Monthly Archives: September 2016
Opioids for Pediatric Patients - “How could you get it so wrong?”
FDA official betrays her anger when asked, “How can you get it so wrong?” Photo: Marianne Skolek-Perez
“Prescriptions and sales of opioids have more than quadrupled since 1999″ - CDC
Marianne Skolek-Perez Global News Centre
(MYRTLE BEACH) Last Thursday and Friday I attended an FDA meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee and the Pediatric Advisory Committee. The purpose of the two day meetings was to discuss prescription opioid analgesics for pediatric patients. The FDA experts and their egos were in plentiful supply as they fell over each other condoning opioids for pediatric patients. Unfortunately the audience in the large auditorium was sparsely attended — no Partnership for a Drug Free Kids and no advocacy organizations.
Douglas Throckmorton, MD, Deputy Director of FDA - I expect an apology!
Douglas Throckmorton, MD
Since the FDA has sat back and approved prescription opioids in record numbers (more than any other country in the world), we can anticipate children being used as pawns by the FDA as they are fed opioids by pharma
Marianne Skolek-Perez Global News Centre
(MYRTLE BEACH) >On August 31 (with 45 minutes) notice, I was asked to participate in a “stakeholders” teleconference with Douglas Throckmorton, M.D., Deputy Director for regulatory programs in FDA’s Center for Drug Evaluation and Research (CDER) to discuss the “FDA’s strongest box warning on opioids”. One of Dr. Throckmorton’s responsibilities at the FDA is ensuring that the benefits of approved drugs outweigh their known risks. >
