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layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-cardHero act-component -styleLanding -titleOnly -skinBlue -titleOnly -btnskinTeal -btnoutlineButtonDefaultInvert"><div class="mc-cardHero__rgnInner act-component-inner" style="background-image:url(/sites/default/files/2021-07/banner-default.png)"><div class="mc-cardHero__rgnMain"><div class="mc-cardHero__backLink" ><a class="af-link" href="/policy/human-health" aria-label="Human Health" >Human Health</a></div><h1 class="mc-cardHero__title" ><div class="af-text">Pain & Addiction</div></h1></div><div class="mc-cardHero__rgnShare"><div class="mc-a2aShare act-component -popLeft -skinLight"><div class="mc-a2aShare__rgnInner act-component-inner"><div class="mc-a2aShare__shareButton jsShareTrigger"><a><i class="fas fa-share-alt"></i></a></div><div class="mc-a2aShare__shareFlyout jsShareFlyout"><div class="mc-a2aShare__a2aButtons"><div class="a2a_kit a2a_kit_size_32 a2a_default_style toolkit-share" data-a2a-icon-color="#000" data-a2a-url="https://www.bio.org/policy/human-health/pain-addiction"><a class="a2a_button_facebook"></a><a class="a2a_button_x"></a><a class="a2a_button_linkedin"></a><a class="a2a_button_email"></a></div></div><div class="mc-a2aShare__closeButton jsShareClose"><a><i class="far fa-times"></i></a></div></div></div></div></div></div></div></div></div></div></div><div class="act-layout act-pane layout layout--bs-columns layout--sub-nav -rgnWidth100 paneSubNav"><div class="section-inner"><div class="act-pane__content row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="oc-orgSubNav act-component -ctaNone"><div class="oc-orgSubNav__rgnInner act-component-inner"><div class="oc-orgSubNav__rgnLogo"><div class="oc-orgSubNav__logo" ><img src="/act-root/bio/assets/images/logo/bio-new-logo-color.svg" alt="logo" class="af-image"></div></div><div class="oc-orgSubNav__rgnMenu"><div class="oc-bsMenuNav act-component navbar-light"><div class="oc-bsMenuNav__rgnInner act-component-inner"><nav class="navbar navbar-expand-lg navbar-light"><div class="navbar-brand"></div><button class="navbar-toggler" type="button" data-toggle="collapse" data-target="#mPbnyO" aria-controls="mPbnyO" aria-expanded="false" aria-label="Toggle navigation"><span class="navbar-toggler-icon"></span></button><div class="collapse navbar-collapse" id="mPbnyO"><div class="mc-bsDropDown act-component"><div class="mc-bsDropDown__rgnInner act-component-inner"><ul class="navbar-nav mr-auto"><li class="nav-item dropdown"><a class="nav-link dropdown-toggle menuL1 " href="/policy/human-health" id="dd8ZVl" data-toggle="dropdown" aria-haspopup="true" aria-expanded="false">Human Health</a><div class="dropdown-menu" aria-labelledby="dd8ZVl"><a class="dropdown-item menuL2 " id="zzgJJG" href="/policy/human-health">Overview</a><a class="dropdown-item menuL2 " id="hfVNvq" 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class="dropdown-item menuL2 " id="n9uLYm" href="/policy/international/multilateral-organizations">Multilateral Organizations</a><a class="dropdown-item menuL2 " id="r2Upx8" href="/policy/international/bio-launches-call-biotechnology-stories">BIO launches call for biotechnology stories</a></div></li><li class="nav-item dropdown"><a class="nav-link dropdown-toggle menuL1 " href="/policy/intellectual-property" id="ushnSI" data-toggle="dropdown" aria-haspopup="true" aria-expanded="false">Intellectual Property</a><div class="dropdown-menu" aria-labelledby="ushnSI"><a class="dropdown-item menuL2 " id="z6odjZ" href="/policy/intellectual-property">Overview</a><a class="dropdown-item menuL2 " id="dNIO6P" href="/policy/intellectual-property/patents">Patents</a><a class="dropdown-item menuL2 " id="cdPWd6" href="/policy/intellectual-property/regulatory-data-protection">Regulatory Data Protection</a><a class="dropdown-item menuL2 " id="azOdUr" href="/policy/intellectual-property/technology-transfer">Technology Transfer</a></div></li></ul></div></div></div></nav></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="act-layout act-pane layout layout--bs-columns layout--top -rgnWidth100 paneTop"><div class="section-inner"><div class="act-pane__content row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"></div></div></div></div><div class="act-layout act-pane layout layout--bs-columns layout--body -rgnWidth100 paneBody"><div class="section-inner"><div class="act-pane__content row"><div class="act-pane__region layout__region layout__region--col-1 col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="oc-compoList act-component"><div class="oc-compoList__rgnInner act-component-inner"><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="mc-contentBasic__body" ><div class="af-text"><p>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.