Comments on: It’s A Crime: FDA Fails To Debar Criminals

By: Justice in Michigan

Justice in Michigan — Tue, 12 Feb 2008 23:22:55 +0000

Tom - Right. That is why debarment applies only to generic companies as companies, so no one would be prevented from access to a needed med.. In my own post, I was referring to the whole range of sanctions (significant fines, etc.) through which FDA _could_ hold a company accountable - those are the scenarios that preemption defenders evoke that virtually never happen. The wider context was what else may be involved with “Republicans getting tough on enforcement against drug companies” (which is how the headline would read).

As far as debarment against generic companies, we would be talking about some version of the generic drug scandal of the 80s - conspiracy and cover-up planned across a company’s management (not a few “bad apples”), the systematic use of bribery, false reporting, etc across those levels, and so on.

By: Tom

Tom — Tue, 12 Feb 2008 19:56:17 +0000

Logistically speaking, I’m curious how you would “kick a drug company out” of the drug industry. Admittedly, I haven’t had time to read the report and probably missed the legal explanation. But in the absence of extraordinary circumstances, if there’s proven criminal activity, why not focus on the individuals responsible instead of an entire organization? Does it make sense to shut down a company, cut off patients from their medicines, toss thousands of uninvolved workers into the streets, and burn the shareholders? Reminds me of my fourth grade gym teacher. If one kid broke the rules, the whole class spent the next hour doing push-ups and squat-thrusts.

By: Justice in Michigan

Justice in Michigan — Tue, 12 Feb 2008 19:37:01 +0000

This is fascinating in a hundred ways. Barton, like Mike Ferguson, has been one of the top recipients of pharma money over the years. So why has it become so “popular” recently for Republicans to chastise FDA for non-enforcement?

Here is my theory. One of the arguments of the pro-preemption crowd is that, even without civil liability, companies and indidivudals will still be held accountable by FDA’s Office of Criminal Investigation (OCI) and Justice Dept. But the reality is - for anyone who’s looked into this - is that such enforcement virtually never happens, and - when it does - it is usually tickles on the wrist. Every pro-preemption brief makes a melodramatic much of what the FDA “can do” to non-compliant companies. What those briefs do not say, however, is that FDA almost never does those things.

Given those facts, FDA preemption has even less claim as rational policy than otherwise. The full escape from accountability that it would provide becomes starkly obvious. Yet most of these Republicans, at least in the past, have strongly supported preempiton.

The absence of FDA enforcement becomes a very “inconvenient truth” in that context. So perhaps that explains some of what we’re now seeing, as much as I would prefer to view it as conversion experiences or something in the water cooler.

By: Matt

Matt — Tue, 12 Feb 2008 19:31:55 +0000

The bottom line here is a bunch of politicians identified a problem: expect no solutions…

Of course the FDA has been letting things slide - they’re funded in part by Big Pharma.

By: Jack2

Jack2 — Tue, 12 Feb 2008 19:12:49 +0000

I love it when republicans, who stopped increasing FDA funding (and in inflation adjusted dollars decreased FDA funding) then criticize the FDA for not being able to meet all of its obligations.