[Congressional Record Volume 158, Number 80 (Thursday, May 31, 2012)]
[Extensions of Remarks]
[Pages E925-E926]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

                                 ______
                                 

                               speech of

                         HON. EDWARD J. MARKEY

                            of massachusetts

                    in the house of representatives

                        Wednesday, May 30, 2012

  Mr. MARKEY. Mr. Speaker, I want to thank Chairmen Upton and Pitts and 
Ranking Members Waxman and Pallone for their work in bringing to the 
floor a bipartisan bill that provides FDA additional resources to bring 
new drugs and medical devices to market. These new resources will 
enable FDA to improve review times for new product applications and 
provide companies greater clarity about compliance requirements and 
their responsibilities.
  There are many important policy improvements in this bill. They 
include:
  A reauthorization of the user fee programs for prescription drugs and 
medical devices, as well as the creation of a new generic user fee 
program that will help slash current review times for these products.
  A reauthorization of two programs that foster the development and 
safe use of prescription drugs for children.
  New incentives for the development of antibiotics, which are needed 
to increase the number of products in the development pipeline.
  Today's bill also includes the reauthorization of legislation I 
authored in 2007 that has helped spur the development of medical 
devices for children. The Pediatric Medical Device Safety and 
Improvement Act, PMDSIA, creates grants that bridge the gap between the 
people who understand the medical need--doctors and innovators--with 
the people who can help turn their ideas into devices on the shelves, 
like manufacturers and federal regulators. Since the grant program's 
inception, the five Pediatric Device Consortia established as a result 
of this language have assisted in advancing the development of 135 
pediatric medical devices. Currently the consortia are managing 80 
active pediatric medical device products.
  The FDA Reform Act also extends a provision of PMDSIA that provided 
profit incentives for companies to develop devices for rare pediatric 
diseases. The original incentive passed in 2007 solely for pediatric 
diseases proved immensely successful. Today's bill strikes a compromise 
to extend this incentive for devices used to treat rare diseases in 
adults as well, while still retaining the incentive for pediatric 
devices. I urge Congress does not negatively impact the development of 
devices for children.
  In addition, we will need to ensure that companies using this 
incentive and making a profit on their device because they got 
pediatric labeling actually continue to sell their device for use in 
children and not only for adults. The Pediatric Advisory Committee at 
the FDA will need to play a vital role in this oversight and in 
monitoring the number of devices sold for adult use as opposed to the 
number sold for pediatric use.
  PMDSIA also included a requirement that device companies provide FDA 
with information on the pediatric populations that could benefit from a 
new device they are looking to sell. This was supposed to help FDA 
track

[[Page E926]]

what devices are available for children and where gaps remain. FDA put 
out a proposed rule and a direct to final rule simultaneously to 
implement the provision, but it withdrew the direct to final rule after 
industry voiced opposition. The regulation has languished ever since.
  The failure to implement this provision of the law has made it 
difficult for FDA to provide Congress information about the 
availability of pediatric medical devices and to identify unmet medical 
device needs, according to a GAO report. I am disappointed that this 
important tracking provision has gone unimplemented for nearly five 
years, and I hope that FDA will comply with the timeframe included in 
the legislation to issue a final rule implementing the law no later 
than December 31, 2013.
  Despite these advances, today's bill is a missed opportunity because 
it fails to address a glaring patient safety issue that affects 
patients around the country.
  Many Americans would be surprised to learn that ninety percent of 
medical devices are not required to undergo clinical testing in humans 
prior to being sold. Instead, most devices, including brain stents and 
hip implants, need only to show similarity to an earlier product to 
make their way to market.
  Under current law, the FDA is required to clear certain medical 
devices as long as they demonstrate their similarity to an earlier 
product. This is true even if the new device is modeled after a 
defective device that caused serious injury or even death.
  If the device is indeed similar to the earlier model, flaw and all, 
FDA's hands are tied. The agency does not have the legal authority to 
deny approval.
  This makes no sense.
  We wouldn't fast-track approval of a new drug that was based on one 
that had been recalled.
  We shouldn't do it here, either, with medical devices.
  This legislation was an important opportunity to address this medical 
device safety loophole, but it doesn't. The loophole remains in place 
and patients are still at grave risk.
  Thousands of patients have already been seriously harmed by this 
loophole. Four years ago, Jaye Nevarez, a 50 year-old mother of three, 
was a healthy truck driver who earned a decent living, played in a 
band, and paid her bills on time. Then her doctor implanted bladder 
mesh, a device that traces its origins back to an older product that 
had to be recalled for causing serious injury and even death.
  Jaye now lives in constant pain. She was forced to quit her job. She 
can't walk without a cane. She lost her insurance and faces a growing 
mountain of medical debt. The bank recently began foreclosure 
proceedings on her home where she lives with her 79 year-old mother.
  Jaye isn't the first to be harmed by this loophole. If we fail to fix 
it, she won't be the last.
  As documented in the accompanying report prepared by my staff--
``Defective Devices, Destroyed Lives'', several medical devices that 
have been recalled because they severely injured patients continue to 
be used as models for new devices--many of these are on the market and 
being implanted in patients today.
  I introduced the Sound Devices Act, providing FDA the ability to 
protect the public from these unsafe devices, but this was not included 
in the bill.
  The definition of insanity is doing the same thing over and over 
again and expecting a different result. When it comes to medical 
devices we have an insane policy that makes no sense.
  Despite repeated testimony from the FDA that the current law 
restricts their ability to assure the safety of medical devices, 
Republicans have refused to acknowledge and address this very dangerous 
loophole.
  This bill must not be the last word on medical device safety. I hope 
my colleagues will join me to close this medical device loophole so 
that we can keep the American public safe from harm.
  Lastly, I remained concerned about the mandatory clinical trials 
database that was created in the 2007 FDA Amendments. This registry and 
results database was meant to directly address issues stemming from a 
lack of transparency of clinical trials. Several high profile examples, 
including the drugs Paxil and Vioxx, gained national attention when 
their manufacturers were found to have suppressed clinical trial data 
that demonstrated safety and efficacy concerns.
  Today, the website requires information about certain clinical trials 
to be publically posted on the database, but loopholes in the 
underlying law still allow researchers and companies to avoid 
publishing unfavorable data, putting human subjects of clinical trials 
at grave risk. To protect the public from potentially dangerous drugs 
and medical devices these loopholes must be closed to provide 
equivalent transparency of all clinical trials. I hope I can work with 
my colleagues to address this serious issue in the very near future.

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