The Debate Over the Approval of New Opioid Drug

Introduction

The Food and Administration agency is set to approve a potent opioid for the market despite the objections from various parties. The FDA aims to approve a new form of an opioid-based painkiller called Dsuvia for usage in hospitals and emergency rooms. On October 12, 2018, an advisory committee in FDA recommended the approval of the drug in a ten to three vote (Bernstein, 2018). The committee is usually composed of various experts on various medical devices and drugs. The chairman of the committee has opposed its approval after reviewing it. The chairman missed the crucial meeting and has publicly urged the administration to reject the drug because of the epidemic of overdoses posed by opioid in the United States. The FDA usually follows the guidance of these committees to make their decisions. The approval would allow a company in California to commercially produce the pill.

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Brown Raeford who heads the FDA's analgesic and anesthetic drug products advisory committee made his opposition public regarding approval of the drug. Brown said that a potent painkiller is not required in medical centers (Bernstein, 2018). He raised his fears that the drug could be diverted to the streets as the effectiveness and safety of the new drug have yet to be fully determined. Brown also said that the drug was up for approval at a time when they were trying to get issues of misuse and abuse of opioid under control in the United States. A study by the Centre for Disease Control (CDC) shows that more than fifty thousand people died of opioid overdoses in 2017 (Bernstein, 2018). In the past, millions of doses of prescription painkillers have been diverted from the pharmaceutical supply to illegal users. Also over the past fifteen years, the United States has faced among its worst drug crisis. The illegal users or suppliers obtain them from relatives or rogue pharmacists and doctors. Pamela Palmer, the chief medical officer at AcelRx, said that the drug is short-acting and pre-measured and would cut the error rate made by some physicians and save lives (Bernstein, 2018). She said that the drug would reduce pain rapidly as it is placed under the tongue then enters the bloodstream quickly (Bernstein, 2018). The pain relief then lasts for about three hours.

Conclusion

This issue presents an ethical dilemma and could eventually become a legal issue if the opponents decide to push the approval to court. On the one hand, the pill has the potential for illicit use creating a drug problem for the public, and on the other, the drug is an excellent painkiller for use after surgery and even the United States army is interested in the tablet for battlefield pain relief they have even funded some of the research.

Reference

Bernstein, L. (2018, October 25). Health Science: FDA set to approve potent opioid for market despite adviser's objections. The Washington Post. Retrieved from https://www.washingtonpost.com/national/health-science/fda-set-to-approve-potent-opioid-for-market-despise-advisers-objections/2018/10/25/8e3619d4-d7c2-11e8-83a2-d1c3da28d6b6_story.html?utm_term=.a29b7684d58d