Congress passed FDARA. What the heck does that mean?

I've been AWOL this week on SB; life, apparently, is not concerned with what is convienent for you. Anywho...

The House on thursday passed the FDA reform bill (H.R. 3580) by a huge margin (405-7) and the Senate passed it last night by a voice vote. As an aside, Sen Burr (R-NC) placed a hold on it but obiviously that didn't end up stopping the passage. Pres. Bush will probably sign it today. And it's a good thing, too. The FDA said it would have to send permanent layoff notices to about 20% of it's workforce if the legislation didn't pass by today.

So, you might ask, what does any of this mean? How did things change? I try to answer what I can.

We don't know
The thing is over 420 pages. Nobody understands all of the implications completely. In fact, this is one of the gripes that Sen Burr had (and perhaps a reasonable one).

Drugs for Kids
The Pediatric Research Equity Act, the Pediatric Medical Device Safety and Improvement Act, and the Best Pharmaceuticals for Children Act were all reauthorized with some changes. Basically, the idea behind these parts is to entice drug makers to do pediatric studies on their drugs so that they can be authorized for child use. If they do the studies, the drug is granted six months of market exclusivity, which as you can imagine, can amount to a huge amount of money. The Senate version originally had 3 months for big moneymaking drugs and the Dems in the house had wanted to make it less than six months. This was compromised out in the house version to make sure it would have broad support to get it passed. No one denies that BPCA works - 132 studies have been done since its enactment and 120 resulted in labeling changes (meaning that uses for children were found or that safety problems were identified). The question was whether the exclusivity was too long. Good people are on either side of this question; shorter exclusivity means better access to cheaper generics, but nobody knows if the shorter exclusivity would be enough to entice Pharma to do the studies. I think it probably would.

Money, Money, Money....MONEY!
Drug companies pay money when they submit a drug application for marketing. In return, the FDA has to review the submissions within a set period of time. The compromise that was made would have $225 million over 5 years go to the agency to hire drug reviewers and put safety programs in place (~150 million for devices, too). As I mentioned before, they would have run out of money real soon without it. A lot of people think that this is a real bad idea (taking money from industry to pay reviewers). I don't and here's why: 1) they get the money whether they approve or not. Saying yes doesn't get you more, and saying no doesn't cut you off. 2) The money isn't specifically for certian reviewers; it goes into a big FDA pot and they use it where they need it. 3) If taxpayers had to foot the bill, the FDA would be woefully understaffed.

Increased Surveillance
As part of the approval, FDA used to require studies to be done post-approval to follow up on safety concerns. However, they didn't have the authority to do anything if the company decided not to do it. That's fixed, they can now levy fines. Also the FDA will not be tracking safety with sytesm (Risk Evaluation and Mitigation Strategy is one part) that aren't exactly clear to me how they will shake out (it doesn't look like anyone else knows either right now).

Fewer People on Advisory Panels Allowed to Have Drug Company Ties.
Pro: Duh. Con: Sometimes the experts in the field have all done research with $ from the company whose drug is under review. This is many times the case for niche drugs; and researchers have to make a living (Burr gripe #2 - well, it was his gripe #3 but his gripe #2 is below)

Clinical Trial Results Made Public
Pro: No more secret corportate studies that hold important data. Con: Will people who don't understand how to interpret a study get the wrong conclusion and make bad choices? The con was another of Sen Burr's gripes.

This is a major improvement overall. Studies that no one knows about are what cause things like Vioxx (if it was handled in a open manner, it still may be on the market, but only for those who it is appropriate for). As for people freaking out, I'm of the opinion that it's great for people to be able to read up on things and ask their doctor about what they have read. I think there will be enough caveats on the webpages that people will get the idea that they need to talk to someone about these things. This may even force doctors to keep up with research in their field. That said, I do see the concern, but I think the pros outweigh the cons.

Direct to Consumer Ads
will be regulated more seriously but the Agency still didn't get the authority to yank them like a lot of safety advocates wanted. That sucks but it's really minor.

Labeling
This is complex so I'll do a whole 'nother post on this. Basically the FDA is now the king of labeling (over companies and over states). There are issues about over-warning creating a diluting of the serious warnings versus 'we should give people all the warnings' type thinking.

All in all it looks like a pretty good piece of legislation. I'll post more as I read more of it and some of the implications of safety surveillance become apparent.

Oh, and happy Friday!