Supremes protect generic makers after dissing innovators

The Supreme Court handed down a decision yesterday that represents a significant victory for the pharmaceutical industry. The court s 5-to-4 ruling shields generic drug makers from failure-to-warn lawsuits as long as their product labels are identical to those of brand-name manufacturers. Generic pharmaceutical companies Teva Pharmaceutical Industries, Mylan Inc. s UDL Laboratories, and Iceland s Actavis were sued for failure to add neurological movement disorders as a possible side effect for the drug metoclopramide (Reglan).

Yesterday s decision posited that the Supremacy Clause of the U.S. Constitution which mandates that federal law preempts a state law in cases when the two laws conflict protects generic drug companies: such companies must continue to use the same labels as their brand name equivalents and are, in fact, barred from modifying or updating an FDA-approved drug label. This ruling contrasts with the 2009 Supreme Court decision in the Wyeth v. Levine case, in which pharmaceutical company innovators the companies who actually developed the original brand-name drugs were held to a stricter standard regarding an allegedly obsolete label.

ACSH s Dr. Elizabeth Whelan, who agrees with the new ruling, observes that, while generic companies are no longer liable for the warning labels that have been approved for the brand name equivalent, it appears that the original inventor of the drug may still be sued for failing to update the label as new side-effects are discovered.