Michael Fitzpatrick

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, I rise today in recognition of the life and service of United States Marine Private First Class Attilio M. Lupacchini, who was laid to rest with full military honors this morning. Private Lupacchini--a native of Yardley, Bucks County, in my district in Pennsylvania--was just 2 years out of high school, when, on December 9, 1950, he made the ultimate sacrifice for his Nation in the mountains of North Korea while on a mission to rescue a group of fellow marines. His platoon leader described Private Lupacchini as a true fighting marine who was small in stature but enormously courageous. After more than 65 years, Private Lupacchini's spirit has returned home and now rests among our Nation's bravest at Arlington National Cemetery, forever providing a place of reflection and remembrance for generations of family members and grateful Americans. From the bottom of my heart, I express my gratitude to Attilio Lupacchini for his membership in the internal ranks of those who sacrificed at freedom's altar.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, today, I would like to honor Philip A. Clemens, a constituent of mine and community leader who is retiring after serving almost 50 years with the Clemens Family Corporation. Mr. Clemens has spent his entire working life with his family business, The Clemens Family Corporation, headquartered in Hatfield, Pennsylvania. Over the years, Mr. Clemens has worked in all areas of the business-- from the clean-up crew to Chairman and CEO, a position he served in for 15 years. With Mr. Clemens' leadership, the Clemens Family Corporation has grown into one of the largest companies in the industry, employing hundreds of my constituents with good-paying, family-sustaining jobs. Mr. Clemens has devoted his knowledge and expertise to not only the growth of his own business, but the future of the meat industry as a whole. His lifelong contributions to the industry are unmatched. For his influence, he's received the highest award given in the industry-- the North American Meat Institute's Industry Advancement Award, the Knowlton Award for industry innovation, and the Research Institute of America's outstanding management award. However, Mr. Clemens isn't just known for his business accomplishments, he's also an active volunteer known by many in our area for his dedication to the Indian Valley and North Penn communities. Some of those roles include his work as the Chairman of the Board of Trustees of Lancaster Bible College, his work with the North Penn United Way, and his efforts with the Profit Sharing Council of America. In addition, he is also very active at the Calvary Church of Souderton, where he serves on the Elder Board. Mr. Clemens is a dedicated family man, a highly successful entrepreneur and a man who generously donates his time to better our community. I am proud and privileged to honor him today and appreciate all he has done for the people of our community. On behalf of the constituents of the 8th District of Pennsylvania, I wish Mr. Clemens a happy, relaxing and pleasant retirement.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, it seems like, too often, issues in this town are predetermined--Republicans care about this; Democrats care about that. There isn't any crossover, and then we are stuck in gridlock. As someone who has spent my time in Congress working to bridge the gap between left and right, I know there is more that unites us than divides us on the big issues. Today, I am proud to highlight another area of bipartisan agreement, criminal justice reform. The SAFE Justice Act is a legislative proposal to modernize and strengthen our criminal justice system for the 21st century, addressing its exploding costs to taxpayers and often disproportionate application. States across the Nation--red and blue alike--have led the way on this important issue, and they offer a blueprint for how we address corrections at the Federal level. The SAFE Justice Act expands on these lessons by seeking to curtail overcriminalization, increase evidence-based sentencing alternatives, reduce recidivism, and increase transparency and accountability. Mr. Speaker, there is a serious, bipartisan appetite to address this issue now, from the House and the Senate to the White House; and I look forward to working with my colleagues to tackle serious criminal justice reform in this Congress.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, I have deep concerns about the direction the Obama administration has taken in reaching this agreement with Iran. While I support all diplomatic efforts to promote peace and cooperation, there is little reason to believe this deal will halt Iran's nuclear program or that the Iranian regime is truly committed to rejoining the international community. Even during negotiations, Iranian leaders have spewed hateful language toward the United States, Israel, and the Jewish people and have unapologetically continued their state sponsorship of terrorism. Next week the bipartisan Task Force to Investigate Terrorism Financing that I am proud to chair will take a closer look at Iran's role in financing terrorist groups around the world, information that I feel is vital to the administration, to Congress, and the American people when reviewing any nuclear agreement with Iran that includes sanctions relief. In the end, this announced deal is under congressional authority to review, and I will only support it if it meets the simple benchmark of forever preventing a nuclear Iran.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, I rise today to honor a very special company in the 8th Congressional District, None Such Farm, which recently was recognized as a Finalist for the Secretary of Defense Employer Support Freedom Award. The Freedom Award is the highest recognition given by the U.S. Government to employers for their support of their workers who serve our country in the Guard and Reserve. Nomination requests come from a Guard or Reserve member who is employed by the organization they are nominating, or from a family member. The award was created to publicly recognize employers that provide exceptional support to their Guard and Reserve employees, and the Department of Defense deems it the highest of all employer recognition awards. 