On September 10 and 11 from 9:00 am to 5:00 pm, 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 made part of this article), 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:
If you can cut it; if you have access to water; and if you have a syringe, then you can IV 16 mg/ml. of oxycodone from one reformulated OxyContin tablet. Reformulated OxyContin, as a drug product, does not deter abuse. (This was demonstrated to me and others at the PMRS facility and proven to be factual).
In 2016 we notified the FDA that a simple method existed in which a reformulated OxyContin tablet can be manipulated into a highly potent injectable solution in 30 minutes. Extraction and injection of reformulated OxyContin in this manner can be accomplished by an untrained, unskilled person on their first attempt using only scissors and water. A demonstration of this technique has been provided to FDA in the form of a 9-minute film. This film should have been shown to the advisory committee as a full-disclosure requirement.
For oxycodone products, declaration of abuse deterrence for the nasal route is a mere smokescreen that does nothing to protect the American public. Despite FDA advocacy for the development and classification of products with claimed abuse-deterrent properties for this route, there is no scientific evidence that intranasal abuse of oxycodone is a more effective route of abuse for oxycodone than oral abuse.
No post marketing results can be attributable to the abuse-deterrent properties of the drug formulation, since the drug formulation does not actually have abuse-deterrent properties. FDA’s error in approving abuse-deterrent labeling on this drug is a critical lapse in judgement, not supported by substantial evidence or required by law.
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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