To: President Donald Trump
Safety Deficit in FDA’s Medical Device Regulatory Framework.
President Trump, there is a critical national health threat in the United States that requires your presidential executive action.
In particular, the medical surgical device known as the power morcellator, which for 23 years has been devastating women’s lives across the United States, for which the Government Accountability Office (GAO)recently criticised the FDA's lack of action.
Why is this important?
I, among thousands of others and their families who have personally been harmed by the Power Morcellator, are fighting for our lives. We and concerned citizens ask for your immediate attention on this health threat and direct support – so that 1) the "Guardians" are honored and H.R. 5404 becomes law, and 2)that you also oversee that Congress acts to dismantle FDA's dangerous 510K predicate legislation as the IOM researched and adamantly advised in 2009.
Dear Mr. President Trump,
I am writing to draw you attention to critical national health threat in the United States.
In particular the medical surgical device known as the power morcellator, which for 23 years is devastating women’s lives across the United States, for which the Government Accountability Office recently criticized the FDA's lack of action.
This disaster in women’s health has highlighted a critical safety deficit in FDA’s medical device regulatory framework. Specifically the 510K predicate legislation, that greenlights new "similar" medical devices through the FDA without any patient clinical trials or post-surveillance. 510K is still in use even after the Institute of Medicine (IOM) strongly advised it to be dismantled as the institute could not ensure device saftey.
But I would also like to draw your attention that the power morcellator disaster has demonstrated that federal law does not require individual physicians to “self-report” adverse outcomes associated with the use of FDA approved medical device back to FDA.
These critical professional failures have led to the premature or unnecessary loss of many unsuspecting American women’s lives.
Mr. President, the power morcellator will most certainly not only be the example of a dangerous medical device harming American patients, undetectable by the safety counterpoints of the FDA’s “radar screen” because of 1) 510K predicate medical device greenlighting and 2) lax or absent safety and reporting requirements.
On June 8, 2016 U.S. Congressional representatives Mike Fitzpatrick (R-PA), Louise Slaughter (D-NY) and Ryan Zinke (R-MT) introduced a bill in honor of the women fallen to disaster by power morcellators. This bill is named the Medical Device Guardians Act (H.R. 5404).
H.R. 5404 seeks to codify a mandate of the AMA’s Code of Medical Ethics regarding physicians’ responsibility to self-report adverse outcomes associated with the use of medical devices (AMA Code of Ethics. Opinion 9.032) – this bill also serves to protect the reporting physician from malpractice liability, should he/she self-report an adverse outcome.
Mr. President, H.R. 5404 is a fully non-partisan and totally bipartisan bill. It will very certainly save lives in the United States and abroad, because it will provide high fidelity danger signals to public health experts at FDA.
But, as you well know, most proposed bills die in the House of Representatives.
We are almost certain that unless you rise with us immediately with executive action and look at this public health threat in the medical device space, and at this simple and cogent legislative measure, H.R. 5404 will die too.
We ask for your immediate attention on this health threat, and direct support – so that the Guardians are honored and H.R. 5404 becomes law and that you oversee that Congress acts to dismantle FDA's dangerous 510K predicate legislation as the IOM researched and adamently advised in 2009.