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FDA Meets to Reformulate OxyContinMarianne Skolek-Perez Salem-News.com Investigative Reporter
Why is the FDA holding an "emergency meeting" on the reformulation of OxyContin?
(MYRTLE BEACH, SC) - September 10 and 11 from 9:00 am to 5:00 pm (EST), the FDA will be holding an advisory committee meeting via an online teleconferencing platform.
The committee will discuss the results of required "post marketing studies" on the reformulation of OxyContin extended-release tablets, manufactured by Purdue Pharma.
Discussion will be held if the reformulated OxyContin has resulted in a meaningful reduction in abuse, misuse as well as fatal and non-fatal overdoses.
The FDA will have background material made available to the public no later than (2) business days before the meeting. A link to participate in this webcast transmission is indicated below this article and I encourage people to participate -- especially attorneys general.
The above meeting was put on the Federal Register notice and meeting in 15 days as an "emergency schedule" without explanation.
In a letter dated September 4, (link below1), Edwin R. Thompson, President, Pharmaceutical Manufacturing Research Services, Inc. (PMRS) offers scientific concerns as to the reformulated OxyContin and the results of FDA required post marketing studies.
Some of the highlights of PMRS concerns are as follows:
Purdue Pharma, maker of OxyContin is currently involved in bankruptcy hearings which would enable them to cut their losses and reorganize. Is the FDA acting as a disgraced, criminal pharmaceutical company's best ally in holding an emergency Advisory Committee meeting with little notice?
Years ago when I began writing and exposing Purdue Pharma for their criminal marketing of OxyContin -- which to date has resulted in hundreds of thousands of addictions and deaths -- I received a telephone call from a Tom Abrams at the FDA.
Mr. Abrams was not happy that I was questioning the number of "warning letters" the FDA had sent Purdue Pharma for their questionable marketing of OxyContin.
I believe at the time of our conversation, the letters from the FDA to Purdue Pharma were approximately 12 in number.
As Mr. Abrams attempted to speak over me, I interrupted him and said "how many warning letters do you plan on sending Purdue Pharma because they don't seem to be listening to you?"
His reply was "we don't have enough people to police Purdue Pharma."
I couldn't believe it and said "you don't think they don't know that?"
Mr. Abrams hung up on me.
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