Tags: fda | opioids | overdose | oxycontin | purdue pharma

Study: FDA Did Not Verify If Opioid-Curbing Effort Worked

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This undated file photo provided by the U.S. Attorneys Office for Utah and introduced as evidence at a trial shows fentanyl-laced fake oxycodone pills collected during an investigation. (U.S. Attorneys Office for Utah via AP)

By    |   Monday, 30 December 2019 05:53 PM

The FDA failed to verify whether a program designed to help control the opioid crisis actually worked because of poor oversight, according to a study published Monday in JAMA Internal Medicine and reported on by the New York Times.

The review, conducted by researchers at the Johns Hopkins Bloomberg School of Public Health, included searching through thousands of FDA documents that were released via a Freedom of Information Act request.

The findings indicate that the FDA could not determine if the program to train more than 160,000 doctors on cutting back their prescribing of opioids did any good.

"What's surprising here is the design of the program was deficient from the start," the study's senior author Caleb Alexander said, according to the Times. "It's unclear why the FDA didn't insist upon a more scientifically rigorous evaluation of this safety program."

The FDA asked Purdue Pharma, the company currently under fire for manufacturing and marketing OxyContin, and other makers of prescription opioids in 2011, to foot the bill for an effort that trained doctors on the dangers of overprescribing painkillers. However, the government agency could not track the results of the program and ascertain if it worked.

According to information posted by the National Institute on Drug Abuse, 47,600 deaths in 2017 were attributed to opioids, the highest in history.

The FDA would not comment on the Times report, but the findings show that the agency fell short of following up on its own effort to help save American lives.

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The FDA failed to verify whether a program designed to help control the opioid crisis actually worked because of poor oversight, according to a study published Monday in JAMA Internal Medicine and reported on by the New York Times.
fda, opioids, overdose, oxycontin, purdue pharma
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2019-53-30
Monday, 30 December 2019 05:53 PM
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