256:
378:
v Cancer, a pediatric cancer advocacy organization, launched the
Compassionate Use Navigator to assist physicians and guide families about the application process. Since then, FDA simplified the application process, but stressed that it cannot require a manufacturer to provide a product. FDA receives about 1,500 expanded access requests per year and authorizes 99% of it.
183:
the FDA annually; this data may be helpful with regard to getting the drug or device approved, or may be harmful, should unexpected adverse events occur. The manufacturer remains legally liable as well. If the manufacturer chooses to charge for the investigational product, that price influences later discussions about the price if the product is approved for marketing.
102:, in which the Abigail Alliance, a group that advocates for access to investigational drugs for people who are terminally ill, tried to establish such access as a legal right. The Supreme Court declined to hear the case, effectively upholding previous cases that have maintained that there is not a constitutional right to unapproved medical products.
1390:
377:
was declined by the drug manufacturer, Chimerix. The company reversed its decision after pressure from cancer advocacy organizations, and Josh received the drug that saved his life. Hardy later passed away in
September 2016 due to complications related to his underlying cancer diagnosis. In 2016 Kids
208:
issued guidelines that members may follow. Each country has its own regulations, and they vary. In the UK, for example, the program is called "early access to medicine scheme" or EAMS and was established in 2014. If a company that wants to provide a drug under EAMS, it must submit its Phase I data to
338:
in the mid-1980s. At its peak, fifteen people received the drug. 43 people were approved for the program, but 28 of the people whose doctors completed the necessary paperwork never received any cannabis. The program stopped accepting new people in 1992 after public health authorities concluded there
242:
Those seeking CSP are required to provide the following information; estimated amount of the unregistered drug the patient, the "licensed drug/device establishment through which the unregistered drug may be procured", and "the names and address of the specialists qualified and authorized to use the
182:
In some cases, it may be in the manufacturer's commercial interest to provide access under an EA program; this is a way, for example, for a company to make money before the drug or device is approved. Companies must provide data collected from people getting the drug or device under EA programs to
221:
Companies sometimes make use of expanded programs in Europe even after they receive EMA approval to market a drug, because drugs also must go through regulatory processes in each member state, and in some countries this process can take nearly a year; companies can start making sales earlier under
151:
The sponsor (generally the company developing the investigational product for commercial use) or the clinical investigator (or the patient's physician in the case of a single patient expanded access request) submits a clinical protocol (a document that describes the treatment plan for the patient)
91:
In general the person and their doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicine's regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the
350:
In
November 2001 the Abigail Alliance for Better Access to Developmental Drugs was established by Frank Burroughs in memory of his daughter, Abigail. The Alliance seeks broader availability of investigational drugs on behalf of people with terminal illnesses. It is best known for a legal case,
195:
that permit manufacturers to provide experimental medicines to terminally ill people without US FDA authorization. Legal, medical, and bioethics scholars, including
Jonathan Darrow and Arthur Caplan, have argued that these state laws have little practical significance because people can already
217:
is obligated to pay for people who fit the criteria to have access to the drug. As of 2016, governments also paid for early access to drugs in
Austria, Germany, Greece, and Spain. Since 2021, France has a system of early and expanded access separated in two systems: AAC and AAP.
170:
In the US, actual provision of the drug depends on the manufacturer's willingness to provide it, as well as the person's ability to pay for it; it is the company's decision whether to require payment or to provide the drug or device for free. The manufacturer can only charge
95:
In the US, compassionate use started with the provision of investigational medicine to certain patients in the late 1970s, and a formal program was established in 1987 in response to HIV/AIDS patients requesting access to drugs in development. An important legal case was
346:
The closure of the program during the height of the AIDS epidemic led to the formation of the medical cannabis movement in the United States, a movement which initially sought to provide cannabis for treating anorexia and wasting syndrome in people with AIDS.
333:
became the legal basis for the FDA's compassionate IND program. People were only allowed to use cannabis under the program who had certain conditions, like glaucoma, known to be alleviated with cannabis. The scope was later expanded to include people with
92:
person at risk has sufficient potential benefit. In some countries the government will pay for the drug or device, but in many countries the person must pay for the drug or device, as well as medical services necessary to receive it.
