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…
October 2, 2020
  On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning emergency use authorization for vaccines to prevent the…
September 28, 2020
September 22, 2020 Re: Docket No. FDA-2019-N-5553: Annual Summary Reporting Requirements Under the Right to Try Act, Proposed Rule Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments…
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