Last August I commented on the Lou Dobbs program that it was unlikely that Congress would take FDA reform seriously “until there were dead bodies.â€
Unfortunately, I was right.
On Friday, in the shadows of tainted Heparin, the Senate passed a budget resolution to give the F.D.A. an additional $375 million, a 20 percent increase over this year.
Some representative quotes on this issue from an article by Gardiner Harris in today’s edition of the New York Times:
“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,†Senator Edward M. Kennedy, Democrat of Massachusetts.
“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,†said Representative Henry A. Waxman, Democrat of California.
And, of course, everyone’s favorite FDA expert, Representative Rosa DeLauro, Democrat of Connecticut, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.â€
Some top agency officials are simply “incompetent,†she added, and real change can occur only with a new administration.
Really, a new administration? Note to Representative DeLauro – the head of every center at the FDA is a career government employee. At the FDA, an agency of roughly 10,000, there are fewer than 10 “political†appointees. Does Ms. DeLauro, the chair of the House appropriations subcommittee with authority over the agency, believe that Dr. Janet Woodcock is “incompetent?†What about CBER’s Dr. Jesse Goodman – widely considered one of the finest scientists in government?
And then, of course, there’s the usual ranting from our favorite Sheep in Wolfe’s Clothing.
Here’s a link to the complete article:
http://www.nytimes.com/2008/03/17/health/policy/17fda.html?scp=2&sq=gardiner+harris&st=nyt
Alas, the title of the article says it all –“Tainted Drugs Put Focus on the F.D.A.â€
And it isn’t even a done deal.
Unfortunately, I was right.
On Friday, in the shadows of tainted Heparin, the Senate passed a budget resolution to give the F.D.A. an additional $375 million, a 20 percent increase over this year.
Some representative quotes on this issue from an article by Gardiner Harris in today’s edition of the New York Times:
“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,†Senator Edward M. Kennedy, Democrat of Massachusetts.
“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,†said Representative Henry A. Waxman, Democrat of California.
And, of course, everyone’s favorite FDA expert, Representative Rosa DeLauro, Democrat of Connecticut, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.â€
Some top agency officials are simply “incompetent,†she added, and real change can occur only with a new administration.
Really, a new administration? Note to Representative DeLauro – the head of every center at the FDA is a career government employee. At the FDA, an agency of roughly 10,000, there are fewer than 10 “political†appointees. Does Ms. DeLauro, the chair of the House appropriations subcommittee with authority over the agency, believe that Dr. Janet Woodcock is “incompetent?†What about CBER’s Dr. Jesse Goodman – widely considered one of the finest scientists in government?
And then, of course, there’s the usual ranting from our favorite Sheep in Wolfe’s Clothing.
Here’s a link to the complete article:
http://www.nytimes.com/2008/03/17/health/policy/17fda.html?scp=2&sq=gardiner+harris&st=nyt
Alas, the title of the article says it all –“Tainted Drugs Put Focus on the F.D.A.â€
And it isn’t even a done deal.