Right-to-try law

[[File:Right to Try Law by State.svg|thumb|

State right-to-try laws by jurisdiction{{Cite web|url=http://righttotry.org/in-your-state/|title=In Your State Right to Try – Movement for Terminal Patients|last=|date=|publisher=Goldwater Institute|access-date=March 13, 2018|quote=Those states not showing adoption (by image inspection) – Alaska, Hawaii, New Mexico, Nebraska, Kansas, Wisconsin, New York, Vermont, Massachusetts, New Jersey, Delaware}}{{legend|#008000|Right-to-try law}}{{legend|#FF0000|No right-to-try law}}]]

In 2014, Colorado became the first state to pass a right-to-try law.{{cite news|url=https://www.pbs.org/newshour/show/right-try-law-gives-terminal-patients-access-non-fda-approved-drugs|title='Right to Try' Law Gives Terminal Patients Access to Drugs Not Approved by FDA|date=June 21, 2014|work=PBS NewsHour|access-date=March 13, 2018|publisher=NewsHour Productions LLC|type=Transcript of television program|quote=This May, Colorado's Democratic governor signed the nation's first 'right to try' bill.}} {{As of|2018|August}}, 41 states had enacted such laws: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.{{Cite press release|title=Oregon 24th state to enact 'Right to Try' law|date=August 13, 2015|publisher=Goldwater Institute|url=http://www.ktvz.com/news/Oregon-24th-state-to-enact-Right-to-Try-law/34713756|archive-url=https://web.archive.org/web/20150816200525/http://www.ktvz.com/news/Oregon-24th-state-to-enact-Right-to-Try-law/34713756|archive-date=August 16, 2015|via=KTVZ.com}}[http://blog.tenthamendmentcenter.com/2016/06/signed-by-the-governor-south-carolina-right-to-try-act-rejects-some-fda-restrictions-on-terminal-patients/ Tenth Amendment Center Blog | Signed by the Governor: South Carolina Right to Try Act Rejects Some FDA Restrictions on Terminal Patients][http://reason.com/blog/2016/09/27/california-becomes-32nd-state-to-pass-ri California Becomes 32nd State to Pass "Right to Try" Law for Terminally Ill – Hit & Run : Reason.com]

In April 2022, Arizona enacted an expanded version of its right-to-try law.{{cite web | last1=Joyce | first1=Tom | title=Arizona expands right to try | url=https://www.thecentersquare.com/arizona/arizona-expands-right-to-try/article_3201abae-c677-11ec-92d2-73155e45f4f2.html | date=April 27, 2022 | work=The Center Square | access-date=April 30, 2022}}{{cite web | last1=Nerozzi | first1=Timothy H.J. | title=Arizona Gov. Doug Ducey signs 'Right To Try 2.0' into law | url=https://www.foxnews.com/politics/arizona-gov-doug-ducey-signs-right-to-try-law | date=April 27, 2022 | work=Fox News | access-date=April 30, 2022}}

In May 2023, Montana passed a bill expanding the Right to Try Act, giving patients to access experimental therapeutics that have passed Phase I clinical trials but are not yet approved by the FDA.{{Cite web |title=SB 422: Expand eligibility for the Right to Try Act {{!}} 2023 Montana Capitol Tracker |url=https://apps.montanafreepress.org/capitol-tracker-2023/bills/sb-422/ |access-date=2024-10-28 |website=Montana Free Press}}{{Cite web |date=2023-05-12 |title=Governor of Montana Approves Bill Expanding Patient Access to Experimental Treatments - a4li.org |url=https://a4li.org/right-to-try-act-expansion-press-release/ |access-date=2024-10-28 |website=a4li.org |language=en-US}}

