Dear CMPI Friends,

Today on CNBC’s “Power Lunch”, co-founder and President of CMPI, Peter Pitts, will discuss the issue of preemption. The segment will air at 12:45 PM.

Please tune in for this cannot miss interview!

Below are two recent blogs from Peter Pitts and CMPI’s Vice-President Robert Goldberg on the issue of pre-emption:

Fear of Five
By Peter Pitts
October 30, 2008

The anti-preemption crowd is running scared.

Their latest attempt to muddy the waters of FDA labeling authority comes in the form of internal FDA documents that, Waxman staffers claim, show career officials oppose agency regulations that weaken consumers' ability to sue drug makers.

Here’s one quote they’re using to make the case for “the FDA doesn’t believe in preemption" ...

"Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," the report quoted Dr. John Jenkins, who oversees FDA's new drug reviews, as saying. "We know that such an assumption is false."

http://www.drugwonks.com/blog_post/show/6422

Waxman Preempts the Facts by Redacting the Record
By Robert M. Goldberg
October 30, 2008

If you read the article that Kevin Freking wrote for the AP, based on a report produced by Henry Waxman entitled.

And you would have missed this penultimate statement from the flurry of memos (I read them all): 

"I agree with the idea that we should preempt state requirements for labeling of drugs. It makes no sense for us not to have a federal system for labeling approved drugs that is based on a careful scientific review of the available data and a consistent application of labeling policies across products. I see this as a legitimate FDA area of involvement given our statutory authority over the drug approval process."

That was John Jenkins. And not one of the memos take issue with the position that FDA should preempt state requirements, especially those dredged up from tort proceedings. 

The issue was and is about whether the FDA had enough control over labeling and safety monitoring in a coordinated fashion to produce the appropriate balance between risk and benefit, patient rights and company behavior. The goal is to encourage companies to do more to make sure labeling reflects the most up to date science and is communicated clearly and quickly to patients and everyone else to improve the use of the product and public health. The idea that FDA officials and their words are being twisted to promote a trial attorney agenda is disgusting beyond imagination...

http://www.drugwonks.com/blog_post/show/6424

To read more on this issue, visit www.drugwonks.com