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Feature Post-marketing Surveillance

Why the FDA can’t protect the public

BMJ 2010; 341 doi: (Published 03 November 2010) Cite this as: BMJ 2010;341:c4753

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FDA is Gold Standard of Review

I read with great dismay the article "Why the FDA can't protect the
public" written by Shannon Brownlee and Jeanne Lenzer. While it is clear
to me that they already made up their minds about the FDA and the medical
device community before writing the article, it is unfortunate that they
didn't spend time acknowledging the cutting-edge advancements and
improvements to patient care medical devices provide every day.

Health care providers and medical device manufacturers strive to
ensure that patients have access to the safest, most efficacious products
that will increase their quality of life. Today, with cutting-edge
technologies and medical advancements, the average American can expect to
live to 78, a 65% increase over the past 100 years. The medical device
industry is perhaps one of the greatest unsung contributors to increased
life expectancy. Research has shown that since 1980, death rates have
declined 16 percent and Americans spend 56 percent fewer days in the
hospital, due in part to medical devices.

Brownlee and Lenzer seem quick to focus on select instances of
unfortunate results, while failing to acknowledge the overwhelming success
rate and positive experiences of millions of Americans each year. In
fact, a recent study of FDA approved medical devices from the past five
years showed that less than one percent of devices were recalled. And,
the overwhelming majority of those recalls were attributed to
manufacturing and design issues in a post-market setting. The fact is
that FDA is the gold-standard for reviewing and approving medical devices.
These numbers clearly contrast the "sky is falling" narrative that
Brownlee and Lenzer are communicating to your readers.

Perhaps worse, they rely on expert commentary in their research by
two individuals who have a long history of criticisms
towards both regulators and medical device manufacturers. Browlee and
Lenzer have already published their opinions in Reader's Digest this past
August. I'm not sure what their goals and methods are in re-writing
stories in multiple publications, but I do know that your readers expect
to hear both sides of every story, and it is unfortunate that the authors
didn't see to it.

Both the FDA and medical device industry share common goals to ensure
patient safety and promote innovation so that patients can lead healthier,
more productive lives. Perhaps the next time Brownlee and Lenzer decide
to look at one of America's most innovative and patient-driven industries,
they will acknowledge this part of the story.

Competing interests: No competing interests

13 November 2010
Mark B. Leahey
President and CEO
Medical Device Manufacturers Association