The 'Fitzpatrick 12' in U.S. Congress: A bipartisan call for FDA accountability on medical device safety

by Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.

Published Aug. 10, 2015, 12:01 p.m. ET

On Friday August 7, 2015 a letter from the United States Congress, was delivered to the attention of the Comptroller General of the United States, Mr. Gene Dodaro – head of the Government Accountability Office (GAO).

You can read this letter here.

The letter was a formal request for the Comptroller General to initiate a GAO investigation into the root causes of a disaster in women's health. This disaster was caused, in great part, by the FDA's careless clearance and absent post-market surveillance of a medical device known as a "power morcellator".

The faces of harm by this device are clearly before our federal government. You can view the harmed here - they are the "guardians" whose battles will serve to protect all others in harm's way, present and future.

The bipartisan letter of August 7 to Mr. Dodaro was signed by twelve representatives in the United States Congress, and was spearheaded by Rep. Mike Fitzpatrick (R-PA) and Rep. Louise Slaughter (D-NY).

Representatives Fitzpatrick and Slaughter, both of whom have constituents with medical issues due topower morcellation, clearly see their responsibility to the American people to fix FDA's broken regulatory framework governing medical device safety.

In their letter to the comptroller general, the "Fitzpatrick twelve" asked the GAO to consider the following questions in their investigation:

1) Did the FDA's reliance on the 510(k) approval policies and procedure sufficiently identify risks of adverse events before the laparoscopic power morcellator was allowed to enter the market?

2) Were the medical device reporting regulations (21 CFR 803) appropriately followed to protect patient safety in the case of the laparoscopic power morcellator by manufacturers, importers, user facilities and the FDA?

3) What activities or training did manufacturers provide to clinicians and what professional society standards, if any, apply to training on the use of these devices?

4) What steps is the FDA taking after issuing the black box warning to further determine whether the laparoscopic power morcellator is safe to remain on the market?

At a time when the United States Congress is characterized by partisan bickering, this request for a GAO investigation demonstrates that our representatives can work to identify and eliminate threats to America's health and wealth.

We hope to confirm the initiation of an investigation by the nonpartisan GAO in the next few weeks. But, there remain no guarantees that even a GAO investigation will prompt Congress into action.

You can read a clear example of congressional ethical dereliction against the people (and women's health) here and here.

We, and many other concerned and affected citizens, applaud the "Fitzpatrick twelve" for their tenacious action on behalf of America's public health. But more importantly, we ask why more of their informed colleagues have not joined them in calling for this GAO investigation – if for nothing else, to understand the root causes of a deadly harm done to many American women and their families for over two decades.

Prominent and powerful names such as Congressman Joe Pitts (R-PA), chair of congress' subcommittee on health, and Congressman Fred Upton (R-MI), chair of the committee on Energy and Commerce, know about the "power morcellator" disaster in women's health, yet have not supported the investigation.

We know that if a GAO investigation is done properly and with care, it will provide information and insight into a wide-scale and severe public health threat – one, which no congressional representative can justify ignoring.

For now, our hats are off to the "Fitzpatrick twelve" for standing outside of party politics and looking for reason, ethics, integrity and justice - and aiming to protect the public with resolve: Mike Fitzpatrick (R-PA), Louise Slaughter (D-NY), Ralph Abraham (R-LA), Rosa DeLauro (D-CT), Bill Pascrell (D-NJ), Lou Barletta (R-PA), Doug LaMalfa (R-CA), Anna Eshoo (D-CA), Jan Schkowsky (D-IL), Chris Smith (R-NJ), Stephen Lynch (D-MA), and Rick Larsen (D-WA).

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.