[Congressional Record (Bound Edition), Volume 148 (2002), Part 15]
[Senate]
[Pages 21107-21109]
[From the U.S. Government Publishing Office, www.gpo.gov]




       THE MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

  Mr. REID. Mr. President, I ask unanimous consent the Senate proceed 
to the consideration of H.R. 5651.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (H.R. 5651) to amend the Federal Food, Drug and 
     Cosmetic Act to make improvements in the regulation of 
     medical devices, and for other purposes.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. KENNEDY. Mr. President, I am pleased to support passage of H.R. 
5651, ``The Medical Device User Fee and Modernization Act of 2002.'' 
Just as passage of a user-fee program was a breakthrough in the 
regulation of critical prescription drugs, this legislation is a 
breakthrough in regulation of lifesaving medical devices, devices that 
can open blocked arteries, keep hearts beating, save the lives of 
stroke patients, and diagnose deadly cancers in time for effective 
treatment.
  Currently, because FDA lacks adequate resources, too many critical 
devices are unnecessarily slowed in their progress to patients' 
bedsides by the regulatory process. At the same time, careful FDA 
oversight is essential to assure that patients not suffer serious 
injury or even lose their lives because of devices which are unsafe or 
ineffective.
  By assessing a modest fee on device manufacturers, raising the level 
of appropriated funds, and setting ambitious performance targets for 
the FDA, this bill is just what the doctor ordered to speed life-saving 
devices to the market while protecting the public health.
  The goal of establishing a user-fee program for medical devices is 
one that I have pursued for more than a decade. I am gratified that 
this legislation finally brings that goal to fruition. It will mean 
life and hope for thousands of patients each year.
  The legislation also improves regulation of potentially faulty and 
harmful reprocessed devices. Patients deserve to know that the devices 
that are used in their medical treatment are safe and effective, 
whether they are being used for the first time or whether they are 
being reused.
  The legislation provides for a new regime of third party inspections 
for device manufacturers who manufacture products for both the United 
States and export. This regime will reduce duplicative inspections, 
while assuring that FDA remains the final arbiter and safety check on 
the quality of the manufacturing process for medical devices.
  For many years, the FDA's Center for devices and Radiological Health, 
CDRH, has needed additional funding and staff to better assure the 
safety and effectiveness of new and innovative medical technologies. As 
the coauthor of the Medical device User Fee Act of 1994, I have long 
advocated medical device user fees and I am proud that we have finally 
secured such funding through a fair and efficient system of user fees.

[[Page 21108]]

