The Opioid Strategy That Couldn’t be Approved by the FDA, Actually Worked

The United States Food and Drug Administration failed to show a key program for addressing misuse and abuse of opioid and this actually paid off as showed by study outcomes. A study was conducted on the risk evaluation and mitigation strategy program by the U.S. FDA. The authors reviewed the FDA documents including more than 9,700 words, referring to the agency’s strategy which was launched in 2012 to address risks linked with long-acting and extended-release opioids.

The complete study findings are published in the journal “JAMA Internal Medicine”

Although these drugs can be clinically helpful for the selected patients, they have been oversupplied and nonmedically commonly used. This accounts for the disproportionate ratio of fatal overdoses.

The agency requisitioned the drugmakers to offer education on safe prescription and to create medication guides to inform patients about risks, as a part of the FDA’s recent strategy to fix the inappropriate prescribing and the misuse of drugs. The FDA required reports on patient safety and the prescriber’s behavior by the companies. More than 5 years after the proper implementation the FDA was still unable to assess the outcomes as concluded by the new study.

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Previous analyses had been funded by different drug companies and the 2016 advisory committee of the FDA noted all the methodological concerns regarding the studies. The agency lacks comprehensive data for risk evaluation and the mitigation strategies to improve drug safety as concluded by the 2013 report of an inspector.

The authors said that the FDA could do more efforts to check the program’s effectiveness. The agency was also being criticized for not taking more aggressive actions.

One of the senior executives of FDA William K. Hubbard said in an editorial that has accompanied the study that the FDA has those tools that could mitigate risks more effectively if the agency could be decisive and confident in using the power for controlling opioid prescribing.

Instead of effective and bold action, the FDA has initiated the Risk Evaluation and the mitigation strategy programs which don’t even fulfill the defined criteria set by the FDA. According to Hubbard, the FDA could have taken a major decision to put restrictions on opioid distribution and it will be the most effective strategy to reduce the harms and risks of opioids.

In the recently published papers, the FDA highlighted the recent statements of the agency officials that the opioid crisis is continuously one of the top health priorities of the FDA and also pointed to the other actions taken by the FDA for mitigating the opioid crisis.

For Instance, the agency has also worked for promoting the development of the non-addictive painkiller, has taken actions against the illegal sales and importation of opioid and designed policy which support treatments for patients with opioid use disorder.

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The FDA has updated its strategy program to broaden its aims of educating providers and patients about the risks of prescription opioids and for better assessment of the effectiveness of the program.

According to the U.S. Centers for Disease Control and Prevention, the rates of opioid prescriptions have been decreased due to different factors. But in some countries, the rates are still higher than the average. The updated guidelines by the agency played a major role in the declined rate. Some other factors including changes in the reimbursement controls, the use of drug databases, increased awareness and new laws and regulations played a significant role.