According to a press release issued by the U.S. Food and Drug Administration(FDA), its Commissioner Margaret A. Hamburg, M.D. has issued the agency’s “Global Engagement Report,” detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The report deals with more than medical devices, covering everything health related, from pharmaceuticals to food, but devices are definitely in there.
Aspiring to be a “global public health agency” is an interesting phrase isn’t it, as it rather implies a degree of control over regulatory activities in countries other than USA. While we all acknowledge that FDA’s reach is wide and its influence (and indeed leadership) over many other countries’ own regulatory affairs unquestioned, it’s a bit rich of it to think of itself as a global public health agency isn’t it?
Let’s be charitable and assume those words don’t reflect the real context of the report, and consider what it really is about, which in medical device terms means protecting Americans against the best efforts of us foreigners to send over our poor quality “stuff”.
Sprinkling FDA’s magic dust over the World
According to the press release, “The report describes the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.”
That presumably means… errr… what does it mean exactly? FDA inspectors are obliged to, and frequently do, visit and audit overseas companies, so from a medtech perspective what does the report really say that’s so different? One answer might be that by being seen to be engaging with us foreigners in a way that somehow dispense a bit of “Americanness” into the way we regulate ourselves, then the FDA’s job of sending out its missionary force of auditors becomes that bit easier and less burdensome.
Of course what it doesn’t say is that we must all change our regulations to mimic FDA’s. It doesn’t say that on the lines at least, but at a time when medical device regulations have never been higher profile and when FDA CDRH spokespeople have referred in somewhat derogatory terms to the weakness of the EU regulatory requirements, describing EU patients as “Guinea Pigs”, one could be persuaded that this is at least in part an effort to make us sharpen up our act. That, or it’s a bit of clever PR to ensure the agency positions itself as the paragon with standards to which we all aspire.
FDA Commissioner’s comments
“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said FDA Commissioner Margaret A. Hamburg, M.D.
It’s a laudable proposition, but I’m still left feeling a bit uncomfortable by the whiff of superiority. How many changes will occur in FDAland as a result of what it learns in Ouagoudougou?
It’s missionary work then
Don’t misunderstand me. This looks like and very possibly is good stuff. I mean how can we honestly say some of the non-CE mark countries carry a regulatory burden that is in the interest of the patient to a greater extent than in the USA? But that’s not the point is it? This is not really about protecting the interests of Egyptians, South Africans, Indonesians or pretty much anyone other than US citizens, so by practising what amounts to an outreach programme, we’re all being “helped” to comply with FDA requirements.
The suspicious journalistic streak in me feels the need to use the word protectionism at this point. It all looks lovely and helpful and “engaging”, but actually it’s a bit patronising at best, and it may result in a hotting up of the debate about which is best…FDA or CE? And the FDA outreachers, desperate to protect their rule book will be in a strong position because they’ve spent so long out in “the bush” (ie not USA).
Anyway, if you want to read it all for yourself, start here.