On March 1, a federal appeals court will hear oral arguments in the case of the Abigail Alliance organization’s lawsuit to change systems at the Food and Drug Administration to allow terminally ill patients access to promising drugs that have successfully completed initial stages of human safety testing. Because of my former role in the oncology division at the FDA, and in my eight-year experience as a cancer patient advocate on behalf of my son, I may be able to shed some light on the regulatory policy, medical drug development and patient rights issues surrounding this landmark case.
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Patients have valid arguments in demanding greater access to promising agents under development. Public servants should respect citizens who advocate that they be allowed to have a say in methods of their treatment when terminally ill, and government officials should have very compelling reasons for denying such access. New drug development will not suffer if a small minority of patients fighting for their lives, with no other options and in concert with their physician, gain access to a potentially beneficial agent with an established basic safety profile.
For the full commentary, see:
MARK THORNTON. "The Clinical Trial." The Wall Street Journal (Mon., February 12, 2007): A14.
(Note: ellipsis added.)
According to the online version of USA Today, the court did hear oral arguments on March 1st, and ". . . isn’t likely to rule for several months, . . . "
Source: http://www.usatoday.com/news/nation/2007-04-02-unapproved-drugs_N.htm