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Subject: Lilly Flags New Court Ruling as Telehealth GLP-1 Lawsuits Begin to Converge
From: Dave Knapp from On The Pen <onthepen@substack.com>
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View this post on the web at https://onthepen.substack.com/p/lilly-flags-ne=
w-court-ruling-as-telehealth

Eli Lilly quietly filed a Statement of Recent Decision this week in its law=
suit against Mochi Health, pointing the judge to a recent federal ruling th=
at could influence how the case proceeds. The move is procedural but strate=
gic, and it signals that the pharmaceutical companies bringing these lawsui=
ts are closely watching each other=E2=80=99s court battles for any preceden=
t that might help their arguments.
A Statement of Recent Decision is essentially a way for lawyers to tell the=
 court that a judge somewhere else has just ruled on a similar legal questi=
on. Lilly=E2=80=99s filing highlights a recent decision issued in Novo Nord=
isk v. Aios (Fella Health), where a federal judge declined to dismiss Novo=
=E2=80=99s lawsuit against a telehealth company accused of promoting compou=
nded GLP-1 medications using marketing language tied to branded drugs.
The reason Lilly believes that ruling matters is simple. The core allegatio=
ns in the Novo case closely resemble the claims Lilly is pursuing in its ow=
n lawsuit against Mochi Health.
Both cases revolve around how telehealth companies market compounded versio=
ns of GLP-1 medications. Pharmaceutical companies have argued that certain =
marketing practices blur the line between compounded medications and FDA ap=
proved products by referencing clinical trial data from branded drugs or us=
ing phrases that imply equivalence with those products.
That issue has been quietly building for months, and it is exactly the type=
 of behavior federal regulators have begun scrutinizing closely over the pa=
st few weeks.
Three weeks ago, On The Pen exclusively reported that the FDA had sent a la=
rge wave of letters to telehealth and compounding related companies operati=
ng in the GLP-1 space. The letters questioned a range of marketing practice=
s, including companies labeling medication vials with telehealth brand name=
s and promotional language suggesting compounded medications contained the =
=E2=80=9Csame active ingredient=E2=80=9D as drugs like Ozempic.
The scope of that enforcement effort became clearer shortly afterward. A fo=
llow up report identified 29 telehealth and compounding related companies t=
hat had received letters from the FDA, many of which operate in the same ec=
osystem now being challenged in pharmaceutical lawsuits.
That regulatory backdrop is important because federal courts have historica=
lly been cautious about stepping into disputes that fall within the FDA=E2=
=80=99s enforcement authority. In several previous cases involving pharmace=
utical marketing claims, judges have ruled that questions about drug labeli=
ng and promotional language are issues that regulators, not courts, are typ=
ically responsible for policing.
The emerging overlap between these lawsuits and FDA enforcement raises a na=
tural question. If the FDA is already examining how compounded GLP-1 medica=
tions are being marketed, could that strengthen the arguments pharmaceutica=
l companies are making in court?
It is not a simple answer. On one hand, the existence of regulatory scrutin=
y could reinforce the pharmaceutical companies=E2=80=99 claim that certain =
marketing practices are problematic. If federal regulators are questioning =
the same types of language appearing in telehealth promotions, plaintiffs c=
ould argue that it supports their broader concerns about how compounded med=
ications are being positioned in the marketplace.
On the other hand, the same enforcement activity could cut the opposite dir=
ection. Defendants in these lawsuits have repeatedly argued that disputes a=
bout drug marketing and labeling belong with the FDA, not with private comp=
anies filing lawsuits under advertising or competition laws. Courts will ul=
timately decide where that boundary sits.
For now, Lilly=E2=80=99s filing signals that the legal battles unfolding ac=
ross the GLP-1 ecosystem are beginning to intersect. Regulatory actions, ph=
armaceutical lawsuits, and telehealth business models are all colliding in =
a way that could shape how compounded obesity medications are marketed in t=
he future.
The next major test in this battle arrives on April 9th, when a federal jud=
ge in San Francisco will hear arguments on Mochi Health=E2=80=99s motion to=
 dismiss. Lilly=E2=80=99s new filing makes one thing clear. The company wan=
ts the court to look closely at the Novo ruling and conclude that the Mochi=
 case should move forward as well. Whether the judge agrees could determine=
 whether this fight stays procedural or enters the far more revealing phase=
 of litigation.
