David Fleming
It's All Academic   www.davidflemingsite.com   
Day 335: Huey Lewis And The News (I Want A New Drug)

March 17, 2024

Dear Mr. Lewis,

I have heard repeatedly, thanks to WCLG, that you are requesting a new drug. It seems it's all the News. As Commissioner of the Center for Drug Evaluation and Research, I wanted to make sure you were aware of the protocols for new drug production per the U.S. Food and Drug Administration. The administration is sure you understand why we want to monitor "new drugs" for safety, no matter how much you want it to replicate the feeling of being in love. Then again, I hope that is exactly why you proclaim, over and over, pretty much every hour of every day, that this drug can't make you sick, crash your car, or feel three feet thick. For the record, we uphold the highest scientific standards and would require a much more precise measurement than feeling "three feet thick."

So, your first step is to review the expectations of new drug development through the Center for Biologics Evaluation and Research (CBER), specifically reviewing the CBER's Biologics License Application (BLA). The term application is actually a tad misleading, as the application requires a few forms for completion. Review first the basic "Application to Market a New or Abbreviated New Drug or Biologic for Human Use" (Form 0356h), recognizing that you will be starting with Form 1571, the Investigational New Drug Application (IND) which will allow you to even use human subjects for testing. The CBER BLA IND forms can be found here. While at our forms website, you will want to become familiar, minimally, with Forms 0431a (General Continuation), 0482d (Request for FSVP Records), 1551 (Report of Sample Analysis), 1570 (Summary of Bacteriological Results), and 1815 (Certificate/Transmittal for an Application). The truth of the matter is that there are 313 forms (and associated documents) that could apply. To provide you some comfort, because I am sure you are already worried about this "hurting your head too much," we do provide contacts for each form.

I have to tell you, though, that I think you are putting way too much expectations on your desired drug. A drug that is both not going to spill (i.e., liquid) and not "come in a pill" is going to be hard to manufacture. Inhalants can be one of the most difficult forms of drugs to get approved these days, mostly because of concerns for the atmosphere. Similarly, to ask for a drug that will both "not keep you up all night" nor "make you sleep all day," is again asking for a very refined product that may fail even before you can do all the necessary clinical trials.

Speaking of clinical trials, many idealists wanting new drugs have no clue about the challenges with the necessary clinical trials. For instance, I have no doubt you could find the required 20-100 volunteers for Stage One among the hippies that hang out with you and your band mates in Northern California. For Phase Two, you will need several hundred subjects who have the disease you wish to eradicate. And in your non-stop whining for a new drug every few hours on MTV, you don't really pinpoint a disease. As best as I can deduce, it is the lonely. I got news for you, buddy, that won't be nearly as specific enough. What is going to happen, then, when you get to Stage 3, when you have to introduce double blind placebo controlled tests? Do you even get what "double blind" means, Mr. Sunglasses?

If we can get your drug through all of these tests, even upon release, the wonderful final part of surveillance for pharmacovigilance kicks in. Pretty big word, isn't it, Mr. Lewis? Let's just say that this is the tracking part of the drug release to check for the dreaded "red eyes" or "dry mouth" you assert cannot be part of your drug. You will be unlikely to get 100% positive results once we are in Phase 4. What will you do then, Mr. Future Back To The Future Boy?

You see, I hate to be the proverbial bureaucrat who comes in and completely upsets your Utopian ideals, but this is what we have government for--to protect the masses from idiot idealists who think that a catchy slogan punctuated by sassy brass notes, slick guitars, and soaring organs is enough to change the world. Ultimately, this letter is intended to help you decide how far you want to go with your new drug obsession. You can try as much as you like, but I heard that you like the truth, to just say so.  Well, this is it, Huey. Now be a sport and go obsess about something under the jurisdiction of the National Endowment of the Arts. You are more likely to get a receptive response there.


Dwight R, Hensley

Dwight Richard Hensley, Jr.

Commissioner, Center for Drug Evaluation and Research

Huey Lewis & The News. "I Want A New Drug." Sports. Chrysalis, 1983. Link here.

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Day 336: Loverboy "Turn Me Loose"

See complete list here.