1394:
369:
declined to hear their appeal. This decision left standing the appellate court decision that people who are terminal ill patients have no legal right to demand "a potentially toxic drug with no proven therapeutic benefit".
230:
In the
Philippines, the usage of unregistered drugs may be allowed through a doctor, a specialist, or health institution or society obtaining a specific compassionate use permit (CSP) from the country's
1208:
362:
373:
In March 2014, Josh Hardy, a 7-year-old boy from
Virginia, made national headlines that sparked a conversation on pediatric access to investigational drugs when his family's request for
152:
that is consistent with FDA's statute and applicable regulations for INDs or investigational device exemption applications (IDEs), describing the use of the investigational product; and
148:
The FDA determines that providing the investigational product will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval;
846:
1405:
307:
110:
As of 2016, regulation of access to pharmaceuticals that were not approved for marketing was handled on a country by country basis, including in the
European Union, where the
210:
1313:
213:
and apply for what is called a "promising innovative medicine" (PIM) designation. If that designation is approved, the data is reviewed, if that review is positive, the
1137:
1022:
Phillips, Lisa (4 September 2008). "Contract Law and
Ethical Issues Underscore the Latest Lawsuit About Access to Experimental Drugs for Duchenne Muscular Dystrophy".
145:
The FDA determines that there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance;
179:
for small group or larger expanded access programs. To the extent that a doctor or clinic is required for use of the drug or device, they too may require payment.
114:
issued guidelines for national regulatory agencies to follow. In the US, Europe, and the EU, no company could be compelled to provide a drug or device that it was
489:
Balasubramanian, G.; Morampudi, S.; Chhabra, P.; Gowda, A.; Zomorodi, B. (2016), "An overview of
Compassionate Use Programs in the European Union member states",
267:
In the US, one of the earliest expanded access programs was a compassionate use IND that was established in 1978, which allowed a limited number of people to use
139:
The person's physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient's disease or condition.
196:
obtain pre-approval access through the FDA's expanded access program, and because the FDA is generally not the limiting factor in obtaining pre-approval access.
1151:
255:
121:
Companies sometimes provide drugs under these programs to people who were in clinical trials and who responded to the drug, after the clinical trial ends.
232:
1268:
1200:
820:
1069:
1231:"Abstract LB-146: Compassionate use navigator addresses challenges and facilitates access to investigational drugs for pediatric oncologists"
760:
142:
That the probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition.
854:
303:
318:
to argue against criminal charges of marijuana cultivation that had been brought against him, because his use of cannabis was deemed a
366:
353:
236:
129:
In the US as of 2018, people could try obtain unapproved drugs or medical devices that were in development under specific conditions.
98:
1321:
930:
49:, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
299:
280:
160:
42:
1325:
295:
1399:
606:
1429:
343:
administration's policies. As of 2011, four people continued to receive cannabis from the government under the program.
1354:
1363:
397:
358:
587:
1434:
961:
1152:"Saved Josh: The gears of a successful patient advocacy campaign (Case study, by Elena Gerasimov) | Kids v Cancer"
1349:
272:
260:
205:
111:
156:
38:
1229:
Gerasimov, Elena; Zhang, Lindy; Moerdler, Scott; Roth, Michael; Goodman, Nancy; Weiser, Daniel (2016-07-15).
214:
1176:
977:
1073:
1024:
235:
for the treatment of their terminally or seriously ill patients. The issuance of CSP is stated under
1230:
1077:
437:"Early access programs: Benefits, challenges, and key considerations for successful implementation"
1359:
847:"FDA : 'Compassionate permits' for imported cannabis-based drugs allowed, but no request yet"
1118:
136:
The person wanting the drug or device and a licensed physician are both willing to participate.
1250:
1100:
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741:
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268:
244:
115:
791:
1130:
276:
945:
The Criminal Law Reporter. 20. Bureau of National Affairs. Arlington, Va. 1976. p. 2300.