IF YOU BELIEVE IN OUR WORK, PLEASE HELP SUPPORT IT BY BECOMING A FOUNDING M=
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}
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}
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@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 650px) {
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@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 370px) {
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}
@media screen and (max-width: 650px) {
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}
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}
@media screen and (max-width: 370px) {
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}
@media screen and (max-width: 650px) {
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}
@media (max-width: 1024px) {
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}
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}
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}
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}
@media (max-width: 768px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 370px) {
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}
@media screen and (max-width: 650px) {
  body .markup div.embedded-publication-wrap .embedded-publication.show-sub=
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}
@media screen and (max-width: 650px) {
  body .markup div.subscription-widget-wrap .subscription-widget.show-subsc=
ribe,
  body .markup div.subscription-widget-wrap-editor .subscription-widget.sho=
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  body .markup div.captioned-button-wrap .subscription-widget.show-subscrib=
e {
    padding: 0px 24px;
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}
@media screen and (max-width: 650px) {
  body .markup div.subscription-widget-wrap .subscription-widget.show-subsc=
ribe .subscription-widget-subscribe .button,
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w-subscribe .subscription-widget-subscribe .button,
  body .markup div.captioned-button-wrap .subscription-widget.show-subscrib=
e .subscription-widget-subscribe .button {
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}
@media (max-width: 650px) {
  body .markup .twitter-embed,
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}
@media (max-width: 650px) {
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    font-size: 14px;
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}
@media (max-width: 650px) {
  body .markup .twitter-embed .tweet-photos-container.two,
  body .markup .tweet .tweet-photos-container.two,
  body .markup .twitter-embed .tweet-photos-container.three,
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  body .markup .twitter-embed .tweet-photos-container.four,
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    height: 200px;
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}
@media (max-width: 650px) {
  body .markup .twitter-embed a.expanded-link .expanded-link-img,
  body .markup .tweet a.expanded-link .expanded-link-img {
    max-height: 180px;
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}
@media (max-width: 650px) {
  body .markup .twitter-embed a.expanded-link .expanded-link-description,
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}
@media screen and (max-width: 650px) {
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    width: unset;
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}
@media (max-width: 420px) {
  body .markup .install-substack-app-embed img.install-substack-app-embed-i=
mg {
    margin: 0 auto 16px auto;
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}
@media (max-width: 420px) {
  body .markup .install-substack-app-embed .install-substack-app-embed-text=
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    margin: 0 0 12px 0;
    max-width: 100%;
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}
@media (max-width: 420px) {
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    display: flex;
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}
@media screen and (min-width: 500px) {
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    height: 42px;
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}
@media screen and (max-width: 420px) {
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cription-discount {
    width: 72px !important;
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}
@media screen and (min-width: 481px) {
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    height: auto;
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}
@media screen and (max-width: 480px) {
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    height: 8px !important;
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}
@media screen and (max-width: 650px) {
  .digest .item .post-meta-item.audience {
    display: none;
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}
@media screen and (min-width: 500px) {
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    width: 42px;
    height: 42px;
    border-radius: 8px;
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}
@media screen and (max-width: 650px) {
  .comments-page .container .comment-list .collapsed-reply {
    margin-left: calc(10 + 32px - 24px);
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}
@media screen and (max-width: 650px) {
  .comment > .comment-list {
    padding-left: 24px;
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}
@media screen and (max-width: 650px) {
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    padding: 24px 0;
