{"id":355834,"date":"2018-08-24T11:04:32","date_gmt":"2018-08-24T16:04:32","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/healthcare\/patient-rights\/right-to-try-laws-and-access-to-experimental-drugs.html"},"modified":"2025-08-23T15:22:18","modified_gmt":"2025-08-23T20:22:18","slug":"right-to-try-laws-and-access-to-experimental-drugs","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/healthcare\/patient-rights\/right-to-try-laws-and-access-to-experimental-drugs.html","title":{"rendered":"Right to Try Laws and Access to Experimental Drugs"},"content":{"rendered":"\n<div class=\"wp-container-core-columns-is-layout-8f761849 fl-sectionWithSidebar fl-container fl-flex fl-flex-wrap fl-gap30\">\n<div class=\"fl-page-articles fl-section-main fl-section-main-full-width\"><h1 class=\"fl-no-margin-top\">Right-To-Try Laws and Access to Experimental Drugs<\/h1>\n\n<section class=\"fl-gutenberg-byline\">\n    <div class=\"fl-gutenberg-byline-content\">\n                    By <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/lyle-therese-a-hilotin-lee-j-d\/\">Lyle Therese A. Hilotin-Lee, J.D.<\/a> | Legally reviewed by <a\n                href=\"https:\/\/www.findlaw.com\/company\/our-team\/jordan-walker-j-d\/\">Jordan Walker, J.D.<\/a>\n                | Last updated\n        <time>\n                            August 23, 2025\n                    <\/time>\n    <\/div>\n\n    \n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-legally-reviewed\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Legally Reviewed\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>This article has been written and reviewed for legal accuracy, clarity, and style by <a href=\"https:\/\/www.findlaw.com\/company\/our-team.html\">FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with <a href=\"https:\/\/www.findlaw.com\/company\/company-history\/editorial-policy.html\">our editorial standards<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n\n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-fast-checked\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Fact-Checked\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>The last updated date refers to the last time this article was reviewed by FindLaw or one of our <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/contributing-authors.html\">contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please <a href=\"https:\/\/lawyers.findlaw.com\/?fli=bylinelink\" target=\"_blank\" rel=\"noopener\">contact an attorney in your area<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n<\/section>\n\n\n<div class=\"fl-key-takeaways fl-mb30\" data-testid=\"fl-key-takeaways\">\n    <div class=\"fl-card-content\">\n        <div class=\"fl-card-body fl-card-bg-teal fl-flex fl-flex-column\">\n                            <h2 class=\"fl-card-title fl-h2 fl-no-margin\">Key Takeaways<\/h2>\n                        <p><i data-redactor-tag=\"i\">Right-to-try laws let terminally ill patients who have exhausted standard treatments seek access to experimental\u00a0drugs that haven&#8217;t received full FDA approval. This is done\u00a0by working directly with their doctors and drug manufacturers. While the federal Right\u00a0To\u00a0Try Act bypasses FDA and IRB review, access to experimental drugs isn&#8217;t guaranteed.\u00a0Manufacturers can refuse, and safety, liability, and insurance issues remain important considerations.<\/i><\/p>\n\n        <\/div>\n    <\/div>\n<\/div>\n\n\n<p>Treatments under the Right\u00a0To\u00a0Try Act often have not received full FDA approval. The Act\u00a0creates\u00a0legal ways for patients to gain access to these investigational drugs. Patients can work with manufacturers and doctors to access these treatments. Consulting with a\u00a0<a href=\"https:\/\/lawyers.findlaw.com\/health-health-care-law\/?fli=dcta\" rel=\"noopener noreferrer nofollow\" target=\"_blank\">healthcare attorney<\/a>\u00a0helps you with an access request and understand your right to try these experimental drugs. They can explore your options and help you maximize your treatment chance.<\/p>\n<h2>History of Right-To-Try Laws<\/h2>\n<p>Colorado was the\u00a0<a href=\"https:\/\/www.pbs.org\/newshour\/health\/colorado-first-state-pass-right-try-dallas-buyers-club-law\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">first state to pass a right-to-try law in 2014<\/a>. Many other states\u00a0followed suit. The movement began with patients and patient advocates getting frustrated by the lack of access to experimental drugs with potential life saving qualities. Patients have to wait for the Food and Drug Administration (FDA) to approve\u00a0medications. The drug approval process often involves three phases of testing, which may\u00a0take years before the drugs become available.