Pharmas Market with Mike Huckman

Turning Up the Heat (Again) on the FDA


For the second time in two weeks, an op-ed item appears in The Wall Street Journal today calling out the FDA for its record on timely approval of cancer drugs.

Last time, Stanford oncologist, Idec co-founder and Pharmacyclics CEO Dr. Richard Miller weighed in. This time, two officials from the cancer patient advocacy group Abigail's Alliance co-authored a piece under the headline, "The FDA's Deadly Track Record." (subscription is required to read full article)

The men claim the agency has delayed approval of a dozen cancer drugs in recent years (Dr. Miller cited five delays in recent months) and has thereby "contributed to a million premature deaths."

And Dendreon-ites are pleased to see Provenge get another prominent mention. Dr. Miller referred to it in his piece and in today's op-ed, the authors say the prostate cancer drug has been delayed because "a small but aggressive club of FDA advisers hand-picked by the director of the agency's Office of Oncology Drug Products, Dr. Richard Pazdur, think the statistics are not yet perfect enough."

The authors conclude that the overall trend is "a massive human tragedy" at the hands of "FDA automatons."

Tomorrow morning, beginning on "Squawk Box" at 7:30a ET I will be doing a report on the number of approved versus "approvable" drugs so far this year. The numbers may surprise you.

Questions?  Comments?