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Drug Manufacturer Points Finger At FDA Label Change Regulation As Cause Of Opioid Problem

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A drug manufacturer is accusing the Food and Drug Administration of helping spark the ongoing opioid epidemic across the United States.

In an interview, Edwin Thompson, who has worked in the pharmaceutical industry for over 40 years, cast the blame to the federal agency which, he claims is the "root cause" of the problem. He cites the early 200s approval of Oxycontin, a powerful narcotic, to be marketed toward patients experiencing chronic pain.

The action allowed access of the drug to more people.

Not For Long-Term Use

In an appearance to CBS's 60 Minutes, Thompson explained that in 2001, the FDA changed the label of Oxycontin to say that the drug is effective for "daily, around-the-clock, long-term" treatment. The change, he said, was made despite the lack of new science to back it up, allowing patients who suffer from back pain or arthritis to get a hold of the powerful painkiller.

"A drug's label is the single most important document for that product. It determines whether somebody can make $10 million or a billion dollars," Thompson told host Bill Whitaker. "Because it allows you to then promote the drug based on the labeling."

Andrew Kolodny, an addiction specialist, has been calling for the label of Oxycontin to be changed since 2011 to make it clear for the public that opioid should not be used by everyone.

"If you're taking them around the clock every day, quickly, you become tolerant to the pain-relieving effect," he stated. "In order to continue getting pain relief, you'll need higher and higher doses."

FDA commissioner Scott Gottlieb declined to give an interview but issued a statement to 60 Minutes saying that the agency is making aggressive actions to address the opioid epidemic. He, however, admitted that the FDA made "many mistakes" along the way, saying that they should have acted sooner to prevent the problem.

Opioid Epidemic In The US

The number of deaths associated with the misuse of opioid has more than four times increased between 1997 and 2017, according to the Centers for Disease Control and Prevention. On average, around 130 Americans die due to opioid overdose every day.

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