Terminally Ill Patients' Access To Experimental Medications Blocked By 'Regulatory Schemes,' Op-Ed Says

Main Category: Public Health
Also Included In: Pharma Industry / Biotech Industry
Article Date: 14 Aug 2007 - 2:00 PDT

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The U.S. Court of Appeals for the District of Columbia issued a decision of "poor quality" on Tuesday when it ruled that terminally ill patients do not have the right to obtain access to unapproved prescription drugs that potentially are lifesaving, Roger Pilon, vice president for legal affairs at the Cato Institute and director of Cato's Center for Constitutional Studies, writes in a Wall Street Journal opinion piece (Pilon, Wall Street Journal, 8/10).

In 2003, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation filed a lawsuit against FDA to obtain access to experimental medications for terminally ill cancer patients. The lawsuit asked FDA to provide a special initial approval of experimental medications that appear effective and allow their sale and distribution to terminally ill patients who have no other approved treatment options.

FDA argued that programs currently exist to provide experimental medications to terminally ill patients and that increased access to such treatments would lead to unacceptable risk.

In the majority opinion, Judge Thomas Griffith wrote, "We conclude there is no fundamental right 'deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill" (Kaiser Daily Health Policy Report, 8/8).

Pilon writes, "The opinion's one virtue is that it brings out clearly how far modern 'constitutional law' has strayed from the Constitution, a document written to protect liberty, not federal regulatory schemes." The authors of the Constitution "would be appalled to see federal bureaucrats standing between dying patients and the medicines that might save them -- sanctioned by a Constitution turned upside-down. Fortunately, this case will be appealed and the Supreme Court may yet examine it afresh," Pilon concludes (Wall Street Journal, 8/10).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Kaiser. "Terminally Ill Patients' Access To Experimental Medications Blocked By 'Regulatory Schemes,' Op-Ed Says." Medical News Today. MediLexicon, Intl., 14 Aug. 2007. Web.
13 Feb. 2012. <http://www.medicalnewstoday.com/releases/79457.php>

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APA

Kaiser. (2007, August 14). "Terminally Ill Patients' Access To Experimental Medications Blocked By 'Regulatory Schemes,' Op-Ed Says." Medical News Today. Retrieved from
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