A reader sent an article from The Pink Sheet (an industry rag focused on Pharma). If you’ve never read industry-specific news publications, you’re really missing out. They’re really facinating and instructive. Sometimes you get early knowledge about industry trends and others, if you’re lucky, that are not so subtle messages to other readers. This is one of the latter($ required, sorry).
The article is entitled “FDA Staffing Problems Extend Beyond Funding Shortfalls; Culture Shift Sought.” I was expecting an article about what changes employees saw as need to change the culture. I was wrong. It’s covering a Summit for Biopharma Execs and the culture shifts that industry wants.
Part 1. “FDA Needs Direct Hiring Authority”. This goes into how there are so many positions open in the FDA but they can’t fill them because HHS took FDA’s ability to hire it’s own staff to make things more consistent and streamlined. Guess how well that worked. So most applicants get better job offers way before they even hear from the agency. The article says about this:
“This is a real opportunity for the pharmaceutical executives to go to [the Office of Management and Budget] and see if they could get direct hiring authority at the agency” Gottleib suggested
“It would be a good test to see just how politically potent this industry is with Bush White House”
Why they don’t just cut the wink and nod and have a itemized homework list at the bottom I don’t know. There’s a more sections on the fact that there are fewer applicants with specialized skills and that the low salaries at the FDA make it hard to keep people. Then comes another good section: “Consensus on Safety a Major Issue”. According to Arnold & Porter Senior Council William Vodra:
FDA operates in “a climate in which every decision can be challenged as being improperly made”
Refering to the fact that now that the reviewers of drugs (MDs and PhDs, mind you), he continues with this complaint:
Power is moving lower and lower in the agency as staff “are not accountable to leadership”
*I totally agree. Where is that iron fist of old? That grand tradition of political interferrence into the science and ethics questions that the reviewers grapple with? Where is the opaque decision making process? We have no use for these new fagled concepts of transparancy. It’s not like the FDA is supposed to work for the public. They are supposed to work only for Pharma! I do not like this turn of things. And lastly, why oh why does FDA even have a press office? They should just have a tape recorder that says “You’re safe, we’re doing a heckuva job, drug companies are the best, no further comment”.
The last paragraphs are “Internal Dissent Undermines Pulic Confidence” and “Whistleblower Protections May Be Expanded” but I think you get the idea already so I’ll stop here.
*The sarcastic paragraph is meant to be read as Paul Frees voicing Meisterburger Burgermeister for full effect.