[Congressional Record Volume 161, Number 97 (Wednesday, June 17, 2015)]
[House]
[Pages H4487-H4489]
From the Congressional Record Online through the 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.
[[Page H4488]]
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.
{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?
[[Page H4489]]
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.
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