I Think I Give Up On The FDA

With tonight's news of Amylin (Nasdaq: AMLN) getting yet another complete response letter (CRL) from the FDA on Bydureon, I am just about ready to give up on the FDA. Even though Bydureon has shown no particular cardiovascular risk, the FDA has decided to ask for a QT study - a request that is going to take at least a year to fulfill (to say nothing of another six months or so for review).

I would love to know why the FDA did not request this back in the first CRL. I cannot stand conspiracy theorizing, but I am beginning to wonder if the FDA has just decided to abandon its supposed mission of evaluating the safety and efficacy of new drugs in favor of just ruling that any and all new drugs are potentially unsafe and therefore unapprovable.

Although I think Amylin has the capital to endure this delay, and I still believe Bydureon is the best drug in its class, I do not know how anybody can just assume that the drug will get approval. It seems clear to me that the FDA does NOT want to approve this drug and will come up with whatever obstacles are necessary to block it.

By the same token, then, this is bad news for any company looking to get a new compound through the FDA. Maybe Big Pharma can still push some compounds through, but it feels like the little companies do not stand a chance.Good luck, then, to Biodel (Nasdaq: BIOD) and its problematic Phase 3 data on Linjeta - if the FDA will not approve Bydureon, I cannot see how Biodel gets through.

I wonder how long this will go on before somebody decides it is time to audit and investigate the FDA and re-examine its mandate. I appreciate and respect the necessity of protecting the public from unsafe drugs, but allowing unmet medical needs to remain unmet simply because of fanciful fears of possible harm does nobody any good. At this point, I argue that the FDA is abusing its mandate and needs a Congressional slap upside the head to remind it of its obligations to facilitate the introduction of new drugs and devices.

Anyways, I do not wish to turn this into a long-winded rant about the FDA, so I will bring this to a close. This is a major disappointment to Amylin shareholders, but it is not the end of the story yet. I still have some hope that this story will work out, but it is definitely going to take longer than I had hoped.

Disclosure - I own shares of Amylin