Who goosed the FDA?

I’m not posting this in GD because I’m not really debating anything, but it could easily become a political debate, so the mods can do what they think is appropriate.

Transfats, antibiotics in livestock, antibacterial soaps… three things that have needed addressing for decades. Suddenly in the last few weeks we’ve seen announcements that the FDA is taking action on all three, and it’s hard not to notice how they’re being announced. Each announcement has been very prominent in the media and they’re obviously timed so that each has some time in the news cycle before the next is announced.

We’ve had an Obama appointee, Margaret Hamburg, in office since May 2009. What’s prompting these actions (or at least announcements) all at once?

Is this Obama deciding that if he can’t work with Congress then he’ll flex his muscles elsewhere?

Are these things that have been quietly in the works for a while that are being announced now as a political maneuver?

Are these nearly simultaneous announcements coincidental? Are there some legal requirements that such things have to be announced in the calendar year before they take affect (thus prompting the sudden end of year announcements)?

Is there some advantage to announcing them as Congressional sessions end for the year? I can see some political advantage in that Congress is heading home for the holidays making it less likely that the usual suspects will try to spin this as the evil socialist Obama imposing his will on us.

I am amazed that anyone would actually pay attention to some minor rule making changes the FDA makes with regard to antibacterial soap.

http://www.fda.gov/newsevents/newsroom/PressAnnouncements/default.htm

I really don’t see the pattern you are talking about. The FDA is announcing stuff all the time.

Maybe this is a tactic to increase appropriations.

After getting the glad hand for announcing these supposedly welcome changes/queries, the FDA can turn around and say “gee, we don’t have anywhere near the money needed to follow through and enforce this stuff” (which is very likely true).

I’ll know the FDA is getting serious when it takes some definitive action against cancer sleaze doc Stan Burzynski.

Not. Seeing the pattern? Maybe it’s my media choices but I’ve been seeing prominent discussion of these announcements, and I do think that they’re all important issues, Burzynski notwithstanding.

My vague assumption was that Sebelius has taken the brakes off Hamburg. She doesn’t have much incentive to play nice with the legislature these days, does she? Hamburg and Sebelius have been eviscerated by the House this year. Add that to the timing, the second half of a second term, and that DC in general seems more willing to ignore bombast from the opposition …

The timing may also be due to a desire to get HHS mentioned in reference to something besides the ACA exchange website debacle. When a change takes place doesn’t depend on the calendar year, but how long a comment period is.

I thought the FDA was more likely to make these types of announcements in the early Spring, but I don’t really have a rigorous analysis to support that.

All three rules will impose serious expense on the related industries.

Look over that list of announcements; most are for the approval of new / new indications for drugs or devices, recalls / enforcement actions, or new / updated agency programs. These three announcements ARE different.

They are very different. These are important issues. I recall seeing a report on the dangers of antibiotic overuse in livestock decades ago and we’re now at the point where people are dying from resistant infections. Agribusiness has successfully fought off regulation for a long time.

Maybe this administration has gotten to the point of saying fuckit, we can’t deal with these people so we’ll just do what needs to be done.

I agree, davidm, that this is unusual behavior for the FDA. Going up against agribusiness can’t be easy.

Now if we could just quintuple their budget…

That is very well expressed.

As for the FDA’s budget, I believe if they implemented themselves half of what they expected from medical products industry, they would be a hell of a lot more efficient. If industry tried to implement such broad and non-specific procedures, so lacking specific instruction & criteria, as the FDA publishes as their own, the agency would slap a warning letter on them so fast it would pin your ears back.