http://www.cnn.com/2009/HEALTH/01/23/stem.cell/index.html
FDA approves embryonic stem-cell research.
My issue is this; how much power does the president have? I find it alarming that a secondary department like the FDA apparently flaps like a wind sock based on the president’s convictions. Shouldn’t they be more autonomous? Shouldn’t the president’s power always have to pass through the filter of Congress, with the occasional kick in the nuts by the judiciary?
H.
I doubt anything would get done, ever, if Congress had a say on every decision or initiative the President ever made. There has to be a balance, though, even if reaching it seems nigh impossible.
In a word, no. The executive branch is the executive branch. If Congress wants to outlaw something, they can always pass that law.
Well, the article wasn’t too specific, but it sounded like Obama merely reversed the restrictions that Bush placed on embryonic stem cell research. So it’s likely that the FDA was prepared to okay it before, and that it was only the executive order from Bush stopping them.
From the article, it sounds like Obama did nothing here. (He hasn’t yet reversed the restrictions [EDIT] on federal funding.)
The FDA has just been dragging its feet for their magical approval because little peer research has been done. Depending on your political tribe, you could either blame lack of federal funds for the lack of peer research that slowed down the FDA, or you could yell at the FDA for blocking the privilege of letting people try new medical ideas, something the FDA has done in the past.
The root of the problem appears to be the FDA. I empathize that some people don’t want to throw the baby (legitimate safety regulations by the FDA) out with the bathwater (feet-dragging shit like this) and prefer to patch holes in the system (by speeding up the process with federal funds). Just saying.
How do you generate peer research on a banned subject?
H.
It was only banned here, right? There are scientists in other countries.
Well, I suppose I still don’t understand this stupid issue then. It was my understanding that privately-funded research was legal, but it looks like you need FDA approval.
I don’t know, if the tribals could shut the fuck up for a moment it might be easier to read the facts from the articles.
Man, this is awesome.
No, I think you’re right, private-funded was still going on. Mea culpa.
H.
Gotcha. It’s hard to navigate through the red-herrings sometimes. And it is pretty exciting, I agree. Especially if it works! :)
It wasn’t banned, just federal research money would not go to institutions that conduct stem cell research. Ok, in effect it was banned…
My issue is this; how much power does the president have? I find it alarming that a secondary department like the FDA apparently flaps like a wind sock based on the president’s convictions. Shouldn’t they be more autonomous? Shouldn’t the president’s power always have to pass through the filter of Congress, with the occasional kick in the nuts by the judiciary?
First, the head of FDA (and all other administrative agencies) is appointed by the President…and that head sets policy that the rest of the agency follows.
Second, FDA is an administrative agency, with limited rule-making power (in the form of regulations, codified in the Code of Federal Regulations), using the power expressly granted to it by Congress. So in effect, the boundries of an administrative agency’s power are set by Congress, and the agency fills in the rest. Often in ways that Congress never expected or intended.
A good example; Congress in Section 510(k) of the Federal Food, Drug, and Cosmetic Act, required any medical device manufacturer with a lower-risk medical device to notify FDA 90 days prior to entering it in to commerce. FDA then took that one paragraph and expanded it into a submission requirement; the process now requires not only notification in the form of a submission with relatively heavy data requirements, but in addition, FDA clearance of that submission, prior entering the device into commerce.
Congress can reform this practice and reign in FDA’s requirements by passing another statute…but rarely does this kind of thing.
And no, you could always do research on stem cells (basic science wise), but FDA has approved this particular clinical study for a particular application, neural regeneration in spinal injury patients.
With respect to the “peer-reviewed part”:
Getting approval was made harder and took longer because the FDA had no other peer-reviewed research outside of Geron’s to consult as it reviewed the proposal, he said.
That appears to me to say that approval for the study took a long time as there have been no other clinical trials using stem cells for neural regeneration in spinal injury patients.
Yep, if you want to market a drug or other product for a specified “indication,” the FDA has to approve the designs of your studies beforehand and has to conclude that the studies demonstrate the product’s efficacy and safety.
Maybe the FDA anticipated pressure from the Bush White House not to approve any such studies of embryonic stem cells. That would be par for the course.
Again, it all depends on your worldview. Someone who thinks Bush would pressure the FDA (what, are they a bunch of pussies that can’t stand up to “pressure” from the most unpopular president in recent history?) would agree with you. Others might say they are just a slow, inept bureaucracy. Hell, they could’ve even been dragging their feet until inauguration week to make themselves look better. Take your pick!
Someone who thinks Bush would pressure the FDA (what, are they a bunch of pussies that can’t stand up to “pressure” from the most unpopular president in recent history?) would agree with you. Others might say they are just a slow, inept bureaucracy.
The FDA official who quit over the foot-dragging behind the OTC approval of Plan B lends credence to the former.
This has nothing whatsoever to do with Obama. The research conducted will make use of stem cells already approved for use in research by George W. Bush (remember that guy: conservative, folksy, kinda bad at public speaking?). The sticking point in approving these particular cells in the research was that there are only a limited supply that are earmarked for research thanks to the efforts of Mr. Bush and his colleagues several years back. Research needs to be well vetted before it can be approved to gain access to this limited supply, and it was tough to do that in this case because similar research was difficult to come by.
The only mention of Obama at all in this is that he is expected to loosen some of the restriction on stem cell research, hopefully increasing the supply of stem cells available to researchers trying to do ridiculous things like finding ways to reverse paralysis and brain damage. I’m sure he’ll pass a law allowing back alley abortions to create a steady flow of stem cells into the hands of these diabolical mad scientists.
Yes, that was sarcasm.
Well, remember that the head of FDA, von Eschenbach, was appointed by Bush. Look at how the former head of EPA was able to influence environmental policy and push Bush’s environmental agenda, often counter to the conclusions reached by his own internal science and legal advisors.
Oh and more on point with FDA, a group of whistleblowers in the Center for Devices and Radiologic Health (group responsible for medical devices in FDA), wrote a letter to Congress and a letter to John Podesta (leader of Obama’s transition team) alleging corruption from the management of CDRH. Including that managers had secret meetings with industry, frequently overruled scientists’ concerns and cleared/approved devices that should not have been cleared/approved, etc.
That is how a president influences an agency. In this case, Bush was a proponent of deregulation, so he appointed a FDA commissioner to act out policies that lead to deregulation (such as the drastic drop in postmarket compliance actions in the past 8 years). It’s simple.
Others might say they are just a slow, inept bureaucracy.
There’s some of the government inertia in this, however, FDA is critically underfunded for it’s mission. That’s really the primary reason for their “slowness.”
Not sure why you went off on a deregulation rant, but it sounds like Houngan had the right idea then in his OP. And lends a little support to the conspiracy theory that they held out for Obama so they could all look like they are buddies now and keep their jobs. :)
There’s some of the government inertia in this, however, FDA is critically underfunded for it’s mission. That’s really the primary reason for their “slowness.”
All government agencies are critically underfunded for the fantastical missions given to them by Congress.
Almost all government agencies have Congressional oversight that controls their mandate and funding. That was part of the New Deal. Give agencies the power to act as de-facto law making entities, but have that checked by Congressional oversight.
I’m not sure who oversees the FDA.