In January 2017, a federal right-to-try bill was introduced in the Senate by Republican Ron Johnson of Wisconsin.{{cite news|title=S.204 – Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017|url=https://www.congress.gov/bill/115th-congress/senate-bill/204?q=%7B%22search%22%3A%5B%22right+to+try%22%5D%7D&r=2|publisher=115th U.S. Congress, 1st session}} Johnson's bill passed the Senate on August 3, 2017, in a unanimous consent motion.{{cite news|title=Senate Passes 'Right to Try' Bill|url=http://www.raps.org/Regulatory-Focus/News/2017/08/03/28171/Senate-Passes-Right-to-Try-Bill/|publisher=Regulatory Affairs Professional Society}} Johnson had threatened to hold up a Senate vote on the FDA Reauthorization Act of 2017 (FDARA), a must-pass piece of legislation that allows the FDA to operate, if a right-to-try amendment was not added to it. He agreed to drop a hold on FDARA in exchange for a unanimous consent motion.{{cite news|title=Johnson Agrees To Drop Hold On FDARA In Exchange For Vote On Revised Right-To-Try Bill|url=https://insidehealthpolicy.com/daily-news/johnson-agrees-drop-hold-fdara-exchange-vote-revised-right-try-bill|publisher=Inside Health Policy}} A companion House bill was introduced in February 2017; the next month it was referred to the House Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.{{cite news|title=H.R.878|url=https://www.congress.gov/bill/115th-congress/house-bill/878?q=%7B%22search%22%3A%5B%22right+to+try%22%5D%7D&r=1|access-date=March 17, 2017|publisher=115th U.S. Congress, 1st session}} On March 21, 2018, the House passed a right-to-try bill, sending it to the Senate for consideration.{{Cite news|url=https://www.politico.com/story/2018/03/21/drugs-right-to-try-congress-434677|title=House passes right-to-try bill on second try|last=Karlin-Smith|first=Sarah|date=March 21, 2018|work=Politico|access-date=May 11, 2018}} On May 22, the Senate passed S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act, and sent it to President Trump, who signed it on May 30, 2018, creating a uniform system for terminal patients seeking access to investigational treatments.{{Cite web |url=https://www.cnn.com/2018/05/30/politics/right-to-try-donald-trump/index.html |title=Trump signs 'Right to Try Act' aimed at helping terminally ill patients seek drug treatments |last=Malloy |first=Allie |date=2018-05-30 |website=CNN |language=en |access-date=2018-05-25}}

The chief advocate of right-to-try laws is the Goldwater Institute, a libertarian think tank based in Arizona, which created the model act on which the state laws are based.{{cite news|title=Goldwater Institute Right to Try Model Legislation|url=https://goldwater-media.s3.amazonaws.com/cms_page_media/2015/1/28/RIGHT%20TO%20TRY%20MODEL%20LEGISLATION%20%25282%2529_1.pdf|access-date=February 19, 2016|url-status=dead|archive-url=https://web.archive.org/web/20160115074936/https://goldwater-media.s3.amazonaws.com/cms_page_media/2015/1/28/RIGHT%20TO%20TRY%20MODEL%20LEGISLATION%20%282%29_1.pdf|archive-date=January 15, 2016}} Kurt Altman, national policy adviser for the institute, has said that right-to-try laws return control of medical decisions "back to a local level".{{cite news|last1=Monir|first1=M|title=States Move to Give Terminally Ill 'Right-to-Try' Drugs|url=https://www.usatoday.com/story/news/nation/2015/02/19/right-to-try-state-legislation-terminally-ill-patients/23667229/|access-date=August 14, 2015|newspaper=USA Today|date=February 19, 2015}} Other proponents include patients and their families, as well as patient advocate groups.{{cite news|last1=Harada|first1=T|title=Afflicted Have the Right to Try|url=http://www.myajc.com/news/news/opinion/afflicted-have-the-right-to-try/nfrq2/|access-date=February 19, 2016|publisher=Atlanta Journal-Constitution|date=May 9, 2014}} Supporters of these laws sometimes describe them as "Dallas Buyers Club" bills, a reference to a movie about an American man with AIDS who smuggled unapproved treatments from foreign countries to fellow patients. Some have likened the efforts of terminally ill patients to procure unapproved drugs in development to those of ACT-UP and other AIDS organizations of the 1980s.{{cite news|last1=Andriote|first1=J-M|title=Who Decides? 'Right-to-Try' Law's Unacknowledged, Deep Roots in AIDS Activism|url=http://www.huffingtonpost.com/johnmanuel-andriote/who-decides-righttotry-right-to-try-law_b_5373157.html|access-date=February 19, 2016|issue=May 22, 2014|work=Huffington Post}}

