**Compassionate Investigational New Drug Program**
The Compassionate Investigational New Drug (IND) program is a pivotal FDA initiative that permits patients with severe or life-threatening conditions to access investigational drugs outside the confines of clinical trials. Originating in the 1970s, this program was established to offer a legal avenue for patients to obtain experimental treatments when no other satisfactory options were available. The Compassionate IND program has undergone significant changes, especially with the increasing acceptance of medical cannabis. In the 1980s, the program made headlines by allowing patients to access cannabis for therapeutic purposes, reflecting a shift in regulatory attitudes towards cannabis. Today, the Compassionate Investigational New Drug program continues to play a crucial role in the FDA’s mission to ensure patient access while maintaining drug safety and efficacy standards. For those engaged in the cannabis industry, the Compassionate IND program is a testament to the evolving relationship between regulatory frameworks and patient needs, underscoring the importance of informed advocacy for medical cannabis access. [Source: FDA.gov]
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
These programs go under various names, including early access, special access, or managed access program, compassionate use, compassionate access, named-patient access, temporary authorization for use, cohort access, and pre-approval access.
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 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.
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 Abigail Alliance v. von Eschenbach, 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.
