FDA employees go to work for Pharma

The real problem the FDA commish needs to tackle

Instead of dealing with the revolving door, the FDA commissioner is talking about misinformation on the internet. I suggest the FDA first needs to focus on what appears to be naked corruption in its ranks.

The FDA commissioner is on a crusade against misinformation. He has called it the leading cause of death, later downgrading his statement to the leading cause of ‘preventable’ death. I am sure he will further downgrade his statement to ‘actually, we don’t know, and it is hard to quantify’ when a reporter presses him on it. I personally find it ironic that one would lambast misinformation with a fabricated statistic.

But all this talk of misinformation is distracting from the ongoing failure at the agency. Billy Dunn was the FDA official in charge of neuroscience. Under his watch aduhelm was approved—an unproven Alzheimers drug, which Medicare declined to cover. After the lower regulatory precedent was set, he left FDA.

Congress has since investigated and reached a damning conclusion. The process was “rife with irregularities”.

Now Billy Dunn has joined the board of directors of Prothena, a biotech company.

Prothena makes an anti-amyloid drug in trials that stands to benefit from the lower regulatory precedent Billy Dunn himself established while at FDA.

The chain of events is not uncommon. In our 2016 BMJ paper, we took a set of medical reviewers at the FDA, and showed that the single most common destination post FDA is pharma.

Here is the breakdown.

What is the public to think? FDA employees have repeatedly lowered the regulatory standards for drug products, and then they are paid generously by companies that benefit from those lower standards. If you work at FDA, the best game plan is to find a standard to lower, and then go to work for the person who benefits. I actually know the stories of other reviewers who went to work for the same company whose drug they approved.

Most of these transitions are not investigated by congress, so we don’t know if the quid pro quo is explicit or implicit, but rest assured the deal is well known. Go to work at FDA. Be a good soldier— approve products— and when you want a pay bump join Pharma.

Meanwhile the irony is that the American people pay for this though exploding health care costs. US health care costs won’t be contained with a revolving door approach to FDA. The bar for new products is so low, we are tripping over it.

The FDA commish needs to focus on this ongoing crisis at the agency. Fighting misinformation with misinformation helps no one. Instead, corruption can be fixed.