One ethical argument for the right to try unapproved treatments is that if patients have the right to die through physician-assisted suicide or voluntary euthanasia, they should also be afforded the right to try.{{cite news|last1=Cohen-Kurzrock|first1=J|title=Health policy: The right to try is embodied in the right to die|url=http://www.nature.com/nrclinonc/journal/v13/n7/full/nrclinonc.2016.73.html|access-date=November 20, 2016|publisher=Nature Reviews|date=May 24, 2016}}

In 2016, Houston oncologist Dr. Ebrahim Delpassand testified to a US Senate committee that he treated 78 patients for neuroendocrine cancer with LU-177 octreotate under the Texas Right to Try law, after the FDA refused permission to include those patients in the clinical trial that he was running.{{cite web| url=https://www.congress.gov/congressional-record/2016/09/28/senate-section/article/S6173-1 |access-date=2017-02-10 | work=The Congressional Record |date=2016-09-28 |title=Statement of Sen. Johnson of Wisconsin}}{{cite web |url=https://blog.cirm.ca.gov/2016/12/19/right-to-try-laws-called-right-to-beg-by-stem-cell-advocates/ |title='Right To Try' laws called 'Right To Beg' by Stem Cell Advocates |date=December 19, 2016 |first=Kevin |last=McCormack |work=The Stem Cellar, The Official Blog of CIRM, California's Stem Cell Agency |access-date=2017-02-10}} However, the drug's manufacturer, Advanced Accelerator Applications, has made this drug available through an expanded access program for patients with neuroendocrine tumors, so it is disputed whether this is a substantiated case of a right to try law being used to gain patients access to an investigational product.{{cite web| url=https://clinicaltrials.gov/ct2/show/NCT02705313 |access-date=2017-03-17 | work=ClinicalTrials.gov |date=2017-02-17 |title= Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Midgut Carcinoid Tumors, Progressive Under Somatostatin Analogue Therapy}} State legislators in Texas and North Carolina have introduced bills that would expand state right-to-try laws to include stem cell and tissue based regenerative therapies currently in development and to allow patients with serious, chronic illness to use the right-to-try pathway.{{Cite web|url=https://capitol.texas.gov/Search/DocViewer.aspx?ID=86RHB008051B&QueryText=%22right+to+try%22&DocType=B|title=HB 805 – Parker|language=en-US|access-date=2019-05-01}}{{Cite web|url=https://legiscan.com/NC/bill/H934/2019|title=NC HB934|language=en-US|access-date=2019-05-01}}

In 2024, following calls for regulatory and legal change that will expand access to controlled substances among terminally ill populations, two legal cases related to expanded utilization of psilocybin are moving through the federal court system. The Advanced Integrative Medicine Science (AIMS) Institute in concert with the NPA filed a series of lawsuits seeking both the rescheduling of and expanded right to try access to psilocybin.{{Cite web |last=Vossel |first=Holly |date=2024-05-21 |title=Laws in Motion to Bring ‘Right to Try’ Psychedelics at End-of-Life |url=https://hospicenews.com/2024/05/21/laws-in-motion-to-bring-right-to-try-psychedelics-at-end-of-life/ |access-date=2025-02-13 |website=Hospice News |language=en-US}}

