Gottlieb Hints at More Enforcement Actions Against Opioids
FDA commissioner Scott Gottlieb has hinted that more approved opioid products could be withdrawn from the market if the agency determines through post-market information that a product’s risks outweigh its benefits. Last month, the agency asked Endo Pharmaceuticals to remove its Opana ER (oxymorphone hydrochloride) opioid pain medication from the market based on such a concern (see earlier story). The agency said at the time that the decision was based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. It said that injection abuse of Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy.
Speaking at a public meeting on opioids 7/10, Gottlieb said FDA is continuously re-evaluating the safety of approved opioid products based on post-market information. “We’re also focused on how we can augment our post market data collection in these areas, which is one of the reasons we have convened this meeting today.” He said that “most of the exposure to opioids isn’t from extended release or long-acting formulations, which include most of the abuse deterrent formulations we’re discussing today. Most of the exposure to opioid drugs comes from the immediate release formulations like hydrocodone and acetaminophen or oxycodone and acetaminophen combinations. America is simply awash in immediate release opioid products. In fact, about 90% of all opioid prescriptions in the U.S. are written for the immediate release formulations of these drugs.”
Those becoming addicted to opioids will eventually move on to seek higher dose formulations of these drugs or illicit street drugs, Gottlieb told the meeting. “But immediate release opioid products may serve as the gateway for patients and non-patients who may continue to use or misuse these products, which could lead to a lot of new addiction,” he said. “And we all need to work to advance policies that rationalize the prescribing and dispensing of these products.”
Gottleib told the meeting that he has asked his staff to “focus on improving prescriber training. Among the questions I’ve asked are these: whether the content of existing programs is appropriate to ensure that prescribing doctors are properly informed about appropriate prescribing recommendations, that prescribers understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment? And are there circumstances under which FDA should require some form of mandatory education for health care professionals.”
Additionally, Gottlieb said that FDA has now determined that a Risk Evaluation and Mitigation Strategy (REMS) plan is necessary for prescribing of immediate release opioid products. “To this end, FDA intends to update the existing REMS on extended release opioid analgesics, and for the first time, extend these same regulatory requirements to the manufacturers of immediate release opioid analgesic products,” he said. “To start this process, the relevant letters, detailing the new requirements, will be sent to IR manufacturers in the coming weeks. The new training will be aimed at making sure providers who write prescriptions for the IR opioids are doing so for properly indicated patients, and under appropriate clinical circumstances. This is part of a broader effort to take new steps to make sure providers are properly informed about suitable prescribing and the risks and benefits associated with opioid drugs.”
In addition to training for prescribers, the REMS will require that training be made available to other health care providers involved in pain management of patients with pain. “This includes nurses and pharmacists. FDA believes that all health care providers involved in the management of pain should be educated about the safe use of opioids,” he said.