DEC 12, 2022 2:00 PM PST

Accelerated Removal of the Previous Approval

WRITTEN BY: Amielle Moreno

Image Credit The U.S. Food and Drug Administration, via Creative Commons license CC BY 2.0, no alterations made

The FDA’s accelerated approval process had attracted criticism from researchers, FDA advisory committee members, and now congress. It was originally designed in 1992 to fast tract treatments for life-saving medications or therapeutics for serious diseases. However, a lack of oversight by the FDA has led to concerns that many drugs on the market are both expensive and unproven. Now it remains unclear if the solution is in the hands of congressional lawmakers or has been in the purview of the FDA the whole time.

One of the more outrageous bloopers in this regulatory process with the 2021 debacle concerning the drug Aducannumab or Aduhelm. A product of the pharmaceutical company Biogen, Aducannumab was purported to slow down the progress of Alzheimer-related dementia. It’s an understatement to say that this the first new drug for Alzheimer’s Disease in 18 years was highly anticipated.

But wish as you might, just because the public and pharmaceutical companies making $56,000 off of each patient a year want their drug to work, doesn’t make it happen.

The director of the FDA FDA Center for Drug Evaluation and Research director Dr. Patrizia Cavazzoni the FDA believed there was “substantial evidence” Aduhelm was therapeutic. This was despite no clinical evidence of daily task improvement.

The only argument for accelerated approval was some post-hoc analysis of two Phase III control trials which ended due to futility. Three of the FDA review panel members for this drug resigned after the green light. Even though it failed to meet the criteria for clinical approval Aducannumab was pushed forward with an FDA request for further studies.

In a recent show of inefficiency, the FDA might finally withdraw its approval of an injectable drug for premature birth prevention. Pushback from the manufacturer of Makena, Covis Pharma, had successfully delayed the process. The FDA had been trying to pull the drug since a lackluster international study in 2019. But bureaucratic backlog was blamed for the delay in removing Makena from the market.

Makena spent over a decade in the marketplace with little to no clinical validity. A final decision on Makena by the FDA Commissioner is still needed.

It appears the FDA increased the rate of their approval withdraws in 2021, perhaps to address concerns. The key to accelerated approval was supposed to be a drug demonstrating validity at strong surrogate endpoints and following through to real endpoints later. At the end of 2021, Health and Human Services found of the 278 approved accelerated drug applications, 104 have “incomplete confirmatory trials.” These include drugs that Medicare and Medicaid have spent $18 billion on purchasing from 2018 to 2021.

The hope now is that a Congressional bill will empower the FDA to tighten accelerated approval requirements and stop its exploitation. Confirmation studies might need to be in progress before accelerated approval is granted. It might be too soon to see if this pressure will push the FDA to demand the reforms necessary for accelerated removal. Though some experts are of the opinion that the FDA’s rules are already quite flexible, and they already possess the power these reforms are purported to provide.

Sources: AP News (1) (2), Fortune, Science (1) (2), HHS, FDA (1) (2) (3), The BMJ

About the Author
Doctorate (PhD)
Amielle Moreno earned her doctorate in neuroscience from Emory University and has dedicated her career to science communication, news coverage, and academic writing/editing. She is a published researcher who has branched out to author articles for various science websites. She recently published an original research article detailing her findings on how sensory areas of the brain respond to social sound. When she's not writing or editing, you can find her spinning the latest neuroscience news into comedy gold, hosting her podcast "Miss Behavior Journal Club." This fortnightly humorous podcast features the latest in behavioral research. Her goal in life is to defend and discover scientific truths.
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