WASHINGTON -- The FDA would like to work with physicians to find a way to curb the opioid epidemic while still allowing patients who need opioids to have access to them, FDA Commissioner Scott Gottlieb, MD, said here Tuesday.
"There aren't a lot of alternatives for the treatment of chronic pain; for certain conditions, opioids are the only things that do work. For metastatic cancer pain [or] sickle cell disease, patients often become dependent on opioids and [require] higher and higher doses," Gottlieb said at a briefing sponsored by the Alliance for a Stronger FDA and the Pew Charitable Trusts.
"We're very concerned about this ... How do we create, in policy, thresholds where we are protecting patients who have a very appropriate need for longer duration of use -- and protecting the doctors who prescribe their drugs -- while trying to address indiscriminate prescribing at the other end of the market, where patients with minor dental procedures ... are getting a 30-day supply of opioids? You shouldn't see that."
"We have to write broad policy and use blunt instruments; it's hard to write policies that can clearly differentiate between the two," he continued. "We are looking to try to work with provider groups and work with the community as much as we can." The agency is currently working with provider groups to formulate guidelines that could be incorporated into drug labeling that could form the basis of how opioids get dispensed. Also, "national e-prescribing could help providers to exert more of their own oversight," Gottlieb said.
The agency also is acting on several other fronts in the opioid crisis, he said. On Tuesday, the FDA , a botanical substance Gottlieb described as "an opioid-like product [that] may be fueling the addiction epidemic." People have been using the drug to treat opioid withdrawal symptoms, and to get high, he noted.
FDA sent the Drug Enforcement Administration (DEA) an "8-factor analysis" of kratom to help with the DEA's decision on how to "schedule" the drug. "We wanted to be very transparent around our concerns," he said.
Loperamide (Imodium) is another drug people are taking in very high doses, both to reduce addiction symptoms and to get a different high, said Gottlieb. However, high doses of the drug can also cause toxicity. To prevent people from buying bottles containing high numbers of loperamide pills and blending them up into a "high-dose milkshake," the FDA announced in January that it is urging loperamide makers to change their packaging.
"We're also going to make calls to intermediaries supplying it [in bulk] to try to encourage them to exercise some public health judgment," he added, musing, "Who would have thought 5 or 10 years ago that we would be talking about loperamide with respect to an addiction problem?"
During a question-and-answer session, Gottlieb was asked what the FDA was doing to address high drug pricing. "We don't address drug pricing, but we have tried to address this challenge with respect to where we can facilitate competition," he replied. Some of the behaviors taking place in the market stymie generic competition, such as the fact that generic companies are having trouble getting dosages they need to prove biosimilarity.
"They can't even get access to physical doses they need to run government-mandated studies," Gottlieb said. "That to me corrupts the system; it impugns compromise we made [that sustains] market-based pricing ... We also need to support brisk competition once lawful patents have lapsed and drugs are expected to face generic entries."
The FDA soon will unveil a "comprehensive plan to promote competition and availability of biosimilars," he continued. "There are some things we can do from a regulatory standpoint to better facilitate the creation of this market ... Health plans have to be willing to demonstrate there's a market for these products." Another guidance will address combination drug/device products that are developed in a way to exclude the entry of generics into a market.
As it works to address all of these areas, the FDA still suffers from a lack of adequate staffing, said Gottlieb. He explained that the way the agency's user fee program is structured, the user fees can only kick in if a program has already been allocated a certain minimum amount of money, which means that programs funded by user fees are virtually guaranteed to get lots of funding, "[while other] programs ... don't have users associated with them and user fees protecting them."
The additional hiring authority the FDA got through the 21st Century Cures law has been helpful, but it just exacerbates the staffing disparities, "with people migrating across centers into higher-paying slots," he said. For example, an attorney with the FDA's Office of General Counsel may be able to raise his or her salary substantially just by going to a user-fee-funded center within FDA.
In addition, hiring at the agency "is historically a slow process, and we lose a lot of talent waiting for job offers to come through," he added. "If coming to FDA is going to be a 12-month process, you'll lose a lot of good people." To address that problem, the agency has implemented a pilot program which reduces the agency's job classifications from more than 10,000 to about a dozen, and "dramatically cuts" hiring time, Gottlieb said; it will be piloted beginning this month with 140 hiring slots at the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research (CDER).
The other challenge in hiring "is that [we] have a senior leadership team that has been there a long time and is coming up at retirement age at about the same time," he said. "If I could keep [CDER director] Janet Woodcock in her position for another 25 years, I would, but I don't think I'm going to be able to do that. We are going to focus on succession planning across the agency."