The head of the Food and Drug Administration recently warned the agency will get much more aggressive with drug makers, potentially forcing companies to pull painkillers off the market.
FDA Commissioner Scott Gottlieb addressed the National Press Club in Washington Friday, arguing the current opioid epidemic requires a much more “intrusive” response from federal regulators than previously expected. Gottlieb said that over the past decade the government failed to address the looming crisis, despite being aware of mounting problems concerning opioid addiction, reports The Washington Examiner.
The FDA will enact stricter standards for their own product review and approval process, including evaluating if the risks for abuse of the drug outweigh the legal benefits of the product. Popular painkillers previously approved by the FDA can be crushed up for snorting or injection.
“To try to get ahead of it now, I think we need to be willing to take much more dramatic action, be much more potentially intrusive than what we thought we might have to do and what would have been our comfort zone five years ago or 10 years ago,” Gottlieb said Friday, according to The Washington Examiner.
For the first time in history, the FDA ordered a drug maker to pull a medication off the market June 8 due to widespread reports of abuse. Endo Pharmaceuticals announced the decision to comply with the FDA request July 6 following an internal review of the drug.
The unprecedented move came in the wake of reports patients were crushing up the pills to inject. Representatives for Endo said they stand by the safety profile of Opana ER and believe the benefits outweigh the risks. They say the pill is safe and effective when administered properly, but will comply and work with the FDA on the issue.
The move reflects the FDA’s new focus on not just the prescribed risks of painkillers, but the risks posed by illegal abuse of the pills.
President Donald Trump declared the opioid epidemic a “public health emergency” Oct. 26, giving states hit hard by opioid addiction flexibility on how they direct federal resources to combat rising drug deaths.
Data from the National Institute on Drug Abuse released Sept. 7 predicts that the addiction epidemic in America will continue to deteriorate, pushing drug deaths to an estimated 71,600 in 2017. If the estimates prove accurate, 2017 will be the second year in a row that drug deaths surpass U.S. casualties from the Vietnam War.
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