FDA approves controversial drug despite warnings


The Food and Drug Administration (FDA) approved a highly controversial opioid. The opioid in question is a highly potent, and dangerous drug that has more risks than benefits in health-care. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. However, despite the warnings, the opioid has been approved by the FDA for use in health-care.

The decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl. According to critics, the decision will only fuel the United States’ drug crisis even further rather than improving it. The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future. Commissioner Scott Gottlieb wrote:

“We need to address the question that I believe underlies the criticism raised in advance of this approval,”
“To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider . . . the epidemic of opioid misuse and abuse that’s gripping our nation?”

Critics and public officials alike have commented on how the FDA should change its approach when evaluating opioid applications. Clearly, something is in the wrong as the United States drug crisis gets worse with every passing day. Although the FDA has pledged to curb the on-going crisis, the statement made by the commissioner gives a clear insight as to how the agency will be moving forward with its drug evaluations.

Image: healthline
Image: Healthline

Gottlieb is committed to bringing a plan the FDA’s Opioid Policy Steering Committee and maybe even the Congress. The plan would presumably help the agency consider a narcotic’s benefit to public health. It’ll also help them evaluate the risk of a drug being misused or abused and also the unique benefits of the drug to the people in pain. The agency would look into all of these factors before making a decision on approving an opioid or not. He wrote:

“In this way, [drug companies] would know up front where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness.” 

Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said. The drug is 30-microgram in pill form. It’s a powerful opioid that’s used typically after surgeries in emergency rooms. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies.

However, despite the FDA’s best wishes and intentions, a lot of people have come forward with criticism. Sidney Wolfe, the founder of Public Citizen’s Health Research Group, said in a statement:

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,”
“It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.

However, the FDA claims to have a strict control on the use of drugs inside a medical facility. Therefore, if there is any diversion, then the risk is among the medical personnel themselves, no one else. However, the point is that there is still a great risk.

The rate of overdose deaths among healthcare workers is quite high, which is why the whole situation is concerning. It remains to be seen how this plays out. If the critics are indeed right, then the FDA will have no choice but to go back on its decision to approve the dangerous opioid. However, the agency should take measures and identify all the risks and benefits involved before making such approvals.

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Olivia Parker

Parker holds a masters in computer science, but her love for movies and everything that goes into making them forced her to divert her strength to entertainment world. She has been interviewed a number of celebrities in her previous jobs.


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