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}
@media (max-width: 650px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (min-width: 541px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (min-width: 541px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 768px) {
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}
@media screen and (max-width: 768px) {
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}
@media screen and (max-width: 768px) {
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}
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}
@media only screen and (min-width: 630px) {
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}
@media screen and (min-width: 541px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 650px) {
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}
@media screen and (max-width: 650px) {
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layer-progress-bar .audio-player-progress-bar-popup {
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}
@media (min-width: 250px) {
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}
@media (min-width: 300px) {
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}
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}
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ner {
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}
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ner {
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}
@media (max-width: 400px) {
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    height: auto;
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}
@media (min-width: 600px) {
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ner {
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}
@media (max-width: 650px) {
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}
@media (max-width: 750px) {
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    top: 45px;
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}
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r {
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}</style></head><body class=3D"email-body" style=3D"font-kerning: auto;--im=
age-offset-margin: -120px;"><img src=3D"https://eotrx.substackcdn.com/open?=
token=3DeyJtIjoiPDIwMjYwMzEzMjEyOTU1LjMuOWI1OTQ3NGIyMzYxNDkxN0BtZzIuc3Vic3R=
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5zdWJzdGFjay5jb20iLCJwIjoxOTA4ODE4MjgsInQiOiJuZXdzbGV0dGVyIiwiYSI6ImV2ZXJ5b=
25lIiwicyI6NDgwODk5MywiYyI6InBvc3QiLCJmIjp0cnVlLCJwb3NpdGlvbiI6InRvcCIsImlh=
dCI6MTc3MzQzNzQwOCwiZXhwIjoxNzc2MDI5NDA4LCJpc3MiOiJwdWItMCIsInN1YiI6ImVvIn0=
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zc_NHj5_Fk" alt=3D"" width=3D"1" height=
=3D"1" border=3D"0" style=3D"height:1px !important;width:1px !important;bor=
der-width:0 !important;margin-top:0 !important;margin-bottom:0 !important;m=
argin-right:0 !important;margin-left:0 !important;padding-top:0 !important;=
padding-bottom:0 !important;padding-right:0 !important;padding-left:0 !impo=
rtant;"/><div class=3D"preview" style=3D"display:none;font-size:1px;color:#=
333333;line-height:1px;max-height:0px;max-width:0px;opacity:0;overflow:hidd=
en;">Another federal judge just refused to throw out a nearly identical tel=
ehealth GLP-1 lawsuit. Lilly is now telling the court the same reasoning sh=
ould apply to Mochi.</div><div class=3D"preview" style=3D"display:none;font=
-size:1px;color:#333333;line-height:1px;max-height:0px;max-width:0px;opacit=
y:0;overflow:hidden;">&#847; &nbsp; &#8199; &#173;&#847; &nbsp; &#8199; &#1=
73;&#847; &nbsp; &#8199; &#173;&#847; &nbsp; &#8199; &#173;&#847; &nbsp; &#=
8199; &#173;&#847; &nbsp; &#8199; &#173;&#847; &nbsp; &#8199; &#173;&#847; =
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imizelegibility;margin: 0;line-height: 36px;font-size: 32px;"><a href=3D"ht=
tps://substack.com/app-link/post?publication_id=3D4808993&post_id=3D1908818=
28&utm_source=3Dpost-email-title&utm_campaign=3Demail-post-title&isFreemail=
=3Dtrue&r=3D4iwoe6&token=3DeyJ1c2VyX2lkIjoyNzM2MjIzOTgsInBvc3RfaWQiOjE5MDg4=
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FU" style=3D"color: rgb(54,55,55);text-decoration: none;">Lilly Flags New C=
ourt Ruling as Telehealth GLP-1 Lawsuits Begin to Converge</a></h1><h3 clas=
s=3D"subtitle subtitle-HEEcLo" dir=3D"auto" style=3D"direction: auto;text-a=
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ce: optimizelegibility;appearance: optimizelegibility;margin: 4px 0 0;color=
: #777777;line-height: 24px;font-size: 18px;margin-top: 12px;">Another fede=
ral judge just refused to throw out a nearly identical telehealth GLP-1 law=
suit. Lilly is now telling the court the same reasoning should apply to Moc=
hi.</h3><table class=3D"post-meta" role=3D"presentation" width=3D"100%" bor=
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r Emoji','Segoe UI Emoji','Segoe UI Symbol';font-weight: 500;text-transform=
: uppercase;letter-spacing: .2px;text-decoration: none" href=3D"https://sub=
stack.com/@onthepen">On The Pen GLP-1 News</a></div></td></tr></tbody></tab=
le></td></tr><tr><td><table role=3D"presentation" width=3D"auto" border=3D"=
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or Emoji','Segoe UI Emoji','Segoe UI Symbol';font-weight: 500;text-transfor=
m: uppercase;letter-spacing: .2px;"><time datetime=3D"2026-03-13T21:29:55.6=
25Z">Mar 13</time></div></td></tr></tbody></table></td></tr></tbody></table=
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e;vertical-align: middle;max-width: 18px" alt=3D""></a></td></tr></tbody></=