Bioethicists and other scholars have questioned the extent to which right-to-try laws will actually benefit patients. Jonathan Darrow, Arthur Caplan, Alta Charo, Rebecca Dresser, Alison Bateman-House and others have pointed out that the laws do not require physicians to prescribe experimental therapies, do not require insurance companies to pay for them, and do not require manufacturers to provide them.{{cite news|last1=Dennis, B|first1=Eunjung Cha, A|title='Right to Try' Laws Spur Debate Over Dying Patients' Access to Experimental Drugs|url=https://www.washingtonpost.com/national/health-science/right-to-try-laws-spur-debate-over-dying-patients-access-to-experimental-drugs/2014/05/16/820e08c8-dcfa-11e3-b745-87d39690c5c0_story.html|access-date=August 14, 2015|newspaper=Washington Post|date=May 15, 2014}}{{cite journal|last1=Darrow, J|display-authors=etal|title=Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs|journal=New England Journal of Medicine|date=January 15, 2015|volume=372 |issue=3 |pages=279–286 |doi=10.1056/NEJMhle1409465|pmid=25587952 |doi-access=free}} Because the laws do not actually provide a right to receive experimental therapies, they could be considered toothless legislation that offers only false hope to dying people.{{cite journal |last1=Yang |first1=Y.Tony |last2=Chen |first2=Brian K.|title="Right-to-Try" Legislation: Progress or Peril? |journal=Journal of Clinical Oncology |date=2015 |volume=24 |issue=33 |pages=2597–2599 |doi=10.1200/JCO.2015.62.8057 |pmid=26195722 |url=https://www.researchgate.net/publication/280241157}}{{cite web |last1=Zuckerman |first1=Diana |title=Right to Try National Law Would Exploit False Hope |url=http://www.center4research.org/right-to-try-exploit-false-hope/ |website=National Center of Health Research |access-date=December 26, 2019}} Even if the laws work as intended, they would be problematic to critics. Because the laws require only that drugs have completed the first of three phases of clinical testing, there is no data on the efficacy of the drugs, especially in very sick people. There is also no safety data on how they would affect very sick people. This makes informed consent on the part of the patient more difficult. Informed consent entails knowledge of the pros and cons of a proposed treatment, then a decision made in light of those pros and cons.{{cite news|last1=Bateman-House, A|title=Right-to-Try Laws: Hope, Hype, and Unintended Consequences|url=http://annals.org/article.aspx?articleid=2443961|access-date=February 19, 2016|publisher=Annals of Internal Medicine|date=September 17, 2015|display-authors=etal}} Some states' right-to-try laws also put patients at risk of losing hospice or home health care,{{cite news|last1=Kearns, L|first1=Caplan, A|author-link=Arthur Caplan|title=Right-to-Try Legislation Punishing|url=http://www.timesunion.com/tuplus-opinion/article/Right-to-try-legislation-punishing-6231527.php|access-date=February 19, 2016|publisher=Albany Times Union|date=April 29, 2015}} and the costs surrounding treatment can be prohibitive, something right-to-try laws do not fix. Bioethicist Alta Charo called the laws "a simplistic way of going after much more complicated issues."{{cite news|last1=Leonard|first1=K|title=Seeking the Right to Try|url=https://www.usnews.com/news/articles/2014/11/18/right-to-try-laws-allowing-patients-to-try-experimental-drugs-bypass-fda|access-date=August 14, 2015|publisher=U.S. News & World Report|date=November 18, 2014}}

