The FDA has been issuing statements since late summer about actions taken to reduce the numbers of deaths from opioid prescription analgesics, and illicit opioids, and to help bring more novel pain management "products."
On October 24, a bipartisan bill called the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act was signed into law. This new legislation grants the FDA additional authorities that FDA Commissioner Scott Gottlieb, MD, said will meaningfully advance our efforts to reduce the scope of the crisis.1
He said the legislation will help the FDA work across 4 "domains" it has identified:
"First, our efforts to decrease exposure to opioids as a way to prevent new addiction; second, advancing innovation in pain medicines that don't have the same risks as opioids; third, the development and use of better treatments to help those with opioid use disorder; and fourth, increasing our enforcement and interdiction work aimed at illicit drugs such as fentanyl, especially when it comes to products being shipped illegally through the international mail facilities (IMFs)," according to a news release on the FDA website.
"The new law also gives the FDA the authority to issue a mandatory recall order for any controlled substance if there is a reasonable probability that the controlled substance would cause serious adverse health consequences or death," Gottlieb said. "Previously, the recall of these types of drugs could only be done on a voluntary basis."
He said the law gives the FDA the authority to require certain types of packaging, such as blister packs, that might discourage typical 30-day prescriptions, although it is not clear how that will have an effect, and to require manufacturers to include "mail-back" pouches or other safe disposal for unused pills.
"This will help get unused medications out of medicine cabinets and is another step afforded by the legislation that can help reduce excess supply that can create a risk for abuse, misuse, and addiction," he said.
Administration to Withdraw 2014 Document on Developing New Pain Drugs, Replacing With New Approaches
Gottlieb released an earlier statement on August 29 saying, "First, we intend to withdraw our existing, 2014 analgesic guidance document on developing new pain drugs. That guidance typically called for a large number of studies to get a general chronic pain indication and may have been difficult to implement because it was so broad. Instead, we've determined that a more focused approach would streamline drug development in specific areas."2
Gottlieb said the FDA would replace the 2014 guidance document with at least 4 new documents, to be released over the next year.
"These new policies will create a more efficient path for new product innovation," Gottlieb said. For example, 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."
The intent, he said, is to broaden the range of new drug development opportunities and help to efficiently bring to market "more novel products for the treatment of pain."
One guidance document to be released, he said, will address how sponsors can demonstrate drugs that can spare the use of opioids in the treatment of acute pain.
Another guidance will outline the information that the FDA will ask drug makers to provide to help assess the benefits and risks when new opioid pain drugs are put into development, Gottlieb said. "This will include an updated framework for evaluating the risks associated with intentional or illicit misuse or abuse of drugs. As I noted, we're explicitly considering the risks associated with illicit use as a factor in how we assess risks and benefits."
A third guidance will outline a path for developing extended-release local anesthetics that can serve as an alternative to the systemic use of oral opioid drugs, he said.
"Finally, we also plan to issue a guidance document to assist sponsors with the development of new non-opioid pain medications for chronic pain that can provide therapeutic alternatives to the use of opioids," Gottlieb said.
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