Back after a bit of a university related diversion - darn, still have to pay the bills.

First a bit of a personal note: Our #3 son is deployed USMC - hooorah! Not in Middle East but deployed to Asia keeping an eye on things there. Hope yours stays safe

Now back to that independent agency idea. Yes, an independent agency for safety evals. (and or a presumably autonomous division within FDA) has indeed been around for a long time as Justice noted. But I do think that every idea has its time.

Very interesting perspective on Hillary, could be she may be in the mood to break ranks with Teddy these days. May be worth another try soon…dynamics there are going to change.

I am not sure what current PhARMA/BIO perspectives might be on this all but I do hope they change a bit (as they did regarding user fees) things as they are just do not add-up to anything helpful to their bottom-lines.

It is the Former,… as long as Hillary and Kennedy are on the HELP Committee,… rest assured IODS will never see the light of day. Industry has these folks in their back pocket.

Not surprisingly, David Graham has supported it for years. Senior management in FDA has been against. The usual argument is that those who approved the drug “know most about it” and thus should not be excluded from deliberations of what happened if it fails. The response is that they would not be excluded. They just may not have final say. Graham et. al. argue that having made a decision to approve a product, and then having to withdraw it, creates an inevitable COI. On some level or other, one is saying (even if one couldn’t have known) that one’s initial decision was (in retrospect) the wrong one.

The major reviews of FDA have been split. The IOM ended up not supporting a fully independent board. As I recall, GAO went closer to doing so. And, as above, as did several earlier reviews from the NAS.

Everything depends on organization, funding, and power. If/when FDA preemption happens and only the FDA as we know it is enforcing accountability - and the inevitable disaster happens (which will make Vioxx look like a picnic) - I believe industry will wish very much they had supported such an initiative.

I spent a lot of time in DC trying to convince legislators to support the Grassley/Dodd Bill. We were quite close in the Senate. Good old Hillary wouldnt go for it. She supported the industry written version. But yet she tells the public,.. she’s not swayed by the Pharmaceutical Industry. Hmm reminds me of her Bosnia story. Maybe she should check out my nephews helmet, the one that was hit by an Iraqi Insurgents bullet.

Former Pharma,
Not Political enough for me!! My Nephew is heading back to Iraq for his second tour. Semper Fi !!!!!!

Independent Office of Drug Safety, Hmmm This needs to be fleshed out more, but it certainly sounds appealing….

But, times and needs change. In thinking through the whole notion a bit more I now do favor this as a potential solution. With the continued issues that fly around drug approval, post-marketing surveillance and the need to maintain a reasonable time line for approvals of more and more sophisticated and potential problematic drugs and biologics something new needs to be tried.

My favorable view on this would be predicated on such an entity being fully funded, independent of FDA and with a chain of review and comment that insulates it from Congressional second guessing. OK, the latter may be a pipe-dream but two outta three aint bad. Maybe there is an area within CDC or NIH that could house such an agency. Possibly such a review office could be staffed by some of the dedicated folks within the Public Health Service as a way to insulate them a bit from Congress. Let’s all put on our thinking caps here. If something is not done to mitigate the current climate of criticism very few truly novel drugs or biologics will ever make it out of the pipeline and survive the current market. This is not an issue of helping the commercial interests of research companies but an issue of creating an environment that helps promotes the health of the public.

“A user-fee would not be necessary if Congress simply and properly provided FDA with all of the funds to do its job. We could all go home and not engage in any of these debates. But, that is just goanna happen, folks.”

I agree - something I’ve been making noise about for a while here. And it is about funding. An earlier study by Dan Carpenter showed pretty conclusively that more money leads to faster reviews (surprise, surprise), regardless of where it comes from.

Before I read FME’s post, I was also going to make the same connection. Industry’s entire annual PFDUFA contribution is, yes, the equivalent of one day in Iraq. By federal standards, this is _not_ huge bucks.

Shifting issues slightly - anyone want to trade FDA preemption for an adequately funded, independent Office of Drug Safety? (Not totally disconnected from the OND; just not under their thumb.) We all know post-marketing is where the most serious problems arise, and only a small bit of PDUFDA money has finally been wrangled out to cover a tad of it.

The cancer drugs do show major life prolonging benefits but in some cases serious SE’s are only realized after a few years on the market and depending on the patient size, data is harder to accrue.

Understanding the human genome has given us the ability to develop more precisely targeted drugs. The benefits of these drugs are so critical that they must be brought to market as quickly as possible. When you see patients who are near death, get up and walk out of the hospital after a few weeks on a pill, it is immoral to not provide that drug to every patient who could benefit from it.

This puts a serious strain on the entire system. The fast tracked drugs are under obligation to continue to provide ongoing data to the FDA.

Clearly, as pointed out, the FDA is challenged with it’s resources.

I do not think that user fees are entirely to blame in this case. Not to get too political, how good would it be if we diverted some of the “war” funds over to the FDA?

The FDA system needs to be brought up to date to be able to allow us all to reap the benefits of our new drug technology.

I am not sure patent issues matter in this sense. Since drugs will have a shorter life span, perhaps the patents could be shorter too. But not before the approval process at te FDA is fixed.