<\/p>\n<h2>What Are Right-To-Try Laws?<\/h2>\n<p>President Trump signed the\u00a0<a href=\"https:\/\/www.congress.gov\/bill\/115th-congress\/senate-bill\/204\/text\" target=\"_blank\" rel=\"noopener\">Right to Try Act<\/a>\u00a0into Law in May 2018. This federal law gives\u00a0eligible patients permission\u00a0to access experimental drugs, biologics, and other medical products. It\u00a0allows doctors and drug companies to give experimental treatments to eligible patients without the threat of liability. Pharmaceutical companies are also protected from legal consequences, whether they provide the treatment or refuse to give it.<\/p>\n<p>Right-to-try laws provide legal ways for patients with life-threatening conditions to gain access to experimental drugs and investigational products. Often, they do so when conventional treatments fail and they are facing limited treatment options. These laws allow patients to use medicines or treatments not yet fully approved by the\u00a0<a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">U.S. Federal Drug Administration (FDA)<\/a>. This means that the agency has not determined the safety, effectiveness, or\u00a0potential side effects of these drugs.<\/p>\n<p>Under this law, the patient and treating physician work with a drug manufacturing company to obtain the drug. For patients to be eligible under the\u00a0<a href=\"https:\/\/www.fda.gov\/media\/133864\/download\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">Right to Try Act<\/a>\u00a0(.pdf download), there are certain criteria that they have to meet:<\/p>\n<ul>\n<li>The patient has a life-threatening condition or disease<\/li>\n<li>The patient used all conventional treatment options and cannot join a clinical trial for the experimental drug at their local medical center<\/li>\n<li>The patient\u00a0understands\u00a0the risks involved and provides\u00a0written consent to their\u00a0doctor about the use of the\u00a0investigational (experimental)\u00a0drug<\/li>\n<\/ul>\n<p>Meeting these requirements only grants legal\u00a0access to the experimental drug. Manufacturers are not required to give you their experimental medicines. Moreover, the FDA cannot compel these manufacturers to give you access to these experimental drugs.<\/p>\n<h2>State Laws<\/h2>\n<p>Most states\u00a0have right-to-try laws. There are key differences between the state versions and the federal law. For instance,\u00a0<a class=\"editor-rtfLink\" href=\"https:\/\/codes.findlaw.com\/ca\/health-and-safety-code\/hsc-sect-111548-2.html\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">California&#8217;s law<\/a>\u00a0only covers those patients that have immediately life\u2011threatening condition. In contrast, federal law covers a broader &#8220;<a href=\"https:\/\/www.findlaw.com\/healthcare\/patient-rights\/death-with-dignity-laws-by-state.html\">terminally ill patients<\/a>&#8221; category of eligibility.<\/p>\n<p>A major similarity between state and federal laws is that there is no guarantee of access to drugs. There are no mandates that compel drug manufacturers to give the drugs to patients. It is strictly based on the manufacturer&#8217;s decision. Often, manufacturers are not willing to participate.<\/p>\n<p>There are many reasons why drug companies would not want to provide experimental drugs to patients. These laws cover unapproved drugs in the\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/current-good-manufacturing-practice-phase-1-investigational-drugs\" target=\"_blank\" rel=\"noopener\">FDA&#8217;s Phase I<\/a>\u00a0drug development, which\u00a0means the drug is only in the phase where they figured it might be\u00a0safe for humans.\u00a0<\/p>\n<p>Patients can experience serious adverse events, which manufacturers often discover in the later phases of testing. If patients experience side effects, it can affect the chances of the drug getting approved later on.<\/p>\n<h2>How Does the Federal &#8220;Right\u00a0To Try &#8220;Act\u00a0Differs From FDA&#8217;s Expanded Access?<\/h2>\n<p>Two related laws govern access to investigational new drugs: the Right to Try Act and the\u00a0<a href=\"https:\/\/www.fda.gov\/news-events\/public-health-focus\/expanded-access\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">FDA&#8217;s Expanded Access Program<\/a>. These laws are essential for patients seeking treatment options. Both laws serve the same populations, but\u00a0a critical distinction lies in the regulatory review of the FDA.