Monday, November 13, 2023

A Quote for Your FDA LDT Comments: Shuren Says "We have to change federal law" to fit today's innovations

Right now, countless groups are working on comments to submit by December 4, 2023, on the FDA's haywire proposal to regulate LDTs.  I say "haywire" not because I'm pro or con regulation, but because the FDA's proposal was full of crazy and "un-executable" twists and turns.  See my white paper.  For example, the cost to industry the first several years was $40B dollars - like the GDP of some countries - and the FDA's cost in labor in a couple years was $4B, compare that to the FDA's total annual budget for all international functions: $8B.

There's a quote in the New York Times from October 30 that might fit into these FDA comment letters.  The NYT article is about regulation of medical artificial intelligence, and Shuren has a remark that is surely equally applicable to genomics:

“If we really want to assure that right balance, we’re going to have to change federal law, because the framework in place for us to use for these technologies is almost 50 years old,” Dr. Shuren said. “It really was not designed for A.I.” -- Dr. Shuren said during the National Organization for Rare Disorders conference on Oct. 16.

50 Year Old Law?

The fifty-year-old law is the Medical Device Act of May 28, 1976, which creates a water shed between devices created and marketed before and after midnight on May 28, 1976.   Nobody would propose that May 28, 1976 was a relevant date for the regulation of modern genomic testing in laboratories.  Nor can anyone today reproduce what was, and was not, being done in a lab somewhere in the US on the afternoon of May 28, 1976.   Genomics would need new FDA law, as much as AI would need new FDA law.

Anyone was was a 40 to 50 year old lab director in 1976 would be in their 90s today, more likely dead by now.

I suspect - actually I'm sure - if you went to the original budget for implementing the FDA Device Act, the budget for 2H 1976, or 1977 or 1978, the budget was based on the need to review a SMALL number of new devices annually.   The original budget, that is, was not scoped to allow the review of tens of thousands of tests at thousands of hospitals by thousands of FDA employees.  That is, before the FDA thought to describe such local hospital lab tests as "devices" or "device systems" and before Congress had said anything about including or excluding hospital tests, it wasn't in the original cards.  The budget for 1997, 1998, would have precluded such massive nationwide LDT regulation.

Who knew?  The Copyright Office is running a public comment on AI and copyright, issued August 30 and interesting reading - here.  And by the way, Copyright extended its comment period to November 29 - here.