  This legislation will provide great benefits to patient health and 
safety. I am confident that these fees will assure greater certainty 
for consumers and manufacturers that the FDA can meet its statutory 
responsibilities for the timely and thorough review of medical devices.
  Under Federal law, medical devices must be reviewed by the FDA prior 
to marketing. These reviews must be completed in accordance with 
ambitious statutory timeframes. While the FDA has done an excellent job 
of reviewing lower risk devices in a timely manner, it has frequently 
lacked the resources and staff to achieve similar success with the most 
sophisticated devices, which require premarket approval.
  Under this legislation, device companies will pay the FDA fees for 
the application they submit for review. These fees will raise nearly 
$150 million over the next 5 years. The legislation also calls for tens 
of millions of dollars in newly appropriated funding for the FDA's 
device center.
  These funds will be devoted to reviewing device applications and to 
assuring the post-market safety of devices. I am pleased that the 
legislation authorizes an additional $3 million in fiscal year 2003 and 
$6 million in fiscal year 2004 for the post-market surveillance of 
medical devices.
  I want to acknowledge the contributions of Senator Hatch in ensuring 
that the user fees are fair and equitable to small businesses and 
startup companies.
  The user-fee program will sunset after 5 years, allowing Congress to 
review whether it has expedited the review of devices and whether 
improvements are needed to better assure public health and safety.
  In addition to medical device user fees, the legislation strengthens 
the FDA's regulation of reprocessed devices. I believe that the 
American people will greatly benefit from the new requirements for 
substantial equivalence determinations and premarket approvals of such 
devices. I am particularly pleased that there are robust requirements 
for the assurance of safety and effectiveness of any reprocessed class 
III devices, such as angioplasty balloons or heart valves.
  Finally, the legislation authorizes a 10-year program for third-party 
inspections of device manufacturing plants. This will enable FDA to 
better target its enforcement resources--resources that we also 
increase in the legislation. To ensure that third parties operate 
appropriately, the bill places important controls over conflicts of 
interest and places third parties at risk of significant civil 
monetary, criminal, and debarment penalties, if they act in a manner 
inconsistent with public health and safety.
  Moreover, the bill limits inspections to plants which manufacture 
devices for export, and ensures that FDA conduct every third inspection 
before additional third-party inspections take place.
  Let me acknowledge the important work of Congressmen Tauzin, Dingell, 
Greenwood, Congresswoman Eshoo, and Senator Gregg, the ranking member 
of the Committee on Health, Education, Labor, and Pensions, in drafting 
this legislation. I also want to acknowledge the leadership role played 
by Senator Wellstone in moving this legislation through the Senate, and 
by Senator Durbin in enduring strong protections over reprocessed 
devices.
  I would like to thank FDA Deputy Commissioner Lester Crawford, 
Associate Commissioner Peggy Dotzell, Associate Commissioner Amit 
Sachdev, Center for Devices Director David Feigel, Linda Kahan, and 
Frank Claunts.
  I want to recognize the hard work and dedication of Michael Myers, 
David Nexon, David Dorsey, and Paul Kim on my staff, as well as Vince 
Ventimiglia with Senator Gregg, Pat Morrisey, and Brent Delmonte with 
Congressman Tauzin, and John Ford and David Nelson with Congressman 
Dingell.
  Let me also recognize the contributions of Patti Unruh and Richard 
McKeon with Senator Wellstone, Lisa German and Daborah Wolf with 
Senator Jack Reed, Adam Gluck with Senator Harkin, Deborah Barrett and 
Stephanie Sikora with Senator Dodd, Christina Ho with Senator Clinton, 
Rhonda Richards with Senator Mikulski, Anne Grady with Senator Murray, 
Dean Rosen with Senator Frist, Anne Marie Murphy with Senator Durbin, 
Bruce Artim and Trisha Knight with Senator Hatch, Karen Nelson and Ann 
Witt with Congressman Waxman, and Steve Tilton with Congressman 
Bilirakis.
  I ask my colleagues to join me in supporting passage of H.R. 5651, 
``The Medical Device User Fee and Modernization Act of 2002.''
  Mr. GREGG. Mr. President, I would like to make a few comments 
concerning the Medical Device User Fee and Modernization Act of 2002, 
which was passed by both the House and Senate earlier this morning.
  This legislation was the product of a tremendous amount of hard 
work--from folks in both Chambers and on both sides of the aisle--and 
includes the most significant improvements in the way medical devices 
are reviewed and regulated, arguably since 1976.
  More importantly, these changes will have a very positive and lasting 
impact on both patients and consumers.
  The legislation accomplishes this in several ways:
  User Fees: First, it ensures adequate resources for the Food and Drug 
Administration (FDA), by creating a new user-fee program, modeled after 
the one used to review drugs and biologics--which has been incredibly 
successful.
  FDA resources at the device center have dramatically declined in the 
last 10 years, resulting in significant staff turn-over (as high as 
10%) and increased review times (more than 400 days per submission when 
the statute requires reviews of 180 days).
  By charging manufacturers a reasonable fee for reviewing their 
products, FDA can hire more staff, meet review deadlines, and ensure 
that patients have timely access to the newest, most innovative medical 
technologies. I particularly want to thank my friend from Utah, Senator 
Hatch, for his work on this issue.
  Moreover, in order to protect some of the smaller companies--
including a substantial number in New Hampshire--the bill in many cases 
exempt or significantly reduce these fees.
  Re-Use: Second, the legislation provides greater protection to 
patients from reused and reprocessed medical devices. The bill ensures 
that medical devices--especially some of the more delicate, high risk 
products, such as angioplasty balloons--are not used over and over 
again on different patients without first demonstrating that this can 
be done safely and reliably.
  On that note, I would especially like to thank Senator Durbin for his 
invaluable assistance in working with us to craft this very important 
provision. I believe that it will save a great many lives. The 
legislation that he and I worked on this summer and have introduced 
separately today represents the foundation for the final product 
included in this bill.
  Third-Party Inspections: Third, it increases the frequency and 
quality of inspections of medical device manufacturing facilities--both 
here and abroad--by allowing inspections from FDA-accredited third-
parties.
  On average, the FDA is currently able to inspect a U.S. facility only 
once every 7 years, and foreign facilities once every 11 years. This is 
unacceptable and in direct contravention to the current statutory 
requirement for inspections every 2 years.
  By augmenting FDA's inspection capabilities, we will help ensure that 
these medical devices are being manufactured in accordance with 
established manufacturing practices.
  Modernizing FDA: Finally, the bill brings FDA regulation into the 
21st century, by instituting electronic labeling, electronic 
registration, and modular reviews of applications. It also establishes 
a more effective review process for the fastest wave of innovative 
combination biotechnologies, including drug and biologics coated 
stents, drug pumps, and engineered tissues.
  Working together, these changes will give FDA the tools it needs to 
work more effectively, and to get the next

[[Page 21109]]

generation of life-saving medical devices into the hands of doctors and 
patients more quickly than ever before.
  I am also pleased to report that this legislation is widely supported 
by the administration, FDA, patient/consumer groups, industry, and 
provider/hospital groups.
  I am proud of what we have been able to accomplish here today and 
believe that this legislation will have a tremendous positive impact on 
people's lives as they enjoy the benefits of today and tomorrow's 
medical technology.
  Mr. DODD. Mr. President, I would like to applaud my colleagues in 
both the House and the Senate, particularly Congressman Billy Tauzin, 
Congressman John Dingell, Senator Judd Gregg, and Senator Ted Kennedy, 
for reaching a compromise on this important legislation. I know that 
there were several difficult issues to be negotiated, and I am pleased 
that we were able to reach a bipartisan agreement before the end of 
this Congress.
  I support this legislation because, first and foremost, it could 
increase the quality of patient care. At the same time, it will also 
prove beneficial to the manufacturers who make these devices, and the 
hospitals and health care providers that use them. By creating a system 
of user fees for FDA approval of medical devices, we are ensuring that 
life-improving and life-saving technologies will be available on the 
market in a more efficient and timely manner. Put more simply, this 
bill could save lives. In creating a user fee structure, we are 
expanding a model that has already proven dramatically successful in 
the prescription drug market.
  This bill will also have a positive impact on patient safety by 
expanding FDA regulation of the medical device reprocessing industry. 
Device reprocessing can certainly be beneficial when used 
appropriately. There are environmental benefits, as well as cost 
savings for hospitals. However, we must ensure that patient safety is 
not sacrificed. This legislation will do that by providing us with a 
better understanding of the impact that reprocessing has on the safety 
and efficacy of devices, and allowing the FDA to prevent the 
reprocessing of devices when safety is in question.
  Again, I thank my colleagues for working so diligently to come to 
this agreement, and I proudly support this legislation.

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