30 companies from across the country were selected as a Finalist for this prestigious award. None Such Farm is the only company representing the Commonwealth of Pennsylvania, and all of us in Bucks County are proud. None Such Farm is owned and operated by the 3rd generation of the Yerkes Family in beautiful Buckingham, Pennsylvania. For over fifty years the Yerkes farm supplied sweet corn for the wholesale market in Philadelphia. In the late 1970's, as the wholesale market began to change, Bill and John Yerkes decided to build a Farm Market. Since 1978, the market has doubled in size, adding a Meat Shop to sell their own farm raised beef, along with a kitchen for high quality ``ready to go'' food. None Such Farm is a staple of Bucks County, with some of the best sweet corn around, along with delicious fruits, vegetables, and beautiful flowers. Today, the Yerkes family heritage lives on--through Leslie, Jon and Scott Yerkes, who made the decision to preserve the 217 acre farm. As a County Commissioner and as a United States Congressman, I have seen the tremendous strides that None Such Farm has made and the dedication it has given to its customers and employees. I am pleased to see the Department of Defense recognize None Such Farm for their good treatment and support of our nation's military families. Thank you to the Yerkes family for taking care of those who serve our country. I am proud of your commitment to our military, and wish you many years of success in the future.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Chairman, I have an amendment at the desk.

Mr. FITZPATRICK. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, first, I want to express my deep appreciation to Chairman Upton and Ranking Member DeGette on this bill. The funding and these innovative reforms will save lives, and that is something that everyone in this Chamber should be proud of. There are a lot of wonderful provisions in this bill, and we should see those provisions through. I am a member, Mr. Chairman, of the Rare Disease Caucus. Like most of us here, I have met with constituents with incredible stories of courage and stories of their battle with diseases without treatments. It would be easy to fall victim to despair, but they don't. They remain beacons of hope, hope for a treatment and hope for a world where no one else has to go through what they did. They look to us to support them and to fight alongside them for these treatments in lifesaving research, and I am proud to stand with them and to fight for them. There is a part of this bill that I believe will do more harm than good, and that is the part that deals with easing medical device safety regulations. While we bring our research and treatments into the 21st century, I think it is equally important we bring our medical device safety regulations into the 21st century as well. As part of a 21st century approach to medical devices, the FDA has established a unique device identification system to adequately identify medical devices through their distribution and use. These codes can significantly improve safety and help track down dangerous recalled products. Currently, these UDIs are not incorporated into all electronic health records, which make it difficult to fully achieve the benefits to patient safety. For example, a claim form might list a procedure like a routine surgery to remove uterine fibroids, but not note the make or model of the device used, such as the laparoscopic power morcellator, a device that the FDA placed a black box warning on, some manufacturers have recalled, and some insurance companies have stopped covering as a result of its devastatingly adverse effects on women's health. It is this tragedy surrounding the power morcellator that has driven me to action, and it is why I offered eight amendments to the Rules Committee which would strengthen our safety laws. This week, I have heard from dozens of these individuals affected by complications from power morcellation. One doctor from California sent me a note about how her sister died 9 months after a routine surgery with a power morcellator. A woman from Massachusetts described her battle with the cancer that was spread by the morcellator. These constituents wrote their letters to Members of Congress and copied my office. Another constituent in New York lost her sister to cancer spread by the morcellator and described her sister's tragedy as ``a routine surgery ending with a death sentence.'' A constituent of mine, a doctor and a mother of six children, is courageously fighting an aggressive cancer that was spread by the blades of the device. What happened, Mr. Chairman, with the power morcellator should never be allowed to happen again, and I think that we missed an opportunity with this bill to tackle this problem head-on. In 2011, the Institute of Medicine found the current, four-decade-old medical device safety process known as 510(k) inadequate, noting ``510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices.'' I wish the bill had addressed this gap that allowed the power morcellator to slip through and cause unnecessary harm to way too many families. It is time we take our medical device safety regulations into the 21st century. I ask my colleagues to join me in this effort and to support this amendment of mine today, which is a small but important step. I am proud to stand for patient safety. I urge my colleagues to stand with me and the thousands of others who have been injured or killed by unsafe medical devices. Mr. Chairman, I yield to the gentleman from Pennsylvania (Mr. Pitts).

