WASHINGTON, D.C. - Stephen J. Ubl, president and CEO of AdvaMed, has released the following statement on the recent Government Accountability Office's (GAO) report designating FDA as a "high-risk" area of the U.S. Government and questioning the agency's ability to meet its public health mission:

"AdvaMed supports a strong and effective FDA and has long advocated that the agency be given adequate resources to continue to fulfill its vital mission to protect and promote the public health.

"While we agree the agency faces enormous challenges that need to be addressed, FDA has a long track record of successfully protecting the health of the American people and the public should have confidence that the agency continues to do its job effectively.
"Of the four areas of concern with FDA highlighted by GAO, we believe it is significant that only one - inspection of foreign manufacturing facilities - involves FDA's oversight of medical devices and diagnostics.

"AdvaMed and its member companies strongly support the goal of ensuring the safety of FDA-regulated products coming into the U.S., and we have long recognized the challenges the agency faces in meeting its responsibilities in this area. Inspections are a core function of FDA, and we strongly believe that Congress should provide appropriate funding to the agency for this purpose.

"We also believe that FDA's current risk-based inspection approach appropriately targets inspectional resources to those products which are expected to have the greatest impact on public health and safety.

"The American public also needs also needs to realize that the medical device industry has an excellent and proven safety record when it comes to its products and, while a part of that record of success, the frequency of FDA inspections is not the main reason for that achievement. The primary reason for this high safety profile is because companies who manufacture devices and diagnostics for U.S. patients are required to have in place robust quality systems to ensure their products are consistently manufactured to specifications."

"FDA inspections to ensure compliance with these quality systems requirements are part of the comprehensive safety programs in place. FDA has often not met its inspectional targets; however, instead of concentrating on arbitrary inspectional targets, FDA should determine its inspectional priorities based on risk-assessment and impact to the public health and dedicate its resources accordingly.

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