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cal-align:middle;"><table role=3D"presentation" width=3D"38" border=3D"0" c=
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lor: rgb(119,119,119);min-width: 38px;box-sizing: border-box;width: 38px"><=
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ne;vertical-align: middle;max-width: 18px" alt=3D""></a></td></tr></tbody><=
/table></td></tr></tbody></table></td><td align=3D"right"><table role=3D"pr=
esentation" width=3D"auto" border=3D"0" cellspacing=3D"0" cellpadding=3D"0"=
><tbody><tr><td style=3D"vertical-align:middle;"><table role=3D"presentatio=
n" width=3D"auto" border=3D"0" cellspacing=3D"0" cellpadding=3D"0"><tbody><=
tr><td align=3D"center"><a class=3D"email-button-outline" href=3D"https://o=
pen.substack.com/pub/onthepen/p/lilly-flags-new-court-ruling-as-telehealth?=
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0,0,0,.1);border-radius: 9999px;text-transform: uppercase;font-size: 12px;l=
ine-height: 12px;padding: 9px 14px;text-decoration: none;color: rgb(119,119=
,119);"><div class=3D"email-button-spacer" style=3D"font-size: 16px;line-he=
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ight: 18px;"></div><span class=3D"email-button-text" style=3D"vertical-alig=
n: middle;margin-right: 4px">READ IN APP</span><img class=3D"icon text-icon=
" src=3D"https://substackcdn.com/image/fetch/$s_!ET-_!,w_36,c_scale,f_png,q=
_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack.com%2Ficon%2FLucideA=
rrowUpRight%3Fv%3D4%26height%3D36%26fill%3Dnone%26stroke%3D%2523808080%26st=
rokeWidth%3D2" width=3D"18" height=3D"18" style=3D"min-width: 18px;min-heig=
ht: 18px;border: none;vertical-align: middle;margin-right: 0;margin-left: 0=
;max-width: 18px" alt=3D""></a></td></tr></tbody></table></td></tr></tbody>=
</table></td></tr></tbody></table></td></tr><tr height=3D"16"><td height=3D=
"16" style=3D"font-size:0px;line-height:0;">&nbsp;</td></tr></tbody></table=
></div></div><div class=3D"post typography" dir=3D"auto" style=3D"--image-o=
ffset-margin: -120px;padding: 32px 0 0 0;font-size: 16px;line-height: 26px;=
"><div class=3D"body markup" dir=3D"auto" style=3D"text-align: initial;font=
-size: 16px;line-height: 26px;width: 100%;word-break: break-word;margin-bot=
tom: 16px;font-family: 'SF Pro Display', -apple-system, system-ui, BlinkMac=
SystemFont, 'Inter', 'Segoe UI', Roboto, Helvetica, Arial, sans-serif, 'App=
le Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol';font-weight: 400;"><p =
style=3D"margin: 0 0 20px 0;color: rgb(54,55,55);line-height: 26px;font-siz=
e: 16px;margin-top: 0;">Eli Lilly quietly filed a Statement of Recent Decis=
ion this week in its lawsuit against Mochi Health, pointing the judge to a =
recent federal ruling that could influence how the case proceeds. The move =
is procedural but strategic, and it signals that the pharmaceutical compani=
es bringing these lawsuits are closely watching each other&#8217;s court ba=
ttles for any precedent that might help their arguments.</p><div class=3D"c=
aptioned-image-container-static" style=3D"font-size: 16px;line-height: 26px=
;margin: 32px auto;"><figure style=3D"width: 100%;margin: 0 auto;"><table c=
lass=3D"image-wrapper" width=3D"100%" border=3D"0" cellspacing=3D"0" cellpa=
dding=3D"0" data-component-name=3D"Image2ToDOMStatic" style=3D"mso-padding-=
alt: 1em 0 1.6em;"><tbody><tr><td style=3D"text-align: center;"></td><td cl=
ass=3D"content" align=3D"left" width=3D"1320" style=3D"text-align: center;"=
><a class=3D"image-link" target=3D"_blank" href=3D"https://substack.com/red=
irect/740bdf32-8a6f-4a81-8b57-2db87688e381?j=3DeyJ1IjoiNGl3b2U2In0.sVDxRtmZ=
85v8kfdamY0krRXGMy3p768BWtuZifRB-Zs" rel=3D"" style=3D"position: relative;f=
lex-direction: column;align-items: center;padding: 0;width: auto;height: au=
to;border: none;text-decoration: none;display: block;margin: 0;"><img class=
=3D"wide-image" data-attrs=3D"{&quot;src&quot;:&quot;https://substack-post-=
media.s3.amazonaws.com/public/images/64afde17-8331-4d60-96bc-deffb87bbdf8_1=
320x1605.jpeg&quot;,&quot;srcNoWatermark&quot;:null,&quot;fullscreen&quot;:=
null,&quot;imageSize&quot;:null,&quot;height&quot;:1605,&quot;width&quot;:1=
320,&quot;resizeWidth&quot;:null,&quot;bytes&quot;:310896,&quot;alt&quot;:n=
ull,&quot;title&quot;:null,&quot;type&quot;:&quot;image/jpeg&quot;,&quot;hr=
ef&quot;:null,&quot;belowTheFold&quot;:false,&quot;topImage&quot;:true,&quo=
t;internalRedirect&quot;:&quot;https://onthepen.substack.com/i/190881828?im=
g=3Dhttps%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F=
64afde17-8331-4d60-96bc-deffb87bbdf8_1320x1605.jpeg&quot;,&quot;isProcessin=
g&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" alt=3D"" wi=
dth=3D"550" height=3D"668.75" src=3D"https://substackcdn.com/image/fetch/$s=
_!gV9H!,w_1100,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%=
2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F64afde17-8331-4d=
60-96bc-deffb87bbdf8_1320x1605.jpeg" style=3D"border: none !important;verti=
cal-align: middle;display: block;-ms-interpolation-mode: bicubic;height: au=
to;margin-bottom: 0;width: auto !important;max-width: 100% !important;margi=
n: 0 auto;"></a></td><td style=3D"text-align: center;"></td></tr></tbody></=
table></figure></div><p style=3D"margin: 0 0 20px 0;color: rgb(54,55,55);li=
ne-height: 26px;font-size: 16px;"></p><table class=3D"static-file-embed-tab=
le" cellspacing=3D"16" data-component-name=3D"FileToDOMStatic" style=3D"wid=
th: 100%;z-index: 5;margin-bottom: 1rem;border: 1px solid rgb(0,0,0,.1);bac=
kground-color: rgb(255,255,255);border-radius: 8px;"><tbody><tr><td class=
