Is FDA Bureaucracy Impacting Innovation in the American Medical Device Industry?

The argument of a restrictive government bureaucracy impacting economic growth is a familiar one, but is it possible to expand the scope of this point of view and apply it to the medical device industry? Recently on The Hill’s Congress Blog, Rep. Joe Pitts posted an article where he postulated the idea that the FDA must find a way to streamline its medical device approval process in order to maintain a competitive edge in the global health market.

Pitts’ article was focused almost entirely on the future of the medical device industry in the United States. Pitts demonstrates his familiarity with the current state of medical device innovation and manufacturing in the United States, calling it “vibrant” and referring to the nearly half million American workers it employs. However, when turning his eye towards what may come for medical device companies operating in the U.S., the Representative is less optimistic, citing increased competition from manufacturers and firms in the European Union – not India or Asia – as the single largest threat to the American medical device industry.

Pitts uses several examples to bolster his case that the FDA is no longer offering an acceptable trade-off between risk and progress in its regulatory decisions. He names extended medical device approval waiting periods as one of the chief issues for American companies frustrated by their attempt to remain profitable and bring products to market, referring to the fact that the E.U. does not offer the same type of regulatory roadblocks. Pitts also provides a more anecdotal example of a specific U.S. medical device company which has complained about the time-to-market disparity between FDA and E.U. device approvals.

At MDCI, we agree with Rep. Pitts that a “race to the bottom” in terms of reducing 510(k) approval times at the expense of quality is not a viable nor even a desirable strategy for the FDA to adopt. However, it is interesting that the Congress Blog post comes at a time when the FDA appears to be at a crossroads in redefining several of its pathways to market and medical device classifications. Pitts’ article also marks a seeming bi-partisan effort involving the Republican representative and Obama’s Democratic White House to create a more transparent and simpler to navigate regulatory environment for medical devices in the United States.

The political pressure continues to mount on the FDA to come up with some type of acceptable compromise between protecting the health of American citizens and fostering the interests and viability of the domestic medical device industry.

Benjamin Hunting
MDCI Blogging Team

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