@emjayzo@grok@_Sgr_A_Star@sudokhanh@himshouse Dr. Makary is head of FDA and came from a telehealth compounding company called Sesame so he is very familiar with $HIMS. He was CMO of Sesame
$NVO is well aware they can't sue $HIMS. The "NVO will sue" is just noise.
There is decades of legal precedent allowing the compounding of medications under the 503A exemption under the FDCA.
The FDCA (federal law) provides no (legal) private right of action for any citizen or company to sue for deemed violations. Many courts have ruled that enforcement of the FDCA is reserved almost entirely to the FDA or the DOJ.
Every lawsuit brought on by NVO or Lilly against telehealth companies to date have been around trademark infringement, or false marketing of safety approvals. Not one has challenged a telehealth company's right to compound under the 503A exemption because 1.) they can't, there is no private right of action, and 2.) because it's legal.
NVO would now like us to believe, that "mass compounding" which is typically a moniker used for 503B pharmacies (which are pharmacies that are allowed to compound in mass or bulk, when a drug is in shortage designation) is the same thing as "too much 503A" exemptions. They're trying to conflate "too much 503A" with actual mass compounding of a 503B.
Last year, Eli Lilly tried using state courts to enforce the FDCA (again, they can't), and attached is how the judge ruled.
THANK YOU FOR YOUR ATTENTION TO THIS MATTER. THE GOD PARTICLE. ๐
@sudokhanh@_Sgr_A_Star@himshouse 503A and 503B compound pharmacies play a role in the Healthcare system. The question is whether or not is compounding outside the lines for 503A guidelines. Dudum says $HIMS is doing everything legal so we have to believe him
@A_May_MD@_Sgr_A_Star@Nyjmitch757@Sandeman52 This Cigna optional offering is just that. Most group plans will exclude these because of the high cost and they are considered lifestyle drugs. Impact may be minimal to $hims
@NighthawkTradez Another point to your $HIMS partnering thesis is that $LLY has to show in good faith that they are bringing down drug costs due to Trumps EO