This Petition Clause analysis was uncontested before the Court and is unrelated to the validity under the Free Speech Clause of the FDA's interpretation of its Dear Doctor letter regulations.
Finally, and critically for purposes of this Comment, the plaintiffs mounted a separate argument: that the generic manufacturers could have employed so-called Dear Doctor letters (28) to "send additional warnings to prescribing physicians." (29) The FDA acknowledged that no statutory provision or agency regulation explicitly prohibited generic manufacturers from "unilaterally" sending such letters.
Indeed, the plaintiffs' merits brief did not once refer to the regulation that, in the FDA's view, brought Dear Doctor letters under the "labeling" regulatory regime.
If the First Amendment forbids the FDA's interpretation regarding Dear Doctor letters, a more principled route for recovery exists.
The Court in Mensing accepted the FDA's interpretation that generic manufacturers may not send Dear Doctor letters to inform physicians of possible risks.
The Mensing plaintiffs did not contest the FDA's interpretation regarding Dear Doctor letters in any meaningful way-and they could not have known that the Court in Sorrell would offer such a robust First Amendment ruling.
And this page has the full BMS Dear Doctor letter
" Sanofi was also directed to conduct an information dissemination campaign through "advisories, dear doctor letters
and patient fora." The advisory was issued after Sanofi released an updated information last Nov.
The FDA also directed Sanofi to conduct an information dissemination campaign through advisories, Dear Doctor Letters
, and forums with patients.
Well, back (although sadly not in magazine form, so you'll have to send your Dear Doctor letters
Well, it's back (although sadly not in magazine form, so you'll have to send your Dear Doctor letters
" The Department of Health unit also said that "Sanofi was further directed to conduct an information dissemination campaign through Advisories, Dear Doctor Letters
and Patient fora." The FDA order comes after a November 29 disclosure by Sanofi that post-clinical trial study of Dengue Tetravalent Vaccine (Live, Attenuated) indicated an increased risk of hospitalization for dengue and "severe" dengue, "predominantly Grade I or II Dengue Hemorrhagic Fever", for patients not previously infected by the virus, which is spread through mosquito bites.