{"id":2088,"date":"2012-07-17T05:26:00","date_gmt":"2012-07-17T00:26:00","guid":{"rendered":"http:\/\/www.policymed.com\/fda-food-and-drug-administration-safety-and-innovation-act-fdasia-and-patient-focused-drug-developme\/"},"modified":"2018-05-06T22:22:06","modified_gmt":"2018-05-06T17:22:06","slug":"fda-food-and-drug-administration-safety-and-innovation-act-fdasia-and-patient-focused-drug-developme","status":"publish","type":"post","link":"https:\/\/www.policymed.com\/2012\/07\/fda-food-and-drug-administration-safety-and-innovation-act-fdasia-and-patient-focused-drug-developme.html","title":{"rendered":"FDA: Food and Drug Administration Safety and Innovation Act (FDASIA) and Patient Focused Drug Development"},"content":{"rendered":"<p><span style=\"font-family: arial,helvetica,sans-serif;\">Last week, <a class=\"zem_slink\" title=\"Barack Hussein Obama, Jr.\" href=\"http:\/\/www.biography.com\/people\/barack-obama-12782369\" target=\"_blank\" rel=\"biographycom noopener\">President Obama<\/a> signed into law the <a class=\"zem_slink\" title=\"Food and Drug Administration\" href=\"http:\/\/maps.google.com\/maps?ll=39.0353363,-76.9830894&amp;spn=0.01,0.01&amp;q=39.0353363,-76.9830894 (Food%20and%20Drug%20Administration)&amp;t=h\" target=\"_blank\" rel=\"geolocation noopener\">Food and Drug Administration<\/a> Safety and Innovation Act (FDASIA).\u00a0Among the numerous provisions contained in this Act are several provisions that will enhance and increase <a class=\"zem_slink\" title=\"Patient participation\" href=\"http:\/\/en.wikipedia.org\/wiki\/Patient_participation\" target=\"_blank\" rel=\"noopener wikipedia\">patient participation<\/a> in <a class=\"zem_slink\" title=\"Medicine\" href=\"http:\/\/en.wikipedia.org\/wiki\/Medicine\" target=\"_blank\" rel=\"noopener wikipedia\">medical product<\/a> regulation.\u00a0 Specifically, Sec. 1137 of the new law will allow the agency to develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions.\u00a0 This will include:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Fostering participation of FDA Patient Representatives as Special Government Employees in appropriate agency meetings with medical product sponsors and investigators; and,<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Exploring means to provide for identification of FDA Patient Representatives who do not have any, or have minimal, financial interest in the medical products industry.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Consequently, Theresa Mullin, Ph.D. Associate Director for Planning and Informatics FDA <a class=\"zem_slink\" title=\"Center for Drug Evaluation and Research\" href=\"http:\/\/en.wikipedia.org\/wiki\/Center_for_Drug_Evaluation_and_Research\" target=\"_blank\" rel=\"noopener wikipedia\">Center for Drug Evaluation and Research<\/a> (CDER) recently gave a <a href=\"http:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDER\/UCM310754.pdf?source=govdelivery\">presentation<\/a> on \u201cPatient-Focused <a class=\"zem_slink\" title=\"Drug development\" href=\"http:\/\/en.wikipedia.org\/wiki\/Drug_development\" target=\"_blank\" rel=\"noopener wikipedia\">Drug Development<\/a>.\u201d\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Presentation<\/strong><strong>\u00a0<\/strong><\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Mullin first outlined FDA\u2019s benefit-risk (B-R) framework, which looks at five (5) key considerations:\u00a0<\/span><\/p>\n<ol>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Severity of Condition<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Unmet Medical Need<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Benefit<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Risk<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><a class=\"zem_slink\" title=\"Risk management\" href=\"http:\/\/en.wikipedia.org\/wiki\/Risk_management\" target=\"_blank\" rel=\"noopener wikipedia\">Risk Management<\/a><strong>\u00a0<\/strong><\/span><\/li>\n<\/ol>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Severity of Condition <\/strong>and <strong>Unmet Medical Need <\/strong>provide regulators with the clinical context for weighing benefits and risks and the associated uncertainties.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Benefit <\/strong>and <strong>Risk <\/strong>incorporate expert judgments based on evaluation of the efficacy and safety data.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Risk Management <\/strong>incorporates expert judgments on the expected impact of efforts to reduce and further characterize risks.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Assessment of a drug\u2019s benefits and risks involves analysis of severity of condition and current state of the treatment armamentarium. \u00a0Patients who live with a disease have a direct stake in drug review process and are in a unique position to contribute to drug development.\u00a0 As a result, FDA noted that its review process could benefit from systematic approach to obtaining patient perspective on disease severity or unmet medical need.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Mullins noted how FDASIA \u2013 the provisions reauthorizing the <a class=\"zem_slink\" title=\"Prescription Drug User Fee Act\" href=\"http:\/\/en.wikipedia.org\/wiki\/Prescription_Drug_User_Fee_Act\" target=\"_blank\" rel=\"noopener wikipedia\">Prescription Drug User Fee Act<\/a> (PDUFA) \u2013 provides resources to support additional program staff to expand activities dedicated to providing review divisions with patient input.\u00a0 FDA will convene meetings with participation from review divisions, the relevant patient advocacy community, and other interested parties.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">FDA will hold four public workshops per year\u2014a total of 20 meetings over 5 years.\u00a0 Each meeting will focus on a different disease area, reviewing the armamentarium for that indication, and identifying areas of unmet need.<strong>\u00a0<\/strong><\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Benefit<\/strong><strong>\u2010<\/strong><strong><a class=\"zem_slink\" title=\"Risk assessment\" href=\"http:\/\/en.wikipedia.org\/wiki\/Risk_assessment\" target=\"_blank\" rel=\"noopener wikipedia\">Risk Assessment<\/a> Framework: Analysis of Condition<\/strong>\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Assessing Evidence and Uncertainties\u2013 for a given drug for a given indication\u2010questions FDA considers include:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What is the treated (or prevented) condition?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What are its clinical manifestations (i.e., symptoms that are either reported or observed)?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What is known about the natural history and progression of the condition, including in specific subpopulations?