881:
Ben Amar M (2006). "Cannabinoids in medicine: a review of their therapeutic potential".
564:
537:
511:
463:
436:
176:
46:
1314:"Expanded Access (Compassionate Use) - Expanded Access INDs and Protocols 2009 - 2017"
1037:
1423:
374:
1246:
956:
922:
Smoke Signals: A Social History of Marijuana - Medical, Recreational and Scientific
710:
Darrow, Jonathan J.; Sarpatwari, Ameet; Avorn, Jerry; Kesselheim, Aaron S. (2015).
172:
712:"Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs"
671:"Practical, legal, and ethical issues in expanded access to investigational drugs"
630:"Practical, legal, and ethical issues in expanded access to investigational drugs"
17:
1374:
1269:"Expanded Access: FDA Describes Efforts to Ease Application Process | FDA Voice"
387:
155:
The person is unable to obtain the investigational drug or device under another
1293:
894:
554:
1254:
737:
453:
761:"Medical Ethicist Arthur Caplan Explains Why He Opposes 'Right-to-Try' Laws"
502:
326:). On November 24, 1976, federal Judge James Washington ruled in his favor.
1051:
902:
776:
745:
728:
711:
696:
687:
670:
655:
646:
629:
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520:
472:
167:
Drugs can be made available to individuals, small groups, or large groups.
1008:
37:
is the use of an unapproved drug or medical device under special forms of
1298:
995:
Werner, Clinton A. (June 2001). "Medical Marijuana and the AIDS Crisis".
311:
957:"Painful journey: Woman aims to gain support for marijuana as medicine"
628:
Darrow, JJ; Sarpatwari, A; Avorn, J; Kesselheim, AS (15 January 2015).
821:"Fact check: Is medical marijuana already allowed in the Philippines?"
365:
reversed an earlier ruling in favor of the Alliance. In 2008, the
1070:"No right to experimental drugs for dying patients: Supreme Court"
254:
275:, under the direction of Marijuana Research Project Director Dr.
588:"US National Cancer Institute – Access to Investigational Drugs"
335:
1368:
792:"Réforme de l'accès dérogatoire aux médicaments (MAJ 29/08/23)"
27:
Program providing access to unapproved drugs or medical devices
1201:"Josh Hardy, Va. Boy Who Inspired Social Media Campaign, Dies"
1177:"Drug company: Ailing 7-year-old Josh Hardy will get medicine"
247:
despite cannabis in general being illegal in the Philippines.
1294:"FDA Simplifies Compassionate Use Application and Drug Costs"
363:
U.S. Court of Appeals for the District of Columbia Circuit
536:
Hyry, HI; Manuel, J; Cox, TM; Roos, JC (21 August 2015).
814:
812:
1406:
United States Department of Health and Human Services
484:
482:
163:(for devices), or to participate in a clinical trial.
339:
was no scientific value to it, and due to President
1099:Correspondent, By Elizabeth Cohen, Senior Medical.
243:product." A CSP may also be obtained for processed
211:
Medicines and Healthcare products Regulatory Agency
175:for individual INDs; it can add some but not all
52:These programs go under various names, including
914:
912:
191:As of February 2019, 41 states have passed
876:
874:
872:
308:Department of Health, Education & Welfare
8:
819:Viray, Patricia Lourdes (18 December 2018).
978:"4 Americans get medical pot from the feds"
601:
599:
597:
430:
428:
426:
424:
422:
420:
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361:. On August 7, 2007, in an 8–2 ruling, the
1101:"Company denies drug to dying child - CNN"
531:
529:
1136:CS1 maint: multiple names: authors list (
727:
686:
645:
563:
553:
510:
462:
452:
1175:Catherine E. Shoichet; Elizabeth Cohen.
1052:"Your Weekly Update of News and Reviews"
491:Intractable & Rare Diseases Research
414:
1126:
1116:
607:"Expanded Access (Compassionate Use)"
357:, in which it was represented by the
39:investigational new drug applications
7:
239:Administrative Order No. 4 of 1992.
1401:Expanded Access (Compassionate Use)
925:. Simon and Schuster. p. 234.
