Monthly Archives: February 2008

Warning! Warning! Warning! (Yawn)

Pursuant to the posting earlier this week which noted the rate of drug safety alerts out of the FDA, there also this week was a story published at that raises the very valid question whether or not patients and … Continue reading

Posted in Drug Safety, FDA Policy | Comments Off

FDA Strategy When Under Attack – Drift

In recent weeks, policymakers have turned up the heat on the FDA.  First, Congressman Bart Stupak (D-MI) sent Dr. Andrew C. von Eschenbach a Valentine by demanding his resignation on February 14.   Less than a week later, Congresswoman Rosa DeLauro … Continue reading

Posted in FDA Image | Comments Off

FDA MedWatch Alerts – Up or Down?

The Health Section of today’s Washington Post runs a story called "Why All the Drug Alerts?  Step-Up Signals FDA Bid for Renewed Trust" which focuses on the uptick in FDA safety alerts about drugs.   The uptick that the Post notes … Continue reading

Posted in FDA Image | Comments Off

Is Pharmacogenomics a Realistic Possibility?

Late last month, the National Health Policy Forum published a background paper called Pharmacogenomics: A Primer for Policymakers written by Leslie Tucker.  It is a really excellent overview of the state of the state on pharmacogenomics and as the title … Continue reading

Posted in FDA Policy | Comments Off

Weekly Roundup – 2/22-08

Inside the Beltway it is cold, foggy and icy.  Hopefully where you are, it is warm and pleasant.  This week I posted on the listing of approvable letters for 2007.  This proved an immensely popular posting, I am happy to … Continue reading

Posted in Weekly Roundup | Comments Off