The report is critical because it defines a life-threatening safety deficit within a federal agency's regulatory apparatus. What's more, the FDA leadership agrees with these findings.
To be clear, the GAO has identified specific safety hazards at FDA's device section and the agency is agreeing with the investigators – that is a significant victory for our public health campaign.
But it is by no means a win. Nothing has changed at the regulatory level – and we believe it will take strong leadership from the White House to fix this imminent threat to American lives.
But Congress can no longer ignore a problem that the GAO confirms has brought disaster to hundreds of American families, all due to this problem at the FDA.
The GAO report has demonstrated the following facts:
1) Cancer upstaging by gynecological morcellation is a serious cancer risk factor in women, though its incidence was seriously underestimated or undermined by the vast majority of American gynecologists. As a result, for over two decades, unsuspecting American women have been harmed.
2) The 510(k) regulatory framework used by FDA Center for Devices and Radiological Health (CDRH) for evaluating and approving medical devices for use in patients does not ensure device safety. And it likely has allowed other dangerous medical devices onto the market.
3) An active surveillance system to detect bad outcomes connected with many medical devices is virtually non-existent.
4) There is no reporting requirement for specific adverse outcomes associated with the use of their specialized devices. Expert practitioners have access to the highest fidelity source of danger signals, which the FDA must get to protect the American public.
We have asked the same members of Congress who requested the GAO investigation now to inform President Trump of this public health hazard and request action.
A presidential executive order to put the FDA's CDRH on notice that it's time for a robust physician reporting system is an absolute necessity, both because of the cancer danger of the power morcellator, and also because this is likely to be the tip of a very large iceberg.
Here is a clear opportunity for the president to exercise his executive powers to protect unsuspecting American lives, to honor the many women fallen to disaster and to even save health care dollars. We can only hope that he and his advisors will grasp this opportunity.