Food and Drug Commissioner Scott Gottlieb on Friday left the door open to the possibility of asking more drug companies to take their prescription opioids off the market.
Gottlieb, who has worked for the FDA in a leadership role under other administrations, said that he thought a stronger approach was needed to tackle the opioid epidemic than had been carried out during the last decade when he said federal agencies were aware the problem but failed to get ahead of it.
"To try to get ahead of it now, I think we need to be willing to take much more dramatic action, be much more potentially intrusive than what we thought we might have to do and what would have been our comfort zone five years ago or 10 years ago," he said at the National Press Club in Washington.
He noted that when his agency is evaluating a drug, it will not only be looking at whether the risks of that drug outweigh their benefits if they are used as prescribed but if the risks outweigh their benefits when they are used illicitly. Examples of illicit use include snorting or injecting opioids to get high, rather than for the treatment of pain during cancer treatment.
The FDA this year asked drug company, Endo, to pull its opioid Opana ER from the market. The move was a first for the agency, which did not have to take additional actions because Endo voluntarily removed its product, whose main ingredient is oxymorphone. News reports later surfaced, however, that Endo was considering putting one of its old drugs back on the market after pulling it in 2012 following patterns of abuse by patients.
Gottlieb said he could not speak to particular drugs when it came to asking other companies to remove opioids from the market. He did, however, indicate he was broadly addressing the reports on Endo.
"FDA will consider taking regulatory actions that could limit patient access to oxymorphone," Gottlieb said, elaborating that the FDA would seek to determine whether certain qualities about the drug, such as its ability to be crushed and snorted, could make it more susceptible to abuse.
He noted that the decision to ask Opana to be taken off the market wasn't rooted in whether the drug's risks were associated with its FDA-approved use for the treatment of pain, but in the way that people were using it illegally by injecting it. The result had caused outbreaks of hepatitis C and HIV.
The FDA and other federal agencies have been looking at ways to reverse the fast-growing opioid epidemic in the U.S., driven largely by addictions to prescription painkillers and also to heroin, the drug's illegal, cheaper alternative. Deaths from overdoses totaled 33,000 in 2015, according to latest-available data from the Centers for Disease Control and Prevention.
The Trump administration has said tackling the opioid epidemic is a priority. President Trump's health chief declared the epidemic a "public health emergency" last week and the FDA specifically has looked at ways that it can reduce abuse through other treatment offerings and through working with doctors and health insurance companies to limit the prescribing of these drugs.