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<td><center><strong><span style="color: #ff0000;">EXTERNAL MESSAGE</span><br></strong>This email originated outside of DEP. Please use caution when opening attachments, clicking links, or responding to this email.</center></td>
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</table><div class=WordSection1><p class=MsoNormal>Hello, I’m emailing about an important FDA comment period on <b>safe and environmental sound disposal of opioid medications</b> that I hope you can engage in. <b>Comments are due June 21<sup>st</sup>!<o:p></o:p></b></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>FDA is proposing to use its <a href="https://secure-web.cisco.com/1toB8LufNyEipRNEwMNg-KaPgNLG464VCU0AS8SRBq-1v67wl3UEtUR1dohw0lSsHf8u3tfLDIfEYLrso7V0DiLbIvuPiTehaensp_NxJNQrBQ42IQYZvJozCEdGrclyzcgQhJWkZtw68btb9Z_leSkW7Uu2zz3K9N63ipM0t5PFxEXytSHRZcJbCxP-nwKfym0x3IuJEHhhJS6oq7bedJwIe-6v-2A7Ib69sfW1h_-5hEI6CnkhKyVakJQdy6HZRX0q6Dp3I98kTIP3vT74PlSgjRk3HuSPXzO8ADcsxiV4U4To6_Qu5fPDdH7AeyaKEI1x4l7qN_y5SPAkHDbhacw/https%3A%2F%2Fwww.fda.gov%2Fdrugs%2Finformation-drug-class%2Fopioid-analgesic-risk-evaluation-and-mitigation-strategy-rems">Opioid Analgesic REMS</a> authority to require that all opioid drugs are dispensed with a prepaid mail-back envelope and educational material. Drug manufacturers will be responsible for providing this secure and safe medicine disposal method and FDA encourages them to innovate in their design of the mailer, packaging, and service.<o:p></o:p></p><p class=MsoNormal>From FDA’s media release: <o:p></o:p></p><p class=MsoNormal style='margin-left:.5in'>“Mail-back envelopes have several favorable characteristics. They do not require patients to mix medications with water, chemicals or other substances nor use other common at-home disposal techniques. Opioid analgesics sent back to Drug Enforcement Administration-registered facilities in mail-back envelopes do not enter the water supply and landfills (instead, they are incinerated). The nondescript mail-back envelopes provided would be postage paid, offering patients a free disposal option. Additionally, there are long-standing regulations and policies in place to ensure that mail-back envelopes are fit for that purpose and can safely and securely transport unused medicines from the patient’s home to the location where they will be destroyed.”<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><b>Comments supporting FDA’s proposed mail-back requirement are needed! <o:p></o:p></b></p><p class=MsoNormal>This is a very positive step by FDA, and an action that many of us have advocated for. Making it easy for patients and family members to dispose of unwanted medication – especially potent opioid drugs - is a key prevention strategy to reduce medicine misuse and help prevent poisonings. Mail-back programs are regulated for security by the DEA and ensure non-retrievable destruction that prevents release of APIs into the environment. FDA’s mailer requirement would be consistent with existing drug take-back programs - using drop boxes, events, and mailers. This requirement would complement widespread messaging promoting take-back and discouraging disposal of leftover drugs in the household trash or down the sewer from local, state, and federal agencies, and many allied organizations and community groups.