=3D"static-file-embed-thumbnail-container default" style=3D"position: relat=
ive;min-width: 74px;max-width: 74px;width: 74px;height: 74px;"><img class=
=3D"static-file-embed-thumbnail default" src=3D"https://substackcdn.com/ima=
ge/fetch/$s_!0Cy0!,w_32,h_32,c_fill,f_auto,q_auto:good,fl_progressive:steep=
,g_auto/https%3A%2F%2Fsubstack.com%2Fimg%2Fattachment_icon.svg" style=3D"wi=
dth: 100px !important;border: none !important;vertical-align: middle;max-wi=
dth: 42px !important;max-height: 42px !important;display: block;-ms-interpo=
lation-mode: bicubic;height: auto;margin: 0 auto;"></td><td class=3D"static=
-file-embed-details default" style=3D"width: 100%;position: relative;vertic=
al-align: center;min-height: 37px;height: 37px;"><div class=3D"static-file-=
embed-details-h1" style=3D"font-family: 'SF Pro Display', -apple-system, sy=
stem-ui, BlinkMacSystemFont, 'Inter', 'Segoe UI', Roboto, Helvetica, Arial,=
 sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol';-webk=
it-font-smoothing: antialiased;-moz-osx-font-smoothing: antialiased;-webkit=
-appearance: optimizelegibility;-moz-appearance: optimizelegibility;appeara=
nce: optimizelegibility;letter-spacing: -0.012em;font-style: normal;font-we=
ight: 600;font-size: 16px;line-height: 26px;">Eli Lilly And Company V Mochi=
 Health Cor...</div><div class=3D"static-file-embed-details-h2" style=3D"fo=
nt-family: 'SF Pro Display', -apple-system, system-ui, BlinkMacSystemFont, =
'Inter', 'Segoe UI', Roboto, Helvetica, Arial, sans-serif, 'Apple Color Emo=
ji', 'Segoe UI Emoji', 'Segoe UI Symbol';-webkit-font-smoothing: antialiase=
d;-moz-osx-font-smoothing: antialiased;-webkit-appearance: optimizelegibili=
ty;-moz-appearance: optimizelegibility;appearance: optimizelegibility;lette=
r-spacing: -0.012em;font-style: normal;font-weight: normal;color: rgb(119,1=
19,119);font-size: 16px;line-height: 26px;">154KB &#8729; PDF file</div></t=
d></tr><tr><td class=3D"static-file-embed-button-container" colspan=3D"2" s=
tyle=3D"text-decoration: none;width: 100%;"><table class=3D"static-file-emb=
ed-button" cellspacing=3D"0" style=3D"width: 100%;vertical-align: center;te=
xt-align: center;font-family: 'SF Pro Display', -apple-system, system-ui, B=
linkMacSystemFont, 'Inter', 'Segoe UI', Roboto, Helvetica, Arial, sans-seri=
f, 'Apple Color Emoji', 'Segoe UI Emoji', 'Segoe UI Symbol';-webkit-font-sm=
oothing: antialiased;-moz-osx-font-smoothing: antialiased;-webkit-appearanc=
e: optimizelegibility;-moz-appearance: optimizelegibility;appearance: optim=
izelegibility;letter-spacing: -0.012em;font-style: normal;font-weight: 600;=
font-size: 16px;"><tbody><tr><td align=3D"center"><a class=3D"static-file-e=
mbed-anchor" href=3D"https://substack.com/redirect/64c08bcc-604f-4639-bc89-=
78ea2acca3dd?j=3DeyJ1IjoiNGl3b2U2In0.sVDxRtmZ85v8kfdamY0krRXGMy3p768BWtuZif=
RB-Zs" rel=3D"" style=3D"text-decoration: none !important;background-color:=
 rgb(238,238,238);border: 1px solid rgb(0,0,0,.1);color: rgb(119,119,119);h=
eight: 20px;width: 100%;display: inline-block;border-radius: 8px;line-heigh=
t: 20px;padding-top: 20px;padding-bottom: 20px;">Download</a></td></tr></tb=
ody></table></td></tr></tbody></table><p style=3D"margin: 0 0 20px 0;color:=
 rgb(54,55,55);line-height: 26px;font-size: 16px;">A Statement of Recent De=
cision is essentially a way for lawyers to tell the court that a judge some=
where else has just ruled on a similar legal question. Lilly&#8217;s filing=
 highlights a recent decision issued in Novo Nordisk v. Aios (Fella Health)=
, where a federal judge declined to dismiss Novo&#8217;s lawsuit against a =
telehealth company accused of promoting compounded GLP-1 medications using =
marketing language tied to branded drugs.</p><p style=3D"margin: 0 0 20px 0=
;color: rgb(54,55,55);line-height: 26px;font-size: 16px;">The reason Lilly =
believes that ruling matters is simple. The core allegations in the Novo ca=
se closely resemble the claims Lilly is pursuing in its own lawsuit against=
 Mochi Health.</p><p style=3D"margin: 0 0 20px 0;color: rgb(54,55,55);line-=
height: 26px;font-size: 16px;">Both cases revolve around how telehealth com=
panies market compounded versions of GLP-1 medications. Pharmaceutical comp=
anies have argued that certain marketing practices blur the line between co=
mpounded medications and FDA approved products by referencing clinical tria=
l data from branded drugs or using phrases that imply equivalence with thos=
e products.</p><p style=3D"margin: 0 0 20px 0;color: rgb(54,55,55);line-hei=
ght: 26px;font-size: 16px;">That issue has been quietly building for months=
, and it is exactly the type of behavior federal regulators have begun scru=
tinizing closely over the past few weeks.</p><p style=3D"margin: 0 0 20px 0=
;color: rgb(54,55,55);line-height: 26px;font-size: 16px;">Three weeks ago, =
On The Pen exclusively reported that the FDA had sent a large wave of lette=
rs to telehealth and compounding related companies operating in the GLP-1 s=
pace. The letters questioned a range of marketing practices, including comp=
anies labeling medication vials with telehealth brand names and promotional=
 language suggesting compounded medications contained the &#8220;same activ=
e ingredient&#8221; as drugs like Ozempic.</p><table class=3D"twitter-embed=
 tweet" role=3D"presentation" width=3D"100%" border=3D"0" cellspacing=3D"0"=
 cellpadding=3D"0" data-component-name=3D"TweetToDOMStatic" style=3D"backgr=
ound: rgb(255,255,255);color: rgb(54,55,55);display: flex;flex-direction: c=
olumn;gap: 12px;max-width: 550px;margin: 32px auto;border: 1px solid rgb(0,=
