Marianne Skolek
July 10, 2012

(MYRTLE BEACH, SC) – This article is dedicated to “Michael David” — every parent’s child — a beautiful young man, loved by many whose life was cut short before his dreams were realized. Fly with the angels, Michael you are very loved and wonderful memories will always be in the hearts of your mom and dad, family, friends and those who never even met you.

The FDA never disappoints me. The big news this week coming from the FDA is that they are “cracking down” on pharmaceutical companies manufacturing and distributing “unapproved” drugs that contain Oxycodone — also known as OxyContin in time release formula. In a statement by the FDA, they cite these “unapproved” drugs containing the highly addictive ingredient in OxyContin had not been evaluated by the FDA for safety, effectiveness, manufacturing quality or appropriate labeling — and cannot be legally marketed in the U.S. The FDA gave the “drug pushers” of these unapproved opioids 45 days to stop manufacturing the drugs.

An FDA spokesperson was quoted as saying “We’re trying our best not to point fingers” when asked for the names of the pharmaceutical companies pushing these dangerous, unauthorized versions of OxyContin.

“It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.”

In 2006, under the Unapproved Drugs Initiative, the FDA sought removal of these “unauthorized” drugs. Do you question what took the FDA so long to initiate this action? I sure do.

The FDA never disappoints me in their protection of big pharma. They don’t seem to be concerned with the epidemic of prescription drugs in this country killing and addicting every day in the thousands. I’d like to point some fingers. Here’s an email I received the other night from the FDA. I guess they wanted to impress me with their diligence at protecting the American people — I wasn’t impressed.

Hi Marianne,

I hope you had a wonderful Independence Day! FDA just issued a press release, in conjunction with a Federal Register notice, about action CDER is taking against unapproved oxycodone products as part of its Unapproved Drugs Initiative. You can find the press release and links to further information here: I thought you would be interested in this action and potentially sharing it within the activist community.


James E. Valentine, MHS
Program Analyst
Office of Special Health Issues
Office of the Commissioner
U.S. Food and Drug Administration
White Oak Bldg. 32 Rm. 5363
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-847-8623 (fax)
[email protected]

I replied to this email — “Too little, too late.” I will continue to expose the FDA for their incompetence and lack of concern for the prescription drug deaths and addictions in this country.

And no I did not have an enjoyable Independence Day as mentioned in the FDA email to me. I had been on the phone with a dad who lost his 18 year old son the year before because his physician over-prescribed opioids to the boy — even after the dad begged the physician to take his son off the dangerous narcotics. The boy had told his dad that he was becoming addicted. The reply the dad received from the doc was “your son needs them.” He needed them so badly that he committed suicide and died in his dad’s arms.

So call me cynical, but I am about finished with the FDA. For them to suggest that I share with the activist community their “too little, too late” action to protect the American consumer is an insult to the tens of thousands of families dealing with the loss of loved ones to death and addiction.

Last year I broke a story that the maker of OxyContin, Purdue Pharma was soliciting children ages 6 to 16 for clinical trials in the use of OxyContin. Links to my articles are provided below. My worst nightmare was realized this week when all major news media broke that Purdue Pharma had 150 children to ingest their highly addictive and lethal drug, OxyContin in clinical trials. It is being reported that by no means does it mean that the FDA will approve the use of OxyContin in children, it is to extend the patent of OxyContin for Purdue Pharm — which will result in billions of dollars to them.

If you believe that OxyContin clinical trials for children is about patent extension, then I have a bridge to sell you.

How much more do families suffering horrific loss due to this prescription drug epidemic need to endure while the FDA plays “pick the pocket” of pharma?

Clinical trials of OxyContin on children ages 6 to 16 – links to my articles where I broke the story last year.

The Reopen America Back to School Special is now live! Earn double Patriot Points on our hottest items!

Related Articles