Mr. FITZPATRICK. Mr. Chairman, I would like to thank Ranking Member Pallone and Chairman Pitts for their support of this amendment. This amendment will, as I said, take a small step toward improving medical device safety in the United States. As I said earlier in my remarks, I have seven amendments that did not make it out of Rules Committee, and I hope to be able to work with the chairman and the ranking member on those issues as well. I urge my colleagues to support the amendment, and I yield back the balance of my time.

Mr. FITZPATRICK. Will the gentleman yield?

Mr. FITZPATRICK. Mr. Chairman, I was actually going to rise in opposition to the amendment, although now it is being withdrawn I see an opportunity here for, perhaps, us to work together on the medical device safety issue. I was going to object and vote against the amendment because it is my concern that the amendment would actually loosen medical device safety regulations and permit safe but ineffective devices to get to the market. I know that this sort of came late in the process. I would have objected because I had seven amendments before the committee to strengthen medical device regulations. But since the amendment is being withdrawn, I would see an opportunity for us perhaps to work together, take a step back and look at all the FDA regulations on medical device safety.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Chairman, I have an amendment at the desk.

Mr. FITZPATRICK. Mr. Chairman, I intend to offer and then withdraw this amendment which will make it easier for land preservation efforts, including under the Federal Forest Legacy Program. During my time as a local official in Pennsylvania as a Bucks County commissioner, I was proud to lead local efforts to preserve the beauty of the countryside and the Bucks County landscape, while advancing smarter development initiatives to reclaim brownfields through commonsense conservation efforts. Along with a task force for that purpose, our community was able to expend approximately $100 million for the preservation of farmland, parkland, and critical natural areas, close to about 15,000 acres in our one county preserved. Now, as a strong advocate for land preservation in Congress, I continue to be a supporter of vital conservation programs, including the United States Forest Service's Forest Legacy Program. My amendment today would reallocate $5.9 million from the Bureau of Land Management, Management of Lands and Resources, to the Forest Legacy Program for the purpose of fully funding two additional preservation projects. The Forest Legacy Program is a Federal program that supports and encourages State and private efforts to protect environmentally sensitive forestlands. The program helps the States develop and carry out their forest conservation plans, while encouraging and supporting acquisition of conservation easements without removing the property from private ownership. Most conservation easements restrict development, require sustainable forestry practices, and protect other values. The additional funding my amendment provides will allow for the protection of 4,000 acres of Pennsylvania forests in the Northeast Connection. Mr. Chairman, the Northeast Connection is a collaboration between the Pennsylvania Department of Conservation and Natural Resources and three groups of over 150 families to conserve more than 4,000 contiguous forest acres which serve as a natural bridge between the 84,000-acre Delaware State Forest, which is managed by the Commonwealth of Pennsylvania, and the 77,000-acre Delaware Water Gap National Recreation Area, managed by the National Park Service. I believe this project is a crucial objective to preserving Pennsylvania's and our Nation's natural resources and beauty. Again, I want to thank the chairman for his hard work on the underlying bill. I look forward to working with the chairman on robust funding for this program.

Mr. FITZPATRICK. I yield to the gentleman from California.

Mr. FITZPATRICK. I thank the chairman for his desire to provide additional resources, if possible, to the Forest Legacy Program. It is a great program for our Nation, well utilized by States and local communities and private landowners. I look forward to working with the chairman. Mr. Chairman, I ask unanimous consent to withdraw the amendment.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, congratulations to the Levittown- Fairless Hills Rotary Club on its 60th anniversary. Yours is a global service organization, founded in 1905 in Chicago and since then has grown to more than 34,000 clubs and 1.2 million members, worldwide. Rotary International has contributed to many service projects on the local and global scale and consistently worked toward the elimination of polio, which is a major Rotary project. In forming your clubs, you gather together business and professional leaders, who will strive to advance high ethical standards and dedicate themselves to humanitarian service. Rotarians contribute to their communities through individual local chapters, such as the Levittown-Fairless Hills Club that each year awards scholarships to local, high school graduates and takes part in the international efforts. In so doing, you are upholding the Rotary International motto: Service Above Self. Again, congratulations to the Levittown-Fairless Hills Rotary Club for 60 years of community service and best wishes for continued success.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, I rise today in recognition of Sandi Adams-Slesch's 30 years of committed service to the people of Tullytown Borough. Tullytown lays on the southern edge of Lower Bucks County along the Delaware River, between Falls and Bristol Townships, and includes part of historic Levittown--the embodiment of the American dream for families who returned home after World War II. Levittown--and Tullytown--has an important place in our local history, and one that is only strengthened by the individuals that live and work there. For three decades, Sandi has attended to the needs of her neighbors and community through her service as Police Secretary of Tullytown Borough. Her thoughtful and dedicated work has earned the praise of her peers and added to the success of her hometown. The continued efforts of involved individuals, like Sandi, make my District of Bucks County, Pennsylvania, a special one to represent. I thank Sandi for dutifully executing her role as Police Secretary for the last 30 years and wish her all the best in her next 30.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, congratulations to Kiwanis International on the 100th anniversary of a global service organization of more than 600,000 members. Kiwanis club members contribute to their communities in countless ways through service projects and fundraising. Along with the recognition of this milestone day, Kiwanis clubs in Bucks County have carried on the Kiwanis mission of changing the world, one child and one community at a time. Each year, Kiwanis raises more than (U.S.) $100 million and acquires 18.5 million volunteer hours toward strengthening their communities and serving children. In addition to its community work, The Eliminate Project is a notable Kiwanis campaign that focuses on saving and protecting millions of mothers and their future children. In partnership with UNICEF, the clubs are working to eliminate a disease that kills one baby every 11 minutes and has pledged to raise (U.S.) $110 million toward this life- saving goal. Again, congratulations for 100 years of dedicated service to the worldwide and local communities and best wishes for future success.

Mr. FITZPATRICK

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. Congress of the United States, House of Representatives, Washington, DC, February 19, 2015. Commissioner Margaret A. Hamburg, U.S. Food and Drug Administration, Silver Spring, MD. Dear Commissioner Hamburg, I write to seek clarification of your agency's regulation of medical devices. I am specifically looking to obtain answers about the 510(k) process, and hoping to gather information about whether the FDA has plans to alter this process in light of recommendations from the Institute of Medicine (IOM) It is my understanding that the 510(k) clearance process for medical devices was established through the Medical Devices Amendments (MDA) passed by Congress in 1976. The process was created as a by-product of the three-tiered medical device regulatory framework created by the MDA to balance competing considerations of ensuring product safety and fostering further innovation. After 1976, medical devices were organized into three classes. Class I--devices for which general controls such as misbranding and adulteration prohibitions and Good Manufacturing Practices (GMP) suffice to reasonably assure safety and effectiveness. Class II--devices that require both general controls and product performance to reasonably assure the same. Class III--devices for which only a premarket approval (PMA) process similar to new drug approval can ensure safety and effectiveness. Section 510(k) was created as part of the MDA's attempt to address medical devices that were on the market prior to its enactment and new medical devices introduced later consistently within this framework. Since its creation, the 510(k) process has come to dominate the path to market for virtually all Class I, Class II, and some Class III medical devices despite the fact that consumer protection is severely lacking. To reinforce this statement, it has been reported that between 1976 and 1990, more than 98 percent of FDA- regulated medical devices were cleared through the 510(k) premarket notification, and in the year 2005, almost 99 percent of devices were cleared through the 510(k) process. In 2011, the FDA sought to address this process, and turned to the Institute of Medicine (IOM) to review the 510(k) process and answer two questions: 1. Does the current 510(k) process protect patients optimally and promote innovation in support of public health? 