Food and Drug Administration responds to pressure for expanded drug access.

  title={Food and Drug Administration responds to pressure for expanded drug access.},
  author={Vicki Brower},
  journal={Journal of the National Cancer Institute},
  volume={106 6},
  • V. Brower
  • Published 1 June 2014
  • Biology
  • Journal of the National Cancer Institute
Compassionate drug use: Current status in India
Compassionate use is in its nascent stage in India owing to the lack of policies and laws needed to govern it and there is a need for regulatory bodies and pharmaceutical companies to work together to extend the spectrum of CU of drugs for the betterment of needy patients.
Right-to-try laws and individual patient “compassionate use” of experimental oncology medications: A call for improved provider-patient communication
Existing norms in oncologic care, for example, often lead patients to pursue intense treatments near the end of life, at the expense of palliation, and improved communication about the risks and benefits of Expanded Access would more often discourage its use.
The Expanded Access Cure: A Twenty-First Century Framework for Companies
This article contends that complying with the new transparency provisions will require drug companies to respond to several unresolved expanded access issues, and provides companies a framework that balances appropriately the desires of individuals and gaining the requisite approvals ensure access not just for one person but for society.
Physician perspectives on compassionate use in pediatric oncology
Allowing children who are not eligible for a clinical trial and for whom there are no known effective therapies may obtain access to investigational agents, including drugs under development for adults, is recommended.
Recommendations to Facilitate Expanded Access to Investigational Therapies for Seriously Ill Patients.
The authors offer several potential strategies to streamline what is otherwise an arduous process for all involved in accessing investigational therapies through expanded access, and present important prospects for improving treatment options for the most seriously ill patients.
[Compassionate use of drugs].
  • E. HemS. Madsen
  • Medicine
    Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke
  • 2016
Going “social” to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access
It is found that patients and their families experience mixed results, but still gravitate towards the use of online campaigns out of desperation, lack of reliable information about treatment access options, and in direct response to limitations of the current fragmented structure of expanded access regulation and policy currently in place.
The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials
It is argued first that excluding vulnerable subjects from participation in pragmatic clinical trials can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future, and second that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in pragmaticclinical trials.