669:Darrow JJ; et al. (Jan 2015).
634:The New England Journal of Medicine
538:"Compassionate use of orphan drugs"
1371:as a named patient import Provider
367:Supreme Court of the United States
354:Abigail Alliance v. von Eschenbach
99:Abigail Alliance v. von Eschenbach
25:
1322:U.S. Food and Drug Administration
1292:Frellick, Marcia (June 3, 2016).
1076:. 14 January 2008. Archived from
1038:10.1097/01.nt.0000337676.20893.50
542:Orphanet Journal of Rare Diseases
441:Perspectives in Clinical Research
259:Medicinal cannabis farmed by the
1393: This article incorporates
1388:
1355:Food and Drug Administration U.S
1241:(14 Supplement): LB–146–LB–146.
1211:from the original on 22 May 2018
997:Journal of Cannabis Therapeutics
955:Rupnow, Chuck (August 9, 1997).
316:Common Law doctrine of necessity
300:National Institute on Drug Abuse
281:National Institute on Drug Abuse
1247:10.1158/1538-7445.AM2016-LB-146
845:Cabal, Ruth (16 October 2017).
765:Oncology (Williston Park, N.Y.)
716:New England Journal of Medicine
296:Drug Enforcement Administration
78:temporary authorization for use
1377:as an Expanded Access Provider
919:Lee, Martin A. (August 2012).
286:The program was started after
1:
279:. It is administered by the
883:Journal of Ethnopharmacology
790:BOREL, CĂ©line (2023-03-13).
314:, had successfully used the
233:Food and Drug Administration
1375:myTomorrows Expanded Access
398:Emergency Use Authorization
359:Washington Legal Foundation
1451:
1350:Europeans Medicines Agency
962:Eau Claire Leader-Telegram
45:for devices, outside of a
976:AP (September 27, 2011).
895:10.1016/j.jep.2006.02.001
555:10.1186/s13023-015-0306-x
273:University of Mississippi
261:University of Mississippi
206:European Medicines Agency
112:European Medicines Agency
1364:EMA Named Patient Import
1360:FDA Personal Importation
1058:(#07–30). 7 August 2007.
759:Caplan, A (2016-01-16).
454:10.4103/2229-3485.173779
503:10.5582/irdr.2016.01054
294:) against the FDA, the
215:National Health Service
132:These conditions were:
1395:public domain material
1056:Consumer Health Digest
729:10.1056/NEJMhle1409465
688:10.1056/NEJMhle1409465
647:10.1056/NEJMhle1409465
264:
62:managed access program
1430:Clinical pharmacology
1009:10.1300/J175v01n03_03
982:Associated Press News
304:Department of Justice
258:
1074:Agence France-Presse
796:OMEDIT Ile de France
609:. FDA. 27 April 2018
310:. Randall, who had
237:Department of Health
74:named-patient access
70:compassionate access
1207:. 22 October 2016.
1156:www.kidsvcancer.org
857:on October 19, 2017
825:The Philippine Star
290:brought a lawsuit (
86:pre-approval access
1129:has generic name (
329:The settlement in
265:
263:for the government
1435:Clinical research
1369:The Socialmedwork
435:Patil, S (2016).
341:George H. W. Bush
320:medical necessity
288:Robert C. Randall
193:right-to-try laws
66:compassionate use
35:compassionate use
18:Compassionate use
16:(Redirected from
1442:
1415:
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1412:
1392:
1391:
1337:
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1334:
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1324:. Archived from
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853:. Archived from
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590:. 17 April 2018.
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524:
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486:
477:
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393:Right-to-try law
269:medical cannabis
245:medical cannabis
222:these programs.
21:
1450:
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1312:
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1235:Cancer Research
1228:
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1205:NBC4 Washington
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1080:on 5 March 2012
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1025:Neurology Today
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351:which it lost,
331:Randall v. U.S.
324:U.S. v. Randall
277:Mahmoud ElSohly
253:
228:
204:In Europe, the
202:
189:
161:IDE application
157:IND application
127:
108:
43:IDE application
31:Expanded access
28:
23:
22:
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58:special access
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