</p></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__titleWrapper"><div class="act-pane__title" ><div class="af-text">The Future Rest on Three Legs</div></div></div><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageLeft -heightAuto -btnskinPurple -btnsolidButtonDefault"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-5 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2019-11/MSC_DNA-Molecule.png?itok=b1CYm0-V" alt="DNA Molecule" class="af-image"></div></div></div><div class="col-lg-7 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__description" ><div class="af-text"><p><strong>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</strong></p><ul><li><p>Support a more comprehensive understanding of the preclinical pain and addiction environment</p></li><li><p>Support investment in research at National Institutes of Health (NIH) and other major centers focused on the biology of pain and addiction</p></li></ul></div></div></div></div></div></div></div></div></div><div class="oc-widgetPane__rgnCell col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageRight -heightAuto -btnskinPurple -btnsolidButtonDefault"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-7 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__description" ><div class="af-text"><p><strong>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</strong></p><ul><li><p>Remove coverage and reimbursement barriers that are preventing patient-centric decisions about and access to the most effective treatments for pain and addiction</p></li><li><p>Advance implementation of and adherence to laws and regulations protecting and promoting access to resources for comprehensive pain and addiction treatment</p></li></ul></div></div></div></div></div><div class="col-lg-5 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2019-11/MSC_Patient-Suffering.png?itok=G_X4HrcA" alt="Patient Suffering" class="af-image"></div></div></div></div></div></div></div><div class="oc-widgetPane__rgnCell col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageLeft -heightFixed -btnskinPurple -btnsolidButtonDefault"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-5 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2019-11/MSC_Researcher-Lab-Swap.png?itok=v9xF1SHA" alt="Researcher in a Lab" class="af-image"></div></div></div><div class="col-lg-7 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__description" ><div class="af-text"><p><strong>3. Stimulate research & development (R&D) of innovative treatments that effectively treat pain and opioid addiction and prevent abuse</strong></p><ul><li><p>Increase leadership engagement, expertise, and resources within the FDA & DEA to promote effective and efficient review of innovative treatments for pain and addiction</p></li><li><p>Modernize and streamline drug development and review processes to enable effective and efficient drug development and review, and stimulate investment in innovation</p></li><li><p>Establish and utilize expedited approval pathways and other incentives to stimulate innovation</p></li></ul></div></div></div></div></div></div></div></div></div><div class="oc-widgetPane__rgnCell rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="mc-contentBasic__body" ><div class="af-text"><div class="ac-basicButton act-component align-center"><div class="ac-basicButton__rgnInner act-component-inner"><div class="ac-basicButton__targetLink"><a aria-label="Read more" class="af-link solidButtonDefault -skinTeal" href="/sites/default/files/2019-11/Opioid-Policy-Framework.pdf" rel="noopener noreferrer" target="_blank"><span class="ac-basicButton__text">Read more</span></a></div></div></div><p> </p></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="mc-contentBasic__body" ><div class="af-text"><div class="oc-itemList act-pane -linkBelow -headerLarge"><div class="oc-itemList__rgnInner section-inner act-pane-inner"><div class="act-pane__titleWrapper"><div class="act-pane__title" ><div class="af-text">Press Releases</div></div></div><div class="act-pane__header"><div class="act-pane__moreLink" ><a class="af-link" href="/press-releases" aria-label="Browse all Press Releases" >Browse all Press Releases</a></div></div><div class="act-pane__content"><div class="oc-itemList__rgnList"><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/press-release/bio-statement-regarding-nomination-robert-f-kennedy-jr" aria-label="BIO Statement Regarding Nomination of Robert F. Kennedy Jr." >BIO Statement Regarding Nomination of Robert F. Kennedy Jr.</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">November 14, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">BIO President & CEO John F. Crowley released the following statement:“A healthy and prosperous society is vitally important to the American people and to the world. The public health, economic security and our national security are best served by strong leadership that respects and advances…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/press-release/bio-released-following-statement-after-yesterdays-announcement-us-department" aria-label="BIO Released the Following Statement After Yesterday’s Announcement From the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Sharing Its Final Notice Exemption for Additional Modification Plants" >BIO Released the Following Statement After Yesterday’s Announcement From the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Sharing Its Final Notice Exemption for Additional Modification Plants</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">November 13, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">“The