New FDA Head Pledges To Develop Harder-To-Abuse Painkillers

By John Lavitt 03/14/16

Dr. Robert Califf's strategy to combat the opioid epidemic includes tamper-resistant formulations and stronger warning labels.

New FDA Head Pledges To Develop Harder-To-Abuse Painkillers
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As the new commissioner of the Food and Drug Administration, Dr. Robert Califf has pledged to fully support efforts to develop harder-to-abuse, tamper-resistant painkillers.

Although the FDA can’t stop the crisis, it can certainly help. Califf pledged to a panel of FDA advisers on March 1 that he would do "everything possible under our authority to prevent abuse, save lives and treat dependence," AP reports. He went on to say that "the promise that we are on a path toward products that are effective in preventing abuse both by patients and non-patients is real. And the agency intends to fully support efforts to advance this technology."

A key element in Califf's strategy is requiring tamper-resistant formulations for painkillers. For example, the latest version of OxyContin is harder to crush for snorting. If an individual tries to dissolve it for intravenous use, it turns into a thick jelly that is difficult to inject. Califf acknowledged that such drugs are not guaranteed to hinder abuse—it remains unclear whether they actually lead to fewer opioid overdoses—but it is a step in the right direction.

The Senate confirmed Califf to head the FDA at the end of February amid vocal objections from some senators that his agency has not done enough to stymie painkiller abuse. In 2014, fatal overdoses tied to these drugs exceeded 28,000, the highest number on record, according to the Centers for Disease Control and Prevention. Opioid overdoses have quadrupled since 2000.

Califf's recent remarks at the FDA's headquarters seemed to address these objections by laying out a strategy for addressing the opioid epidemic that focuses on stemming the tide of abuse. "What we can do is work with prescribers, professional associations, patient advocates and state and local partners—essentially the entire country—to encourage safe use and disposal of opioid medications," he said.

In February, Califf promised to add stronger warning labels to the most commonly prescribed opioids, and to consult more with outside advisers.

Other anti-opioid abuse efforts by the FDA include requiring drug manufacturers to provide additional studies examining the long-term safety and effectiveness of long-acting opioids for chronic pain. In January, a government report found that the agency has been doing a bad job of tracking the safety of new drugs after they go on the market.

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Growing up in Manhattan as a stutterer, John Lavitt discovered that writing was the best way to express himself when the words would not come. After graduating with honors from Brown University, he lived on the Greek island of Patmos, studying with his mentor, the late American poet Robert Lax. As a writer, John’s published work includes three articles in Chicken Soup For The Soul volumes and poems in multiple poetry journals and compilations. Active in recovery, John has been the Treatment Professional News Editor for The Fix. Since 2015, he has published over 500 articles on the addiction and recovery news website. Today, he lives in Los Angeles, trying his best to be happy and creative. Find John on Facebook, Twitter, and LinkedIn.