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Feb-22-2019 19:13printcomments

FDA at the Root of the Opioid Epidemic

The root has always been at the top (the FDA) ...Now let's do something about it!

Dr. David Kessler, who was FDA commissioner in the 1990s, tells 60 Minutes, "There are no studies on the safety or efficacy of opioids for long-term use." Sunday at 7 p.m. ET/PT on CBS

(MYRTLE BEACH, SC) - In my 17 years of writing and speaking of the ever worsening prescription opioid epidemic, I have maintained that the root of the epidemic is at the top -- the FDA.

Purdue Pharma, maker of the highly addictive and dangerous opioid, OxyContin unleashed a holocaust of deaths and addictions by working with the FDA to win approval for long-term use of opioids -- in particular OxyContin.

I have worked with Attorneys General, attorneys, elected officials, physicians and entities who were as determined as me to expose the FDA and Purdue Pharma for their parts in encouraging opioids for long-term use.

This Sunday night, February 24, CBS 60 Minutes (check your local listings) will focus on David Kessler, MD, the former FDA commissioner admitting they erred in allowing pharma to promote opioids for long-term use.

Here is the link to the 60 Minutes press release/preview:

Today the sealed deposition of Richard Sackler, one of the owners of Purdue Pharma who allowed OxyContin to be criminally marketed, was made available to the public.

Here is a link to that eye-opening deposition that was taken in the State of Kentucky settlement:

In 2018, I wrote about a Memorandum of Law in Support of Plaintiff (Pharmaceutical Manufacturing Research Services Inc’s (PMRS) Motion for Summary Judgment filed against the United States Food and Drug Administration (FDA) and the United States Department of Health and Human Services (HHS).

I encouraged every Attorney General and law firm in the country suing Purdue Pharma, maker of OxyContin to read this filing carefully and apply it to current and future lawsuits.

It had been thought that the FDA and HHS were “untouchable” in the prescription opioid epidemic destroying lives in the tens of thousands. I have long written and spoken that this epidemic’s roots were at “the top” -- the FDA.

PMRS has dispelled the myth that these federal agencies in place to protect the American people could use the approval process of dangerous opioids with the mentality of “fire, aim, ready.”

Here are some highlights of the PMRS filing against the FDA and HHS:

    In the past two years, it has come to light that FDA has been approving opioid drug products for treatment of chronic pain despite a lack of substantial evidence, as is required by 21 U.S.C. 355(b) to support the efficacy of those products in a chronic use setting.

    In the past years, it has come to light that FDA’s current methodology for approval of so-called abuse deterrent labeling for opioids does not satisfy the requisite statutory standards, is scientifically flawed, and results in false and misleading labeling. Such labeling gives a false sense of security as to any meaningful solution to the raging opioid epidemic.

    Rather than addressing improper approval processes for opioids with labeling for treatment of chronic pain, FDA pursued abuse deterrent formulation and labeling, an approach that has done nothing but fuel the opioid crisis.

    Despite the continued lack of scientific evidence to support the use of opioid products for treatment of chronic pain, on July 18, 2001, FDA changed the labeling for OxyContin and other opioids.

    Specifically, FDA supported labeling updates that changed the indication of OxyContin for treatment of acute pain to chronic . In support of their determination, FDA merely stated that the basis for this change was “to reinforce the appropriate patient population for whom this product is intended.”

    More recently, in March 2016, the CDC conducted a comprehensive review of the scientific evidence supporting the effectiveness of long-term opioid therapy for chronic pain, and concluded that “the few randomized trials to evaluate opioid efficacy for longer than 6-weeks had consistently poor results.”

Private law firms may not want to “take on the FDA and HHS” citing not having the resources to hold these agencies accountable in the prescription opioid epidemic. It is a different scenario with every Attorney General in the country who has an obligation to go to the root of the prescription opioid epidemic and stop the loss of human life in the tens of thousands.

It’s time for “ready, aim, fire” to sweep the FDA and HHS clean and save lives — not enable the pharmaceutical industry to earns billions of dollars while we continue to lose a future generation compliments of agencies failing to protect the American people.

Maybe the personal injury lawsuits to be filed as a result of the FDA's admission of complacency in the opioid epidemic won't be far behind.


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JEagle February 22, 2019 8:53 pm (Pacific time)

"...FDA’s current methodology for approval of so-called abuse deterrent labeling for opioids does not satisfy the requisite statutory standards.." Not surprising considering some of the people at FDA put their careers ahead of public device and public well being. The amount of lawyers at FDA (i.e. Garcia Gorka te al. in his FDA FOIA office) trying to "hide public information" from tax payers and the amount of nepoatiam amongst staff is beyond belief. And people think the FDA has the best interest of the public?! No, they don't. They care for the pharmaceutical profits than the public's health.

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