0,0,.1);direction: ltr;border-radius: 12px;padding: 16px 16px 12px;font-fam=
ily: system-ui,-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica=
,Arial,sans-serif,'Apple Color Emoji','Segoe UI Emoji','Segoe UI Symbol';fo=
nt-size: 14px;line-height: 20px;font-weight: 400;box-sizing: border-box;-we=
bkit-font-smoothing: antialiased;text-rendering: optimizelegibility;transit=
ion: color .25scubic-bezier(.19,1,.22,1),background-color .25scubic-bezier(=
=2E19,1,.22,1),box-shadow .25scubic-bez=
ier(.19,1,.22,1),border .25scubic-bezi=
er(.19,1,.22,1),border-radius .25scubic-bezier(.19,1,.22,1),opacity .25scub=
ic-bezier(.19,1,.22,1),filter .25scubic-bezier(.19,1,.22,1),stroke .25scubi=
c-bezier(.19,1,.22,1),transform .25scubic-bezier(.19,1,.22,1),scale .25scub=
ic-bezier(.19,1,.22,1),outline .25scubic-bezier(.19,1,.22,1);margin-bottom:=
 20px;margin-top: 20px"><tbody><tr><td style=3D"padding:0px;"><a href=3D"ht=
tps://substack.com/redirect/5c69dfeb-29d4-440d-86a7-c581b25a06e6?j=3DeyJ1Ij=
oiNGl3b2U2In0.sVDxRtmZ85v8kfdamY0krRXGMy3p768BWtuZifRB-Zs" style=3D"text-de=
coration:none;color:inherit;display:block;"><table role=3D"presentation" wi=
dth=3D"auto" border=3D"0" cellspacing=3D"0" cellpadding=3D"0"><tbody><tr><t=
d><table role=3D"presentation" width=3D"auto" border=3D"0" cellspacing=3D"0=
" cellpadding=3D"0"><tbody><tr><td style=3D"vertical-align:middle;"><img cl=
ass=3D"custom-css-email-avatar avatar-QIQ5yR" src=3D"https://substackcdn.co=
m/image/fetch/$s_!mmlq!,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F=
%2Fpbs.substack.com%2Fprofile_images%2F2009463593637449728%2Fu-ieMTW0.jpg" =
alt=3D"X avatar for @ManOnThePen" style=3D"box-sizing: border-box;border: n=
one;vertical-align: middle;-ms-interpolation-mode: bicubic;max-width: 100%;=
width: 40px;height: 40px;min-width: 40px;min-height: 40px;object-fit: cover=
;margin: 0px;display: inline;border-radius: 50%" width=3D"40" height=3D"40"=
></td><td width=3D"12" style=3D"min-width:12px;"></td><td style=3D"vertical=
-align:middle;"><table role=3D"presentation" width=3D"auto" border=3D"0" ce=
llspacing=3D"0" cellpadding=3D"0"><tbody><tr><td><div class=3D"pencraft pc-=
reset line-height-20-t4M0El font-text-qe4AeH size-13-hZTUKr weight-semibold=
-uqA4FV reset-IxiVJZ" style=3D"list-style: none;color: unset;font-size: 13p=
x;line-height: 20px;text-decoration: unset;margin: 0;font-family: system-ui=
,-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-se=
rif,'Apple Color Emoji','Segoe UI Emoji','Segoe UI Symbol';font-weight: 600=
;">On The Pen&#8482;</div></td></tr><tr><td><div class=3D"pencraft pc-reset=
 color-secondary-ls1g8s line-height-20-t4M0El font-text-qe4AeH size-13-hZTU=
Kr weight-regular-mUq6Gb reset-IxiVJZ" style=3D"list-style: none;font-size:=
 13px;line-height: 20px;text-decoration: unset;color: rgb(119,119,119);marg=
in: 0;font-family: system-ui,-apple-system,BlinkMacSystemFont,'Segoe UI',Ro=
boto,Helvetica,Arial,sans-serif,'Apple Color Emoji','Segoe UI Emoji','Segoe=
 UI Symbol';font-weight: 400;">@ManOnThePen</div></td></tr></tbody></table>=
</td></tr></tbody></table></td></tr><tr height=3D"12"><td></td></tr><tr><td=
><div class=3D"pencraft pc-reset line-height-20-t4M0El font-text-qe4AeH siz=
e-15-Psle70 weight-regular-mUq6Gb reset-IxiVJZ text-aFN1BV" style=3D"list-s=
tyle: none;color: unset;font-size: 15px;line-height: 20px;text-decoration: =
unset;margin: 0;font-family: system-ui,-apple-system,BlinkMacSystemFont,'Se=
goe UI',Roboto,Helvetica,Arial,sans-serif,'Apple Color Emoji','Segoe UI Emo=
ji','Segoe UI Symbol';font-weight: 400;white-space: pre-wrap">$HIMS $LLY $N=
VO &#128680; OTP EXCLUSIVE BREAKING: LARGE NUMBER OF FDA LETTERS SENT TO GL=
P-1 TELEHEALTH COMPANIES. - QUESTIONING MARKETING PRACTICES (labeling vials=
 with telehealth names when they don&#8217;t originate from the telehealth =
company itself) - USING PHRASES LIKE: &#8220;Same active</div></td></tr><tr=
 height=3D"12"><td></td></tr><tr><td><table role=3D"presentation" width=3D"=
auto" border=3D"0" cellspacing=3D"0" cellpadding=3D"0" style=3D"width:100%;=
"><tbody><tr><td><div class=3D"pencraft pc-reset color-secondary-ls1g8s lin=
e-height-20-t4M0El font-text-qe4AeH size-13-hZTUKr weight-regular-mUq6Gb re=
set-IxiVJZ" style=3D"list-style: none;font-size: 13px;line-height: 20px;tex=
t-decoration: unset;color: rgb(119,119,119);margin: 0;font-family: system-u=
i,-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-s=
erif,'Apple Color Emoji','Segoe UI Emoji','Segoe UI Symbol';font-weight: 40=
0;"><span class=3D"pencraft pc-reset reset-IxiVJZ" style=3D"list-style: non=
e;color: unset;text-decoration: unset;margin: 0;">9:59 PM &#183; Feb 20, 20=
26</span><span class=3D"pencraft pc-reset reset-IxiVJZ" style=3D"list-style=
: none;color: unset;text-decoration: unset;margin: 0;"> &#183; </span><span=
 class=3D"pencraft pc-reset reset-IxiVJZ" style=3D"list-style: none;color: =
unset;text-decoration: unset;margin: 0;">15.8K Views</span></div><div class=
=3D"emailSeparator-mtbezJ" style=3D"border-bottom: 1px solid rgb(0,0,0,.1);=
width: 100%;height: 0;font-size: 16px;line-height: 26px;"></div><div class=
=3D"pencraft pc-reset color-secondary-ls1g8s line-height-20-t4M0El font-tex=
t-qe4AeH size-13-hZTUKr weight-regular-mUq6Gb reset-IxiVJZ" style=3D"list-s=
tyle: none;font-size: 13px;line-height: 20px;text-decoration: unset;color: =
rgb(119,119,119);margin: 0;font-family: system-ui,-apple-system,BlinkMacSys=
temFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif,'Apple Color Emoji','S=
egoe UI Emoji','Segoe UI Symbol';font-weight: 400;"><span class=3D"pencraft=
 pc-reset reset-IxiVJZ" style=3D"list-style: none;color: unset;text-decorat=