Medical and health experts have also voiced concerns. If the laws were to grant patients access to unapproved drugs, they could hasten death or cause increased suffering.{{cite news|last1=Gorski|first1=D|author-link=David Gorski|title=The False Hope of 'Right to Try' Metastasizes to Michigan|url=https://www.sciencebasedmedicine.org/the-false-hope-of-right-to-try-metastasizes-to-michigan/|access-date=February 19, 2016|publisher=Science-Based Medicine|date=July 21, 2014}} Peter Temin wrote that "there is always a chance that any given drug will fail to cure a condition or will induce an adverse reaction," such as becoming sick, or sicker, or even dying.{{cite book|last1=Temin|first1=P|author-link=Peter Temin|title=Taking Your Medicine: Drug Regulation in the United States|publisher=Harvard University Press|location=Cambridge|pages=1–2}} Drugs that are not fully studied may lead to more adverse reactions in patients. The laws reduce FDA oversight of drug regulation.{{cite news|last1=Silverman|first1=E|title='Right to Try' Laws Wrong to Skirt FDA|url=https://www.bostonglobe.com/business/2015/10/12/right-try-laws-are-wrong-usurp-fda/54tlCnBEQ4DHMlkYd1ZIdJ/story.html|access-date=February 19, 2016|newspaper=Boston Globe|date=October 12, 2015}} Another criticism is that state right-to-try laws may be unconstitutional, because they involve states regulating medicine despite federal legislation that regulates the interstate marketing of medicine.{{cite journal|last1=Yang, T|title='Right to Try' Legislation: Progress or Peril?|url=https://ascopubs.org/doi/full/10.1200/JCO.2015.62.8057|access-date=January 6, 2021|journal=Journal of Clinical Oncology|date=July 20, 2015|volume=33 |issue=24 |pages=2597–2599 |doi=10.1200/JCO.2015.62.8057|pmid=26195722 |display-authors=etal|url-access=subscription}} Various authors have predicted that right-to-try laws would be struck down if taken to court.{{cite news|last1=Adriance|first1=S|title=Fighting for the 'Right to Try' Unapproved Drugs: Law as Persuasion|url=http://www.yalelawjournal.org/forum/right-to-try-unapproved-drugs|access-date=February 19, 2016|publisher=Yale Law Journal|date=December 4, 2014}}{{cite news|last1=Farber, D|title=How State Right-to-Try Laws Create False Expectations|url=https://www.healthaffairs.org/do/10.1377/forefront.20150522.047884|publisher=Health Affairs Blog|date=May 22, 2015|doi=10.1377/forefront.20150522.047884|display-authors=etal}} A 2014 paper in JAMA Internal Medicine argued that right to try laws "seem likely to be futile."{{cite news|last1=Zettler, P|first1=Greely, H|title=The Strange Allure of State 'Right-to-Try' Laws|url=http://archinte.jamanetwork.com/article.aspx?articleid=1910562|access-date=February 19, 2016|publisher=JAMA Internal Medicine|date=December 1, 2014}}

In April 2017, oncologist David Gorski wrote in Science-Based Medicine that the right-to-try law is harmful to society as it is popular with the public who do not understand how the FDA works, Gorski calls this "placebo legislation. They make lawmakers feel good, but they do nothing concrete to help actual patients." Gorski states that right-to-try laws enable "cancer quack" like the Burzynski Clinic to operate for years. "It's also important to remember that the real purpose of right-to-try laws is not to help patients, but to neuter the FDA's ability to regulate certain drugs, consistent with the source of this legislation." Gorski further states that these laws "rest on a fantasy... of false hope ... that is rooted in libertarian politics ... that claims that deregulation is the cure for everything."{{cite web |last1=Gorski |first1=David |author-link=David Gorski|title=The cruel sham that is right-to-try raises its ugly head at the federal level again |url=https://sciencebasedmedicine.org/the-cruel-sham-that-is-right-to-try-raises-its-ugly-head-at-the-federal-level-again/ |publisher=Science-Based Medicine |access-date=31 May 2018 |archive-url=https://web.archive.org/web/20180531165719/https://sciencebasedmedicine.org/the-cruel-sham-that-is-right-to-try-raises-its-ugly-head-at-the-federal-level-again/ |archive-date=31 May 2018|url-status=live}}

