The New FDA Motto: Safety First
13 CommentsBy Ed Silverman // February 26th, 2008 // 6:10 pm
That’s what FDA commish Andy von Eschenbach plans to tell a congressional committee tomorrow. The idea, which is all about bolstering oversight, will create a database listing possible side effects and methods for following up any questions or issues, according to The Wall Street Journal. Part of the plan involves granting new powers to the Office of Surveillance and Epidemiology, which keeps watch over safety issues surrounding available meds. However, the Office of Drug Safety still won’t have final say on label changes or efforts to yank a med.
“What we’re doing is to create an integrated approach…that isn’t going to perpetuate problems of the past but really try to embrace what have to be solutions of the future,” Andy says in his customary bureaucratic speak. “What you’re driving toward is the need to make these decisions in an objective, rational, systematic kind of way that’s open and transparent and that’s based on science and scientific analysis of the data, and to remove it from situations in which the decision may be affected…by somebody has a vested interest just emotionally, and intellectually.”
Ultimately, the FDA is supposed to implement a second phase to the plan, called Safe Use, that will focus on ensuring that drugs are used safely in the real world, the paper adds. But an agency official said there were few details available yet about the plan. Hmm…. Maybe the entire effort should be called Common Sense First.
pg
“The New FDA Motto: Safety First”
Fantastic idea, how come it took them so long to think of it (!)
truthman
pg
“The New FDA Motto: Safety First”
Fantastic idea, how come it took them so long to think of it (!)
Haha..
Maybe when an organization has the arm of pharma shoved so far up it’s backside for so long it begins to affect it’s judgement..
Laurie
What a unique concept! Honesty, full disclosure,no conflicts of interest and accurate scientific evidence. How sad that he just realized now that this IS the job of the FDA!!
Justice in Michigan
I’m taking bets ….
Lisa Van S
I wouldnt bet on Andy,..thats for sure.
Bless The Truth
I don’t believe him! May be when I see, I will reconsider!
Dan
What one says and what one does are two entirely different concepts. Historically and progressively, the FDA has failed the public miserably, with health care in particular. Half of thier funding comes from the pharma industry, so it’s likely the public is not the priority of the FDA anymore, although the Administration was created to protect the citizens. And the FDA’s relationship with pharma has become more visible over the years, from everything from the user fee act to authorizing off label discussions of meds.
Also, I hear the staff at the FDA is not enough to cover all of thier duties, therefore morale is quite low, to the point that the FDA is giving sizable bonuses to present FDA employees if they do not leave the administration.
Lisa Van S
Ed
How about a poll.
Lisa Van S
Hmmm,.. an Independent Office on Drug Safety would be nice. That would have taken care of the problem and Andy wouldnt be babbling so much.
Donna
What’s going on here, did somebody bump the cradle and wake a sleeping baby, funny how everyone with power jump’s when the s— hit’s the fan….safety first….how many year’s late…..toooo funny and how stupid they look….
Donna
yes poll please
Justice in Michigan
Just to ride my usual horse….
With the recent FDA rule changes on labels, and preemption a virtual certainty to be upheld by the Supreme Court, FDA really has no choice but to say they are up to the job, etc.. What is surreal about it is that the half-dozen negative studies of its capacities, etc. won’t just dry up and go away, much as they might wish. And FDAAA was so diluted, it won’t help a great deal.
Thus, much as we wish that the path we’re on makes sense (as many, including me, found a way to believe what we knew better as we approached the Iraq war), there is essentially no reason at all to believe these assurances. And there are very robust reasons not to believe them.
Tom
The basis of this program (and another one called “Safe Use”) probably lies in approval of the recent FDA Amendments Act, which grants significant new funds and head count to overhaul the Office of Drug Surveillance and Epidemiology. The Act was approved unanimously in the Senate and 405-7 in the House last fall (Dems and Reps in agreement, imagine that!). It underwrites access to external medical databases and other technical resources for safety evaluations, and grants new authority to initiate safety trials, labeling changes, and risk mitigation strategies. This is a huge deal for the agency - maybe the first time in years that it has received a FUNDED rather than an UNFUNDED mandate to add responsibilities and oversight activities. The system will probably not meet growing expectations that all rare side effects must be identified in pre-approval clinical trials, but it should help to catch them earlier and put communications on emerging safety data into better perspective. I imagine AVonE is wrapping all of this into something with broader PR appeal than the uninspiring name Congress gave the Act - thus “Safety First” and “Safe Use”.