Calling the opioid crisis the “toughest public health challenge that we face at FDA,” Scott Gottlieb, MD, commissioner of the FDA, recently revealed several new strategies to curb the epidemic.
The issue of opioid abuse is of serious concern to health experts — CDC data suggest the epidemic claims 91 lives a day, and is responsible for more than six of every 10 drug overdose deaths.
The FDA’s course of action was revealed on the heels of last week's CDC report indicating that opioid prescriptions declined from 2010 to 2015, but the opioid prescription rate in 2015 was three times higher than the rate reported in 1999.
“The crisis of opioid addiction is a public health tragedy of enormous proportions,” Gottlieb said before a FDA scientific meeting on opioids. “We need to confront it like any explosive epidemic.”
He said one new strategy includes updating the Risk Evaluation and Mitigation Strategy plan on extended-release opioid analgesics, and for the first time, extending these same regulatory requirements to the manufacturers of immediate-release opioid analgesic products. Gottlieb indicated that new training will be aimed at making sure providers who write prescriptions for the immediate-release opioids are doing so for properly indicated patients, and under appropriate clinical circumstances. Gottlieb also said letters detailing the new requirements will soon be sent to the manufacturers of such products in the coming weeks.
“It’s time to take direct action to address the close to 200 million opioid analgesic prescriptions each year that are for the immediate-release products,” he said. “[The] FDA believes that all health care providers involved in the management of pain should be educated about the safe use of opioids… We’re [also] actively exploring the question of whether, in the future, there should be mandatory provider education, and how we’d operationalize such a condition.”
A second new action Gottlieb described was a survey of doctors to determine whether naming conventions involving opioids can be improved.
“I want to make sure that the nomenclature we use to describe and label these products is accurately conveying their properties to those who prescribe and use them. In particular, we want to make sure that the labels and nomenclature enable providers to adequately distinguish between the risk of abuse and the risk of addiction,” Gottlieb said. “Through the regulatory lexicon we use to describe these products and their abuse deterrent features in drug labeling, we don’t want to improperly convey a perception that a product that’s resistant to manipulation and abuse is somehow also less prone to fueling addiction, when that is simply not true.”
Gottlieb also indicated the FDA will continue to re-evaluate the safety of approved opioid products based on postmarket information on an ongoing basis, and, when warranted, seek the removal of products from store shelves, as it did with Opana (oxymorphone hydrochloride) last month. Endo Pharmaceuticals, the company’s manufacturer, stated in a press release that “it continues to believe in the safety, efficacy and favorable benefit-risk profile of Opana when used as intended,” and that it “has taken significant steps over the years to combat misuse and abuse,” but it complied with the FDA’s request last week.
He said these new efforts supplement existing strategies implemented since he was confirmed as commissioner, such as exploring whether the FDA should take further steps to ensure that the number of opioid doses that an individual patient can be allocated is more closely aligned with the medical indication and examining how the agency balances benefit and risk regarding controlled substances.
Gottlieb stated that cooperation among the FDA, drug companies and medical professionals is a must for the plans to succeed, but also indicated that any actions must require sufficient deliberation.
“This is a public health emergency. We are treating it that way and we’ll continue to take assertive new steps,” he said. “We need to work together and take more vigorous steps to address it. But we need to make sure all of our actions are carefully considered with broad stakeholder input, and based on sound science.” – by Janel Miller
Disclosure: Gottlieb is FDA commissioner.