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By: Scott Whitaker, President and CEO, AdvaMed
January 18, 2019

Setting the Record Straight on the Safety of Medical Devices

The Washington Post recently published an opinion piece by critic Jeanne Lenzer and a colleague which contained misleading and inaccurate claims regarding the safety of medical devices and FDA’s oversight of these products. I want to set the record straight so that patients can have confidence in the safety and effectiveness of the medical devices they depend on to live longer, healthier, more productive lives.

America’s medical technology industry is dedicated to providing patients worldwide with safe, innovative treatments and cures to solve some of our most pressing health care challenges, including cancer, heart disease and diabetes.

Regrettably, the column’s authors get basic facts wrong, and paint an inaccurate, one-sided picture of an industry that has done so much to improve patient care and ease human suffering.   

To begin with, the authors lament there is no readily-available site to report problems should patients have issues with their devices. As I write this, the first four Google results for “report problem medical device” take you directly to the FDA website where patients, doctors, and device makers can do exactly that.

The authors erroneously claim there are “loopholes” in FDA’s review process that allow products to market without human clinical trials. This is false and displays a gross misunderstanding of the medical device review paradigm. FDA evidence requirements are based on the risk posed by the device and what the agency deems is necessary to determine its safety and effectiveness. Clinical trials are often not necessary and other mechanisms – bench testing, animal studies, biocompatibility testing, etc. – can provide greater assurance of safety and effectiveness. There is no medical precedent – no studies, no literature – that shows that human trials produce safer devices when they have already undergone rigorous bench and other premarket testing. 

Another false claim leveled by the authors alleges that representatives of my association, AdvaMed, “met secretly” in 2015 with then FDA Commissioner Rob Califf on provisions of the 21st Century Cures Act of 2016 that “lowered” evidence requirements for device approvals.

First, any meeting with the FDA Commissioner is on the public docket, so there is no such thing as a “secret meeting.” Secondly, there were dozens of public meetings, listening sessions and congressional hearings (not to mention an electronic public docket) over a two-year period before the legislation received near unanimous support in the House and Senate and was signed by President Obama. This was one of the most transparent legislative processes in the history of American lawmaking. To suggest that a single meeting somehow resulted in the inclusion of provisions without adequate scrutiny is false and cheapens all the hard work that went into this landmark law.

Finally, Lenzer and Brownlee’s assertion that the Cures Act somehow lowered the evidence bar for device approvals is directly contradicted by the legislation, which explicitly states: “Nothing in this paragraph alters the standards for premarket approval of a device.”

The authors opine that FDA is a “captive agency,” and call for the elimination of the user fee programs that medical device and other FDA-regulated industries pay to supplement the agency’s appropriations. This is not unique to FDA; numerous federal agencies and industries have similar programs. FDA does not agree to “faster approvals” in exchange for these fees as claimed. If a device does not meet the agency’s standard for safety and effectiveness it will not go to market. Period.

In an ideal world, FDA would receive sufficient funding via federal appropriations. Unfortunately, that has not happened. Before the device user fee program, FDA funding was either flat or falling for several years, while the pace of innovation and types of new products in the pipeline were more and more complex, requiring even more agency resources. Faced with an increasing product review backlog, FDA, Congress and industry jointly decided that adopting a user fee was the best solution. Since then, the program has been a success for all involved: Patients have timely access to new innovations; FDA has supplemental funds to ensure comprehensive and efficient reviews; and the medical device sector has the predictability it needs for long-term planning.

No regulatory system is perfect, and industry is willing to engage with all stakeholders on ways to make the process better. But to completely ignore the incredible benefits that medical devices and diagnostics have brought to millions of people worldwide – thanks to the diligence of manufacturers and the oversight of FDA – is irresponsible and a disservice to the patients we proudly serve.