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FDA fuelled opioid crisis by failing to police pharmaceutical companies, new study shows

Published on 02/01/20 at 09:49am

The FDA’s Risk Evaluation and Mitigation Strategy (REMS), which began in 2012, failed to successfully police the companies creating opioids like Oxycontin, a new study shows.

On Monday, Jama Internal Medicine published a report based on a review of more than 9,700 pages of FDA documents pertaining to REMS.

REMS was part of the FDA’s strategy to crack down on inappropriate prescribing and misuse of drugs that have fuelled the opioid crisis. The agency mandated that drug makers offer education on safe prescribing, and that they create medication guides informing the patients of the risks.

The Jama Internal Medicine study found that “more than 5 years after implementation, the FDA was unable to assess whether these outcomes were achieved.” The companies involved did not gather the right kind of data to allow a thorough assessment, and these deficiencies in REMS were never addressed by the FDA.

An editorial written by retired FDA senior executive William K. Hubbard accompanied the report, in which he criticises the FDA’s limited scope in its use of REMS.

“The FDA has tools that could mitigate opioid risks more effectively if the agency would be more assertive in using its power to control opioid prescribing, manufacturing, and distribution,” Hubbard wrote, adding “instead of bold, effective action, the FDA has implemented the Risk Evaluation and Mitigation Strategy programs that do not even meet the limited criteria set out by the FDA.”

Hubbard also suggested how the FDA could best tackle the opioid crisis, writing: “Restricting opioid distribution would be a major decision for the FDA, but it is also likely to be the most effective policy for reducing the harm of opioids. It is time the federal government got serious about regulating opioids.”

Other critics not involved in the report gave their verdict on REMS. Dr Andrew Kolodny, the co-Director of opioid policy research at the Heller School for Social Policy and Management at Brandeis, said the program was “a really good example of the way FDA has failed to regulate opioid manufacturers. If the FDA had really been doing its job properly, I don’t believe we’d have an opioid crisis today.”

The FDA has responded to the study saying that “the opioid crisis continues to be one of the FDA’s top public health priorities”.

Overdoses from opioids have passed car crashes and gun violence to become the leading cause of death for Americans under 55, and the epidemic has killed more people than H.I.V. at the peak of that disease.

Nearly 400,000 people have died overall, and it has put a massive strain on local services. The total economic cost of the crisis could range from $50 billion to over $1 trillion.

Conor Kavanagh

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