ion: unset;margin: 0;">5 Replies</span><span class=3D"pencraft pc-reset res=
et-IxiVJZ" style=3D"list-style: none;color: unset;text-decoration: unset;ma=
rgin: 0;"> &#183; </span><span class=3D"pencraft pc-reset reset-IxiVJZ" sty=
le=3D"list-style: none;color: unset;text-decoration: unset;margin: 0;">7 Re=
posts</span><span class=3D"pencraft pc-reset reset-IxiVJZ" style=3D"list-st=
yle: none;color: unset;text-decoration: unset;margin: 0;"> &#183; </span><s=
pan class=3D"pencraft pc-reset reset-IxiVJZ" style=3D"list-style: none;colo=
r: unset;text-decoration: unset;margin: 0;">58 Likes</span></div></td></tr>=
</tbody></table></td></tr></tbody></table></a></td></tr></tbody></table><p =
style=3D"margin: 0 0 20px 0;color: rgb(54,55,55);line-height: 26px;font-siz=
e: 16px;">The scope of that enforcement effort became clearer shortly after=
ward. A follow up report identified 29 telehealth and compounding related c=
ompanies that had received letters from the FDA, many of which operate in t=
he same ecosystem now being challenged in pharmaceutical lawsuits.</p><tabl=
e class=3D"twitter-embed tweet" role=3D"presentation" width=3D"100%" border=
=3D"0" cellspacing=3D"0" cellpadding=3D"0" data-component-name=3D"TweetToDO=
MStatic" style=3D"background: rgb(255,255,255);color: rgb(54,55,55);display=
: flex;flex-direction: column;gap: 12px;max-width: 550px;margin: 32px auto;=
border: 1px solid rgb(0,0,0,.1);direction: ltr;border-radius: 12px;padding:=
 16px 16px 12px;font-family: system-ui,-apple-system,BlinkMacSystemFont,'Se=
goe UI',Roboto,Helvetica,Arial,sans-serif,'Apple Color Emoji','Segoe UI Emo=
ji','Segoe UI Symbol';font-size: 14px;line-height: 20px;font-weight: 400;bo=
x-sizing: border-box;-webkit-font-smoothing: antialiased;text-rendering: op=
timizelegibility;transition: color .25scubic-bezier(.19,1,.22,1),background=
-color .25scubic-bezier(.19,1,.22,1),box-shadow .25scubic-bezier(.19,1,.22,=
1),border .25scubic-bezier(.19,1,.22,1),border-radius .25scubic-bezier(.19,=
1,.22,1),opacity .25scubic-bezier(.19,1,.22,1),filter .25scubic-bezier(.19,=
1,.22,1),stroke .25scubic-bezier(.19,1,.22,1),transform .25scubic-bezier(.1=
9,1,.22,1),scale .25scubic-bezier(.19,1,.22,1),outline .25scubic-bezier(.19=
,1,.22,1);margin-bottom: 20px;margin-top: 20px"><tbody><tr><td style=3D"pad=
ding:0px;"><a href=3D"https://substack.com/redirect/55800a63-6a33-47a0-838a=
-13f24653f215?j=3DeyJ1IjoiNGl3b2U2In0.sVDxRtmZ85v8kfdamY0krRXGMy3p768BWtuZi=
fRB-Zs" style=3D"text-decoration:none;color:inherit;display:block;"><table =
role=3D"presentation" width=3D"auto" border=3D"0" cellspacing=3D"0" cellpad=
ding=3D"0"><tbody><tr><td><table role=3D"presentation" width=3D"auto" borde=
r=3D"0" cellspacing=3D"0" cellpadding=3D"0"><tbody><tr><td style=3D"vertica=
l-align:middle;"><img class=3D"custom-css-email-avatar avatar-QIQ5yR" src=
=3D"https://substackcdn.com/image/fetch/$s_!mmlq!,f_auto,q_auto:good,fl_pro=
gressive:steep/https%3A%2F%2Fpbs.substack.com%2Fprofile_images%2F2009463593=
637449728%2Fu-ieMTW0.jpg" alt=3D"X avatar for @ManOnThePen" style=3D"box-si=
zing: border-box;border: none;vertical-align: middle;-ms-interpolation-mode=
: bicubic;max-width: 100%;width: 40px;height: 40px;min-width: 40px;min-heig=
ht: 40px;object-fit: cover;margin: 0px;display: inline;border-radius: 50%" =
width=3D"40" height=3D"40"></td><td width=3D"12" style=3D"min-width:12px;">=
</td><td style=3D"vertical-align:middle;"><table role=3D"presentation" widt=
h=3D"auto" border=3D"0" cellspacing=3D"0" cellpadding=3D"0"><tbody><tr><td>=
<div class=3D"pencraft pc-reset line-height-20-t4M0El font-text-qe4AeH size=
-13-hZTUKr weight-semibold-uqA4FV reset-IxiVJZ" style=3D"list-style: none;c=
olor: unset;font-size: 13px;line-height: 20px;text-decoration: unset;margin=
: 0;font-family: system-ui,-apple-system,BlinkMacSystemFont,'Segoe UI',Robo=
to,Helvetica,Arial,sans-serif,'Apple Color Emoji','Segoe UI Emoji','Segoe U=
I Symbol';font-weight: 600;">On The Pen&#8482;</div></td></tr><tr><td><div =
class=3D"pencraft pc-reset color-secondary-ls1g8s line-height-20-t4M0El fon=
t-text-qe4AeH size-13-hZTUKr weight-regular-mUq6Gb reset-IxiVJZ" style=3D"l=
ist-style: none;font-size: 13px;line-height: 20px;text-decoration: unset;co=
lor: rgb(119,119,119);margin: 0;font-family: system-ui,-apple-system,BlinkM=
acSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif,'Apple Color Emoj=
i','Segoe UI Emoji','Segoe UI Symbol';font-weight: 400;">@ManOnThePen</div>=
</td></tr></tbody></table></td></tr></tbody></table></td></tr><tr height=3D=
"12"><td></td></tr><tr><td><div class=3D"pencraft pc-reset line-height-20-t=
4M0El font-text-qe4AeH size-15-Psle70 weight-regular-mUq6Gb reset-IxiVJZ te=
xt-aFN1BV" style=3D"list-style: none;color: unset;font-size: 15px;line-heig=
ht: 20px;text-decoration: unset;margin: 0;font-family: system-ui,-apple-sys=
tem,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif,'Apple =
Color Emoji','Segoe UI Emoji','Segoe UI Symbol';font-weight: 400;white-spac=
e: pre-wrap">BREAKING &#128680; &#128680; &#128680; FULL LIST OF 29 COMPOUN=
D/TELEHEALTH COMPANIES WHO RECEIVED FDA LETTERS (AS PREVIOUSLY EXCLUSIVELY =
REPORTED BY ON THE PEN) &#8226; 24HrDoc, Inc. dba 24HrDoc &#8226; Alan Heal=
th Technologies Inc. dba Alan &#8226; Aspen Aesthetics dba Fifty 410 &#8226=
; Belle Health LLC dba Belle</div></td></tr><tr height=3D"12"><td></td></tr=
><tr><td><table role=3D"presentation" width=3D"auto" border=3D"0" cellspaci=
ng=3D"0" cellpadding=3D"0" style=3D"width:100%;"><tbody><tr><td><div class=
=3D"pencraft pc-reset color-secondary-ls1g8s line-height-20-t4M0El font-tex=
