FDA's Public Assurance Following Valsartan Recalls

FDA's Public Assurance Following Valsartan Recalls

Introduction

According to FDA Associate Commissioner for Regulatory Affairs, Melinda K. Plaisier, generic drugs are safe and effective to use and undergo rigorous standards and regulatory inspections to ensure the safety and quality of all generic drugs. FDA is attempting to reassure the public about the safety of generic drugs, particularly those made in foreign countries, following the valsartan recall issue.

The call came after concerns were raised by a former FDA inspector, Massoud Motamed, who stated that he had warned about problems with valsartan manufacturing facilities in China and India at least a year before the recall began, but federal regulators ignored him.

There are currently 10 class action lawsuits and one individual action pending in District Courts across the U.S. against Valsartan. Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J.