Janet Woodcock, MD is the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). CDER determines what drugs are safe and effective to improve the quality of life for people in the United States and is promoted as overseeing testing in clinical trials. However, clinical trials are more often than not conducted in the labs of the maker of the drug — not in the labs of the FDA. The FDA relies on the pharmaceutical testing lab to advise of the outcome of their clinical trials.
Dr. Woodcock previously served as FDA’s deputy commissioner and chief medical officer. She also led CDER as director from 1994–2005. Woodcock’s tenure with the FDA coincides with that of David Kessler, MD, Commissioner who was featured on a recent CBS 60 Minutes expose wherein he admitted that Purdue Pharma’s highly addictive opioid, OxyContin was not approved for long-term chronic pain use. Here is the link to the CBS 60 Minutes broadcast.
Woodcock has been quoted as saying “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”
I encourage people who have lost family members to addiction and death under Dr. Woodcock’s reign of power to read a book entitled “Big Pharma, Big Greed – the inside story of one lawyer’s battle to stem the flood of dangerous medicines and protect public health” written by Stephen A. Sheller, Esq. One of the statements in Mr. Sheller’s book that should challenge Woodcock’s “gold standard for drug approval and safety” under her leadership is the following:
On the FDA’s role in the drug development process, Woodcock has likened the agency’s oversight to that of a building inspector saying “Someone else builds the building according to code. The FDA writes the code, and then comes in at the end and inspects the results to make sure they’re up to code.”
Mr. Sheller counters Dr. Woodcock’s analogy on the drug approval process by saying “In my view, the problem is the code is flawed from the start and the inspectors are in cahoots with the builder. One reason is the revolving door between the FDA and the pharmaceutical industry.”
On January 24, 2004 then-Attorney General (AG) Richard Blumenthal of Connecticut (now US Senator of Connecticut) submitted a Citizen Petition (CP) to the FDA entitled “Petition to Require Purdue Pharma L.P. to Revise the Labeling of OxyContin Tablets to Strengthen Warnings of the Greater Potential for Developing Side Effects and Adverse Drug Reactions Due to Prescribing Dosing Frequencies in Excess of the Recommended Guidelines.”
Although the FDA had two conflicting dates on their website as to the time frame to respond to a Citizen Petition of 5 months or 6 months, Janet Woodcock, MD did not respond to Blumenthal’s 2004 Citizen Petition until 2008. Way beyond the 5 to 6 months the FDA is required to respond. Provided below is a link to Woodcock’s response to Blumenthal — all 18 pages of it.
One of the comments Dr. Woodcock stated in her reply was that “…..although higher total daily dosages were associated with fatal outcomes, it cannot be concluded that the higher total daily dosages are causally associated with fatalities given the other variables have not been measured.” Further, she writes “…there is no maximum dose for opioids.”
So answer me this Dr. Woodcock — how many lives could have been saved when AG Blumenthal sent the FDA his Citizen Petition in 2004 if you had acted on it in a timely and scientific manner? What do you think? Hundreds? Thousands? Tens of Thousands?
If the FDA under Woodcock’s CDER direction is to be the “watchdog” of the American people in keeping them safe from dangerous drugs, maybe it’s time for the pit bull to be terminated in the interest of saving innumerable lives.
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