“Open Public Hearings” at FDA Co-Opted by Big Pharma

Conflicts of interest abound when the public weighs in on drug approvals.

On March 27th, 2018 in a nondescript room at the FDA, a woman stood before a panel of FDA advisors and told the heartbreaking story of how her son had died of a fentanyl overdose. She spoke of his struggles with withdrawal symptoms, and how fear of withdrawal kept him from getting adequate treatment. She closed with this statement:

She was one of six speakers at the open public hearing before the FDA Psychopharmacologic Drug Advisory committee. Her travel and accommodations, she noted, were paid for by US Worldmeds, the makers of lofexidine, which was being considered for FDA approval. It was formally approved for treatment of opioid withdrawal a few months later.

What’s going on?

This scene — patients, advocates, drug companies, presenting their comments to an FDA approval panel is repeated every time a new drug is up for consideration. The “open public hearing” portion of the advisory panel meeting typically lasts an hour.

Anyone can petition to speak, and in theory if too many petitions are received, the FDA engages in a lottery. This seems good — the public should have a voice in these decisions.