2. If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally? IOM found that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the thirty-five year old 510(k) process, the IOM concluded that the FDA's finite resources would be better invested in developing an integrated pre-market and post- market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlined its criteria for the framework in a comprehensive report they provided to your agency that same year. Following the release of IOM's recommendation, the US Senate Committee on Health, Education, Labor & Pensions (HELP) held a full committee hearing entitled ``Medical Devices: Protecting Patients and Promoting Innovation'' on November 15, 2011. During this hearing, Jeffrey Shuren, the Director of the Center for Device and Radiological Health (CDRH) within the FDA, provided testimony to Committee Members about CDRH's premarket review process and the center's plan to improve the predictability, consistency, and transparency of their regulatory processes. When asked about 510(k) Mr. Shuren stated that getting rid of this clearance process as IOM suggested would be highly disruptive to both the FDA and medical device manufacturers, but assured the Committee that the FDA would focus on trying to improve the process along with the safety of medical devices. Nearly four years has passed since this hearing and to my knowledge, the 510(k) process remains the same. I respectfully request that you answer the following questions regarding this process: 1. Does the 510(k) mechanism ensure patient safety in the medical device arena by requiring premarket safety testing? 2. Does the 510(k) mechanism have a specific mechanism for surveillance of adverse outcomes? What are the legislative barriers to FDA surveillance of adverse outcomes in the medical device space? 3. The majority of medical devices in the United States are cleared via the 510(k) process. This process operates based on a ``predicate'' system. What is the process through which FDA makes the determination that a device is an appropriate predicate? 4. Type 2 devices are reviewed via the 510(k) mechanism. Who assigns a device as being a type 2 device? Is this determination reviewed by any expert committees, and how? If not, why not? Are there specific examples where the Type 2 status was assigned, but was then later changed or should have been changed? 5. As previously mentioned, A committee of The Institute of Medicine concluded and subsequently testified to the senate HELP committee, in 2011, that the 510(k) legislation cannot ensure patient safety and must be overhauled. What specific steps did the FDA take to mitigate the patient safety deficit in response to this analysis? 6. The Institute of Medicine report of 2011 also expressed significant concern to FDA and congress regarding the lack of pre-market safety testing requirements and absence of any post-market adverse outcomes surveillance mechanisms in 510(k). What are the barriers at FDA for implementation of such safety standards in the medical device space? 7. What specific guidelines does the FDA currently use to determine if a device is eligible for a 510(k) application? 8. Does the FDA currently permit persistence of devices approved via 510(k), whose predicate device has been found to be faulty? The FDA's primary focus should be to ensure patient safety. Please consider the following questions regarding the reporting process and post-market surveillance techniques for harmful medical devices: 9. Does FDA have a legal and prosecutable ``positive mandate to self-report adverse outcomes in the medical device space'' for individual practitioners? If so have there been any prosecutions for failure to report? 10. Does FDA have a legal and prosecutable ``positive mandate to self-report adverse outcomes in the medical device space'' for hospitals? If so have there been any prosecutions for failure to report? 11. Does FDA have a legal and prosecutable ``positive mandate to self-report adverse outcomes in the medical device space'' for device manufacturers? If so have there been any prosecutions for failure to report? 12. The FDA has a database that could be used to report adverse outcomes in the medical device space, known as MAUDE. Public concerns have been raised that this database is a ``dead mail-box'' with inefficient to ineffective monitoring. How is the MAUDE database monitored? And how are safety concerns registered in MAUDE addressed by FDA? 13. Is there a role for implementation of new legislation to require a window of post-market surveillance of adverse outcomes related to the use of new devices? And can the FDA under its current authority mandate post-market surveillance of adverse outcomes related to the use of new devices? 14. Can the FDA, under its current legal authority, mandate a positive duty for practitioners, organizations that provide health care services, and manufacturers to report adverse outcomes to the FDA? And is there a role for new legislation focused on more strongly and clearly mandating a ``positive requirement to self-report adverse outcomes'' to FDA by practitioners, hospitals and manufacturers? 