Liberty or Death? FDA life-saving drug access regulations

Access to beneficial drugs is not a sexy issue, but it is important and emotional. Ought altering FDA regulations to improve the access in life-or-death cases be a partisan issue? How you feel on a pending lawsuit may tell.

But first imagine: your daughter is in the last stages of cancer. Then your doctor reports there is a new drug in development showing real signs of extending her life. You try to get it for her, but standing in the way are FDA regulations forbidding access to unapproved new drugs. By the time the drug will get through the approval phase, it will be too late. Something like that faced Frank Burroughs.

It ultimately proved too late for Frank’s daughter, but an organization he founded which bears her name, The Abigail Alliance , is suing the FDA to alter its regulations to allow earlier access for patients in dire necessity to developmental drugs which show promise. (The technical name for the earlier proposed access is Tier 1. There are already ad hoc voluntary expanded access programs that pharmaceutical companies may be allowed to offer for free, but the idea being presented in the challenge to the FDA is for a general right of patients to purchase a promising developmental drug without a waiting period or a requirement that the company donate the drug. )

This is important and sensible enough that it should be embraced by all parties. Greens, progressives, and Democrats should embrace it for compassion’s sake; Republicans, conservatives, and libertarians ought to embrace it for placing rational limits on government regulation. A source familiar with the issues and politics has noted to me that what political resistance there is has come from a few on the “progressive” side who find objectionable the idea that purchasing experimental drugs to save lives will “favor the rich.”

It’s a strange egalitarianism that prefers equality in death to opportunity for life. This issue should not be partisan -- the Abigail Alliance isn’t -- but is it true that some people are so full of “compassion” that they have forgotten the meaning of cruelty? If that is the case, could it become partisan?

Posted by at October 20, 2003 9:10 AM