Leavitt Tells Congress FDA Needs More Authority
3 CommentsBy Ed Silverman // February 22nd, 2008 // 4:00 pm
In a letter to Congress, he says the agency lacks “explicit jurisdiction” in other countries hampers its ability to inspect facilities and investigate manufacturers that violate US laws. And Leavitt called for legislation to give the FDA jurisdiction abroad. The letter was sent to Republicans on the House Committee on Energy and Commerce, Bloomberg News reports.
“Current law has not kept up to date with modern technology and global marketing realities,” Leavitt wrote in his letter, which was sent to Republicans Joe Barton of Texas and John Shimkus of Illinois. “An amendment would better enable FDA to address criminal conduct that occurs entirely outside of the United States and threatens the health and safety of consumers within the United States.”
The FDA is under fire after a series of episodes in which various meds, pet food, seafood and toys imported from China were found to be tainted with harmful chemicals in the past year. Earlier this week, FDA officials disclosed that they failed to inspect a Chinese plant that makes an ingredient in a blood thinner that has been tied to life-threatening side effects because of a mix-up in paperwork.
The FDA conducts annual inspections of about 7 percent of overseas drugmakers that ship to the US, a pattern suggesting the FDA would take 13 years to visit them all, according to a report by the Government Accountability Office, the investigative arm of Congress, Bloomberg notes.
A White House task force headed by Leavitt called for a new approach to protecting against tainted imports of food and other products in September. The government needs to better identify which imports are most likely to be contaminated and require the most intense review, according to the panel.
The FDA wants to station employees in five regions of the world to improve the safety of exports of food and drugs, agency Commissioner Andrew von Eschenbach said on Jan. 24.
Dr. No
This is a ton of BS be Leavitt. When I was in cGMP manufacturing in the mid 90s the US FDA would inspect foreign facilities twice a year, at least that was the policy and I saw them show up. Further, then the FDA would require that all production is up to cGMP and documented up the wazoo even IF the “manufacturing realities” are as they are. The FDA has the power to investigate internationally, they just don’t have the people for it or the time or both.
Now, there are more facilities, and less (educated) inspectors and the whole system goes down and they don’t follow their own policies. Mind that the Baxter blow up is a typical federal SNAFU in that they can’t even find the right address. What good is more power to them if they catch the wrong guy, can’t read Chinese, are to dumb to follow their own policies, don’t even show up??
Matt
It is just like Congress to analyze a problem and misdiagnose a solution. Politicians are great at pointing out problems but terrible at solving them. Solutions in politics equate to money, but never accountability or responsibility.
Just what the FDA needs - more power. Haven’t they proven they can’t even take reponsibility for the power that has been given them?
Justice in Michigan
Disagree. Some of FDA’s problems do have to do with cash-starvation. This was particularly true after PDUFA, when more of CDER’s basic budget had to be shifted over to meet PDUFDA contributions - all (and still mostly) on the OND side. Thus a good many post-marketing surveillance programs simply couldn’t be paid for. This is part of the reason the FDA had fourth-tier computers and still relies on Medwatch. Even Janet Woodcock, not known to be a whiner, described CDER as having a “sweatshop environment.” That’s part of why many of the people who can leave, do leave. And some of these are the best.
The entire FDA annual budget - of which about 1/3 is CDER - is now about $2.7 billion. NASA gets about five times that much. EPA six times. Homeland security, 17 times. It’s a bit over what Vioxx made in a good year. It’s a quarter of what Lipitor makes in a single year. For the entire agency. If we’re talking CDER, Lipitor makes twelve times the entire CDER budget for a single year.
Money is a big issue. It’s also part of why FDA does not pursue potential criminal investigations or pursue them to their conclusion. This is a decades-long pattern. Congress grants a few new powers, and starves the agency to death.
If you want to be outraged, aim it at some of FDA senior management. Aim it at the people who reject negative NDA’s or try to get people to rewrite them. Blame it on the shmoozers, the wimps, the con-men, and the opportunists. There are definitely some of those in senior positions. And blame it on Congress for making it easy for them to stay there. And blame it on administrations (not only the current one) who have not come up with a competent commissioner in many years.