[Congressional Record (Bound Edition), Volume 161 (2015), Part 7]
[House]
[Pages 9852-9854]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     REPEAL THE MEDICAL DEVICE TAX

  The SPEAKER pro tempore. Under the Speaker's announced policy of 
January 6, 2015, the gentleman from Pennsylvania (Mr. Fitzpatrick) is 
recognized for 60 minutes as the designee of the majority leader.
  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

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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.

                              {time}  1815

  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?

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       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 your diligent and timely reply.
           Sincerely,
                                                 Mike Fitzpatrick,
                                               Member of Congress.

  Mr. Speaker, I yield back the balance of my time.

                          ____________________