15. Please explain the asymmetry between the safety and reporting requirements imposed on the medical device, versus drug industries, by FDA? The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. Please respond to the following questions regarding the CDRH: 16. How many people are employed at the CDRH and in what capacities? How effective is this staff at protecting patient safety and is the first and foremost priority of this group's agenda to protect and promote patient safety? What consumer/ patient protection mechanisms have been established by the CDRH to promote patient safety and how is the efficacy of these mechanisms evaluated? 17. Does the CDRH consider the medical device industry as equal stake-holder to patients and consumers in the United States? Lastly, as you are likely aware, many safety concerns have been raised in conjunction with the use of power morcellators in routine surgeries. Please consider the following questions regarding that specific device. 18. Recently, FDA placed a black box warning on a device known as a power morcellator. FDA recognized and reported to the public that as many as one in 350 unsuspecting American women undergoing morcellation will be at risk of having their occult uterine cancers upstaged with devastating consequences. Johnson & Johnson, the largest manufacturer of the power morcellator subsequently voluntarily recalled its product from the worldwide market. Other manufacturers, such as the german company KARL STORZ, have elected not to recall the product and many gynecologists continue to believe the risk to be minimal. a. Given the avoidable nature of this potentially deadly hazard and unwillingness of industry advocates and many gynecologists to abandon this practice, why did FDA elect not to ban this device from market? b. Was there any role for the FDA commissioner's office to exercise its authority under Title 21 of the Code of Federal Regulation, Section 895? And why was this option not exercised? 19. The FDA's analysis demonstrated that up to one in 350 unsuspecting American women undergoing morcellation were put in deadly harm's way using FDA authorized power morcellators. The American Journal of Obstetrics and Gynecology subsequently demonstrated that the incidence may be as high as one in 156. It, therefore, appears that morcellation and Power morcellators may have caused the unnecessary or premature deaths of many hundreds (if not thousands) of American women for over 2 decades. It now appears that the manufacturers of power morcellators and many gynecological specialty organizations had full knowledge of this hazard. However, no one appears to have reported this potentially deadly hazard back to FDA, a complication associated with the use of this device until December 2013-20 years after the device was introduced to market using 510(k) clearance. a. Can you confirm that this is, in fact, the case? The reporting of adverse outcomes associated with the use of medical devices is a requirement set forth in the Code of Federal Regulation, Title 21, Section 803. This requirement was not followed by the manufacturers, practitioners, hospitals, or specialty organizations. b. Is there any role for the FDA, the HHS Office of Inspector General or the United States Congress to inquire and hold FDA, the device manufacturers or the gynecological specialty organizations accountable for the loss of life in the United States? Thank you in advance for you diligent and timely reply. Sincerely, Mike Fitzpatrick, Member of Congress. Mr. Speaker, I yield back the balance of my time.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, I move that the House do now adjourn.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Chairman, I thank the chairman, and I thank my colleague Ms. Sinema for her work on this important amendment and for her work as well on the task force established to investigate terrorism financing. Today, the terror threat faced by our Nation and our intelligence community is more diverse and sophisticated than it has ever been before. Organizations like Hezbollah, ISIS, and Boko Haram can no longer simply be considered terrorist groups. They have grown into much more dangerous entities, ones with the abilities to self-finance their actions through means far beyond traditional methods, from illicit oil sales and human trafficking to regional taxation and antiquity dealing. In order to effectively combat such evolved threats, U.S. policy must also evolve. As chair of the bipartisan Task Force to Investigate Terrorism Financing, established by the Committee on Financial Services, I have worked with lawmakers and policy experts to guarantee the U.S. response to terror's new revenue streams are quickly and effectively choked out. This amendment is important to ensure each level of our government, from Congress to the intelligence community, has identified the problem, as well as potential weaknesses, and is ready to address the threats that we face. By both expressing the sense of Congress that our intelligence agencies must dedicate resources to eradicate terror revenue mechanisms, as well as report to relevant committees on their strategies, this amendment strengthens the underlying bill and Congress' understanding of our global response to terrorism. The threat to freedom and democracy posed by the Islamic State and groups like it circles the globe, and the United States can ill afford to combat these enemies on the battlefield alone. Any strategy against terror groups worldwide must attack not only militarily, but at their funding source. Organizations, no matter how complex, cannot effectively function without requisite resources. Mr. Chairman, our intelligence community is second to none, and I am certain that, together, we can formulate and carry out long-term solutions to combat terror financing. I thank the chairman for his leadership on this issue and Ms. Sinema for offering this amendment.