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FDA, facts and the fun in idle speculation
There are facts and there’s the stuff that surfaces when facts are in short supply, but as Groucho Marx might have said, facts goes out your front door and rumors come innuendo.
Following are three developments that have emerged over the past two months, but just what do we really know about all these goings-on?
Who’s next at FDA?
It was hard to be in the life science business and not hear about FDA commissioner Margaret Hamburg’s plan to leave the agency by the end of this month, and the news sparked a ton of speculation, especially given that the agency had just hired Robert Califf of Duke University.
Califf – described in the agency’s Jan. 26 statement as “a recognized global leader in cardiology, clinical research, and medical economics” – will lead the personalized medicine effort at FDA, but does that make him a candidate for the next commissioner?
Maybe. But of the past 10 FDA commissioners, only two had prior experience at the agency (Jane Henney and Lester Crawford), and neither was hired for the commissioner’s post from directly within FDA. They were both working elsewhere when they got the bad news.
One difficulty for the next appointee is that he or she can be guaranteed the job only for the next 22 months because there will be a new head honcho at the White House by January 2017. That fact might seem to argue for an in-house candidate, but that would be an exceptional outcome all the same.
The rumor mill is quiet for now, but give it a couple of days.
FDA and LDT regs: Boomerang in the making?
It’s easy to forget that boomerangs were invented quite a while back to bring down a more or less nimble source of protein, but getting hit in the head by one’s own projectile is not unheard of at any stage of social development. Girish Putcha of Palmetto GBA said in a January meeting on FDA regulation of lab-developed tests that the agency’s efforts could push some LDTs to doctors’ offices.
There have been rumblings that industry might sue FDA over its proposed regulation, but the more likely scenario might be that identified by Putcha. Obviously he would know better than I about such things, given that he gets paid to pay attention to the goings-on at clinical labs. That’s not the same as saying it would play out that way, but it wouldn’t be the strangest reaction to FDA’s regulatory moves, either.
Lest the notion be greeted with chortles and skepticism, let’s recall that the calls for healthcare reform in the 1960s were sparked in part by physicians ordering tests conducted at labs owned by (you guessed it) physicians.
Conflicted over conflict of interest?
We’ve heard tons about FDA advisory committees and conflicts of interest, but more data have emerged about the situation, and they don’t favor the furor over conflicts of interest.
A January report addressing those concerns for pharmaceutical advisory committees concluded that there was almost zero evidence that conflicts of interest affected the outcomes of these advisory hearings. In fact, seemingly conflicted panel members were more likely to surprise the authors of the report with their votes than non-conflicted members.
In other words, those with conflicts went out of their way to vote in a way that ran against their financial interests. Is this innuendo finally out the door?
Midwest med-tech rising
The Midwest might not have as much funding activity as some parts of the West Coast or other established hotbeds for innovation, but potential med-tech entrepreneurs and would be investors would be foolish to overlook this region, according to a report from BioEnterprise.
The med-tech companies are consistently finding funding in the Midwest, and were even able to raise dollars during the tumultuous years following the economic meltdown. Since I began my tenure at Medical Device Daily in 2007, the region has produced strong numbers consistently.
The study points out that Midwest healthcare companies attracted $1.8 billion in new investments across 243 companies in 2014. The totals are the highest recorded in both dollars and number of companies funded since BioEnterprise began compiling the report in 2005, surpassing the banner 2007 by 46% and 2013 by 135%.
The Report was funded, in part, by philanthropic support from the Fund For Our Economic Future, the Cleveland Foundation and the Burton D. Morgan Foundation.
My conversation with BioEnterprise’s president/CEO Aram Nerpouni, revealed that the area is growing and that it offers a diversified range of funding opportunities. While there is still some room to grow, it seems highly likely that the funding rounds will continue to grow.
