FDA

Coordination and the FDA: Establishing the ‘Right to Try’ experimental treatments

The first big project for the Institute will be assisting a New Mexico local government unit engaging the Food and Drug Administration (FDA) through the coordination process. The objective is to coordinate with the FDA so that their policy with regard to allowing performance of experimental cancer treatments will be consistent with a local government’s policy of protecting its terminally ill patients suffering from cancer by allowing them to try the experiments.

By far this is the biggest issue ever undertaken by a local government exercising its authority to insist that federal agencies work coordinately with local governments attempting to reach consistency between elected local officials and appointed federal regulators.

For years, terminally ill cancer patients have been forced to avoid experimental treatments or leave their homes and go to a foreign nation for the treatment. Sweeping the nation right now is the “right to try” legislation by which legislators authorize “right to try” efforts.

The problem is that even when federal legislation is enacted, the bureaucratic regulators take their own sweet time to implement the laws passed. So, you have a slow, almost ineptly so, Congress, followed by an implementing unwilling bureaucracy. With regard to Right to Try and cancer the FDA, for example, will drag out the writing of regulations, giving all opponents ample opportunity to voice their objections to which Food and Drug will take another interminably long time to respond.

In the meantime, while Congress, like Ol’ Man River, “jes keeps movin’ along” at its own slow Mississippi River type flow, a New Mexico local government can take action through implementation of the coordination process. The Institute is ready to help them take the fast step forward.

There is a famous line in the eternally popular musical “My Fair Lady” where Eliza Doolittle, the leading lady, says she is tired of Words! Words! Words:

“I’m so sick of words!
I get words all day through;
First from him, now from you!
Is that all you blighters can do?
Never do I ever want to hear another word.”

When my professor of constitutional law at Chicago Law School, Philip B. Kurland, who would later become Senator Sam Erwin’s personal counsel and adviser during the Watergate Hearings, was pushing to get out his first Supreme Court Review, he told Chip Wood, the Director of the University of Chicago Press that he didn’t want to talk to him, because “like My Fair Lady I am tired of words, words, words. I want to talk only to Mrs. Grant (Lodice). She gets things done.”

With coordination, that is our pledge: we will get things done. We always have from the start in Owyhee County Idaho helping protect the livestock ranches throughout the County, right through today. We will fight to get away from and out of the entanglement of words and get to the action. Instead of saying to the FDA, “let’s talk about your position; we say, “we’re here to get the right to try; when do we start?”

Lynn Mizzi Brysacz, member of the faculty at Glendale Community College wrote on her blog on June 17, 2914 of her concern that research writers use such convoluted, especially cloned, terms that the student or reader is left with confusion and lack of progress: “However, if the writers all have doctoral degrees and if people with doctoral degrees make up less than 1% of the population (as Sue Henderson advised us last week), does that 1% isolate itself with a language not understood by most of the rest of the world? I can see researchers wanting (and needing) to develop their own language; yet it seems antithetical to the idea of social justice when this language cannot be understood by 99% of the population.” See her article on her blog: “Words, words, words, I’m so sick of words!” (Eliza Doolittle in “My Fair Lady”) The article is also posted on the Institute website.

Federal bureaucratic language and most statutory legislative language could easily have been the topic of Ms. Brysacz because the way bureaucrats write fits her description of research language. No one can mangle the King’s English like a bureaucrat seeking delay or a member of Congress trying to placate sixteen different interests in one sentence.

So, while Congress and the state legislatures lumber toward the Right to Try, we will get there quicker and more directly with coordination. We always have, we will now, and we always will.1


[1] We approve and support all the Right to Try efforts in Congress and in the State legislatures, but while well-meaning legislators slowly move through the process, we will take the direct route through coordination.

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