<\/p>\n<p>The FDA&#8217;s Expanded Access Program, known as &#8220;compassionate use,&#8221; has operated for over 30 years. The Right to Try Act was passed\u00a0in 2018. The critical distinction between these laws is the FDA&#8217;s regulatory oversight. The laws differ greatly due to\u00a0required\u00a0FDA review and approval by the\u00a0<a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC7416898\/\" target=\"_blank\" rel=\"noopener\">institutional review board (IRB)<\/a>. The Right to Try Act\u00a0completely bypasses these regulatory safeguards.<\/p>\n<p>In addition, Expanded Access requires a two-page form. A physician submits this form, which the institutional review board will examine before deciding whether or not to\u00a0approve it. In contrast, the Right to Try Act allows physicians to directly request investigational drugs from manufacturers.\u00a0<\/p>\n<p><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC7081483\/\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">Studies show<\/a>\u00a0that many drug manufacturers prefer the FDA Expanded Access program. A Government Accountability Office review found a key problem. Over half of drug companies\u00a0require additional steps before approving right-to-try requests\u00a0and\u00a0would ask for FDA or IRB review. This suggests that drug manufacturers value regulatory oversight for patient safety.<\/p>\n<h2>Did\u00a0COVID-19 Impact\u00a0Right-To-Try Usage?<\/h2>\n<p>Many people expected COVID-19 to increase the number of patients who would use right-to-try laws and a rise in\u00a0patient access to experimental vaccines and other treatments. However, documented cases using the Right to Try Act during this public health emergency\u00a0showed\u00a0that drug companies preferred\u00a0other alternatives.<\/p>\n<p><a href=\"https:\/\/www.biospace.com\/relief-reports-us-collaboration-partner-announces-expansion-of-aviptadil-us-expanded-access-and-right-to-try-programs-for-patients-w-covid-19-respiratory-failure-who-ve-exhausted-all-approved-therapies\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">NeuroRx<\/a>\u00a0provided one of the few instances of a company willing to expand access to drugs it was still testing. In January 2022, it announced that it was\u00a0expanding its Expanded Access and right-to-try programs for Aviptadil. It was made\u00a0available to certain patients who suffered\u00a0from COVID-19 Respiratory Failure and have used all conventional therapies.<\/p>\n<h2>Legal Risks and Liability Considerations<\/h2>\n<p>The federal Right to Try Act\u00a0provides broad immunity protections. It shields doctors, manufacturers, sponsors, and dispensers from liability. An exception to this only applies in gross negligence cases or willful misconduct, but\u00a0state laws could create a complex legal landscape. Healthcare providers should consider malpractice standards when giving experimental treatments. This is important for medications and treatments that are outside FDA oversight.<\/p>\n<p>According to a clinical analysis, right-to-try laws face particular challenges. These challenges often arise during informed consent procedures. Clinical trials have federal regulations and standard consent protocols. Right-to-try does not have uniform FDA requirements and IRB oversight. The absence of these standard disclosures could cause a potential legal dilemma. This challenge could occur if patients suffer adverse outcomes or\u00a0claim inadequate disclosure of risks.<\/p>\n<p>Disputes with insurance coverage often arise when patients participate in experimental treatments. This creates significant financial liability for families. Patients should consult with\u00a0<a href=\"https:\/\/lawyers.findlaw.com\/health-health-care-law\/?fli=dcta\" rel=\"noopener noreferrer nofollow\" target=\"_blank\">healthcare attorneys<\/a>\u00a0before pursuing experimental treatments. These treatments are expensive and may not be covered by insurance.<\/p>\n<h2>Considering Right-To-Try Treatments? Get\u00a0Legal Guidance From a Healthcare Attorney<\/h2>\n<p>Right-to-try\u00a0laws can be confusing\u00a0and gaining access to an experimental drug can be overwhelming. Seeking legal advice from a\u00a0<a href=\"https:\/\/lawyers.findlaw.com\/health-health-care-law\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">healthcare attorney<\/a>\u00a0may make things a little less difficult. They can help you understand your rights in both federal and state laws. A\u00a0healthcare attorney\u00a0can also assist you in learning more about accessing investigational treatments and\u00a0protect your patient rights if\u00a0legal issues arise.<\/p>\n\n\n<div class=\"was-this-helpful\">\n    <div\n            class=\"was-this-helpful__question-container\"\n            aria-labelledby=\"was-this-helpful__question\"\n            role=\"group\"\n    >\n        <span\n                id=\"was-this-helpful__question\"\n                class=\"was-this-helpful__question fl-text-lg-bold\"\n        >Was this helpful?