Well we are in the dog days of summer here in the Beltway, but lots has been going on nonetheless – not only at the FDA and on the Hill, but with that thing called my job. I have been busy as all getout, which is using some of my western drawl for the weekly roundup.
In all seriousness, there has been a great deal of activity and much I would have liked to have written about had other matters not intruded. Here are a few of the highlights:
- FDA Says NO, NO, NO – It isn’t August 11th yet, the official date for CDER’s Complete Response Letters from going into effect, but that hasn’t stopped the agency from sending some out. In addition to those reported on earlier in the week with Eisai and Venda, Schering Plough announced receipt of a not-approvable letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia – this in spite of a unanimous recommendation by an FDA Advisory Committee panel. This week someone inquired whether or not there was a listing of drugs where the FDA overruled an advisory committee recommendation, and while I know of no such list, I can say that I seem to be seeing it with much more frequency – Provenge advocates will attest. All Schering Plough said was that there were no efficacy issues but did not address other issues. And then UCB announced that it received a not-approvable letter for lacosamide for the treatment of diabetic neuropathic pain in adults. Not a good week for pharmas or their investors.
- FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample – The agency has approved a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient’s tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors. PathChip, the gene expression array used in the Pathwork Tissue of Origin test, is custom-designed for Pathwork Diagnostics of Sunnyvale, Calif., by Affymetrix Inc., of Santa Clara, Calif. PathChip is the first custom Affymetrix gene expression array to be cleared for diagnostic use. Question FDA – Why don’t you put approval announcements on YouTube the way you do for MedWatch alerts? Isn’t the news of an approval just as important to get out as the news of a risk. Isn’t the announcement of a benefit every bit as important as the announcement of a risk? Think about it!
Ok, that’s it for me – it’s been a long week. Have a good weekend everyone.