Biotechnology Innovation Organization (BIO) applauds today's announcement from the USDA's Animal and Plant Health Inspection Service (APHIS) expanding the scope of biotechnology exemptions for modified plants under 7 CFR part 340. This promising update supports the latest advancements in…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/press-release/bio-statement-lawsuit-over-340b-rebates" aria-label="BIO Statement on Lawsuit Over 340B Rebates" >BIO Statement on Lawsuit Over 340B Rebates</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">November 12, 2024</div></div><div class="mc-teaserBasic__description" ><div class="af-text">BIO strongly supports a manufacturer’s ability to use a 340B rebate as an appropriate option to make 340B pricing available to covered entities."Manufacturers should have the choice to effectuate 340B pricing in the manner they deem most efficient and appropriate under the statute," said BIO's EVP…</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80 -linkRight"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-contentBasic act-component"><div class="mc-contentBasic__rgnInner act-component-inner"><div class="mc-contentBasic__body" ><div class="af-text"><div class="oc-itemList act-pane -linkBelow -headerLarge"><div class="oc-itemList__rgnInner section-inner act-pane-inner"><div class="act-pane__titleWrapper"><div class="act-pane__title" ><div class="af-text">Letters, Comments & Testimony</div></div></div><div class="act-pane__header"><div class="act-pane__moreLink" ><a class="af-link" href="/letters-testimony-comments" aria-label="Browse all Letters, Comments & Testimony" >Browse all Letters, Comments & Testimony</a></div></div><div class="act-pane__content"><div class="oc-itemList__rgnList"><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-submits-comments-cdc-clinical-practice-guideline-prescribing-opioids" aria-label="BIO Submits Comments on CDC Clinical Practice Guideline for Prescribing Opioids" >BIO Submits Comments on CDC Clinical Practice Guideline for Prescribing Opioids</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">April 11, 2022</div></div><div class="mc-teaserBasic__description" ><div class="af-text">On Monday, April 11th, BIO also submitted comments in response to the CDC’s recently published Clinical Practice Guideline for Prescribing Opioids. In the comments submitted, BIO primarily requested that the CDC revise its language referencing naloxone to be consistent with more general and product…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-submits-comments-fda-draft-guidance-development-non-opioid" aria-label="BIO Submits Comments on FDA Draft Guidance for the Development of Non-Opioid Analgesics for Acute Pain " >BIO Submits Comments on FDA Draft Guidance for the Development of Non-Opioid Analgesics for Acute Pain </a></div><div class="mc-teaserBasic__summary" ><div class="af-text">April 11, 2022</div></div><div class="mc-teaserBasic__description" ><div class="af-text">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…</div></div></div></div></div><div class="mc-teaserBasic act-component -fontMedium -textOnly"><div class="mc-teaserBasic__rgnInner act-component-inner"><div class="mc-teaserBasic__rgnMain"><div class="mc-teaserBasic__titleLink" ><a class="af-link" href="/letters-testimony-comments/bio-comments-fda-docket-standards-future-opioid-analgesic-approvals-and" aria-label="BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction" >BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction</a></div><div class="mc-teaserBasic__summary" ><div class="af-text">November 18, 2019</div></div><div class="mc-teaserBasic__description" ><div class="af-text">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…</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div><div class="oc-compoList__rgnSection"><div class="oc-widgetPane act-pane -rgnWidth80"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="embedGeneralSectionPane"><div class="oc-widgetPane act-pane -rgnWidth100"><div class="oc-widgetPane__rgnInner section-inner act-pane-inner"><div class="act-pane__content"><div class="oc-widgetPane__rgnList row"><div class="oc-widgetPane__rgnCell rowFirst rowLast col-lg-12 col-md-12 col-sm-12"><div class="mc-cardMediaSide act-component -mediaImage -imageLeft -heightFixed -btnskinPurple -btnsolidButtonDefault"><div class="mc-cardMediaSide__rgnInner act-component-inner"><div class="mc-cardMediaSide__rgnMain row"><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnMedia"><div class="mc-cardMediaSide__image" ><img src="/sites/default/files/styles/bio_media_side_card_auto/public/2024-03/bio-action-patient-advocacy-alliances-2.png?itok=OEy7dzQ9" alt="Become an Advocate for Biotechnology" class="af-image"></div></div></div><div class="col-lg-6 col-md-12 col-sm-12"><div class="mc-cardMediaSide__rgnContent"><div class="mc-cardMediaSide__info"><div class="mc-cardMediaSide__title" ><div class="af-text">Become an Advocate for Biotechnology</div></div><div class="mc-cardMediaSide__description" ><div class="af-text"><p>Sign-up to join BIOAction, BIO's grassroots advocacy program. 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