreements SCOTUS Settlement

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