Pain & Addiction

Long-term solutions to combating the opioid crisis will depend upon the development of novel and safer, next-generation therapies to treat both pain and addiction. To get these new innovations to the patients whose lives depend on them, the policy and regulatory environment keeps pace with advances happening in the lab.

The Future Rest on Three Legs
DNA Molecule

1. Advance our understanding of the biology of pain and addiction to enable the development of innovative treatments for pain and addiction and ensure appropriate and optimal use of existing therapies

  • Support a more comprehensive understanding of the preclinical pain and addiction environment

  • Support investment in research at National Institutes of Health (NIH) and other major centers focused on the biology of pain and addiction

2. Ensure patients suffering from pain or addiction are able to receive the right treatment at the right time with the right support, without stigma

  • Remove coverage and reimbursement barriers that are preventing patient-centric decisions about and access to the most effective treatments for pain and addiction

  • Advance implementation of and adherence to laws and regulations protecting and promoting access to resources for comprehensive pain and addiction treatment

Patient Suffering
Researcher in a Lab

3. Stimulate research & development (R&D) of innovative treatments that effectively treat pain and opioid addiction and prevent abuse

  • Increase leadership engagement, expertise, and resources within the FDA & DEA to promote effective and efficient review of innovative treatments for pain and addiction

  • Modernize and streamline drug development and review processes to enable effective and efficient drug development and review, and stimulate investment in innovation

  • Establish and utilize expedited approval pathways and other incentives to stimulate innovation

Letters, Comments & Testimony
November 18, 2019
Biotechnology Innovation Organization (BIO) comments on the FDA docket, Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO also believes that risks associated with opioid therapies can be surmounted through further…
December 23, 2020
On Wednesday, December 23rd, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s October 2020 public workshop titled, “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” In its…
December 9, 2020
The Biotechnology Innovation Organization (BIO) submits these comments in response to the U.S. Environmental Protection Agency’s (EPA) request for public input on proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs).1 In particular, EPA’s…
Patient-Take-Action
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