New Report Shows FDA Failed to Adequately Address Opioid Crisis

A new report by researchers at Johns Hopkins University shows that the Food and Drug Administration (FDA) failed to adequately address the opioid epidemic that has caused enormous suffering throughout the United States. The documents show the FDA failed to appropriately conduct oversight of the pharmaceutical industry and did not adequately train doctors to handle opioids and the associated risk of addiction. These failures contributed to the rise of opioid addiction in the United States, which kills around 72,000 people per year.… Read the rest

Off-Label Marketing of Fentora Leads to $425 Million Penalty

On September 27, 2007, the Food and Drug Administration issued a warning about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action came less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths. Cephalon has just recently agreed to settle the U.S. Justice Department investigation of its allegedly illegal off-label marketing of Fentora (fentanyl buccal) and Actiq outside the indications on their labels. Cephalon denied it marketed the drugs improperly and claims the problems are a result of improper prescribing.

In settling, they have … Read the rest