Should The FDA Be An Independent Agency?
21 CommentsBy Ed Silverman // December 14th, 2011 // 8:58 am
The outrage and hand-wringing continues over the unprecedented decision last week by US Human & Health Services Secretary Kathleen Sebelius to overrule the FDA and thwart a move to ease access to the Plan B pill, which is also known as the morning after pill. The move has generated intense debate that the White House politicized the FDA in favor of promoting sound science.
Those who supported approval of the pill saw the move as not only dangerous, but ironic, given that President Barack Obama had made a point, earlier in his administration, of insisting that decision making must favor science, not politics. Now, though, he is being widely criticized, by some, for pandering to conservatives as he campaigns for re-election. The FDA had favored making it possible for girls who are 17 and younger to get the pill without a prescription.
Yesterday, 14 US Senators wrote Sebelius for an explanation. “We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence” (see here).
To opponents, Plan B is problematic because the pill prevents a fertilized egg from implanting in the womb, which equate this with abortion. But supporters of greater access argue that nearly half of all pregnancies are unintended, and that preventing teenage girls from gaining easier access denies them a safe and effective way to prevent unintended pregnancies (see more here).
Sebelius had the legal right to overrule the agency, although the FDA earlier this week offered a tortured explanation for complying with her orders. The agency explained that Teva Pharmaceuticals erred by submitting data and usage studies for Plan B One-Step, which contains twice the active ingredient of Plan B and has a different dosing regimen. This was cited as legal grounds for rejecting easier access (read here).
So where does this leave the FDA? Has the Obama administration embarked on the proverbial slippery slope in which FDA decisions may be influenced by politics or, arguably, other interests? And even if such influence does not occur again, is the agency reputation tarnished because future decisions will be subject to second-guessing and worse?
“The possibilities opened by this decision are frightening. A radical pro-business secretary could now, in principle, bypass the clinical trial system and the FDA approval process and decide to approve a drug. A different secretary, one distrustful of the pharmaceutical industry, could stop a drug despite strong scientific support behind it,” writes Daniel Carpenter, the Allie S. Freed professor of government at Harvard University and the author of “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA” in an op-ed in The New York Times (see this).
His solution? Make the FDA an independent agency. “Americans have already done this, through the Federal Reserve, to protect our money supply from political meddling; it’s time to do it for drugs,” he argues. Like the Fed, an FDA commish should get a six-year term. And while he acknowledges White House interference could still occur, a president could not hide behind his cabinet secretaries when tussling with an independent agency.
Of course, independence is in the eye of the beholder. The FDA continues to receive industry funding in the form of user fees that are used to support the drug-review process, which some agency critics argue say leaves the agency open to influence. Nonetheless, establishing an independent would not give the White House automatic veto power over such decisions. But what do you think? Is this a good idea?
Should the FDA Become An Independent Agency?
- Yes (71%, 119 Votes)
- No (29%, 48 Votes)
Total Voters: 167
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Here Comes Da Judge
Carpenter could not have picked a worse example. Bernanke et al make policy by sticking their fingers in the wind. Besides, an independent agency would have to abide by sunshine laws,and Woodcock would never go for that.
Greg Pawelski
Virtually all politicians are going to be widely criticized, by some, for pandering as they campaign for re-election. Make the FDA an independent agency like the Federal Reserve protects our money supply from political meddling? Come on! Independence IS in the eye of the beholder! House Speaker Boehner still thinks Federal Reserve decisions are politically motivated. To conservatives, you’re going to be damned if you do and damned if you don’t.
Nycprochoicemd
Thanks for bringing this up. I’d like to point out that plan be doesn’t prevent implantation of a fertilized egg. All the studies show it prevents ovulation and that women who take plan be after ovulating get pregnant at the same rate we would expect if they had taken nothing
Nothing New
Are we talking about a private company or independent agency that runs off of money provided to them by the industry that they regulate? Too late. That is the FDA. Plan B is just another example of political intervention circumventing the mission of one of its own agencies (think EPA, etc.). The Plan B situation becomes dirty water and a firestorm of rhetoric because of the taboo subject matter. But least we forget another political intervention when it comes to the Lucentis/Avastin situation. Lucentis seems an easy target for overpriced medicines and certain government agencies and representatives are actually promoting the off-label use of Avastin (not the same drug as Lucentis) for wet AMD. This off-label promotion is exactly what the FDA vows to cease in its effort for public safety. So, the FDA approves, the NIH/NEI run CATT and promotes Avastin use prior to results, and then said results demonstrate safety issues of compounding Avastin and treating the eye. Oh, and the VA stops using Avastin because of the safety issues. The governmental web of confusion and infighting is sticky and we are the flies struggling for freedom. We should just go back to a monarchy of inbreeding and be done with it…unless Plan B gains larger access to the public. Restart Plan B argument.
Anne PME
The U.S. dollar is getting to be an outdated currency…maybe we could make the FDA a separate agency and make the new currency… prescriptions drugs…maybe not given that we don’t produce them anymore…but then again, given his dislike of the current Treasury Sec., it would be interesting to see what Eliot Spitzer might have to say…
Retired
Unfortunately, I would have to vote yes and no for the following reasons;
From the standpoint of safety and efficacy the answer is yes…an independent agency. From the standpoint of fulfilling public health needs there should be an alternate agency (if one does not already exist) that will offer analyzed judgment on the value the specific product brings to the consumer not only in costs but mostly in bringing quality of life to consumers.
