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The US FDA is planning to withdraw its existing guidance on the development of pain products and replace it with more specific documents as part of the agency's efforts to combat the opioid crisis.

FDA has discussed the idea of additional guidance previously, but Commissioner Scott Gottlieb offered the most details to date in a voluminous Aug. 29 announcement.

The existing guidance typically urges a large number of studies to get a general chronic pain indication, "and may have been difficult to implement because it was so broad," Gottleib said. "Instead, we’ve determined that a more focused approach would streamline drug development in specific areas."

In its place, "we plan to issue at least four new guidance documents … over the next six to twelve months. These new policies will create a more efficient path for new product innovation," he said.

"The new guidance documents will recommend the study of one or two populations for innovators who wish to pursue a more limited indication for the treatment of specific kinds of pain. This will broaden the range of new drug development opportunities that are available. Our new approach should also help more novel products for the treatment of pain come to market more efficiently."

The four new guidances will address:

  • Drugs that can spare the use of opioids in the treatment of acute pain. This guidance will "set forth the FDA’s current thinking on how sponsors can demonstrate a clinically meaningful reduction in the use of opioid pain medications when used for acute pain."

  • Assessing the benefits and risks of new opioids in development. This guidance will "include an updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of drugs," Gottlieb said. "We’re explicitly considering the risks associated with illicit use as a factor in how we assess risks and benefits."

  • Extended-release local anesthetics. This guidance will "address the clinical pharmacology, the proper evaluation of safety and efficacy, and the types of studies that may support approval of these products," which can serve as an alternative to oral opioids.

  • Non-opioid pain medications for chronic pain

The new development standards for pain products are an example of just how quickly the agency's thinking on opioids has been evolving since the guidance that now appears woefully out of date was issued in just 2014.

Gottlieb's announcement contains a blunt assessment of the earlier approach the medical community had to opioid addiction.

"The reason that we find ourselves with a crisis of such proportion is that as a medical profession, we’ve been one step behind its sinister advance," he said. "Collectively, we didn’t take all the steps we could, when we could, to stop the advance of this crisis. We shunned hard decisions. As a profession, providers were too liberal in our use of these drugs well past the point where there were signs of trouble, and the beginning of a crisis of addiction."

Gottlieb has spoken previously about how he served at the agency when opioid addiction was not treated as a national crisis. "I've learned some hard lessons," he said in his statement, which contains an urgent sense of mission.

"I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis. We must all be able to say we did everything we could. That we acted as aggressively as needed. And that we succeeded."

Gottlieb noted that agency's various efforts, extensively listed in the announcement, were already helping to produce some success.

"A recent FDA analysis of commercially available data showed steep drops in dispensing of opioid analgesics in retail outpatient settings," Gottleib said. (See chart.)

 FDA Prescription opioid analgesics


In the first six months of 2018, the volume of opioid analgesics dispensed was 74.1 metric tons of oral morphine equivalent, down more than 16 percent from the first half of 2017, when the volume dispensed was 88.8 metric tons.

"Earlier declines were there, but smaller," he said. The volume of opioid analgesics dispensed in the first half of 2017 and 2016 were about 10.4 percent and 3.4 percent less than the preceding year.

"These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs."

A Changing Epidemic

But as FDA ramps up its effort to make opioids safer and alternatives more available, "the epidemic is turning from one that was largely dominated by addiction formed in the medical setting, involving prescription drugs, to one that increasingly implicates the use of illicit drugs, including highly potent fentanyls," Gottlieb noted.

"These drugs are obtained illegally, often through purchases made on-line, and in many cases shipped through the international mail."

The shift means that, even with FDA partnering with Customs and Border Protection on package inspection and cracking down on internet pharmacies, opioids may be destined to remain a national crisis for the foreseeable future regardless of whether Gottlieb and agency staff are able to shepherd a new generation of safer pain medications onto the market.

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