<\/span>\n        <button\n                class=\"was-this-helpful__button fl-text-sm\"\n                aria-label=\"Yes\"\n                value=\"yes\"\n        >\n            <span class=\"was-this-helpful__button-text fl-text-bold\">Yes<\/span>\n            <i class=\"was-this-helpful__button-icon\">\n                <svg width=\"22\" height=\"22\" viewBox=\"0 0 22 22\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                 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  class=\"fa fa-angle-right medium\"\n                        aria-hidden=\"true\"\n                    ><\/i>\n                <\/button>\n                <button\n                    class=\"was-this-helpful__feedback-button was-this-helpful__feedback-button--cancel fl-button primary disabled\"\n                    type=\"reset\"\n                >\n                    <span class=\"fl-button-content\">Cancel<\/span>\n                    <i\n                        class=\"fa fa-times-circle medium\"\n                        aria-hidden=\"true\"\n                    ><\/i>\n                <\/button>\n            <\/div>\n        <\/form>\n    <\/div>\n    <div class=\"was-this-helpful__thank-you-message\" role=\"status\">\n        <i class=\"was-this-helpful__thank-you-message-icon fa fa-check\"><\/i>\n        <p class=\"was-this-helpful__thank-you-message-text\" aria-live=\"polite\"><\/p>\n    <\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"fl-section-sidebar\"><div class=\"fl-editors-summary\" data-testid=\"fl-editors-summary\">\n    \n    <div class=\"fl-editors-summary-content\" data-testid=\"fl-editors-summary-content\">\n                    <h2>Can I Solve This on My Own or Do I Need an Attorney?<\/h2>\n                <div class=\"fl-editors-summary-content-main\" data-testid=\"fl-editors-summary-content-main\">\n            \n        <\/div>\n        <ul class=\"fl-list-style-none\">\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    Medicare and Medicaid issues can often be handled on your own\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    Attorneys are helpful when the health care system is complex\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    Complex heath care cases (such as medical malpractice, bioethics, or health advocacy) may need the support of an attorney\n\n                <\/li>\n                    <\/ul>\n                    <div class=\"fl-editors-summary-content-description\" data-testid=\"fl-editors-summary-content-description\">\n                <p>Protect your patient rights with an attorney at your side. 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<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>With right to try laws, terminally ill patients can have access to experimental treatments not yet approved by the U.S. Food and Drug Administration, but this can come with certain risks and liabilities. Find out more about this and related topics at FindLaw&#8217;s Medicine and the Law section.<\/p>\n","protected":false},"author":41135,"featured_media":0,"parent":355799,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"app\/Http\/Controllers\/Templates\/ArticleWithBreadcrumbsController.php","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_autodraft_ids":[],"_cloudinary_featured_overwrite":false,"_sb_is_suggestion_mode":false,"_sb_show_suggestion_boards":false,"_sb_show_comment_boards":false,"_sb_suggestion_history":"","_sb_update_block_changes":"","_is_real_time_mode":false,"_realtime_collaborators":"","footnotes":"","cf_checklist_status":[]},"categories":[2740],"tags":[],"state_laws_tags":[],"flmsa":[],"class_list":["post-355834","page","type-page","status-publish","hentry","category-healthcare"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages\/355834","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/users\/41135"}],"replies":[{"embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/comments?post=355834"}],"version-history":[{"count":1,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages\/355834\/revisions"}],"predecessor-version":[{"id":399366,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages\/355834\/revisions\/399366"}],"up":[{"embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages\/355799"}],"wp:attachment":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/media?parent=355834"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/categories?post=355834"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/tags?post=355834"},{"taxonomy":"state_laws_tags","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/state_laws_tags?post=355834"},{"taxonomy":"flmsa","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/flmsa?post=355834"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}