The FDA is acting to counter the negative publicity generated by recent events surrounding antidepressants, vaccines (got the flu yet?) and
painkillers (like vioxx). Today the FDA announced it is creating an independent Drug Safety Oversight Board (DSB). The board will be comprised of
current FDA personnel as well as personnel from other government departments like Health and Human Services (DHH) and Veteran's Affairs. All members
of the new DSB will be appointed by Acting Commissioner Dr. Lester M. Crawford.
The U.S. Food and Drug Administration said on Tuesday it was creating an independent drug safety board after the agency's monitoring of drugs
already in the marketplace was criticized amid the withdrawal of arthritis drug Vioxx.
The FDA already has an Office of Drug Safety but consumer groups and some lawmakers have said it lacks sufficient independence and resources.
The new board will include representatives from the FDA and medical oversight experts from other agencies like the Veterans Administration, an
administration official said, and will consult with patient and consumer groups.
The Bush administration proposed a 24 percent increase in funding for FDA's Office of Drug Safety in its recent 2006 budget proposal, including 25
Please visit the link provided for the complete story.
So this is a positive move right?
Acting Commissioner Crawford is Bush’s nominee for FDA Commissioner and was Deputy Commissioner when all of those stories about anti-depressants,
vaccine concerns and painkillers surfaced.
In my opinion
these raise concerns about how the FDA is run. Not to mention all the conspiracy theories about how the FDA and the Bush
administration are in the pocket of Big Pharma.
Crawford is the guy who stated that drugs from Canada where dangerous (What You Can't Say About
He’s also the guy who suggested that whistleblower Dr. David J. Graham consider a new assignment. Seems he didn’t like what Dr. Graham had to say
about the agency's approach to drug safety in Senate Hearings. (FDA Scientist Says He Faces
He’s been a stark defender of the Agency in the face of the vaccine debacle, claiming that nothing is wrong at the FDA
(U.S. Knew Last Year of Flu Vaccine Plant's Woes
And the neocons want him as FDA Commissioner.
According to the Reuters report a government run agency (i.e. a public agency) is apparently short on resources with a lack of independence. Can’t
blame the government for that right?
Funny how they found enough money for a 24% budget increase that includes the hiring of 25 new people to coincide with the creation of a new
It will still be a government body run from within
the Agency. So one has to ask… independent from what?
I wonder if the current FDA personnel to be chosen by Crawford will include “troublemakers” like Dr. Graham and what new hires from DHH he will
Nice way to circumvent those annoying whistleblowers no?
Oh and the actual FDA announcement
makes no mention of how this will improve the drug
APPROVAL process. Just some nice words about, increasing independence and transparency to improve Drug Safety MONITORING (i.e. after market approval)
including plans for a nice new Drug Watch Web page for them to publish “independent” information.
Still think it's a positive move?
[edit on 2/15/2005 by Gools]
[edit on 15-2-2005 by Banshee]