The FDA Could Receive How Much Federal Funding?
6 CommentsBy Ed Silverman // July 1st, 2010 // 8:49 am
The FDA is always under the gun, and both critics and supporters often point to a lack of funding. So how much money might be headed its way in fiscal 2011? Yesterday, the House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee did a mark up and suggested $2.57 billion in funding – $55 million above the budget request. This is discretionary spending.
Overall, the agency would have $3.8 billion for oversight - roughly $214 million above last year’s bill - when including $1.2 billion in user fees, notes Rosa DeLauro, the Connecticut Democrat who chairs the subcommittee, who has been harping on drug safety lately. [EDITORS' NOTE: Yes, there was a math problem earlier and we have clarified the numbers]. So the proposal includes an extra $65 million for reviewing generic drug applications, direct-to-consumer ads and ads that specifically target doctors. More funds would also be used for safety reviews of drugs already available, inspections of foreign plants and safeguarding clinical trials. There is also a directive that the FDA report on developing standards for a “track and trace system” that would document all parties involved in the supply chain in an effort to thwart counterfeiting.
Specifically, there would be a$15 million increase over the agency’s request for the office of generic drugs; a $3 million increase for the review of DTC ads; $2 million for reviewing industry communications to doctors and a $7 million increase over the request for the Center for Devices and Radiological Health. There is also language that “outlines the need to create an independent office on post-market drug evaluation,” De Lauro says in a statement. “As we learned from the hearing the subcommittee held about the Avandia case, there may be an inherent bias when those that approve drugs continue to play a role in determining their safety in a post-market environment.”
Justice in MI
Hi Ed et. al.–I’m still a little fuzzy on the math.
Besides CDER, which has made up about 1/4 of the FDA budget, where else do user fees go–biologics? devices? vet. med?
The last time I checked the entire CDER budget was around $300+ million from public funds and a bit more via PDUFA, for a total of $600+ million (perhaps more).
I still don’t grok how that gets us up to $3.8 B for the whole agency unless the other depts (non-CDER) are getting a lot more from the gov and user fees than I realized.
Thanks for any clarification.
Ed Silverman
Hi Justice,
The $3.8 billion includes the $2.6 billion that would be appropriated in the proposal and $1.2 billion in user fees across the agency, according to the subcommittee spokeswoman, who checked with staffers at my request, since there was some murkiness in the original statement issued. To drill down further, however, I will have to get back to you.
Regards
ed
pharmavet
Even as a pharma person I say that it is time that we get rid of user fees so that we can at least remove the appearance of conflicts of interest.
pharmavet
I would also give vastly more money to FDA in the area of enforcement of food safety. Currently inspectors wear two hats, so that the person who inspects your API manufacturing facility may have an expertise in grain or livestock, but not necessarily in pharmaceuticals. I would like someday to be able to go to my favorite burger joint and order a medium rare hamburger. All they will serve me currently is a well done charburger that’s been nuked at high enough temperatures to kill any potential traces of E. Coli, since they don’t trust whatever FDA or USDA tells them. There have been enough such outbreaks in the recent past to warrant such caution.
Justice in MI
Thanks, Ed. No need to drill further. Always appreciated.
M Helm, MD
Pharmavet, If you have concerns about food safety, you may consider going ‘off the grid.’ I’ve found local producers for vegetables, fruit, and meat. Another option is kosher or halal butchers - much less likely to end up with feed lot beef. Goes without saying that you should generally avoid processed foods.
Food safety/security should be considered a national security issue, and yes, I agree it is grossly underfunded.
On the other hand, developing mechanisms to ‘thwart conterfeiting’ would likely provide disproportionate benefits for brand name manufacturers. Pfizer has worked diligently on this issue, and will likely come up with a better solution than the FDA could. I say leave ‘thwarting’ conterfeit drugs to private industry, but provide criminal and civil penalties for those involved (not that our laws reach where the fakes are made).
I wish there was a more diligent examination of processes/standards for approval - includingg acceptable study designs with active (standard of care) comparators.