EFTA02455520.pdf

"Deepak Chopra MD, FACP, Clinical Professor of Medicine... <FDA Op-Ed Draft.docx>"

"Nancy S. Cetel, MD, President and Founder... <FDA Op-Ed Draft.docx>"

"Joseph B. Weiss, MD, FACP, Clinical Professor of Medicine... <FDA Op-Ed Draft.docx>"

"Deepak Chopra MD, FACP, Clinical Professor of Medicine, University of California, San Diego"

"Chairman and Founder, The Chopra Foundation"

"Nancy S. Cetel, MD, President and Founder, Speaking of Health"

"Joseph B. Weiss, MD, FACP, Clinical Professor of Medicine, School of Medicine, University of California San Diego"

"From: Deepak Chopra Sent: Monday, August 1, 2016 12:29 PM To: Jeff Epstein Subject: Fw: Draft OpEd piece on FDA sharing confidentially"

"Deepak Chopra 2013 Costa Del Mar Road Carlsbad, CA 92009 The Chopra Foundation"

"Rough draf is attached as a Word document, feel free to modify, edit, add, delete, rewrite, etc. ... Love, Joe & Nancy"

"Rough draf is attached as a Word document, feel free to modify, edit, add, delete, rewrite, etc. ... Love, Joe & Nancy"

"Pharmaceutical submissions to the FDA should include genomic analysis of subject populations and outcomes."

"The FDA and congress needs to take the lead, and public health and safety should be its priorities."

"If you approve, we can send the final version to our friend Dan Henninger, Deputy Editor at WSJ."

"Dan Henninger, Deputy Editor at WSJ."

"Merck's anti-inflammatory drug Rofecoxib (Vioxx)"

"the FDA has repeatedly issued administrative rulings that have actually helped the pharmaceutical industry avoid regulatory oversight and keep these u"

"One of the more recent drug approvals that was later withdrawn was in 2004 for Merck's anti-inflammatory drug Rofecoxib (Vioxx)"

"In 1962, Congress passed amendments to the 1938 law... the 1962 Kefauver-Harris Amendments"

"The most comprehensive list of unapproved drugs is not maintained by the FDA, but rather by the National Library of Medicine, which identities 88,212 "

"The FDA was created in 1906 but surprisingly was not required to assess drug safety and efficacy until 1938."

"After forty years of being marketed without FDA approval the manufacturer of the popular thyroid replacement drug Synthroid finally reluctantly agreed"