Daily Archives: August 7, 2016

Looking into the eyes of evil at an FDA Advisory Committee Meeting!

Webster, holding phone, Katz is on the right with his head tilted down. Photo: Marianne Skolek

Webster, holding phone, Katz is on the right with his head tilted down. Photo: Marianne Skolek

“You are responsible this year alone for 26,000 deaths and sat in the Advisory Committee meeting today and recommended the approval of yet another opioid that will kill in the thousands. How many more deaths will you be responsible for and how do you sleep at night” – Marianne Skolek’s question to Nathaniel Katz, MD

Marianne Skolek-Perez Global News Centre

(MYRTLE BEACH)  Thursday I attended my first FDA Advisory Committee meeting. It was for consideration of yet another dangerous extended release opioid — it will mark 7 approved this year.  This right off the FDA Agenda sheet:

“The committees will discuss new drug application (NDA) 208602, morphine sulfate extended-release tablets, submitted by Egalet U.S., Inc., with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.  It has been formulated with the intent to provide abuse-deterrent properties.  The committees will be asked to discuss whether the data submitted by the applicant are sufficient to support labeling of the product with the properties expected to deter abuse.”

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