BIO Submits Comments on FDA Draft Guidance for the Development of Non-Opioid Analgesics for Acute Pain
April 11, 2022
On Monday, April 11th, BIO submitted comments in response to the FDA’s recent draft guidance on the Development of Non-Opioid Analgesics for Acute Pain. In the comments submitted, BIO reaffirmed its commitment to working with the Agency to achieve its stated priority of “fostering the development of novel non-opioid analgesics.” Additionally, BIO proposed several recommendations for improving the draft guidance. For example, BIO urged the FDA to prioritize implementation of policy that promotes efficient and effective development of non-opioid analgesics to support a general acute pain indication and encouraged the Agency to expedite efforts to publish policy on development of non-opioid analgesics for chronic pain as well.
Most notably, BIOexpressed concern that the FDA is setting a higher bar for the development of analgesics with novel mechanisms of action (MOA) by stating a likely requirement for “clinical trials in more than two different pain populations to support a general acute pain indication.” This language contradicts previous policy for the basis of approval and counters regulatory precedent. Furthermore, BIO highlighted that using the MOA as the determinant obscures the evidentiary standard. Assuming there is clear rationale for the drug and good grounding in biology, BIO strongly recommended the Agency hold any non-opioid for acute pain, whether a novel MOA or not, to the same evidentiary standard of two studies.
Download Full Comments Below
BIO COMMENT LETTER Development of Non Opioid Analgesics for Acute Pain
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
On Monday, April 11th, BIO submitted comments in response to the FDA’s recent draft guidance on the Development of Non-Opioid Analgesics for Acute Pain. In the comments submitted, BIO reaffirmed its commitment to working with the Agency to achieve its stated priority of “fostering the development of novel non-opioid analgesics.” Additionally, BIO proposed several recommendations for improving the draft guidance. For example, BIO urged the FDA to prioritize implementation of policy that promotes efficient and effective development of non-opioid analgesics to support a general acute pain indication and encouraged the Agency to expedite efforts to publish policy on development of non-opioid analgesics for chronic pain as well.
Most notably, BIOexpressed concern that the FDA is setting a higher bar for the development of analgesics with novel mechanisms of action (MOA) by stating a likely requirement for “clinical trials in more than two different pain populations to support a general acute pain indication.” This language contradicts previous policy for the basis of approval and counters regulatory precedent. Furthermore, BIO highlighted that using the MOA as the determinant obscures the evidentiary standard. Assuming there is clear rationale for the drug and good grounding in biology, BIO strongly recommended the Agency hold any non-opioid for acute pain, whether a novel MOA or not, to the same evidentiary standard of two studies.