Friday, September 20, 2019

Very Brief Blog: ACLA Sends Letter on Pharmacogenetics Policy to FDA

In 2018, FDA then-Commissioner Gottlieb made a number of remarks adverse to pharmacogenetic panel testing, and this ramped up in 2019 with actions against LDT pharmacogenetic testing reports created at the Inova health system precision medicine program.  (Genomeweb provides an open access article here; see also background explainedinside the ACLA letter, linked below).


On September 18, 2019, the ACLA sent a 4-page letter to the FDA protesting the recent actions as unnecessary and counterproductive.
  • See the letter here
  • See the ACLA press release here.   
The letter argues that FDA exceeds its authority, provides contradictory instructions at different timepoints or places, and in part makes assertions that "defy common sense."  ACLA also is concerned this is not a good-faith action by FDA at a time when ACLA, FDA, and Congress are working on new legislative frameworks for diagnostics (e.g. VALID act; here, here).


A few weeks ago, AMP released a best-practices statement for pharmacogenetics.  See trade press here, the 3-page AMP statement here.  This policy statement is quoted in ACLA's letter.


Mental Health Groups Write Azar

On September 26, the open-access news feed from Politico noted that several large mental health groups had written Secretary Azar and FDA Acting Commissioner Sharpless critical of the FDA's stance on PGx tests for psychiatry.  Open access version here (or here).  Actual 3 page PDF letter here.


The MolDx program releases several PGx LCDs in August 2019 in draft form (here).  In June, MolDx held an information-gathering public meeting on PGx, here.

To my knowledge, MolDx hasn't yet posted its transcript of the June meeting, but I've put a transcript in the cloud here.


On September 18, 2019, ARUP held a webinar on pharmacogenetics, here.  I missed it, but the slides are online.


Bonus - actual word cloud of ACLA letter:

Published Survey of PGx Lab Industry

For a "horizon scan of clinical labs offering PGx," 2018, see Haga and Kantor in Health Affairs, here.

Argument that FDA Labeling is Incomplete 

The FDA argues that some LDT PGx drug-gene  associations, including for CPIC, are off-label or not endorsed by FDA labeling.   Advocates argue strenuously that this is sort of nonsensical; FDA labels are often incomplete and the FDA knows it.   For an example of how drastically incomplete buprenorphine labeling is, relative to what seems to be consensus public policy efforts, see here.