FDA Chief: Drug Companies Must Fund Opioid Efficacy Studies

The commissioner of the United States Food and Drug Administration (FDA), Scott Gottlieb, says that addressing the opioid epidemic requires a bolder plan of action, and that the agency will require drug companies to initiate studies on whether opioids are effective treatment for chronic pain. Depending on the results of those studies, the FDA could change labeling requirements and even restrict the use of some prescription opioids that have long been used to treat prolonged pain conditions.

In a statement issued Tuesday, Gottlieb wrote, “Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.”

“At the FDA, we’ve committed to taking more rapid action in the face of new threats, like the growing prevalence of illicit fentanyl that’s contributing to overdose deaths,” he wrote, noting that the agency would advise physicians to cut back on prescriptions, as well as how certain drugs are prescribed and in what quantity. A recent study found that synthetic opioid fentanyl was overprescribed for years, and that the FDA knew but did little to act. In its statement on Tuesday, the agency chief noted that cutting back on prescription quantities is just as important as curtailing the number of prescriptions in the first place, writing, “This means no more 30 tablet prescriptions for a tooth extraction.”

In the wide-ranging agenda, Gottlieb also took aim at whether long-term use of opioids for pain relief can cause a reduction in efficacy, and wrote that existing products will also be subject to review. One reason some patients get hooked on opioids is that over time, individuals may experience less benefit from the powerful drugs and take larger quantities in order to gain the same relief. That can quickly slide into substance abuse, and opioid addiction can spiral into unintended overdose. Opioid overdoses now outpace auto accidents as an accidental cause of death in the U.S. and Gottlieb notes that in addition to restricting access to opioids, another way to contain the crisis is to make naloxone more widely available, possibly over the counter.

Gottlieb also noted that in the year ahead, the FDA will continue to strengthen enforcement against illicit opioids, including border drug busts, and will take steps to promote the development of other non-addictive drugs to treat pain.