Safeguarding the Right to Try
24 Pages Posted: 1 Feb 2017 Last revised: 15 Aug 2017
Date Written: July 29, 2017
The United States’ drug approval system is broken. It blocks Americans from potentially lifesaving medicines and treatments until those treatments receive final approval from the Food and Drug Administration (FDA). And it takes an average of 14 years and $1.4 billion for a drug to make its way through the clinical trial process and obtain FDA approval. But this is time that dying patients do not have. Patients are forced to suffer in limbo with no say in their own destinies. All of this despite the fact that one of the bedrock principles of medical ethics is patient autonomy: decisions about health care are ultimately for the patient to make.
A new project, called Right to Try, aims to change this. Now law in 33 states, Right to Try statutes protect the right of terminally ill patients to access medicine that has received basic safety approval from the FDA — and that is being given to patients in ongoing clinical trials — but that has not yet received final approval for sale. This article looks at some of the legal and ethical implications of these laws, and of the cumbersome, “consistently overconservative,” and sometimes life-destroying bureaucratic process by which the FDA restricts access to treatments patients need.
Keywords: right to try, FDA, federalism, due process, food and drug administration, clinical trial, compassionate use, expanded access
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