The Food and Drug Administration is planning new steps to encourage the development of nonaddictive alternatives to opioid pain medications, Commissioner Scott Gottlieb said in an interview.
As part of the effort, the agency plans to withdraw its existing 2014 guidance to the drug industry on pain medicines. That document is overly broad, Gottlieb said, and is sometimes a barrier to new products and innovations. The current guidelines call for a large number of studies to get FDA approval for general use for chronic pain, he added.
Over the next six to 12 months, the agency plans to issue several documents intended to spur development of medications for specific types of pain. The result should lead to smaller clinical trials, faster approvals and quicker launches of novel therapies, Gottlieb said.
One of the advisories will provide drug companies information on what the FDA is looking for in non-opioid medications for chronic pain, while another will detail how manufacturers can show that their product reduces patients' exposure to opioids for acute pain. Yet another will update drugmakers on how they should assess the risks of illicit use of their drugs, a factor in FDA reviews of drugs.
The move is the latest of varied FDA efforts to combat the opioid epidemic, which Gottlieb has repeatedly said is a top agency priority. On Tuesday, for example, the agency sent warning letters to four online networks operating 21 websites that illegally market unapproved medications. It directed the networks to immediately stop selling the products.
