Drugs

Don’t Harm FDA’s Expanded Access Program: Public Citizen

Public Citizen Health Research Group director Michael Carome says those interested in providing patients additional access to unapproved medications should press Congress for legislation to further enhance FDA’s expanded access program, rather than backing “right-to-try” legislation that would undermine the program. Writing in an online Stat News column, Carome says that right-to-try legislation being considered in the House “would expose countless vulnerable patients, many of whom would harbor false hopes of likely benefit, to drugs that have little probability of benefit but substantial risk of serious harm, including dying earlier and more painfully that they otherwise would have, without appropriate safeguards.”

He writes that while he understands the desire to access experimental medical products from those who have exhausted treatment options, he also has a deep appreciation of the essential role that federal requirements play in protecting vulnerable patients from harm and exploitation that may result from exposure to unproven experimental drugs.

Carome reviews the history of state and federal attempts to pass right-to-try legislation and also outlines the workings of the FDA expanded access (compassionate use) program.

He says those backing right-to-try say that FDA is preventing thousands, if not millions, of seriously ill patients from accessing a wide array of miracle cures. “But this is a misleading narrative,” he writes. “First, FDA grants more than 99% of all expanded access program requests and, in urgent circumstances, can respond to such requests within one or two days. The real hurdle to access to experimental drugs is often pharmaceutical companies which, for a variety of often legitimate reasons, choose not to make their experimental drugs available to patients outside the context of well-designed and monitored clinical trials. Congress cannot force companies to do otherwise.”

He cites a 2012 Government Accountability Office review that found that FDA had taken steps to streamline the expanded access program and improve patient access to experimental drugs.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome