WASHINGTON, D.C. – Congressman Mike Fitzpatrick (PA-8) sent the following letter to the Food and Drug Administration Tuesday regarding dramatic changes in the reporting of adverse events caused by the medical device Essure:
Dear Dr. Shuren,
Information has been brought to my attention that shows a dramatic change in how Adverse Event Reports relating to the permanent sterilization device Essure were submitted to the FDA coinciding with the agency’s announcement that it was reviewing the safety of the device.
As you know, when a manufacturer submits an Adverse Event Report to the FDA one of the data fields to be filled is “Reporter Occupation.” Examples of how that field can be coded by the manufacturer include “Physician,” “Health Professional,” “Nurse,” “Pharmacist,” “Paramedic,” “Risk Manager,” and “Other.”
As it relates to Essure, from January 2002 through June 2015, the manufacturer of the device submitted nearly 600 Adverse Event Reports in which the “Reporter Occupation” field was coded as “Physician.” This corresponds to the narrative information included in the report in which it clearly states the information in the report came from a medical doctor, a Gynecologist/ Obstetrician, a physician, or other similar term.
However, this coding changed dramatically in July 2015. I find this extremely concerning given the fact that on July 17, 2015, the FDA announced it was reviewing the safety and effectiveness of the Essure device.
After the FDA’s public announcement, Adverse Event Reports received by the agency from the manufacturer of Essure no longer coded reports from medical doctors as Physician reports. Instead, almost every report received from a physician between August 2015 and February 2016 listed the Reporter Occupation field as “Other.” This is a clear change from how the manufacturer coded prior to FDA’s announcement despite the same keywords, like medical doctor or Ob/Gyn, being found in the narrative portion of the reports. A similar change was noted in reports received from nurses.
I respectfully request the FDA to review the Adverse Event Reports from physicians and provide answers the following questions:
1. Did the FDA request the manufacturer to change how it was coding physician reports?
2. If the FDA did not request this change, is there a legitimate basis by which a manufacturer would suddenly change how they code reports from medical doctors and Ob/Gyns and code the occupation as “Other” instead of as “Physician”?
3. Was the FDA aware of this change?
4. Did the manufacturer of Essure notify the FDA it was changing how it reported the Report Occupation field within the Adverse Event Reports?
5. Was the FDA aware of this change prior to the September 24, 2015 Advisory Committee meeting related to Essure?
6. Does the FDA review Adverse Event Reports with the Reporter Occupation field coded as “Physician” differently than reports coded as “Other?” Are “Physician” reports given more weight when FDA is reviewing Adverse Event Reports than reports coded as “Other?” If so, please describe the differences in how the FDA reviews a report received from a physician compared to other types of reports.
7. If the FDA were to generate a list of Adverse Event Reports received from “Physicians” about Essure, would reports coded as “Other” be included? If the Reporter Occupation is listed as “Other,” does the FDA conduct additional analysis of the narrative portion of the report to determine if the report came from a medical doctor?
8. Is it illegal for a manufacturer to knowingly manipulate data listed on an Adverse Event Report?
9. What are the penalties for knowingly submitting false information to the FDA in an Adverse Event Report?
10. Has the FDA ever held a manufacturer accountable for falsifying or intentionally miscoding information submitted in an Adverse Event Report?
I appreciate your prompt attention to this request. Should you have any questions, please do not hesitate to contact Justin Rusk on my staff.
WASHINGTON, D.C. – Congressman Mike Fitzpatrick (PA-8) Wednesday called on Vice President Joseph Biden to take action on reforming medical device review and monitoring processes as part of the Administration’s “Cancer Moonshot” initiative – specifically highlighting power morcellators.
“As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices. In 2016 there will be an estimated 595,690 cancer deaths in the United States. We must guard against unsafe medical devices from contributing to those staggering statistics,” wrote Fitzpatrick. “While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor, and quickly take action should those devices do harm. Unfortunately, we are too late for many women who, because of morcellation, were not given a fair chance to fight and beat their cancer. But we have a chance to protect others.”The complete letter is below:
Dear Vice President Biden,
I applaud your efforts as part of the cancer Moonshot program to make cancer a thing of the past. This program will have life changing effects on the more than 14 million people living with cancer in the United States.
As part of the Cancer Moonshot, President Obama called for the development of a virtual Oncology Center of Excellence within the Food and Drug Administration (FDA). The purpose of the center is to “support the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer.” While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe. Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.