t-qe4AeH size-13-hZTUKr weight-regular-mUq6Gb reset-IxiVJZ" style=3D"list-s=
tyle: none;font-size: 13px;line-height: 20px;text-decoration: unset;color: =
rgb(119,119,119);margin: 0;font-family: system-ui,-apple-system,BlinkMacSys=
temFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif,'Apple Color Emoji','S=
egoe UI Emoji','Segoe UI Symbol';font-weight: 400;"><span class=3D"pencraft=
 pc-reset reset-IxiVJZ" style=3D"list-style: none;color: unset;text-decorat=
ion: unset;margin: 0;">6:41 PM &#183; Mar 3, 2026</span><span class=3D"penc=
raft pc-reset reset-IxiVJZ" style=3D"list-style: none;color: unset;text-dec=
oration: unset;margin: 0;"> &#183; </span><span class=3D"pencraft pc-reset =
reset-IxiVJZ" style=3D"list-style: none;color: unset;text-decoration: unset=
;margin: 0;">21.9K Views</span></div><div class=3D"emailSeparator-mtbezJ" s=
tyle=3D"border-bottom: 1px solid rgb(0,0,0,.1);width: 100%;height: 0;font-s=
ize: 16px;line-height: 26px;"></div><div class=3D"pencraft pc-reset color-s=
econdary-ls1g8s line-height-20-t4M0El font-text-qe4AeH size-13-hZTUKr weigh=
t-regular-mUq6Gb reset-IxiVJZ" style=3D"list-style: none;font-size: 13px;li=
ne-height: 20px;text-decoration: unset;color: rgb(119,119,119);margin: 0;fo=
nt-family: system-ui,-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Hel=
vetica,Arial,sans-serif,'Apple Color Emoji','Segoe UI Emoji','Segoe UI Symb=
ol';font-weight: 400;"><span class=3D"pencraft pc-reset reset-IxiVJZ" style=
=3D"list-style: none;color: unset;text-decoration: unset;margin: 0;">15 Rep=
lies</span><span class=3D"pencraft pc-reset reset-IxiVJZ" style=3D"list-sty=
le: none;color: unset;text-decoration: unset;margin: 0;"> &#183; </span><sp=
an class=3D"pencraft pc-reset reset-IxiVJZ" style=3D"list-style: none;color=
: unset;text-decoration: unset;margin: 0;">4 Reposts</span><span class=3D"p=
encraft pc-reset reset-IxiVJZ" style=3D"list-style: none;color: unset;text-=
decoration: unset;margin: 0;"> &#183; </span><span class=3D"pencraft pc-res=
et reset-IxiVJZ" style=3D"list-style: none;color: unset;text-decoration: un=
set;margin: 0;">57 Likes</span></div></td></tr></tbody></table></td></tr></=
tbody></table></a></td></tr></tbody></table><p style=3D"margin: 0 0 20px 0;=
color: rgb(54,55,55);line-height: 26px;font-size: 16px;">That regulatory ba=
ckdrop is important because federal courts have historically been cautious =
about stepping into disputes that fall within the FDA&#8217;s enforcement a=
uthority. In several previous cases involving pharmaceutical marketing clai=
ms, judges have ruled that questions about drug labeling and promotional la=
nguage are issues that regulators, not courts, are typically responsible fo=
r policing.</p><p style=3D"margin: 0 0 20px 0;color: rgb(54,55,55);line-hei=
ght: 26px;font-size: 16px;">The emerging overlap between these lawsuits and=
 FDA enforcement raises a natural question. If the FDA is already examining=
 how compounded GLP-1 medications are being marketed, could that strengthen=
 the arguments pharmaceutical companies are making in court?</p><p style=3D=
"margin: 0 0 20px 0;color: rgb(54,55,55);line-height: 26px;font-size: 16px;=
">It is not a simple answer. On one hand, the existence of regulatory scrut=
iny could reinforce the pharmaceutical companies&#8217; claim that certain =
marketing practices are problematic. If federal regulators are questioning =
the same types of language appearing in telehealth promotions, plaintiffs c=
ould argue that it supports their broader concerns about how compounded med=
ications are being positioned in the marketplace.</p><p style=3D"margin: 0 =
0 20px 0;color: rgb(54,55,55);line-height: 26px;font-size: 16px;">On the ot=
her hand, the same enforcement activity could cut the opposite direction. D=
efendants in these lawsuits have repeatedly argued that disputes about drug=
 marketing and labeling belong with the FDA, not with private companies fil=
ing lawsuits under advertising or competition laws. Courts will ultimately =
decide where that boundary sits.</p><p style=3D"margin: 0 0 20px 0;color: r=
gb(54,55,55);line-height: 26px;font-size: 16px;">For now, Lilly&#8217;s fil=
ing signals that the legal battles unfolding across the GLP-1 ecosystem are=
 beginning to intersect. Regulatory actions, pharmaceutical lawsuits, and t=
elehealth business models are all colliding in a way that could shape how c=
ompounded obesity medications are marketed in the future.</p><p style=3D"ma=
rgin: 0 0 20px 0;color: rgb(54,55,55);line-height: 26px;font-size: 16px;"><=
span>The next major test in this battle arrives on April 9th, when a federa=
l judge in San Francisco will hear arguments on Mochi Health&#8217;s motion=
 to dismiss. Lilly&#8217;s new filing makes one thing clear. The company wa=
nts the court to look closely at the Novo ruling and conclude that the Moch=
i case should move forward as well. Whether the judge agrees could determin=
e whether this fight stays procedural or enters the far more revealing phas=
e of litigation.</span><br></p><div style=3D"font-size: 16px;line-height: 2=
6px;"><hr style=3D"margin: 32px 0;padding: 0;height: 1px;background: rgb(0,=
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pearance: optimizelegibility;appearance: optimizelegibility;margin: 1em 0 0=
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cessing&quot;:false,&quot;align&quot;:null,&quot;offset&quot;:false}" alt=
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h/$s_!vBbu!,w_1100,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A=
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