Former FDA Commissioner questions integrity of FDA & Big Pharma

There have been numerous debates over the years involving Big Pharma’s collaborative role with the U.S. government to potentially regulate the vaping industry out of existence.  But are these merely conspiracy theories, or are these stories based in cold, hard facts?

Believe it or not, many Americans might mistakenly assume that the U.S. Food and Drug Administration (FDA) is funded 100% by the federal government.  The truth is far more devious.

For example, many vapers might be surprised to learn that pharmaceutical companies have been paying the FDA millions of dollars in “annual fees” since the 1990s.  When companies began to complain about excessively long approval times on new medications, the U.S. Government stepped in and essentially said, “Okay!  You want faster approval times?  Then you’re going to have to pay for it.”

And, in an instant, the FDA immediately became at least partially funded by the very drug companies that they were granted the federal authority to police and regulate.  It’s the perfect example of the fox guarding the hen house.

Former FDA Commissioner Dr. Herbert Ley’s famous quote

After three long years of running the FDA in the late 1960s, former commissioner Herbert Ley resigned in utter frustration.  The San Francisco Chronicle immediately interviewed him and asked why he quit, to which he replied with the following quote.

“The FDA protects the big drug companies, and is subsequently rewarded, and using the government’s police powers, they attack those who threaten the big drug companies.  People think that the FDA is protecting them.  It isn’t.  What the FDA is doing and what the public thinks it is doing are as different as day and night.”

That was nearly 70 years ago, and things haven’t changed much since.  In a Wall Street Journal article of 2006, reporter Anna Wilde-Mathews mirrored Dr. Ley’s disapproval of the FDA, and went a few steps further.

“Regulators usually don’t negotiate their budgets with the industries they oversee... For most of its history, the FDA was funded entirely by Congress. But in the early 1990s, companies unhappy with the pace of drug approvals agreed to pay the FDA millions of dollars in annual fees to help speed its performance. Because the industry and the agency renegotiate every five years over the size of fees - and what they can be used for - drug makers can have considerable input, into which programs receive funding.”
“Each time the arrangement has been renewed, the FDA has gained new funding. In return, industry has wrung concessions. In the 1997 deal, the review time for a standard application dropped from 12 months to 10 months. In 2002, the FDA agreed to a number of changes, including a new deadline for how fast the agency would respond to companies’ requests for meetings about their drug applications.”

Herein lies the problem.  The U.S. government apparently sees no conflict of interest in the incestuous collaboration between the FDA and Big Pharma.  And when well-intentioned FDA scientists attempt to correct the national dialogue surrounding an issue as controversial as vaping by attempting to publish supportive scientific research, they are often told to keep quiet or worse.  Far too often, they are instructed to either change their scientific conclusions or be fired.  Can vaping survive in this battle of good vs. evil?  Only time will tell.


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