Device Lag at the FDA

A new survey of the FDAs impact on medical technology innovation reports that the FDA is slow, inefficient and costly.  The survey is from the Medical Device Manufacturers Association so take it with a grain of salt (but see below). What is most telling, however, is how manufacturers rate the FDA compared to its European counterpart(s).

Overall Experience: 75 percent of respondents rated their regulatory experience in the EU excellent or very good. Only 16 percent gave the same ratings to the FDA…

Respondents also cite specific concerns with the FDA process (not just a general complaint of slowness which could be efficient) such as:

…44 percent of participants indicated that part-way through the regulatory process they experienced untimely changes in key personnel, including the lead reviewer and/or branch chief responsible for the product’s evaluation.

As a result:

On average, the products represented in the survey were available to patients in the U.S. a full two years after they were available to patients in Europe (range = 3 to 70 months later).

In some cases, respondents said they initiated their regulatory processes within and outside the U.S. at the same time, but received clearance/approval in the U.S. much later. In anticipation of long, expensive FDA reviews, others said they decided to seek or obtain European approval first in an effort to generate sales overseas that could help fund their U.S. regulatory efforts.

The survey has a good discussion of potential biases. To those not familiar with the industry it might seem obvious that the MDMA would want to bash the FDA but my experience is that companies in the business don't like to complain. Indeed, the survey notes:

A number of companies indicated that they would not respond due to fear of retribution from the FDA (despite assurances we would maintain their confidentiality).

See FDAReview for more on the FDA. Hat tip: Mike Mandel.

Addendum: Loyal reader Josh Turnage has produced a video plea to the FDA on behalf of his mother to leave Avastin approved for breast cancer.


Perhaps Americans are unusually suspicious of their national (i.e. Federal) government because it is unusually incompetent. So someone said at McArdle's blog re the healthcare reforms; could he have been right?

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In the industry, no one says a bad thing about the FDA. I am surprised they got anybody to answer. In my view, the fact that no one, and I mean no one, wants to criticize the FDA, says all you need to know about the agency.

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"The 1,190-patient trial found 15 percent of women on chemotherapy had no signs of disease when they underwent surgery, compared with 17.5 percent of those also given Avastin. The difference wasn’t statistically meaningful, researchers said yesterday at the San Antonio Breast Cancer Symposium."

That would be terrible if we made an alternative to standard Chemo available, especially considering how Chemo has probably been refined for decades and Avastin is statistically insignificantly better in its first iteration.

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I take Neal's point, but can we be more specific? What in particular are European regulators doing that American regulators should replicate? Are they dropping proof of efficacy? Less staff turnover?

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Just about everyone is going to die. Therefore we need new products that don't exist today. I wonder if it's all a big ruse to pretend we don't have to experiment in humans. If the government blesses it, somehow it isn't really experimenting in humans.

So, don't bother bringing something that has a different side-effect profile even though we are going to a personalized, cocktail approach for some of these fatal diseases because we don't want to deal with the CYA.

We probably already have outsourced the function to Europe. Letting them do it and then waiting some arbitrary period probably makes us look prudent.

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The issue is that for new diagnostics (Medical Devices include diagnostics), there is little regulatory structure in place. Essentially, you declare conformance to the standard and start selling.

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Your blog is my stepping stone, my friend. Thanks for the heads up on this subject.

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Yes, and the European countries approved thalidomide for morning sickness back in the late 50's, while the plodding FDA wanted to wait and get more information on what side effects might present in newborns.

I'm not a fan of regulation for its own sake, but some things do require great judiciousness. Being born with phocomelia is a bit of a negative externality.

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