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>There is a dynamic back story to FDA’s good, evidence-based decision. This new requirement is not a certainty yet. For years, FDA has been receiving pressure in many forms from manufacturers of medicine disposal products to choose their disposal mixtures or pouches or this mandatory nationwide requirement. Those companies are pressuring FDA’s leaders and lobbying Congress. Yet their products remain inadequately tested for consumer safety, for effectiveness, or for environmental protection. It is not clear that any of the medicine disposal products make drugs non-retrievable. Ultimately all of those products are designed for trash disposal of a liquid or semi-solid mixture of pharmaceuticals and other incompletely identified materials. In the docket already, there is a comment from a medicine disposal product manufacturer supporting their products over DEA-regulated mail-back. There are other comments from entities with ties to those companies.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Your supportive comments, even brief ones, can make a significant difference. Here is more information to assist you in commenting by June 21<sup>st</sup>.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>“<b>Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting</b>”<o:p></o:p></p><p class=MsoNormal><b><i>Comments are due by or on Tuesday June 21, 2022. <o:p></o:p></i></b></p><p class=MsoNormal><a href="https://secure-web.cisco.com/138N0PJiXBAmXJKtaIt9GLjwePKdP_zgCnz5PcrjO-2TvJXN_-qvMBzjjasuyO0Lh9yuxlGaKFXMpNsYxGdf-Ld1j11EfuTIyOtqdcJc0_g_pcrP6nsuBfhs_s3fZaZaQOdmJkfqXZrXl5Lyd1ymfDC22VxFHnKb_LpJRtJe5jhS67Fai1GdwfowNqQYFOZaIDL8sudvXBi1sjntNol8mbcPHUVzYr7rGZX2fi-9uWYKtHEaBjmljpQjFO9lF_v0VxV97jbDN6nj8U0aRN-v5XlD0p-O8KXOxqzIfSgQrt2R8mnM_H5Ifd11jWmtqhVSle9p1O7pJ8dGqBcA41pkSHA/https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-considers-new-approach-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary">https://www.fda.gov/news-events/press-announcements/fda-considers-new-approach-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary</a><o:p></o:p></p><p class=MsoNormal>Federal Register link for comments: <a href="https://secure-web.cisco.com/1jsaLZIqVLCtjRgqATvIMM6Iiq5jAp2Qq4xykvzJkk7VYUPiCsPR2WHt9gHbLgx9xkrcBKwRfKjXymUn3MxEKBFEdNA4ESsEx7S9V2J3xWKXlWneEOsMBsaEUpjtDI6vK8xqbd02RmLSu4f6rPhW17Q02r-HtiOab5Lab5IvNuIrv-fRBp261TBAD-qCL46_gj3Kwj05Evob07VKrVBciHnzpscGQ0jHYBfC0CRg5SpqowzgJYxhpRPjlR9MpcKEv0Z0NRONXSCyVO49onjyMa9dkhwwGmU0Qyi57tWhzkIi66RASeb2JYY-Q4FmpxZE9chZhNMa4g3f2Vpt_7yTXxA/https%3A%2F%2Fwww.regulations.gov%2Fdocket%2FFDA-2022-N-0165">https://www.regulations.gov/docket/FDA-2022-N-0165</a> <o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Some background resources that support of FDA’s mail-back envelope requirement:<o:p></o:p></p><ul style='margin-top:0in' type=disc><li class=MsoListParagraph style='margin-left:-.25in;mso-list:l0 level1 lfo1'>2019 comment letter from San Francisco Department of the Environment supporting using REMS authority to require mail-back envelopes with opioid prescriptions. <a