Editing Food and Drug Administration (section)

===Patients' rights to access unapproved drugs===
The [[Compassionate Investigational New Drug program]] was created after ''Randall v. U.S.'' ruled in favor of [[Robert C. Randall]] in 1978, creating a program for [[medical marijuana]].<ref>{{cite web |url=https://www.vice.com/en/article/the-us-government-has-sent-this-guy-300-joints-each-month-for-34-years/ |title=The US Government Has Sent This Guy 300 Joints Each Month for 34 Years |date=September 9, 2016 |access-date=October 14, 2017 |archive-date=October 14, 2017 |archive-url=https://web.archive.org/web/20171014142910/https://www.vice.com/en_us/article/dp3e4y/the-us-government-has-sent-this-guy-300-joints-each-month-for-34-years |url-status=live}}</ref>

A 2006 court case, ''[[Abigail Alliance v. von Eschenbach]]'', would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses", after they have completed Phase I testing.<ref>{{cite web |url=http://www.abigail-alliance.org/WLF_FDA.pdf |title=Abigail Alliance Citizen Petition to FDA |access-date=March 11, 2007 |archive-url=https://web.archive.org/web/20070221153207/http://abigail-alliance.org/WLF_FDA.pdf |archive-date=February 21, 2007}}&nbsp;{{small|(119&nbsp;KB)}}</ref> The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The [[US Supreme Court]] declined to hear the case, and the final decision denied the existence of a right to unapproved medications.

[[Criticism of the Food and Drug Administration|Critics]] of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. The AIDS crisis created some political efforts to streamline the approval process. However, these limited reforms were targeted for AIDS drugs, not for the broader market. This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.<ref>{{cite book | vauthors = Madden BJ |url=https://archive.org/details/freetochoosemedi0000madd |title=Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering: Bartley J. Madden: 9781934791325: Amazon.com: Books |date=July 2010 |publisher=Heartland Institute |isbn=978-1-934791-32-5}}</ref><ref>{{cite news |url=https://www.wsj.com/articles/SB10001424052702303812104576441610360466984 |work=The Wall Street Journal | vauthors = Boldrin M, Swamidass SJ |title=A New Bargain for Drug Approvals |date=July 25, 2011 |url-access=subscription |access-date=August 3, 2017 |archive-date=July 9, 2017 |archive-url=https://web.archive.org/web/20170709173632/https://www.wsj.com/articles/SB10001424052702303812104576441610360466984 |url-status=live}}</ref>