In January 2019 Jann Bellamy added that the right-to-try does not ensure "that only patients who have no other treatment options receive access; that costs are appropriate; that informed consent is legally and ethically sound; and that the proposed treatment plan offers a favorable risk/benefit profile for the patient." Additionally, "there is no regulatory infrastructure spelling out just how patients and physicians should go about accessing investigational drugs or how drug companies should respond."{{Cite web|url=https://sciencebasedmedicine.org/right-to-try-laws-create-tremendous-legal-uncertainties-fda-expanded-access-preferable/|title="Right to try" laws create tremendous legal uncertainties; FDA expanded access preferable|last=Bellamy|first=Jann|website=Science-Based Medicine|language=en-US|access-date=2019-02-27}} Harriet Hall, MD expressed concerns that patients may not completely comprehend the risks involved in taking medications available under the right-to-try law, nor understand the low probability of success, especially patients who were not healthy enough to qualify to participate in clinical trials.{{cite web |last1=Hall |first1=Harriet| author-link=Harriet Hall|title=Health Freedom, Right to Try, and Informed Consent |url=https://www.skeptic.com/reading_room/health-freedom-right-to-try-and-informed-consent/ |website=Skeptic |access-date=26 December 2019}} She states these patients may have other medical conditions that could make them more vulnerable to complications from experimental treatments.

When Trump signed the legislation into law in May 2018 he said, "We will be saving—I don't even want to say thousands, because I think it's going to be much more. Thousands and thousands. Hundreds of thousands. We're going to be saving tremendous numbers of lives."{{cite web |last1=Hamblin |first1=James |title=The Disingenuousness of 'Right to Try' |url=https://www.theatlantic.com/health/archive/2018/06/right-to-try/561770/ |website=The Atlantic |access-date=August 3, 2019}} As of June 2019 only two patients have received access to experimental medical products through the federal right to try pathway. In February 2019, one of the namesakes of the federal law, Matt Bellina, who has ALS, said that he gained access to an experimental treatment through the drug company Brainstorm. Brainstorm said it would not accept any other patients for trials.{{cite news|last1=Florko|first1=Nicholas|date=February 5, 2019|title=Prominent 'right-to-try' advocate is getting treatment under the new law|publisher=STAT News|url=https://www.statnews.com/2019/02/05/one-right-to-try-advocate-is-getting-treatment-under-the-new-law/|access-date=May 1, 2019}} Frank Mongiello, who also has ALS, still has not found access to a treatment program. In an interview his wife said, "We had a lot of hope that if the right to try was passed it would give an incentive for the drug companies to make available the drugs. But now it doesn't seem as though the drug companies are giving away their drugs either."{{cite news|last1=Florko|first1=Nicholas|title=A year after Trump touted 'right to try,' patients still aren't getting treatment|url=https://www.statnews.com/2019/01/29/right-to-try-patients-still-arent-getting-treatment/|access-date=May 1, 2019|publisher=STAT News|date=January 29, 2019}}

