On November 21st, FDA Commissioner Scott Gottlieb released a statement discussing the government’s efforts to combat the opioid epidemic. In the guidance, Gottlieb stresses the importance of decreasing “unnecessary exposure to opioids,” while ensuring those with acute and chronic pain have access to proper painkillers. He goes on to discuss the strategy behind opioids with abuse-deterrent formulations, or ADFs, that make tablets much more difficult to crush and snort or dissolve and inject.
So far, the FDA has approved 10 opioids with ADFs, but doctors have been slow adopt them for a number of reasons. The main reason however seems to be tied to the higher price, as these new formulations are only available in the form of brand-name products. To support the transition and drive prices down, the FDA issued a final guidance to help the industry develop generic versions of ADF opioids.