href="https://secure-web.cisco.com/160YJ78bZWfh-hbAwMzX0d-jTMlUCwgQzw1OraY14JD94cNgt5BMjpxLpJFgqgtm_ovwXMzec_7H1hAh-9tlJgVKKG8pQB1izBzdKodoD6erBNNQna2Ar3Vpa0H0dE9Fm35EkUR6Zptd_REeusQdoRtk94zvgSMxdFRwZSqTRTjNF9xPtZskheK7KwQdvoh7hC5WaCbtE26_frycXq81A0nXFxYqJwT7ZiXjC-mqGLFsDA20-tVPLskujk7Y8ncVsp0OQE7DGQaANUOkhlKGyET2yDRfPiqnNt5lmG42bHAkzqbHWZeX-QiFlY1MpfqTFWcm140uZxrM2_584S7zYqg/https%3A%2F%2Fwww.regulations.gov%2Fcomment%2FFDA-2019-N-1845-0126">https://www.regulations.gov/comment/FDA-2019-N-1845-0126</a> Portions of this letter could be adapted for your comments. <o:p></o:p></li><li class=MsoListParagraph style='margin-left:-.25in;mso-list:l0 level1 lfo1'>Link to my 2019 report for SF DOE “Medicine Disposal Products: an overview of products & performance questions” describing the many unknowns and concerns with these products: <a href="https://secure-web.cisco.com/1FXaxGp-m9p8_kOJRUbRLHUi9TFm5_lftO1i9RAJX7sHqhM22n80u_33hvt8acseL8LTn6V2XpeJHmlQ6V-_GZUTj4R2Wj_cxOLPbM30_knJDfSiHIsZRdRSeX70ogktx_b-pcYBuEZ4Zc3kTpkKFPVvQOYq-RktZIE1kFz0jK9AD38pPciZBMC0MKmjzPREnrGqQWkq5vw-rteWsIOGmd1RTscvZlO0fvTjd0_yiure5aLkSBm-KeEE9j9rRkuhpI50qbd5QIJ9aNCTFumHTtoSK73sQXrKD38Ly8yNvuaL--cS3MM7czfAdkyoDcZPC/https%3A%2F%2Fsfenvironment.org%2Fsites%2Fdefault%2Ffiles%2Ffliers%2Ffiles%2Fmedicinedisposalproducts_march2019.pdf">https://sfenvironment.org/sites/default/files/fliers/files/medicinedisposalproducts_march2019.pdf</a> <o:p></o:p></li><li class=MsoListParagraph style='margin-left:-.25in;mso-list:l0 level1 lfo1'>Link to my PowerPoint presentation with talking points for a June 2021 Duke University workshop sponsored by the FDA on Exploring Options for Safe and Effective In-Home Opioid Disposal <a href="https://secure-web.cisco.com/13WJFNw2pJYnOLABiHdWgFaur43A3nXyFua0sRQUzKqIZuyM_0CHp2n7KQFB6D2_fY8GuWqTmtPqMM197RomvyUav82COM93GUIyHNhYS2TTkIhqepFuk_ro2qoRTDP86iMVNE8lwI8crIxAM6sA9qVrUAatkyXMv3C7r-93czer5JUGwu2D5cnO3smOJBSLbVhRhFD84Gx_Suxt_wNDooh5X4PznehQZdBGq69NPqqPRgP4kiQIw1L13hdCW0nEX2wnBqSLRgLXy4Aza14KTXS18mPCL4t_FBgUlIcKMDbvYcvHwsYdeA0yVqv0wBCbHLhqDSm3LFlqZrlF8N-0bYg/https%3A%2F%2Fdocs.google.com%2Fpresentation%2Fd%2F1ewyN33DGVwHJP4Te1MXPvTMmjifu_xUV%2Fedit%3Fusp%3Dsharing%26ouid%3D115293893377595943300%26rtpof%3Dtrue%26sd%3Dtrue">https://docs.google.com/presentation/d/1ewyN33DGVwHJP4Te1MXPvTMmjifu_xUV/edit?usp=sharing&ouid=115293893377595943300&rtpof=true&sd=true</a> (this is a Google docs link, if you cannot access, please email me)<o:p></o:p></li></ul><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Thank you!<o:p></o:p></p><p class=MsoNormal>Margaret<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><i><span style='font-size:10.0pt;font-family:"Candara",sans-serif'>Margaret Shield, PhD<o:p></o:p></span></i></p><p class=MsoNormal><i><span style='font-size:10.0pt;font-family:"Candara",sans-serif'>(pronouns: she/her/hers)<o:p></o:p></span></i></p><p class=MsoNormal><b><i><span style='font-size:10.0pt;font-family:"Candara",sans-serif'>Community Environmental Health Strategies, LLC</span></i></b><b><o:p></o:p></b></p><p class=MsoNormal><span style='font-size:12.0pt'><a href="mailto:margaret.shield@CEHstrategies.com"><i><span style='font-size:10.0pt;font-family:"Candara",sans-serif;color:blue'>margaret.shield@CEHstrategies.com</span></i></a></span><o:p></o:p></p><p class=MsoNormal><i><span style='font-size:10.0pt;font-family:"Candara",sans-serif'>mobile: 206-499-5452</span></i><o:p></o:p></p><p class=MsoNormal><span style='font-size:12.0pt'><a 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