Natalie Harp, who was invited onto the stage by President Trump while he was speaking in June 2019, at a Faith and Freedom Coalition conference, a coalition of conservative evangelical Christians, said that the legislation saved her life. Harp, who states she was diagnosed with Stage 2 cancer and left housebound by a medical error one year after the bill passed, declared the legislation saved her life and she praised the Trump administration's fight for healthcare.{{cite news |title=Millennial fighting cancer thanks Trump for 'Right to Try' during faith conference appearance |url=https://www.foxnews.com/politics/millennial-fighting-cancer-thanks-trump-for-right-to-try-during-faith-conference-appearance |work=Fox News |date=26 June 2019| author1= O'Reilly, Andrew}}{{cite web | url=https://www.fdareview.org/2019/06/24/right-to-try-legislation-helps-patient-battling-bone-cancer/ | title=Right-to-Try Legislation Helps Patient Battling Bone Cancer | author1= March, Raymond |date=24 June 2019 | publisher=Independent Institute | website=FDAReview.org}}This is also known as off-label use, which is not uncommon. Harp's claims were called into question by former FDA official Peter Lurie and Simon Fraser University professor of health sciences Jeremy Snyder.{{Cite news |last=Wan |first=William |date=August 25, 2020 |title=Natalie Harp said Trump saved her life. Experts doubt that’s true. |url=https://www.washingtonpost.com/health/2020/08/25/natalie-harp-bone-cancer-trump/ |access-date=July 6, 2024 |work=The Washington Post}}{{Cite web |last=Pavia |first=Will |date=2024-07-06 |title=Meet Trump’s ‘human printer’ who claims he saved her from dying of cancer |url=https://www.thetimes.com/world/us-world/article/natalie-harp-donald-trump-prints-paper-520f8wjhw |url-status=live |archive-url=https://archive.today/20240524215206/https://www.thetimes.com/world/us-world/article/natalie-harp-donald-trump-prints-paper-520f8wjhw |archive-date=24 May 2024 |access-date=2024-07-06 |website=The Times |language=en}} Snyder noted that Harp had been given "an FDA-approved immunotherapy drug for an unapproved use", which had been allowed prior to Right to Try.{{Cite news |last=Snyder |first=Jeremy |date=November 15, 2019 |title=Trump brags that he’s helping patients access medical ‘miracles.’ He isn’t. |url=https://www.washingtonpost.com/outlook/trump-brags-that-hes-helping-patients-access-medical-miracles-he-isnt/2019/11/15/14690142-00df-11ea-8501-2a7123a38c58_story.html |access-date=July 6, 2024 |work=The Washington Post}}

The federal [https://www.congress.gov/115/bills/s204/BILLS-115s204enr.pdf Right to Try law] requires that sponsors report an annual summary to the FDA of uses, including serious adverse events, number of doses used, number of patients dosed, and the intended use of the product. A proposed guidance document for the reporting requirements was released in 2020;{{Cite web|date=2020-07-24|title=Annual Summary Reporting Requirements Under the Right to Try Act|url=https://www.federalregister.gov/documents/2020/07/24/2020-16016/annual-summary-reporting-requirements-under-the-right-to-try-act|access-date=2021-04-19|website=Federal Register}} the final guidance has not been released. Until that guidance is released, the usage of right to try will be uncertain. According to available records, very few patients accessed unapproved medical products through Right to Try until recently.{{Cite web|title=Right to Try: A 'well-intentioned' but 'misguided' law|url=https://www.healio.com/news/hematology-oncology/20200303/right-to-try-a-wellintentioned-but-misguided-law|access-date=2021-04-19|website=www.healio.com}} In February 2021, NeuroRX CEO Jonathan Javitt gave an interview indicating that its drug, aviptadil, had been used in over 500 patients with COVID-19, after the phase IIb/III trial failed to show significant benefit. FDA rejected the application for Emergency Use Authorization,{{Cite news|date=2020-12-30|title=Relief Therapeutics stock plunges after FDA rejects COVID-19 emergency approval|language=en|work=Reuters|url=https://www.reuters.com/article/uk-health-coronavirus-relief-hldg-idUKKBN2940WF|access-date=2021-04-19}} prompting Javitt and NeuroRX to allow use of aviptadil as a possible "hail mary" drug for severely ill COVID-19 patients.{{Cite web|title=NeuroRx chief lines up Hail Mary for once-rejected Covid-19 drug|url=https://endpts.com/neurorx-chief-lines-up-hail-mary-for-once-rejected-covid-19-drug/|access-date=2021-04-19|website=Endpoints News|language=en}}

• Expanded access
• Psilocybin decriminalization in the United States

{{Reflist}}

• [http://righttotry.org/ Right To Try]
• [https://web.archive.org/web/20190913232455/https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try Right to Try – FDA]
• Hearing, [https://energycommerce.house.gov/hearings/examining-patient-access-investigational-drugs/ Examining Patient Access to Investigational Drugs]. The Health Subcommittee Of The Committee On Energy And Commerce. U.S. House Of Representatives. October 3, 2017

Category:Medical regulation in the United States

Category:History of drug control in the United States