In 2007, a subcommittee of the FDA’s Science Board released a report which, among other things, found that the FDA had a “weak scientific base and inadequate scientific workforce.” Recently, the same committee of national experts from various scientific disciplines assessed the progress of the FDA in firming up its “scientific base.” The Committee’s findings were published in a September 2015 report titled, “Mission Possible: How FDA Can Move at the Speed of Science.”
While the report opens by touting the “significant strides” the FDA has made in strengthening its scientific capabilities, the Committee “notes with concern” that medical product quality control procedures have not kept pace with advances in research and product development.
In an era in which Congress is pushing for increased deference to the pharmaceutical and medical-device industries, it is deeply troubling that the FDA is supposedly out-manned on the scientific front.
On the pharmaceutical fraud and medical device fraud frontlines, qui tam relators and the Justice Department confront manufacturers who commit fraud by providing inflated survival or other data for their pharmaceuticals or medical devices.
At times, with the assistance of whistleblowers, the government is able to pull back the “scientific” curtain masking these products. However, because of the limitations of the False Claims Act, not all “fraud on the FDA” is reachable.
The simple reality is that Congress needs to step up and provide the necessary resources for the FDA to hire and retain the world’s greatest scientific minds. Otherwise, the deficit at the FDA will continue to be taken advantage of by wrongdoers within the pharmaceutical and medical device industries.
More information for whistleblowers is located at the Nolan Auerbach & White website.