Question one - What is your opinion of how the FDA has handled the Opioid Epidemic?
Question two - Why do you oppose Janet Woodcock being nominated for FDA commissioner?
Gary Carter, MA
The American public has been duped in believing the FDA is an agency designed to protect the American public. Nothing could be further from the truth. The FDA has buried its head in the sand in order to benefit the greed of Big Pharma and at the cost of our children
Janet Woodcock's track record at the FDA has been one of support for Big Pharma interests and greed over the safety of the American public. Her approval of oxycontin for children as young as eleven years old is in my mind criminal.
Barbara Van Rooyan, CA
In 2005 my husband and I submitted a Citizen Petition to the FDA requesting relabeling of OxyContin for severe, non-chronic pain only. Such a move could have prevented incalculable number of deaths. However, it took the FDA eight years to respond to our petition and then it was to deny it. Now, 16 years later there still are no studies that confirm the efficacy or safety of OxyContin for chronic non-cancer pain. The FDA is clearly not only complicit in fostering the opioid crisis but is, in my opinion, nearly as responsible as Purdue Pharma and the Sackler family.
Among her many transgressions, Woodcock was at the helm of the FDA when Purdue and FDA officials met behind closed hotel room doors to compose the liberal labeling of OxyContin. This was the cornerstone for Purdue’s success in building a 35 billion dollar empire off the deaths and addictions of half a million people.
Ed Bisch, PA
Purdue Pharma is the #1 villain in starting the Opioid Epidemic but the FDA is the #2 villain because they literally allowed it by only taking nothing more than token steps to curb it.
Woodcock has been in FDA management before OxyContin ignited this epidemic which was approved with unsubstantiated claims. Additional tests were requested by FDA but this was overridden by FDA management.
In 2001 under her watch FDA relabeled OxyContin with wording that actually generated more sales which led to more deaths.
Pete Jackson, IL
FDA has failed to protect the health and safety of the American people by approving opioids to be used for a broad spectrum of pain indications for which they have never been proven safe and effective. The continued approval of opioids for use in treating chronic non-cancer pain as the opioid epidemic exploded - despite repeated warnings from public health experts, advocates for victims such as myself, and in many cases over the objections of its own expert advisory committees - is a remarkable failure of our government to protect us from the harm inflicted by these lethal drugs.
Janet Woodcock has played a central role as she presided over the staff that reviewed opioid drug applications. The opioid epidemic happened on her watch. As a bereaved parent I personally tried to reason with her in an extensive letter but she never even responded. She represents the status quo, a status quo that has been overly deferential to the opioid industry within FDA. What is desperately needed is an independent voice, someone who can understand and respond to the harm being inflicted on the American public by the extensive overprescribing of opioids.
Emily Walden, KY
The FDA's job is to ensure the safety of drugs and protect public health, for the last 20 years they have ignored the opioid crisis and fast tracked opioid approvals.
Under Woodcock the decision to change opioid labels to include long term use and clinical trial redesigns caused more death and addictions throughout the country. The approval of Opana in 2006 is one example of FDA's complete disregard for safety, many more opioid approvals followed as the deaths increased.
Lee Nuss, FL
The FDA with whom we trusted with our food and drugs have done nothing for we the people. They chose big Parma with misleading relabeling of OxyContin causing more addiction and death.
For years Woodcock has made terrible decisions on public safety. As the opioid epidemic raged on, she continued to approve new and stronger opioids without regarding the potential for addiction.
The Pharmacist, Dan Schneider
In my opinion the number #1 culprit in starting the Opioid Epidemic is Purdue Pharma with its misleading and aggressive marketing Campaign of Oxycontin claiming 1% addiction and major benefits for management of Moderate to severe Chronic Pain, when it was truly designed for a much smaller market for short term pain, cancer and end of life pain.
The #2 culprit is the FDA which in 1995 accepted Purdue’s false and misleading BS and approved Oxycontin for chronic pain and its low incidence of addiction.
Because of her part in accepting Purdue's misleading information and approving Oxycontin which has lead to the Opioid Epidemic and countless loss of lives, there is no way that she should lead this agency.