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How severe is the condition for those who have it?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How does severity vary across the sub<\/em><em>\u2010<\/em><em>populations we have defined? (Note specific subpopulations and nature of differences.)<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What is the basis for our assessment of the condition and its severity? (Note any relevant literature, clinical experience, expert opinion, etc.)<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What are the major uncertainties in the available information? What are their implications?<\/em><strong>\u00a0<\/strong><\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Benefit<\/strong><strong>\u2010<\/strong><strong>Risk Assessment Framework: Unmet Medical Need<\/strong>\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Assessing Evidence and Uncertainties \u2013for a given drug for a given indication\u2010FDA considers:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What other pharmacological therapies are approved for this condition?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How effective are these alternative therapies?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How does their effectiveness vary by sub<\/em><em>\u2010<\/em><em>population?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How well tolerated are these alternative therapies?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How does tolerance vary by sub<\/em><em>\u2010<\/em><em>population?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What off<\/em><em>\u2010<\/em><em>label pharmacological therapies might be considered?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How effective and how well tolerated are they reported or believed to be?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What non<\/em><em>\u2010<\/em><em>pharmacological therapies might be considered?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>How effective and how well tolerated are they reported or believed to be?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What kinds of evidence are available about the use of alternative treatments for this condition?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What is the strength of evidence in each case?<\/em><\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\"><em>What are the major uncertainties in the evidence? What are their implications?<\/em>\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The presentation then discussed Patient\u2010Reported Outcome (PRO) Measures, which FDA defined as <strong>\u201c<\/strong>any report of the status of a patient\u2019s health condition coming directly from the patient, without interpretation by physicians or anyone, about how the patient functions or feels in relation to a health condition and its treatment.\u201d\u00a0 FDA reviews PRO instruments and looks at whether the instrument measures the concept it is supposed to measure.\u00a0 FDA looks at whether the instrument is:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Well\u2010specified and reliable<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Specific for target population<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Specific for target indication<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Adequate measurement properties (e.g., content validity)\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The presentation then noted that qualitative research can be used to establish PRO content validity.\u00a0 This might include:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Focus groups to generate a pool of patient outcome\u2010related domains and their components (e.g., What symptoms and functions or activities impacted by disease that are most important to patients)<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Surveys including a larger and more diverse sample patients with a given condition (e.g., examine the importance and relevance of domains identified by literature review, expert opinion or among a smaller set of patients, to validate these items and perhaps explore other measurement characteristics)\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Mullins then used the example of people with chronic pain.\u00a0 Focus groups conducted with patients who experience chronic pain identified 19 aspects of their lives (outcome domains) that are significantly impacted by the presence of their symptoms and for which improvements were important criteria that they use in evaluating the effectiveness of any treatment.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Next Steps Patient<\/strong><strong>\u2010<\/strong><strong>Focused Drug Development<\/strong>\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Throughout the rest of this summer, FDA will develop preliminary list of 20 disease areas for public comment to inform planning for the set of 20 PDUFA V meetings.\u00a0 FDA will also develop a basic roadmap that could be used by patient groups interested in pursuing need for and development of PRO measures in a specific disease area.\u00a0 This roadmap will identify important but currently unaddressed aspects of their disease experience to potentially be considered in evaluating new therapies.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">In September 2012, FDA will publish an FR notice with the preliminary list of 20 disease areas for public comment.\u00a0 In October 2012, FDA will plan to hold public meeting to:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Discuss the proposed list of disease areas for the PDUFA meetings and get public input;<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Discuss strategies for getting broader public input and basic roadmap for identification of important patient outcomes and strategies for collaborative development PRO measures\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>FDA Patient Representative Program<\/strong><strong>\u00a0<\/strong><\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The Patient\u2010Focused Drug Development initiative will also add to the existing FDA programs designed to integrate patients\u2019 perspectives.\u00a0 FDA\u2019s patient advocacy programs are run by FDA\u2019s Office of Special Health Issues.\u00a0 One of their main programs is the <a href=\"http:\/\/www.fda.gov\/forconsumers\/byaudience\/forpatientadvocates\/patie%20ntinvolvement\/ucm123858.htm\">FDA Patient Representative Program<\/a>.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Patient Representatives provide FDA with the unique perspective of patients and family members directly affected by serious or life\u2010threatening disease.\u00a0 Patient Representatives serve in the several ways, including:\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">On Advisory Committees, where they offer the patient perspective, ask questions, and give comments to assist the committee in making recommendations.