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Expanded Access Program (EAP)
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'''Compassionate use''' or the '''Expanded Access Program''' in the [[United States]] that allows limited access to unlicensed drugs, for example investigational drugs, under certain conditions.<ref name="FDA-EA">{{Cite web | url=https://www.fda.gov/news-events/public-health-focus/expanded-access | title = Expanded Access|website=FDA | date = Mar 23, 2021|access-date=2022-04-13 }}</ref> Similar compassionate use programs exist in other countries, including countries in the European Union.<ref name="EMA">{{Cite web | url=https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use | title = Compassionate use | website=European Medicines Agency|access-date=2022-04-13 }}</ref> ==Serious or life-threatening conditions== Compassionate use is typically restricted to only people with life-threatening or serious illness, which the FDA defines as: {{Quote|text=Serious disease or condition means a disease or condition associated with morbidity that has [[severe and very severe ME|substantial impact on day-to-day functioning]]. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one."|source=Keywords, Definitions, and Resources, Expanded Access β FDA.<ref name="seriouscondition">{{Cite web | url=https://www.fda.gov/news-events/expanded-access/expanded-access-keywords-definitions-and-resources | title = Expanded Access {{!}} Keywords, Definitions, and Resources|website=FDA | date = |access-date=2022-04-13 }}</ref>}} Most programs also require patients to have exhausted all available treatment options or to have no available comparable or satisfactory alternatives for the patient. There are typically other restrictions or limitations as well.<ref name="FDA"/><ref name="EMA"/> ==ME/CFS== The drug [[Ampligen]] is used by some patients under the US's '''AMP-511''' or earlier programs. It is given by twice-weekly infusions, with the main clinics being [[Hunter Hopkins]] in North Carolina, and [[Daniel Peterson]]'s Sierra Internal Medicine in [[Nevada]]. In clinicial trials for Ampligen a as [[Karnofsky Performance Score]] (KPS) of between 20 and 60 has been required. The KPS score goes from 0 (dead) to 100 (excellent health). ==Ampligen== Ampiglen (rintatolimod) is a drug used by some [[ME/CFS]] patients through expanded access.<ref name="TownCFS">{{Cite web | url=https://www.newyorker.com/culture/personal-history/a-town-for-people-with-chronic-fatigue | title = A Town for People with Chronic Fatigue Syndrome|website=New Yorker | date = Sep 3, 2019 | first = Mike | last = Mariani|access-date=2022-04-13}}</ref> ==See also== *[[Ampligen]] ==Learn more== *[https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use Compassionate use] - European Medicines Agency *[https://www.fda.gov/news-events/public-health-focus/expanded-access Expanded Access] - FDA *[https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians Expanded Access | Information for Physicians] - FDA ==References== {{Reflist}} [[Category:Ethics]] [[Category:Management strategies]]
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