Regulatory Focus™ > News Articles > Snowstorm Costs Device Company a Million Dollars

Snowstorm Costs Device Company a Million Dollars

Posted 02 May 2014 | By Alexander Gaffney, RAC 

For most people, a snowstorm costs them time digging out their car or a sore back from shoveling. But for medical device manufacturer STAAR Surgical, a February 2014 snowstorm wound up costing it about one million dollars.

How, you ask?

The company was scheduled to meet with a US Food and Drug Administration (FDA) Advisory Committee on 14 February regarding a premarket approval (PMA) application for its Toric ICL intraocular implant. FDA's advisory committees provide the regulator with influential, though non-binding, advice that the agency usually follows.

Unfortunately for STAAR, that was also the date of a massive snowstorm in the DC region, one which shut down the government and dumped more than a foot of snow in parts of the suburbs surrounding DC.

As a result of the shutdown, FDA postponed STAAR's advisory committee meeting by one month, presumably delaying its eventual approval. While the company received a positive vote from the panel at the March hearing, it is still awaiting final approval from FDA.

Bad Weather, Higher Costs

And as STAAR explained in its most recent earnings report, that month has proven especially-and unexpectedly-costly

In a statement on the company's website, STAAR President Barry Caldwell said the company's expected advisory committee costs were "nearly double our original forecast and led to the GAAP net loss for the quarter."

STAAR said it spent $1.4 million on the Advisory Panel meeting itself, but also incurred higher than expected R&D costs of $2.1 million "driven by the cost of the FDA Advisory Panel meetings."

The take-away for companies: Perhaps it's better to aim for a spring, summer or fall Advisory Committee panel meeting, when weather is far less likely to derail the approval of your company's product.


h/t Mass Device


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