Saturday, August 04, 2012

Why Pharma/Med Device Co's Apply for Approval in Europe FIRST

The U.S. has a regulatory problem which is affecting private companies' willingness to even submit applications for approval on innovative healthcare therapies such as medicines and medical devices in the U.S.  Hence, Europe gets all the new things before we do.  This is no accident - it happens regularly - and if one tunes into the investor updates from any publicly-held firm in the drug, biotech or medical device space, they hear it all the time: "Pending EMA Approval; U.S. FDA Submission To Follow".

Echo Therapeutics' Glucose Monitor

To give you a very current example (from this week), a Philadelphia company known as  Echo Therapeutics [] which is trying to bring a needle-free, transdermal glucose monitor to market intended for critical care patients, but will be meeting with European regulators before it even bothers a submission to the U.S. FDA.  The following is lifted directly from a story dated August 2, 2012 (see that story HERE):

"The next step will for the Philadelphia company will be to meet with the European regulatory authorities and the U.S. Food and Drug Administration. It plans to seek CE Mark approval in Europe before before completing a pivotal trial and filing for FDA approval."

Let me go on record as saying that Echo has told investors it wants to carve a niche for itself in the critical care area, not in consumer products, but the point is that the company will apply in Europe now, get the CE approval mark before they even complete any additional clinical trials needed for FDA approval.

If you're like me, you're no doubt questioning why the Europeans continue to get all the new stuff so soon, yet we frequently have to wait for years and years and years before we get the exact same products.

Low Glucose Suspend Feature Still Not Available in the U.S.

The most obvious example is Medtronic Minimed's Low Glucose Suspend (LGS) feature on the Paradigm Veo insulin pump -- the one that stops pumping any more insulin when the CGM detects someone is already hypoglycemic unless the patient overrides it.  That feature has been available in most of Europe (and is now sold in over 40 other countries) since 2009.  Yet here we are in the U.S., approaching the end of the third quarter of 2012, and that safety feature still is not yet approved for patients in the U.S.  Amy Tenderich at called it "Safety Paralysis" in which the FDA has become so risk averse that they bog down everything in layers and layers of new pre-approval requirements. (see HERE).  While I'd really like to think that was true, but frankly, I think we may be giving the FDA a little too much credit for working overtime to safeguard us all.  The reality is a bit simpler:

Medical Businesses Avoid Dealing With the FDA Until Later

The FDA is now under increased scrutiny from more than a few U.S. lawmakers for a host of different reasons, not the least of which is their slow-as-molasses review process that companies (who employ Americans) are complaining about, and the agency's conflicts-of-interest policies for reviewers (some lawmakers want to make it EASIER for the FDA to allow reviewers who stand to gain financially from their decisions at the FDA ... not a good idea IMHO, but some lawmakers are pushing down that path anyway).  Lawmakers are also trying to make the FDA responsible for economic development, which I believe is a subject best assigned agencies like the U.S. Department of Commerce, but that's another area our lawmakers are pushing (this idea is a BAD idea IMHO) today.

Core Issue is Simply Stated:

It's become a standard business practice and operating procedure for global medical device and pharma/biotech companies to apply in Europe first (and Australia, and elsewhere for that matter), and often that precedes the U.S. by YEARS.  The logic makes perfect sense if you're a company: the approval process elsewhere (like Europe) is straightforward and once you have an approval, you get to sell your product to millions of Europeans (almost all of whom have healthcare insurance or nationalized healthcare), even while the FDA pussyfoots around.  You have a responsibility to your shareholders, so you need the cash flow to start ASAP.  But that also means that no one wants to bother with the FDA until much, much later because the agency is such a pain-in-the-@$$ to work with.

Considering the FDA relies almost exclusively on what's known as a "surrogate" endpoint of HbA1c reduction (see me post HERE for more background on that), the sluggishness of the FDA is IMHO simply unacceptable.  I could potentially understand that if we got new innovations sooner than everyone else, but we don't.  If the FDA sees HbA1c is reduced and disregards almost eveything else, why the heck can't they move any faster?  That's due in no small part because companies no longer apply in the U.S. first.  In fact, they avoid it until after they've received approvals in Europe, Australia, New Zealand and in some cases, even Brazil and Mexico.  They delay dealing with the FDA until they cannot wait any longer.

Changing perceptions for businesses that perceive the U.S. FDA as a slow and unpredictable regulatory agency with vague guidance on key issues is why no company really wants to deal with the FDA even while there are millions of potential customers here.

What Can Patients Do?

The most obvious one is to make our voices heard loud and clear and that we are going to continue commenting on what the FDA is doing, as is our right as citizens. Slow decisions are one example, but beyond that, the FDA's also over-relies on HbA1c reductions, which IMHO is a real impediment to getting appropriate decisions.  Beyond that, patients can file what's known as a "Citizen's Petition".  In practice, public companies have used Citizen's Petitions to complain about the FDA revealing so-called "trade secrets", things the FDA cannot reveal to the public about their manufacturing processes.  However, if the companies were to sue the FDA for revealing those trade secrets, they would have to produce evidence to the courts of what those secrets are, but in doing so, those would then be in the public domain (open to anyone via a Freedom of Information Law ["FOIL"] request.  Needless to say, industry would rather bitch to lawmakers about how they are being harmed by the FDA, when in fact, it is we as American citizens who are really the victims.

FYI: A trade secret is a formula, practice, process, design, instrument, pattern, or compilation of information which is not generally known or reasonably ascertainable.  Examples may include secret formulas which are revealed to the FDA as part of the approval process, but cannot be shared by the FDA with the public.  However, these are difficult to prove difficult to defend.  However, Citizen's Petitions may be filed by any U.S. citizen, and the FDA is bound by law to investigate and respond to the petitions.  But, I would like to recommend to anyone interested in the subject a few resources that ARE open to the public.

FDA Announcements via Federal Register RSS Feed/E-Mails  

First are Federal Register Notices on FDA Announcements.  The link to that can be found at (long link:  Here, you will find all FDA notices that are published (by law) in the Federal Register.  I would also call your attention to the fact that there, you will also find an RSS feed for these announcements (under the heading "Subscribe") which also offers and e-mail option.  Personally I find the RSS feed far more convenient, as any Federal Register updates automatically feed there, whereas e-mails are done in batch mode and may be delayed somewhat.  They offer the option to subscribe via Google Reader or Yahoo! Reader, or via an RSS link which I presume could be used in something like Microsoft Outlook.  The Federal Register FDA link above does a pretty decent job of the recently published stuff, and for items where comment deadlines are approaching.

Next I have a link to past FDA DOCUMENTS, which is a place you can find historical FDA guidance (no new updates there, but there you can find stuff that was released in the past).  That can be found at (long link:  This is more useful if you have a need to refer to past guidances that were published by the U.S. Food and Drug Administration.

Subscribe Today!

I would implore those of you in the diabetes online community to take advantage of the FDA Federal Register RSS or e-mail feed.  While a lot will not be of interest, when draft guidance documents related to biotechnology medicines like insulin, or diabetes medicines or medical devices (including blood glucose meters) are released, you'll literally be among the first to know!


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Chris Stocker said...


This post is awesome. After hearing you and Bennet speak a lot about the FDA at the Roche Summit, I have a new passion for learning more about the FDA, how it works, and how we can help get these life savings products into the USA quicker.

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Thank you again.