FDA Stakeholders Break their Silence

The Reagan-Udall assessment of the FDA has made some truth come to light about the broken PMTA process.  

In July the FDA commissioned an independent review of the food and tobacco programs after widespread criticism of the FDA’s handling of the baby food shortage and PMTA process. FDA Commissioner Robert Califf chose the Reagan-Udall Foundation to perform this task. This non-profit group was established in September of 2007 by Congress to support the FDA and their work.

Part of the process of this evaluation is to solicit feedback from stakeholders. Comments posted during this period have shed some light on the internal issues within the FDA and are making a lot of vapers say “I told you so.”

Some comments even go as far as to question the FDA’s leadership, painting them as bullies with biased opinions not based on science but rather based on political agendas.

 One commenter quoted here is directly criticizing the ability to exercise “best scientific practices” 

“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion)”

Another commenter quoted here paints a very grim picture of what staff is put through on a daily basis. 

“Staff are burned out and constantly told to do more in less time and blamed for not meeting insane deadlines,” the commenter wrote. “In cases where reviews are finished and scientific decisions are made they are also overruled by political agendas and pushed to change decisions.”

So if the FDA is ignoring the science behind these applications and pushing a political agenda do they really have any business being in charge of these decisions?

Clearly this approach and these decisions are not appropriate for public health.  Vapers in the US deserve to know the truth about this life saving technology. The FDA, which is put in place to protect public health, is creating chaos, spreading misinformation and losing the trust of the American people. 

The vapor community is so thankful to these brave staffers that have come forward to speak the truth. I know we are all looking forward to seeing what comes of this discovery and hoping it makes a difference for vapers and smokers.

To read all the comments, please visit the Reagan-Udall Foundation’s stakeholder portal.


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