Power morcellators are FDA-cleared medical devices that are used to remove uterine fibroids. The blades of this device shred the uterine fibroids, which are then removed through a laparoscopic incision. For over two decades, morcellation was marketed as a safe, routine procedure. However, if a uterine fibroid is harboring an undetectable cancer, the morcellation of that cancerous tissue and its removal through the abdominal cavity can spread that cancer throughout a woman’s body. This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. And tragically for too many women, this routine procedure ended with a death sentence.
Although the risk of spreading unsuspected cancers in women is as high as 1 in 352 cases, for decades the device stayed on the market, and it was only in November 2014 that the FDA put a black box warning on the device. It took a victim of morcellation and mother of 6, Dr. Amy Reed, to get the FDA take notice. It took the families of those who lost mothers, sisters, and wives, and those who continue to battle the cancer spread by morcellation, to get the FDA to take action.
As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices. In 2016 there will be an estimated 595,690 cancer deaths in the United States. We must guard against unsafe medical devices from contributing to those staggering statistics. While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor, and quickly take action should those devices do harm. Unfortunately, we are too late for many women who, because of morcellation, were not given a fair chance to fight and beat their cancer. But we have a chance to protect others. We must take action.
There are simple steps we can take today to improve patient safety for tomorrow’s beneficiaries of innovative new devices. One simple way we can do this is to ensure that serious injuries and deaths caused by medical devices are promptly reported to the FDA. For years there was evidence that morcellation was spreading cancer in women. But those reports never made it to the FDA. For years women were dying from the cancer spread by this device. But their deaths were never reported to the FDA by the hospitals, the device manufacturers, or the doctors who were charged with their care.
This was despite federal requirements that FDA be informed about unsafe devices. We must do more to strengthen medical device reporting regulations to ensure that dangerous devices, like the morcellator that spread cancer in women for decades, are quickly identified and removed from the market before they can do more harm.
I applaud your leadership on this important mission that will undoubtedly save lives, and look forward to continuing to work with you to help eliminate cancer as we know it.
Please do not hesitate to contact me if I may be of assistance.
WASHINGTON, DC – Congressman Mike Fitzpatrick (PA-8), a member of the House Financial Services Committee, released the following statement regarding the Department of Labor’s release of its finalized fiduciary rule:
“While I share the Administration’s concerns to protect retirees and individuals planning for their retirement, I have serious concerns that this rule will have the unintended consequence of placing quality and affordable financial advice out of reach for the millions of American families that need it most. It is important that elected officials carefully review this new rule to ensure investors are receiving the best advice and small businesses are spending more time advising their customers rather than complying with new Washington mandated regulations.”
During five hearings and a markup on the proposed rule, the Financial Services Committee learned:
"The calculations underlying these numbers misinterpret and incorrectly apply the findings of the very same academic research cited as the foundation of the claims, and do not consider the significant harm to retirement savers that is sure to result if the Department adopts the rules as currently drafted. In fact, these assertions do not stand up when tested against actual experience and data.” - Paul Schott Stevens, President and CEO of the Investment Company Institute
“Securities and Exchange Commission Chairwoman Mary Jo White told lawmakers Tuesday that if the agency proposes a rule to raise retail investment advice standards, it may not mesh perfectly with a separate Labor Department rule that will soon be finalized.”
“First and foremost, we continue to be very concerned that the DOL has proposed a rule that will severely restrict African Americans’ and low- to moderate-income Americans’ ability to save for retirement. The new regulations also will make it more difficult for our members – as small business owners – to sponsor retirement savings plans for themselves and for the benefit of their employees.” – National Black Chamber of Commerce
“As a result of the proposed rule, African American families will have less opportunity to achieve their retirement goals because the lower-cost commission-based services they benefit from today will no longer be available for IRAs." – Ivan Earle, Chairman of Primerica’s African American Leadership Council
Congressman Mike Fitzpatrick is serving his fourth term in the U.S. House of Representatives. He represents Pennsylvania’s 8th district which includes all of Bucks County as well as a portion of Montgomery County. He serves as the Vice Chairman of the House Financial Services Subcommittee on Oversight and Investigations.Read More
LANGHORNE, PA – Congressman Mike Fitzpatrick (PA-8) released the following statement Monday regarding the announcement of the Food and Drug Administration’s five-month review of the permanent sterilization device Essure:
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.
Frankly, I’d contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering. It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths. As my constituent, Dr. Amy Reed, a victim of unsafe devices herself, testified at the FDA in September, ‘[w]e don’t need to hurt any more women.’ If the FDA is going to order another study, then at minimum they should take Essure off the market during that time. A 60 day comment period and another study while this device remains on that market only guarantees more women harmed.
Because the FDA is failing to act, I believe Congress must. That’s why, moving forward, I will advocate for a number of legislative actions to address this issue, including:
- Continuing my call for the House and Senate to take up and pass the E-Free Act to revoke the FDA approval of Essure;
- Working to block government agencies - such as the DOD and VA - from purchasing this unsafe device; and
- Introducing new legislation to eliminate the blanket civil liability protections that device manufacturers like Bayer currently receive for a non-life-saving device like Essure because those harmed deserve a voice in court.
Simply put, it’s time for Congress and the FDA to get serious about reforming medical device safety laws.”
Fitzpatrick has been the leading voice in Congress calling for removal of Essure from the market – introducing the E-Free Act in November of 2015. Ahead of the FDA’s report, Fitzpatrick wrote to the agency urging them to consider possible inconsistencies in the number of fetal deaths caused by the device and also legal complaints alleging illegal kickbacks.
More than 25,000 women reported symptoms including extreme pelvic and abdominal pain, migraines, loss of teeth and hair, and the coil cutting into the uterus and other organs in the abdominal cavity. 10,000 have filed formal complaints with the FDA.Read More
WASHINGTON, D.C. – Chairman Mike Fitzpatrick (R-PA) and Ranking Member Stephen F. Lynch (D-MA) together held the first hearing of the newly-reauthorized Task Force to Investigate Terrorism Financing Wednesday focused on trade-based money laundering.
Trade-based money laundering has been widely recognized as the most common form of money laundering and value transfer method utilized by crime and terrorist organizations, allowing these groups the ability to move billions of dollars annually virtually undetected. Given the considerable volume of international trade and the value of the transactions, the effects of trade-based money laundering can result in extensive repercussions for global commerce and government revenues. In response, the Department of Homeland Security established the first Trade Transparency Unit (TTU) in 2004 to examine anomalies and financial irregularities in trade data to identify instances of trade-based money laundering and customs fraud.
“In an increasingly connected world, trade-based money laundering allows terror and criminal syndicates to disguise their billions of dollars annually through the use of trade transactions in an attempt to legitimize their illicit origins. This cannot be allowed to continue,” said Fitzpatrick. “Building on what we know and have learned, this session of the task force will take a much closer look at this process as well as investigate several lesser known methodologies mentioned in previous hearings, including terror funding streams from Latin America, developing our regional partners’ capabilities to combat terror financing and the funding of foreign based terrorists.”
“With the complexity and rapid growth of international trade, there is ample opportunity for terrorist financers and criminal organizations to exploit the global financial system and engage in trade-based money laundering with low risk of being caught. We must increase transparency in the global trade network in order to increase the ability of the Financial Action Task Force (FATF) and other organizations to investigate this illicit money laundering and to halt this revenue source for terrorist organizations,” said Lynch. “I look forward to working closely with Chairman Fitzpatrick and our colleagues to address this critical issue and other potential vulnerabilities in the global financial system during the new session of the Task Force to Investigate Terrorism Financing.”
Testifying at the hearing were:
Mr. John Cassara, former U.S. Intelligence Officer and Treasury Special Agent
Mr. Louis Bock, former Senior Special Agent, U.S. Customs and Border Protection
Mr. Farley Mesko, Co-Founder and Chief Executive Officer, Sayari Analytics
Dr. Nikos Passas, Professor of Criminology and Criminal Justice, College of Social Sciences and Humanities, Northeastern University
“[The Department of Homeland Security] has neither the customs nor financial expertise to make the [Trade Transparency Unit] initiative a success. The loser here is our ability to tackle trade-based money laundering and tax revenue loss on a grand scale along with a missed opportunity to target funding flowing to terrorist targets such as ISIS which, of necessity, do participate in global trade,” said Bock.
Key Takeaways from the Hearing:
The Department of the Treasury, citing Immigration and Customs Enforcement information, has described trade-based money laundering as capable of laundering billions of dollars annually.
Key characteristics of the international trade system make it both attractive and vulnerable to illicit exploitation, including the enormous volume of trade, the complexity of foreign exchange transactions, and the limited ability to exchange customs data between countries.
Although trade-based money laundering is widely recognized as one of the most common manifestations of international money laundering, it appears to be less understood among policymakers than traditional forms of money laundering.
On Monday, the Drug Enforcement Agency (DEA) announced arrests targeting Lebanese Hizballah’s External Security Organization Business Affairs Component (BAC), which is involved in international criminal activities such as drug trafficking and drug proceed money laundering. The proceeds from illicit drug sales are laundered internationally and used to purchase weapons for Hizballah’s involvement in Syria. As the DEA notes, this multi-national investigation “spans the globe… and once again highlights the dangerous global nexus between drug trafficking and terrorism.”
Building on previous findings, the task force will continue to hold hearings with U.S. terror financing officials and global counterterrorism experts to identify weaknesses in current policy, while working to ensure terror groups are unable to financially support their operations.Read More
“[P]reservation of our environment is not a partisan challenge; it’s common sense. Our physical health, our social happiness, and our economic well-being will be sustained only by all of us working in partnership as thoughtful, effective stewards of our natural resources.” - President Ronald Reagan, 1984
One of the important areas of agreement in the nation’s capital is the unifying understanding of the importance of protecting and conserving our national resources.
Together, Republicans and Democrats in this Congress have continued advancing that common objective by working together to protect open spaces and wild places, while keeping the government’s reach in check. Through educational initiatives and supporting programs with successful track records, I am proud to advocate for bipartisan steps to address what President Reagan knew was a common sense issue, not a partisan challenge.
Land and resource conservation has always been an area of bipartisan agreement – and one which Congress has worked to strengthen this session. From reforming the tax code to extend tax incentives for landowners who set aside property for conservation purposes to fully funding the Forest Legacy program, steady progress is being made.
Additionally, there has been renewed focus on the Land and Water Conservation Fund (LWCF). For more than 50 years, this program has been the leading program in protecting America’s natural heritage and providing recreation opportunities for everyone - at no cost to taxpayers. The LWCF fund is supported entirely by a portion of royalties oil and gas companies pay for the right to drill in federal waters.
It is the only federal program dedicated to the continued conservation of our national parks, forests, wildlife refuges, wilderness, Civil War battlefields, state and local parks, working forests and critical wildlife areas. Thanks to LWCF, Americans have enjoyed unfettered access to land within and surrounding our national parks, monuments, forests and historic sites from Pennsylvania to Alaska.
As the lead Republican sponsor of legislation permanently reauthorizing the LWCF I’ve worked with a growing coalition of House members to protect our nation’s most important conservation program.
While this vital program was allowed to lapse – expiring in September for the first time in history – Congress took action this month to provide a three year extension of the LWCF. This short-term extension removes the specter of uncertainty from the immediate future, but we must not top short of a long-term solution. With 200 co-sponsors of my legislation in the House and 18 in the Senate, support for permanent reauthorization is strong. Congress must act so future generations can reap the benefits of America’s natural beauty and diversity.
Ensuring that children and students of all ages have access to nature is one part of the puzzle, while educating them to appreciate the importance of the natural environment and act as future stewards is equally important. That is why I am proud to have advocated for legislation that passed as part of the larger Every Student Succeeds Act to bolster American students’ environmental literacy by strengthening their environmental education opportunities.
The provision contained in ESSA comes from the No Child Left Inside Act (NCLI) which I introduced alongside Congressman John Sarbanes (D-MD) in this Congress and the previous. NCLI provides access to federal grants for teachers who design and implement environmental education programs both in and outside the classroom. By encouraging new environmental curricula, the measure also cultivates partnerships and strengthens relationships between school districts, colleges, environmental nonprofits, parks and other community-based organizations – such as the Bucks County Conservation District which is a strong proponent of this idea.
Promoting environmental education is a down payment on our future. Study after study shows that connecting kids to the world around them improves achievement in science as well as reading, math and social studies – all subjects that strengthen our global competitiveness. The enactment of this important measure inspires the next generation of doctors, scientists and engineers and fulfills our responsibility to promote environmental stewardship and conservation throughout the nation.
Paired together, these examples highlight the progress of concrete environmental efforts being undertaken in bipartisan fashion. Through conservation, education, the continued responsible use of our natural resources, and the forces of free market innovation, we can build on America’s tradition of working together as effective stewards of our national resources.Read More
As we’ve seen in recent days and weeks, the threats posed by terrorist organizations like ISIS — as well as lone actors — is real and evolving. As the president correctly noted in his national address, we must work together — Republicans and Democrats, Congress and the Administration — to accomplish the common goal of a safe America and a stable international community.
With the rise of ISIS, Hezbollah, Boko Haram and others, the United States has witnessed a new and dangerous brand of terrorist group: one that funds itself and operates as a transnational criminal organization. This evolution in funding practices made it necessary for the federal government to reevaluate how it combats these threats to ensure we are doing everything possible to financially hinder these groups. On March 25, of this year, the House Committee on Financial Services responded by adopting the initial resolution to create the Task Force to Investigate Terrorism Financing.
With Ranking Member Stephen Lynch, Vice Chair Pittenger and a bipartisan group of 21 members, we held five hearings and briefings with multiple government agencies charged with counter-terror and counter threat finance responsibilities.
The initial six months of operation shed significant light on multiple issues with regards to counter threats finance and anti-money laundering initiatives.
Building on what we know, a new session of the Task Force to Investigate Terrorism Financing will take a much closer look at several topics, including: trade-based money laundering, terror funding streams from Latin America, developing our regional partners’ capabilities to combat terror financing and the funding of foreign based terrorists.
It is my goal to advance upon the findings from our previous work to discover additional ways Congress may better assist our intelligence, law enforcement, and defense communities to cut off funding streams to terror groups seeking chaos and destruction. To this end, I am confident we can succeed together.
2400 Rayburn HOB
Washington, DC 20515
Congressman Mike Fitzpatrick is a lifelong resident of Bucks County, where he has been an active member of his community for decades. In the 113th Congress, Mike’s number one priority is job creation. Mike recognizes that government does not create jobs, but fosters an environment in which the private sector can create permanent, family sustaining jobs.
Mike graduated from Bishop Egan High School in Fairless Hills and earned his bachelor’s degree while working his way through St. Thomas University in Miami, Florida. Upon graduation, Mike was awarded the university’s highest service award.
Following graduation, Mike returned to Pennsylvania and in 1988, he graduated from Penn State’s Dickinson School of Law. While attending law school Mike was the Business Manager of the Dickinson Journal of International Law. Mike is admitted to practice law in both Pennsylvania and New Jersey.
In 1995, Mike was appointed to the Bucks County Board of Commissioners where he served for ten years. As a Bucks County Commissioner Mike was a champion of responsible county social service programs, job creation and efficient government administration. He fought to preserve over 11,000 acres of beautiful farmland, parkland and critical natural areas. His record on open space earned him recognition from a variety of environmental organizations, including the Greenspace Alliance.
During his time as Commissioner, Mike led the fight to establish the county’s first Enterprise Zone, a project that eventually led to the creation of over 4,000 private sector jobs in Bucks County.
As a Member of the 109th Congress Mike demonstrated himself to be an independently- minded advocate for his constituents. He fought for stronger borders, lower taxes and smaller budget deficits. Locally he worked successfully to bring the National Veterans’ Cemetery to Bucks County. Mike was also instrumental in flood mitigation efforts along the Neshaminy Creek watershed, which had been plagued by persistent flooding.
Mike returned to Congress in 2011 after practicing law in Bucks County focusing on representing small businesses and local governments.
Mike and his wife Kathy have been married twenty-four years and have six children – three girls (Katie, Maggie and Molly) and three boys (Jimmy, Mick and Tommy). An Eagle Scout, Mike has remained active in Scouting and is a past-President of the Bucks County Council of the Boy Scouts of America.
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Did you know that small businesses employ 70% of the US working population? Get out there this week and support... https://t.co/Yf3uiczdm4
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ICYMI: Check out my most recent #CongressmansNotebook as seen in this past weekend's Bucks County Courier Times & The Intelligencer: bit.ly/1pWXDyA
Did you know that small businesses employ 70% of the US working population? Get out there this week and support your local small businesses! #DreamSmallBiz
Saturday was another successful Drug Take Back Day across #PA8. Take a look at the amount of expired or unused prescription medication collected
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