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, Mae Krier of Levittown, Bucks County, Pennsylvania, was a young woman when our country went to war in 1941. As men answered their Nation's call, millions of women left their homes for factory jobs, working as riveters, buckers, welders, and electricians. Mae Krier, who is approaching her nineties, still beams with pride when she recalls her days as a riveter on Boeing's B-17 warplane assembly line. American women like Mae gained notoriety as Rosie the Riveters, and they remain a symbol of strength and confidence for our Nation. In paying tribute to these American heroes who served our country during World War II, let us also gratefully acknowledge the women who served patriotically on the home front with continued recognition of a national Rosie the Riveter Day. To all the Rosie the Riveters, on behalf of Pennsylvania's Eighth District, thank you for your contributions to our country and your role in the legacy of the Greatest Generation.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, I rise today in recognition of a career of service both to our country and to those preparing to defend it. Since 1988, Glenn Sulmasy has served our Nation as an officer in the United States Coast Guard. Since 2001, Captain Sulmasy has served on the faculty of the United States Coast Guard Academy as a professor of law and risen to the chairmanship of the department of humanities. In each role, Captain Sulmasy has worked tirelessly to engage and educate cadets, faculty, government officials, and the public on national security law, public policy, and international conflict. He is a recognized expert in these areas. Captain Sulmasy's expertise has not been limited to the academy. He is the author of multiple books and countless publications, a noted academic on the topic of national security, and a fellow in Homeland Security and National Security Law for the Center for National Policy here in Washington, D.C. There is no doubt his knowledge has been an asset to our Nation as it struggles to understand the security intricacies of our current world. His commitment to the protection and defense of our Nation is commendable. And as he prepares to retire from the Coast Guard Academy, I join with countless other Americans in thanking him for his service and wishing him the best of luck in the future.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, on June 14, 2015, Archbishop Charles Chaput will celebrate a Mass commemorating the close of the year-long celebration of the 50th Anniversary of St. John the Evangelist Parish. The parish has faithfully attended to the spiritual needs of the community for 50 years, providing a place of prayer, meditation and reflection. Furthermore, the parishioners in the Lower Makefield, Bucks County church, built bonds of charity throughout the community with their devotion to those most in need. They dutifully collect and distribute food and clothing, school supplies, and visit the sick and homebound, year after year. St. John the Evangelist Parish has extended its mission, reaching out to the needy in nearby Trenton, New Jersey and Philadelphia, as well as supporting church missions worldwide. In so doing, the parishioners have demonstrated their faith through their good works. Congratulations on this anniversary year with all best wishes for the continuation of your community of the faithful far into the future.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Speaker, for decades Vietnam veteran and Levittown, Bucks County, resident Jesse Hill has dedicated himself to preserving the memory of those lost in Vietnam and bringing awareness to those still missing. In Vietnam, Jesse served with distinction with the Army 1st Cavalry Division for two tours of duty between 1967 and 1969, when he earned a Purple Heart for his service and his personal sacrifice. Upon returning home, he became a founding member of the Delaware Valley Vietnam Veterans, or DV3, as they call themselves. Today, Jesse continues to recognize the service and sacrifice of all who fought and fell in that war and others since, especially Iraq and Afghanistan, through the Donald W. Jones Flag Memorial. Named after a fellow cofounder, Jesse's leadership has sustained this impressive display for 30 years. The Flag Memorial has been located in various sites across Bucks County over the years, including the Washington Crossing Historic Park, Core Creek Park, Silver Lake Park, and now at Falls Township Community Park, where it draws an annual crowd of thousands of veterans and grateful community members. Having participated in planting flags at this powerful memorial with members of my staff for several years, I am always humbled by the sacrifice that each flag represents and grateful for Jesse's commitment to remembering those we have lost in conflict. I thank Jesse and all the members of the Delaware Valley Vietnam Veterans for their continued work and support of the veterans in our region and their service to our Nation and our community.

Mr. FITZPATRICK

Mr. FITZPATRICK. Mr. Chairman, I have an amendment at the desk.