<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">As consultants for review divisions \u2013the clinicians and scientists who review data submitted to determine whether the product\u2019s benefits outweigh the potential risks<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">As presenters at FDA meetings and workshops on disease\u2010specific or regulatory and health policy issues\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The Programs activities include:<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Recruitment of New Patient Representatives<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Selection of Patient Representatives for: <\/span>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Advisory Committees<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Consultation with Review Division<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Conducts Training For Patient Representatives <\/span>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Individual FDA 101 Training<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Monthly Webinars<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Annual Workshop for Newly Recruited Patient Representatives\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">In choosing Patient Representatives, FDA looks for someone who brings a personal viewpoint to the process and communicates a collective patient perspective.\u00a0 A <span style=\"text-decoration: underline;\">patient <\/span>perspective is created when a person goes through personal experience with the disease.\u00a0 A <span style=\"text-decoration: underline;\">collective patient <\/span>perspective is created when the person has knowledge of others\u2019 disease experiences and conveys this collective patient perspective.<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">\u00a0Patient Representatives provide Advisory Committee and FDA insight on issues, problems, and\/or questions pertinent to the viewpoint of patients and family members living with a specific serious or life\u2010threatening disease.\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Personal experience with\/knowledgeable about the specific illness<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Ability to articulate the perspective of patients<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Experience as a patient advocate<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Formal affiliation with a patient advocacy organization<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">The ability to identify issues through communication with patient constituencies\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Patient Representatives serve on an Advisory Committee when a product or therapy related to specific illness is under review, as either voting or non\u2010voting member\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Voting: must be appointed as special government employees (SGEs); requires disclosure of personal financial information to the FDA in order to determine whether their financial interests pose a possible conflict of interest on an advisory committee<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">Non\u2010voting: may only vote on procedural matters concerning the conduct of the meeting<\/span><\/li>\n<li><span style=\"font-family: arial,helvetica,sans-serif;\">In both cases: expected to provide the patient perspective, ask questions, and offer comments to assist the committee in making recommendations<strong>\u00a0<\/strong><\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\"><strong>Drug Development Patient Consultant Program<\/strong>\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">FDA also uses patients in its Drug Development Patient Consultant program.\u00a0 This program incorporates the perspective of patient advocates into the drug development process; allows opportunity to participate in the FDA drug review regulatory process.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">Patients are selected to participate in meetings by matching a specific illness and proposed indication for the new therapeutic drug being developed.\u00a0 Patients may participate in meetings (via telephone ) between the FDA and drug companies.\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial,helvetica,sans-serif;\">The newly selected patient consultant receives training and participates in monthly telephone lecture series in preparation for these meetings.\u00a0 To provide consultation to both FDA and the drug company, it is important that the patient consultant have background information on the drug under review.\u00a0 About three weeks before each meeting, the patient consultant is mailed the meeting package containing the meeting issues and questions. The patient consultant reviews the meeting package in preparation for the meeting.<\/span><\/p>\n<div class=\"zemanta-pixie\" style=\"margin-top: 10px; height: 15px;\"><a class=\"zemanta-pixie-a\" title=\"Enhanced by Zemanta\" href=\"http:\/\/www.zemanta.com\/?px\"><img decoding=\"async\" class=\"zemanta-pixie-img\" style=\"float: right;\" src=\"http:\/\/img.zemanta.com\/zemified_e.png?x-id=d86e680d-2f41-446e-ad41-8e5f81e8e47e\" alt=\"Enhanced by Zemanta\" \/><\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Last week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA).\u00a0Among the numerous provisions contained in this Act are several provisions that will enhance and increase patient participation in medical product regulation.\u00a0 Specifically, Sec. 1137 of the new law will allow the agency to develop and implement strategies to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10259,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5,19,57],"tags":[191,192,85,193,169,189,1101,170,190],"class_list":["post-2088","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda","category-innovation","category-pdufa","tag-barack-obama","tag-drug-development","tag-fda","tag-fdasia","tag-food-and-drug-administration","tag-mullin","tag-new","tag-prescription-drug-user-fee-act","tag-risk-management"],"_links":{"self":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/2088"}],"collection":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/comments?post=2088"}],"version-history":[{"count":1,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/2088\/revisions"}],"predecessor-version":[{"id":10260,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/2088\/revisions\/10260"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media\/10259"}],"wp:attachment":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media?parent=2088"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/categories?post=2088"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/tags?post=2088"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}