The U.S. Food and Drug Administration (FDA) will require drug manufacturers to study whether opioids are really effective in alleviating chronic pain. This is one of the steps taken by the government to harness the use of the narcotic drugs, which engendered the drug epidemic, explained the FDA Commissioner, Scott Gottlieb.
Some studies have already indicated that opioids are not effective for pain after 12 weeks of therapy and many health officials say long-term use of opioids can lead to addiction, prompting the users to build up a tolerance and seek larger doses. However, controlled, conclusive research is scarce.
The findings of opioid ineffectiveness through rigorous studies could allow the FDA to change the labeling on a few opioid-based medications and enforce special guidelines for prescribing, dispensing and administering. The agency would even prohibit the use of opioids in some cases.
Gottlieb said in an interview, “We are going to impose a mandate on existing products… to answer the question that people have been posing for years: whether you have declining efficacy, and whether that declining efficacy can lead to addiction.”
Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, said that the FDA already has all the clinical research it needs to tighten restrictions on using opioids for chronic pain by changing the guidelines on how they should be prescribed and administered.
Kolodny said, “Here we go again. That’s exactly what the FDA said to us in 2013… Five years later, we don’t have the studies and another FDA commissioner says, ‘We’re going to do the studies.”
The FDA Commissioner said, “The new research is aimed at all immediate, long-acting and extended-release opioid tablets taken by patients outside of health-care settings.” “It would cover products already on the market and new applications.”
However, it would not include painkillers that are used for a shorter duration in the hospital set-up.
Opioid painkillers were actually intended for the severe pain caused by cancer and end-of-life care. However, in the late 1990s, pharma companies helped encouraged physicians to prescribe them to patients with less serious conditions.
Gottlieb added, “The FDA also is mandating a second study to determine whether opioids can actually cause users to become more sensitive to pain, a condition known as hyperalgesia. Preparations for that research by a consortium of companies are further along and it should start soon.”
After Kolodny’s group protested that opioids should be considered unsafe and ineffective for chronic pain in 2013, the FDA ordered similar research, which included an attempt to determine whether painkillers cause hyperalgesia, or chronic pain.
Gottlieb explained that those studies were difficult to carry out because the FDA, at that time, had authority only to involve post-market studies of safety and not the efficacy.
In 2017, the vast majority of opioid prescriptions written were for generic versions. The research will be required of those companies that produce brand-name opioid drugs. Also, generic drug producers will be required to follow the same changes.
According to a section of the Support for Patients and Communities Act that has passed in October, the FDA acquired the authority to demand the research on the effectiveness of the drugs. Previously, the FDA had the authority on the safety studies of drugs, but the new section passed in October will allow for the effectiveness studies as well.
Gottlieb said that the drug manufacturers would be informed of the new requirement. However, a spokesperson for Purdue Pharma declined to comment, which was pleaded guilty for deceptive marketing of opioids in 2007.
The FDA Commissioner previously said the agency must be more aggressive when it comes to fighting the opioid crisis, which killed more than 47,000 people in 2017 due to a drug overdose. According to the CDC, the number of opioid prescriptions written annually declined steeply in 2017 and even the drug overdose deaths leveled off. In the U.S., still, opioid overdose deaths are six times higher when compared with the figures in 1999.
