FDA threatens legal action for opioid supply chain violations

In its latest move to stop the spread of illicit opioids, FDA is threatening to take legal action against companies if drug supply chain security violations are not promptly remedied. FDA Commissioner Scott Gottlieb also announced that the agency is developing two guidances to describe how it weighs the risks of illicit use in evaluating opioid products, and to encourage focused development of non-opioid alternatives.

On Feb. 12, McKesson Corp. (NYSE:MCK) became the recipient of FDA's first warning letter under the Drug Supply Chain Security Act. The letter highlighted a tampering incident that involved opioids, as well as other incidents involving drugs to treat HIV, seizures, bipolar disorder and high blood pressure...