FDA and Oxycontin – From the July 27th Show

In the June issue of US Pharmacist, Janet Woodcock, the Director of the FDA’s Center for Drug Evaluation and Research is quoted during testimony before the Senate Education, Labor, Health and Pensions Committee on April 24, 2008……….“We cannot be the quality-control unit for the world”. Woodcock also said that the increasingly large number of pharmaceutical ingredients manufactured abroad makes it nearly impossible for the FDA to ensure the safety of all drugs sold in the United States……This same article reported that 80 per cent of the bulk ingredients in the pills that you are swallowing are being imported and the FDA publicly admits it has little resources to inspect the manufacturing facilities the bulk ingredients are coming from……I want to emphasize from this that we have a high ranking official from the FDA admitting that it is virtually impossible to ensure the safety of all the drugs being manufactured in the United States…..and the mainstream press remains silent……
Recently, I have been telling you of the example of the insect that was found in the Stearyl Alcohol in 2002 in the Purdue Pharma facility that made Oxycontin……….At the time of the 2003 inspection I reported on……… Purdue Pharma still had no idea where or who manufactured the Stearyl Alcohol for them in 2002 and the FDA continued to allow that bulk product to be put into a pill that was reportedly part of killing thousands of people……I have since been sent a letter from a listener that is dated September 9, 2001 and it shows that the manufacturing plant that was used to make Oxycontin was sited for poor manufacturing procedures and the problems with the Stearyl Alcohol went back much further than the 2002 time frame I gave you last week……..It appears that the FDA knew that Purdue was having trouble adhering to Good Manufacturing Procedures well before my documentation and the FDA continued to allow Purdue to produce what is reportedly the most deadly prescription drug in America…………The new news this week…………is that in 2003 the FDA knew that Purdue was manufacturing Oxycontin tablets….and I quote…..”friability testing was not performed on Oxycontin tablets as required and the frequency of the hardness checks was inadequate”……I continue to wonder how the attorneys missed this six years ago…………….There you have it….the FDA knew that the product that was reportedly part of killing thousands of people in the six years previously knew the proper safety procedures for a safe product were not being adhered to……….
Almost three weeks ago…….I sent some information to the FDA for the attention of the Office of Criminal Investigations at the FDA……and I continue to wait for a response…..…..Aside from the proven poor conditions in the Purdue Plant which the FDA ignored, it appears that Purdue may have knowingly………. knowingly had defective product going out into the channels of distribution in 2002 and This Radio Show is trying to find out what the FDA knows about this…………Again, this is radio, so any person affiliated with Purdue or the FDA is welcome to come on the radio show and talk about the insect in the Stearyl Alcohol in 2002.……or …the letter sent by the FDA in November of 2001, or why the tablets weren’t being properly inspected before distribution in the 2002 – 2003 time frame and why the FDA continued to allow Purdue to manufacture……. reportedly, by the FDA’s own reporting standards, the deadliest active prescription product without knowing where the bulk products were coming from. This is a continuing story that I think might make national news as it develops……Stick with us on this story and if I hear from the FDA or Purdue, I will let you know………..The Prescription Addiction Radio Show – Breaking the Silence