Congressman Mike Fitzpatrick (R-PA): A call to federal arms in defense of public health

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

Published July 2, 2015, 9:55 a.m. ET

On June 17, 2015 a congressman from Pennsylvania delivered a five-minute speech before the general assembly on the floor of the United States House of Representatives. We ask that you watch this speech with care at this link.

Congressman Mike Fitzpatrick, well recognized as a solid, pro-industry conservative, warned his colleagues in the United States congress of a severe public health hazard: the medical device industry is not being regulated by FDA with patient safety as its first and foremost priority.

Fitzpatrick's message to his congressional colleagues was clear. We take the liberty to paraphrase his sentiments: We have a problem. The American people have a problem. The legislation governing one of our federal agencies is creating a public health hazard. He emphasized that the medical device industry is suffering from a lack of sufficient FDA oversight – despite the FDA's being one of the largest federal public health agencies in the United States.

Acting in response to this clear failure in federal regulation, he formally addressed the FDA, in writing, demanding an explanation. Four months have elapsed from the time of this congressional letter's hand delivery to FDA - but there has been no response from that agency's leadership.

Fitzpatrick recognizes his duty to the American people from his federal seat – and he is concerned. He clearly and publicly stated: "…it's becoming clear that the reporting system for faulty and deadly devices is broken…". Yet both the FDA and his colleagues in Congress remain silent thus far.

So we ask: Senator Alexander, Senator Casey, Senator Markey, Senator Toomey, Senator Warren, Congressman Pitts, Senator Schumer, Senator Gillbrand, all standing members of the United States congress – what will you do to secure the medical device regulatory space for the American people?

Many have died unnecessarily or prematurely. Many more remain in harm's way.

We, again, remind the United States congress that the "power morcellator disaster" in women's health is a bellwether case for public health and patients safety in the United States.

Congressman Fitzpatrick of Pennsylvania has sounded the alarm clearly on the floor of the United States House of Representatives for all his colleagues to hear. What remains to be seen is if our federal representatives find themselves capable of containing this severe legislative public health hazard – despite powerful industry forces to the contrary.

Will congress act cogently and deliberately in light of the harm that has been done to many unsuspecting American families? Congressional action, or lack thereof, on the "power morcellator" disaster will be telling of the state of affairs and purpose in our federal government.

For now, our many thanks go to Congressman Mike Fitzpatrick of Pennsylvania for apparently being a lone voice of reason - standing in defense of patient safety and public health and calling his colleagues to arms.

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.