FDA’s Advisor Accuses the Agency Manipulating the Approval Process of High-Strength Opioid Drug Dsuvia

A senior official in the Food and Drug Administration has accused the agency of compromising safety of American lives by approving high strength Opioid drugs despite the opioid epidemic that plagues the country. The chair of FDA’s advisory committee Dr. Raeford Brown has said in interview with The Guardian, that the FDA has manipulated the approval process to favor big pharmaceutical corporations.

Opioid drugs include prescription pain killers which help in relieving acute pain but the drugs also induce a pleasurable feeling in the brain. The heightened pleasure has made the drugs highly addictive leading to an opioid crisis in the country. Opioid overdose has led to deaths and about 150 people die of opioid overdose every day in the United States. In 2017, 47,000 people died of opioid overdose.

Dr. Brown told the guardian that there is a waging war among FDA about the FDA’s opioid approval policy as some sections of the agency have failed to learn the lessons from the opioid epidemics which has claimed thousands of lives every day over the past twenty years. He accused the agency of putting the interests of narcotics manufacturers first over the public health after the approval of a high strength opioid drug Dsuvia.

Last year, four US senators wrote to the FDA Commissioner Scott Gottlieb urging him to disallow the approval of the powerful, very high strength drug Dsuvia as it is a detriment to public health. The drug which was rejected by an advisory committee in 2017 over public safety concerns was resubmitted to the FDA in 2018 but FDA intentionally excluded the members from the drug safety committee who had earlier rejected the drug from the hearing. The senators raised concerns about the credibility of the approval process as Dr. Brown, a strong critic of the drug was absent at the hearing to attend a professional conference in San Francisco.

The roots of the opioid crisis can be traced back to the early 1990s when pharmaceutical companies assured the medical community that patients won’t become addicted to the opioid drugs, which lead healthcare providers to prescribe the drugs at greater rates. The FDA’s role in the crisis has been far from innocent, bordering criminality, according to some critics. The FDA helped spread the opioid epidemic after the agency approved the first narcotic high strength drug, OxyContin and numerous others in the following years. Some accuse it of behaving more like a business partner of pharmaceuticals companies than as a regulator in charge of public safety.

Dr. Brown told that the credibility of the agency has to be questioned after it overruled the decision of advisory committee of rejecting Zohydro, a drug reportedly ten times powerful than regular painkillers. He added that the agency shares a cozy and friendly relationship with the drug industry. The FDA was recently in the middle of controversy after it was revealed that its senior officials responsible for drug approvals indulge in pay to play scheme where companies pay for attend meetings to draw up approval criteria for prescription narcotics. The blame partly goes to FDA’s Modus operandi as since 75% of the agency’s funding comes from the drug industry. The funding model exposes FDA’s conflict of interest which raises doubts about its role as an independent regulator to drug companies if it gets paid by them.

About the Author

Sabyasachi Ghosh

Sabyasachi Ghosh is an experienced market research analyst and consultant, with over six years of experience in end-to-end project management. He has worked at numerous leadership positions and has a vast experience of compiling high-quality market research reports. Sabyasachi is an authoritative voice in the market research sector, and has been cited in top industry publications. He is a travel junkie, and loves to travel far and wide with his friends.

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