Repealing the Medical Device Tax

Floor Speech

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Mr. FITZPATRICK. Mr. Speaker, there is no doubt that the medical device tax that is found within the President's Affordable Care Act sends American jobs overseas, hurts American jobs here in the United States, raises healthcare costs for all Americans, and stifles innovation.

While I have supported the House's action to repeal this onerous tax and support innovation, it is important that I highlight an important issue to my constituents back home in Bucks County, Pennsylvania, because it is tied into this whole debate. That issue is medical device safety, and it is patient safety.

Many who serve in this Chamber may have seen the headlines over the past several months regarding a medical device known as a power morcellator and, specifically, the devastating damage it has caused to women's health by spreading unsuspected cancer throughout their body.

These devices are gynecological tools used to remove uterine fibroids and have been on the market for over two decades, but only recently, we have learned that the use of these devices increases the risk of spreading unsuspected cancers in women to as high as 1 in 350 cases.

That finding prompted the FDA to issue a black box warning on the devices last fall. Several major insurance companies have stopped covering the procedure, and some medical device manufacturers have pulled them from the shelves--all appropriate steps to be taken when it becomes clear that a previously approved device has potential to harm instead of help.

As a lawmaker, I must ask: How is it that we have gotten to this point? What are the FDA and the medical device industry's protocols?

That is why, on February 19 of this year, I sent a letter to the FDA asking pointed questions about the current streamlined regulatory process that the power morcellator went through, known as 510(k).

I asked about FDA's reporting process for dangerous devices and their postmarket surveillance techniques. I asked for detailed explanations on why the power morcellator remains on the market, despite the high risks that have now been revealed.

To date, nearly 4 months from the date that this letter was hand-delivered to the FDA, I have not received a written reply. I will insert my letter to the FDA into the Record.

These are important questions, the answers to which will inform any next steps that we need to take.

My constituents want answers. I want answers. And I think this Chamber needs answers so that we can properly begin to address these gaps in our device safety regulations that allowed the morcellator to slip through the cracks for so long.

Ensuring the safety of our constituents is paramount to each Member of this body, and that is what I seek when it comes to this issue. I am hoping the FDA will partner with me. I am hoping that every Member of this body will partner with me.

Industry and government need to work together to develop a robust, modernized postmarket device surveillance program that allows us to catch issues like the power morcellator faster and encourages responsive reporting protocols so if a doctor finds an issue with a device, the manufacturer and the FDA are promptly notified and provided accurate data to take the next appropriate steps.

But, unfortunately, it is becoming clear that the reporting system for faulty and deadly devices is broken. A recent Wall Street Journal story highlighted how, in 2006, a doctor from central Pennsylvania started to raise the alarm and asked questions about power morcellators. He was seeing an alarming number of cancerous tissues arriving at his lab that were coming in from morcellation surgeries. He estimated the occurrence at somewhere in the range of 1 in 300.

It took the FDA and industry nearly a decade to come to that same conclusion. Within that decade, an unknown number of women were harmed and deceased because their cancers went from localized and treatable to stage four and metastasized within days of being spread by the blades of this device.

What happened with the power morcellator should never be allowed to happen again. We need to ensure that risks are adequately assessed before devices hit the market. We need to monitor the devices once they are on the market. And we need to have efficient and effective reporting procedures in place. And those within industry and the FDA need to be held accountable if it is found that they are turning a blind eye to these issues.

I hope that my colleagues will join me in ensuring that patients and safety always come first.

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