The controversial Aduhelm, a newly FDA-approved medicine for Alzheimer, is currently being questioned by various medical experts and critics.
Anti-depressant pills named Fluoxetine are shown March 23, 2004 photographed in Miami, Florida. The Food and Drug Administration asked makers of popular antidepressants to add or strengthen suicide-related warnings on their labels as well as the possibility of worsening depression especially at the beginning of treatment or when the doses are increased or decreased.
Related Article: Yelp Now Lets Businesses List Their Vaccination Policy and Indicate if Employees are Vaccinated
Because the Food and Drug Administration quickly approved the new medicine using its Accelerated Approval Program, the U.S. HSS (Department of Health and Human Services) announced that it would investigate the drug.
The government health department confirmed its plan on Wednesday, Aug. 5. The confirmation of the HSS investigation came just two months after FDA approved the use of Aduhelm.
On the other hand, the Department of Health and Human Services explained that their upcoming review would specifically check FDA's accelerated approval pathway, which was used on various controversial medicines, such as the new Aduhelm.
Aduhelm To Be Investigated By HHS
According to Tech Crunch's latest report, the U.S. HHS explained that the Aduhelm approval of FDA is currently creating various concerns. The health department added the Food and Drug Administration is now being questioned because of possible scientific disputes within the agency.
A nurse holds the hands of a person suffering from Alzheimer's disease on September 21, 2009 at Les Fontaines retirement home in Lutterbach , eastern France. Scientists working in seven countries announced last week they had uncovered variants of three genes which play a role in Alzheimer's, a discovery that should throw open many new avenues for tackling this mind-killing disease.
Also Read: Facebook Blocks COVID-19 Misinformation Researchers from NYU, Cuts off Access to Ad Library
These include the allegations of an inappropriately close relationship between the FDA and the industry, the advisory committee's vote against approval, and more.
Because of concerns from various critics and medical experts, the Department of Health and Human Services said that it needs to conduct the investigation as soon as possible to reveal more information about the new Alzheimer's drug.
In other news, other health researchers are focusing on COVID-19. New anti-coronavirus technologies include the new COVID-19 single-domain antibody. On the other hand, experts also released new COVID-19 x-ray images to show the alarming difference between unvaccinated and vaccinated individuals' lungs.
What is FDA's Accelerated Approval Program?
The U.S. Food & Drug Administration website explained that its Accelerated Approval Program allows new drugs to have early approvals. They added that only medicines of severe conditions could have this pathway.
"The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval," added the health department.
For more news updates about the new Aduhelm and other controversial drugs, always keep your tabs open here at TechTimes.
This article is owned by TechTimes
Written by: Griffin Davis
