Old news, new news and non-news

February 6, 2015 – 11:47 AM | By Mark McCarty | No comments yet
Ever heard a publisher say 'there's no news today'?

Ever heard a newspaper publisher say ‘there’s no news today’?

It’s fun trying to report the news, especially when there’s so much non-news masquerading as news. But I’m sure you’re tempted to say to yourself, “this old-news/new-news/non-news dilemma is news?”

Point taken. Anyway, let’s take a look at a couple of recent stories of note, newsy or not.

Old news; the combo products GMP guidance

FDA has issued a combination products draft guidance for good manufacturing practices compliance, but this is not the first such attempt and surely will not be the last.

FDA has taken several cracks at this topic, including a draft guidance in 2004, which came a scant two years after the agency formed the Office of Combination products. Following the 2004 effort, FDA announced in the Sept. 23, 2009, Federal Register that the GMP situation called for rulemaking when addressing single-entity and co-packaged combination products.

Barely four more years would pass when FDA announced yet again in the Jan. 22, 2013, Federal Register that it had finalized the rule developed in 2009, and the latest guidance points to the 2013 rule, noting that a set of GMP requirements had already been in place for human cells and other tissue-based therapeutic products.

This will prove to be one of the more iterative FDA guidances as the 21st Century unwinds if only because materials science is enabling a lot of advances that were previously just pipe dreams. There are a lot of advances in basic research of interest, including a story I wrote for the Dec. 17, 2014, issue of Medical Device Daily on an effort to create synthetic neural circuits based on mesenchymal stem cells (MSCs). Would the use of nanomaterials in addition to the MSCs make this a device or a biologic?

FDA will have to answer that and a whole lot of other questions as science pushes the envelope completely out of shape in the years ahead.

New news; Scientists aren’t always right

To be perfectly frank, this is hardly new news, but what’s a blog for if not the exercise of artistic license? There’s an article at the online portal for Perspectives on Psychological Science questioning whether science is as reliable as is often claimed.

Author John Ioannidis of the Stanford University Prevention Research Center takes up the question in the context of psychology, but anyone who attends FDA advisory meetings on a regular basis might see some of this in other branches of medical science, too. Among Ioannidis’ observations is that history “suggests that major catastrophes in scientific credibility are unfortunately possible,” and he stated further, “the argument that ‘it is obvious that progress is made’ is weak.”

I bring this up only because it is remarkable at times how routinely policymakers and the general public are inclined to accept the idea that a question is beyond dispute just because a scientist say “it’s this and not that.”

Three cheers for civil religions, eh?

Non-news; guidance for trials for nail fungus

“Surely you jest, Mark,” you might say upon reading this. Nope, surely I don’t jest. FDA actually has a draft guidance out for clinical trials for treatments of fungal nail infections, said to be distinct from trials for products that clear nails that have been clouded by whatever, fungal nail infections included.

In addition to being stunningly small in scope, this draft guidance has an ick factor that is just off the charts. Oh, marone!


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