Dexcom Reports – The FDA Strikes Again

Dexcom Reports – The FDA Strikes Again

As Diabetic Investor has been reporting the ultra-conservative regulatory environment at the FDA is not just preventing new drugs from getting to market but is slowing the introduction of new devices into the marketplace. This fact was reinforced while listening to Dexcom’s (NASDAQ:DXCM) third quarter earnings call. Dexcom’s CEO Terry Gregg outlined the numerous challenges and hurdles being placed in-front of the company by the FDA. As Mr. Gregg indicated the every changing requests from the FDA are slowing new product introduction and placing new burdens on device companies.

Although it was not stated another disturbing message came through during this afternoon’s call, in that, due to the FDA America is in serious danger of falling behind Europe and the rest of the world in having the best devices available for patients with diabetes. This is especially disturbing as the diabetes epidemic continues to explode. The reality is these new and improved devices could well help improve patient outcomes and ultimately lower overall healthcare costs. Thanks largely to the FDA; patients once again are being forced to wait for this new and better technology that will soon be available in Europe.

As Mr. Gregg eluded too during his remarks this new regulatory environment is adding substantial costs to product development. It’s bad enough that new products are being prevented from reaching patients, even worse the companies submitting these new products are being forced to spend even more money to satisfy the FDA appetite for data. At the moment the FDA is like a hungry elephant that eats everything in its path yet never feels satisfied or full and continues to seek even more food.

Thankfully for Dexcom their core business is doing quite well and under Mr. Gregg’s expert guidance should be able to navigate this difficult FDA environment. While he may be unhappy with these every changing request’s for even more data, Mr. Gregg is keeping his eye on the prize and will do whatever is necessary to see Dexcom and patients with diabetes come out on top.