Well, Congress is back and writing enough letters to the stakeholders in the pharmaceutical industry to keep the Post Office in the black for many months! The cherry blossoms have peaked and we have settled into several days of gloomy weather here inside the Beltway. And each day that passes, I am more sure that we are sitting on the cusp of revolutionary reform of both the food and drug industries.
Here is a little of what happened this week:
- GSK Gets Serious Warning Letter – GlaxoSmithKline received what can best be described as a very serious warning letter from the Atlanta District Office (not from DDMAC) after an inspection focused on GSK’s compliance with Postmarketing Adverse Drug Experience (PADE) reporting requirements and other postmarketing reporting requirements relating to Avandia (rosiglitazone maleate). The agency felt that GSK failed to report data relating to clinical experience, along with other data and information. This is probably not a singular event as far as industry is concerned and may signal a much more aggressive posture on the part of the FDA. See excellent coverage on this topic on the In Vivo blog.
- Eye on FDA Makes a Top 100 List – The Blog LiveSmarter – labelled as a "blog for improving daily living through insights into health, wellness, finance, and education" and published by the Online Nursing Degree Directory listed their Top 100 Academic Medical Blogs under various categories. Under the category of "Drugs/Medicine" made the list! With e-drugsearch.com, that puts us on two top 100 rankings. Thanks everyone!
- New Blog Comes to the Family – The editors of Pharmaceutical Technology magazine recently started a blog called PharmTech Talk. The blog is an extension of the magazine, which covers all aspects of pharmaceutical manufacturing and regulation. Check it out. It is striking to note how many print publications are turning to blogs.
- Andy’s Take This Week – As feared, the Commissioner’s weekly one-way conversation called Andy’s Take with us took a turn for the worse as he seemed unable to resist the temptation to go the "look what we’re doing to keep you safe" route instead of serious talk about the trouble the agency is in and what he is going to do to restore confidence, which would have been a far better use of the time and space and effort. This week he talks about the fact that the agency found a high level of selenium in a supplement. Not exactly the stuff that captures the imagination nor that might stem the flow of investigations from Capitol Hill.
That’s it for this week. Thanks.