Friday, January 10, 2020

Very Brief Blog: Coalition Files Citizen Petition, Urges FDA Stop Actions Against LDT PGx Labs

According to an article on January 10, 2019, in Genomeweb, a "Coalition to Preserve Access to Pharmacogenomics" has filed a federal Citizen Petition "asking the US Food and Drug Administration to stop its oversight attempts to limit these services.

  • See Genomeweb article here.
  • See Citizen Petition here.
    • The petition is signed by Hyman Phelps attorneys Gibbs and Javitt.
    • Dated January 9, 2020.

Nerd Note Deluxe!

The FDA published a draft 20pp guidance on how it handles Citizen's Petitions in October, 2018  here.  (Although primarily in regard to malicious submissions intended to delay competitors).  The corresponding Federal Register announcement was 83 FR 49935, October 3, 2019, here.  The agency received 21 comments (here, bottom).  For my money the most interesting was a 6 p comment from the Federal Trade Commission (here).