Sermo in the Blogsphere

Ask Your Doctor: Physicians' Thoughts on the FDA and Accelerated Approval

Dr.Miller's Blog

August 15, 2007

I recently posted a discussion on Accelerated Approval on Sermo to see what other doctors had to say on the topic.

[Sermo is an online physician network claiming more than 20,000 members where you can post questions, discussion topics and comments. Questions are presented in a poll-like format and physicians can "vote" in their answers.]

A couple of physicians wrote comments indicating that they didn't think it was a bad idea for the FDA "to go slow, wait to have enough data, and thoroughly test for adverse effects."

But as one physician pointed out:

"I'm afraid that the fda has been hopelessly burned by latecoming adverse event reports (ie vioxx) and that any drugs with the safety profiles that our drugs do will have little chance at accelerated approval unless they raise the dead with no definable side effects."

Several others argued that the FDA needs to take into better consideration the severity of the disease and treatments available when approving new drugs - which boils down to the FDA simply executing on its existing intent and promise of accelerated approval for patients with terminal illnesses:

"In a situation where there are already 10s or even 100s of drugs out there in certain drug class, such as antihypertensives, drugs for cholesterol lowering, NSAIDs, going slow and being cautious about long term side effects is incredibly important. In oncology and in the past, HIV, patients often do not have the time to wait for the FDA to grant approval for a drug."

"Although my other hemeonc brethren and sisteren might disagree, I think that the approval process for drugs for dying patient might need to be different. These patient do not have the luxury of time and most of the time, they have a higher tolerance for the unknown. As to why they don't participate in clinical trials, some patients are too ill (medically), some do not wish to be randomized, some cannot travel 100 miles to a phase I/II center."

"Common sense tells me that life and death meds, such as new antitumor meds, should be treated differently than 'lifestyle' meds."

When I first posted the discussion, I wasn't sure how familiar the network was going to be with the FDA's drug approval process - while I've been completely immersed in the process at different points throughout my career, some practicing physicians understandably may not know the intricacies of FDA policy. But the twenty or so comments thus far reflect an open and very good debate.

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