James Blair's comment on the public docket is a must read. Hopefully Janet Woodcock sees it. I encourage everyone to read the letter he posted.
See below as well.
PRIVATE OFFICE
PHONE: 202-808-5500
FORMER SPECIAL.
ASSISTANT TO THE PRESIDENT
HONORABLE JAMES G.V. BLAIR
WASHINGTON, D.C. 20502
October 27, 2019
Docket No. FDA-2019-N-3936 for "Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments."
Dear Members:
On behalf of the millions of United States military veterans I extend my personal appreciation to you and
the FDA staff as you begin your reviews of the proposed expanded label for one of the most important
drugs in the 21st Century, the drug Vascepa.
Various professional medical organizations like the American Heart Association (AHA), American College
of Cardiology (ACC), American Diabetes Association (ADA), European Society of Cardiology (ESC), and the
Institute For Clinical & Economic Review (ICER) represent independent and non-partisan research
organizations and medical professionals like yourselves that have recently conducted objective
extensive evaluations or assessments of the drug Vascepa as it relates to the recent Reduce It Study and
the drug's therapeutic value in the area of cardiovascular disease including other related diseases such
as diabetes.
Both individually and collectively these highly regarded organizations have either endorsed or indicated
support for Vascepa as a recommended drug for the treatment for cardiovascular disease and many
cardiovascular related diseases like diabetes. Most recently I ICER indicated Vascepa to be a very cost
effective drug for such treatment(s).
Never before (since statins) has there been such an intense collective rigorous analysis of all clinical
data and a public dialogue with all stakeholders including professional medical organizations, the
Data Monitoring Committee, Sponsor, Amarin Corporation, and key FDA staff (including senior
leadership) over the last 6-7 years.
In lieu of the above, as a veteran and advocate for over 25 million veterans (many of whom are facing
serious cardiovascular related illnesses and diabetes) I highly support the expeditious review and
accelerated approval by the FDA of the expanded label for Vascepa.
Assuming such an approval it is further requested that the FDA Commissioner recommend to the
Secretary, Health & Human Services, Secretary of Veterans Affairs, and Secretary of the Department
of Defense that the drug Vascepa be immediately listed in all applicable formularies so that both
veterans and active duty military personnel have immediate access to this imporlant life-saving and
cost effective drug for the treatment of cardiovascular disease and diabetes.
Sincere
Hon. James G.V . Blair
Additional Personal Note: Approximately 3 years ago l was diagnosed with two aneurysms as a result of
artherioscelerosis. Approximately a year ago l was prescribed 2-4 grams of Vascepa off label to
determine if the drug would have any effect and reduce arterial plaque levels. On October 17, 2019 l
had a CTA with and without contrast of my arterial plaque levels. The results are rather eye opening
with a reduction of 15-18% in arterial plaque and reductions in the size of both aneurysms.
Such important and key information should be included as a part of your Committee's evaluation of the
drug's effectiveness in area of cardiovascular disease.
JGVB
