Interesting omnibus piece from by Warren Ross of Medical Marketing & Media on the various slings and arrows being tossed at the worlds premier medical regulatory agency.
Here’s the first paragraph:
The FDA seems to be under fire from all sides these days, with everyone from drug industry pooh bahs to would-be watchdogs nipping at its heels. The agency, some charge, is going slow on approvals due to a risk-averse culture deepened through the experience of Vioxx and other product safety crises. Resignations are up, morale is down and the put-upon bureaucrats are laying low, the story goes. Others complain that reviewers are subject to political and corporate pressure through PDUFA and a nefarious web of relationships.
And here’s a link to the complete article:
http://www.mmm-online.com/Whats-Up-with-the-FDA/article/104861/
Here’s what I had to say about the David Grahmatization of the whistleblower culture:
Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not “weep and whine and try to get decisions made that are based on politics rather than on science.†Whistleblowers, he acknowledges, at least deserve “grudging respect†for letting it be known who they are, “but what is truly damaging are the silent leakers†who try to force political pressure on FDA decisions. “The motive may be either to get drugs approved or not approved—it cuts both ways.â€
As Jimmy Durante said, “I’m surrounded by assassins.â€
Here’s the first paragraph:
The FDA seems to be under fire from all sides these days, with everyone from drug industry pooh bahs to would-be watchdogs nipping at its heels. The agency, some charge, is going slow on approvals due to a risk-averse culture deepened through the experience of Vioxx and other product safety crises. Resignations are up, morale is down and the put-upon bureaucrats are laying low, the story goes. Others complain that reviewers are subject to political and corporate pressure through PDUFA and a nefarious web of relationships.
And here’s a link to the complete article:
http://www.mmm-online.com/Whats-Up-with-the-FDA/article/104861/
Here’s what I had to say about the David Grahmatization of the whistleblower culture:
Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not “weep and whine and try to get decisions made that are based on politics rather than on science.†Whistleblowers, he acknowledges, at least deserve “grudging respect†for letting it be known who they are, “but what is truly damaging are the silent leakers†who try to force political pressure on FDA decisions. “The motive may be either to get drugs approved or not approved—it cuts both ways.â€
As Jimmy Durante said, “I’m surrounded by assassins.â€