The Godfather
I suggest that Sibelius farm out the reviews like Don Corleone, e.g. we can have Clemenza handle safety reviews since he knows about adverse events, Michael can handle efficacy because he knows what it takes to do a good job, and in case things go off track we always have Luca Brasi to clean up the mess.
HelicalZz
Independent how? Just from HHS or quasi-so like the Fed, maybe. But please, not independent like say ‘credit rating agencies’. We have seen how that can implode, and the FDA could well be head down that path with current funding mechanisms (I don’t think they are, but vigilance is needed).
Zz
tedw
A few points…
• If the FDA was independent, the appointment of its leader would just become more politicized. It wouldn’t change how things go down.
• If you think there’s outrage over this decision, imagine the reaction if the FDA recommendation was accepted.
• I’ve worked on advertising and promotion for Plan B, as well as several oral contraceptives. While hormonal contraception does in fact prevent ovulation, my understanding is that it can also prevent implantation of a fertilized ovum. I don’t know this is established, however as you might imagine, no one in the hormonal contraception biz likes to talk about it. If you use an oral contraceptive proactively there’s no fertilized egg to prevent from implanting, so it’s moot. Perhaps not so with Plan B.
• If you think politics are effecting FDA decisions in this administration, well it’s nothing compared to the previous one. Doesn’t make it right, but it’s a LOT better now than it used to be.
• If Obama wins re-election, bring the Plan B issue back. I bet the result will be different
Tim
The FDA is already a total political animal, with staff who truly believe they work for pharma (well, actually they do. Look at who funds the agency now through users’ fees).
To think that it honestly protects public safety and health is false, as 100,000 people every year die from prescription drug side effects here in the U.S. alone.
If you want to know what the FDA REALLY thinks of the advice it gets, attend any advisory committee meeting and see how committee members are treated when they voice their intent to vote “no” on approving something pharma wants. Sometimes they are even bullied by FDA staff. Then notice how members of the public are treated during the public comment period. Many of these are family members who have had a loved one killed by a prescription drug. It is a shameful scene.
The drug safety aspect of the FDA is a farce and this aspect of the agency should be moved elsewhere.
Justice in MI
Glad we’re finally discussing this aspect.
As others have suggested, it is not clear to me how divorcing FDA from HHS would prevent the most egregious kind of intrusions we’ve seen over the years. The Sebelius move was certainly unprecedented, in its way. But would an independent agency as Dan Carpenter describes be less vulnerable to sagas like the Jersey boys and the knee device, Tom Lantos and fen-phen, the schmoozers and sleazes who have been Commissioners, Deputy Commissioners, Chief Counsels etc.?
I’d need more details about who was appointed and how in key leadership roles to make a call. It is perhaps relevant that the apparent Republican frontrunner almost succeeded in reverting FDA to is pre-thalidomide status during his “high times” in the 90s. That is something to contemplate since hoping for sanity or integrity seems increasingly dicey in American political reality/theater.
Noah Berkowitz
This is the time to FDA to be independent.
Justice in MI
Just to be clear, I meant _certain_ Commissioners, etc. when I referred to “schmoozers” and “sleazes.”
In the meantime, there is also the 3/4 of FDA not about drugs. Is the proposal for the whole agency to be independent of HHS, or only CDER?
vince
The FDA stopped being an “‘independent” agency long ago when it became a partner with instead of a regulator of big pharma. This piece is a tempest in a teapot.
Justice in MI
Disagree. FDA under Goddard, Kessler, and, indeed, Hamburg not the same as under others. Frances Kelsey would have gotten nowhere if she hadn’t had support above her at the agency.
Conversely, FDA under the Wall Street Journal editorial board, the Washington Legal Foundation, the Club for Growth, and the Scaife/Olin foundations, et. al. is a different animal.
Real politics matter.
Justice in MI
Tentative conclusion–
Rather than trying to make FDA “indepdendent”–which may well be chimerical in the context of appointments, etc.–I’d rather see the issues of regulation, corruption, influence peddling, intimidation of scientists, etc. fought out in the political arena. Not behinc semi-closed doors.
It is precisely because I am not confident that such “independence’ can be genuine, that I think we have a better chance of meaingful change fought out directly, and openly, on the political battlefield.
Healthy Clean
They can’t operate well under their own steam. They absolutely need Congressional oversight. Lord help us if they were to be totally independent, say like the Post Office.
The FDA needs a colonic. Then clean-out what’s left.
Kathleen
Independant from industry influenced “science”? YES!!!
But the question does not specify that, so I can’t answer…plus, that example about the Federal Reserve is just plain creepy!
A recent audit of the Federal Reserve shows unprecedented lawlessness in their more than $16 trillion in secret loans to banks all over the world, see- http://sanders.gov/newsroom/news/?id=9e2a4ea8-6e73-4be2-a753-62060dcbb3c3
…so, hell no to the FDA being like the Federal Reserve!!!
original industry insider
The answer is for Congress to pass a new law that basically emasculates the FDA of any decision making authority, essentially reducing its function to that of a pass through operation, much like regional sorting centers funnel the mail to the main US post offices.
FDA would sort out the NDA’s in Rockville, then distribute the documents to private contractors who report their findings not to FDA but a respected group like National Academy of Sciences. The NAS will have final and binding decision making authority that will have been codified under the same law that strips FDA of all of its regulatory authority.
original industry insider
JiM, you forgot to mention the American Enterprise Institute, the Heritage Foundation, the Hoover Institute and the Tea Party.
Esteban Lonza
Absolutely yes yes! There’s too much political pressure already that could affect public health. It’s frustrating!!!!!