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An Interesting Surprise in FDA’s New Policy Guidance Doc on Buprenorphine Treatment for Opioid Use Disorder (OUD)

Buried inside are surprising assertions of fact none of the money players will admit out loud

Heather S. Wargo
5 min readMar 22, 2019


It was with trepidation that I opened the email link to the document from FDA titled FDA in Brief: FDA finalizes new policy to encourage widespread innovation and development of new buprenorphine treatments for opioid use disorder.

Every time a document emerges from the Fed re: The Opioid Epidemic…

…I am disappointed and angry.

Painful disease patients lose rights, are further marginalized — patients are restricted even more and misunderstood even worse than previously.

Always a lose/lose since the Benevolent Gov decided to “do something” about non patients, recreational users- people stealing prescribed opioid medications.

“Non medical use of opioid medication”.

How throttling prescriptions to legitimate patients who need them will stop recreational users who do not care about laws or following them is beyond logical comprehension.

However, that is the solution thought up by our esteemed elected officials.

Congress and state assemblies certainly have no issue legislating beyond their pay grades, in fact, practicing medicine without a license.

Reading the email, I was shocked, SHOCKED! to read the quoted message from departing FDA Director Scott Gottlieb.

I reread it three times to make sure I wasn’t misunderstanding what I was seeing!

He says:

It’s part of the FDA’s public health mandate to promote appropriate use of therapies.

Misunderstanding around these products, even among some in the medical and addiction fields, enables stigma to attach to their use.

These views can serve to keep patients who are seeking treatment from reaching their…



Heather S. Wargo

Italian American Writer in PA wilds. Gen X survivor attempting to climb shrinking narrow. Despite all my rage, still just a rat in a cage.