What Vacancies? FDA Conflict Rules & Advisory Panels
7 CommentsBy Ed Silverman // November 30th, 2011 // 8:23 am
Earlier this year, FDA commish Margaret Hamburg bemoaned the lack of qualified, unconflicted experts available to participate on advisory committees. And last month, a trio of US Senators introduced a bill that would reverse three-year-old agency regulations that bar experts with financial ties to drug or device makers from serving on those committees without a waiver (see here and here).
Those regulations, which include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000, were instituted amid concerns that the FDA was not doing enough to address conflicts. The issue emerged in the wake of various safety scandals and a subsequent clamor for panelists who would be largely divorced from substantive industry influence.
The legislative effort comes amid complaints that the FDA is not approving new devices, in particular, fast enough. As for drugs, the agency recently released data showing 35 new meds were approved over the past 12 months, which is nearly the highest number of approvals in the past decade (see this). Whatever the numbers, the FDA does not appear to have a huge problem filling its advisory committees.
Through the first nine months of the recently ended fiscal year, the vacancy percentage for panelists for the Center for Drug Evaluation and Research remained around 25 percent, which was below the 30 percent reached in 2009, according to the most recent available agency data (see this). Over the same period, the percentage of vacancies on Center for Devices and Radiological Health panels have been declining - from 28 percent in October 2010 to 13 percent this past June (look here).
Meanwhile, the percentage of conflict of interest waivers granted for FDA advisory members has remained far below the 12.78 percent target that was established (read here). And the percentage of vacancies overall has been declining, from 35 percent in July 2010 to 20 percent in June 2011 (look here).
The upshot is that the FDA does not appear to be having much difficulty finding experts without industry ties, despite the protestations from the pols who want the regs loosened - Minnesota Democrat Amy Klobuchar, North Carolina Republican Richard Burr and Colorado Democrat Michael Bennet, who introduced the Medical Device Regulatory Improvement Act to “streamline” FDA regs for devices.
For those who are curious, Klobuchar has received campaign donations from Medtronic (see this), and Burr received contributions from several drug and device makers, including Pfizer, Merck, GlaxoSmithKline and Medtronic (read here), according to the OpenSecrets database run by the Center for Responsive Politics.
Salient point
Although the vacancy numbers seem to be declining, they still look awfully high. I mean, how many industries have a 13% vacancy rate in this economic climate? Natural gas, maybe?
Furthermore, when we compare the reduction in vacancies at CDER–which is only 5% over 2 years–it seems important that the base we’re working off was during the first year of a new presidential administration, which would presumably skew higher.
Not saying the senators are right on this, but their argument is not completely without merit.
Bette
This is yet another attempt to weaken and water down an already watered down agency. We have the evidence that the drug safety effort is a disaster - just look at the number and $$ of fines for off-label marketing and the roll call of those harmed or killed by drugs with purposely hidden lethal side effects.
The front end - approval - is already loaded with landmines and roadblocks put there by an industry out to make a buck no matter what.
Here’s hoping this never gets out of committee.
Diana Zuckerman
Two important issues:
#1. Advisory Committee slots are not paid, so it isn’t like a vacancy in an industry. On the contrary, the FDA pays exact travel expenses and a small stipend on the day of the public meeting, but if the Advisory Committee member does their job and actually reads the thousands of pages of material before the meeting, that time is not compensated. Now perhaps you understand why there are vacancies, and why many of the doctors and academics who volunteer do so because of potential speaker fees or other financial gains in their future dealings with drug and device companies.
#2. The $50,000 conflict of interest threshold is only for the current year. If the company that makes a drug or device gave you a million dollars 13 months before the Advisory Committee meeting to review their medical product, that does not count as a conflict of interest. In fact, if the company gave you $10 million a year for the previous 20 years, but not in the last 12 months, I don’t think you even need to tell the FDA about it. And the company can give you another $10 million a month after the FDA approval decision, and that doesn’t count either.
Despite the lack of adequate compensation for the work involved, serving on an FDA advisory committee is an interesting experience and it would be great if public health experts and physicians who do not have financial conflicts of interest would sign up. Here’s how: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/CommitteeMembership/AdvisoryCommitteeVacancies/default.htm
Salient point
Diana-Have to confess I had no idea these were unpaid positions. Of course that invalidates everything I said above.
Why aren’t people compensated for their time on these panels? This is a capitalist country. You’re not going to get the right people performing tasks adequately if there’s no incentive.
Piling on a bunch of regulations about how they can’t have industry ties only adds to the preposterous naivete of this set-up.
vince
At least 50% of academic experts have no conflicts but since the FDA views itself as a partner with industry it just can’t seem to find those experts. At least not any that would help with sales.
john
I had always thought of these committees as being staffed by the therapeutic specialty of the IOM, the “best and brightest” being brought in to advise the FDA’s own formidable experts on the most important decisions it makes.
Recently I had the opportunity to dig into the professional backgrounds of the members voting on a key drug approval decision. Roughly half of the committee members were from second and third tier institutions and many had less than 10 peer reviewed publications in the field that they were representing. This will sound very harsh, but I suspect that some of these had no conflict of interest in part because industry was not all that interested in them.
I’d have to agree with SA, these should be highly compensated positions. If you are going to rely on volunteers, the value of these meetings is not going to be what it should be. If compensation doesn’t solve the problem, relaxing COI requirements would be a second step.
john
Sorry, that first sentence should have read “equivalent of IOM”