[Congressional Record Volume 140, Number 89 (Tuesday, July 12, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: July 12, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
        INTRODUCTION OF THE MEDICAL DEVICE USER FEE ACT OF 1994

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                          HON. HENRY A. WAXMAN

                             of california

                    in the house of representatives

                         Tuesday, July 12, 1994

  Mr. WAXMAN. Mr. Speaker, I am pleased to introduce the Medical Device 
User Fee Act of 1994. This bill will solve a problem that all of us 
have heard much about during the past several years--namely the delays 
at the Food and Drug Administration in reviewing medical devices.
  Mr. Speaker, under Federal law, medical devices must be reviewed by 
the Food and Drug Administration prior to marketing. That review should 
be completed within 180 days for new devices, and within 90 days for 
devices that are substantially equivalent to devices already on the 
market.
  Unfortunately, during recent years, the FDA has been unable to meet 
these statutory timeframes, and device companies have argued that they 
and the public are being harmed by these delays.
  The Medical Device User Fee Act of 1994 will give the FDA the 
additional resources that it needs to do a thorough and timely review 
of medical devices. Under the bill, device companies will pay fees for 
device applications submitted to the agency. These fees will raise 
approximately $115 million during the next 5 years.
  The money will be dedicated to the review of medical device 
applications and to other activities that are related to devices and 
are specified in the bill. The FDA has stated that with this additional 
money it will significantly expedite the review of medical device 
applications and substantial equivalence submissions.
  The bill will sunset after 5 years. At that time, Congress will be 
able to review whether device user fees have achieved their purpose of 
expediting the review of device submissions.
  Mr. Speaker, this legislation will produce significant benefits to 
the public and the industry. If it is enacted, it will get lifesaving 
medical devices to sick people faster. Device companies will benefit 
because the additional resources that the bill will generate will 
result in shorter review times for requests to market new devices.
  The bill reflects extensive discussions with the device industry and 
the Food and Drug Administration. The bill was drafted after 
consultation with members of the Energy and Commerce Committee and the 
Senate Committee on Labor and Human Resources.
  I want to specifically acknowledge the important role that Mr. 
Dingell, the chairman of the Energy and Commerce Committee, played in 
drafting a bill that could gain the widest possible support from 
consumer groups, the industry, and the administration. Mr. Dingell has 
been a tireless advocate of soliciting additional resources for the 
Food and Drug Administration. Two years ago, he helped steer the 
Prescription Drug User Fee Act of 1992 through Congress, and hopefully, 
with his help, we will be able to enact a medical device user fee bill 
this year.
  I also want to acknowledge the important role that Senator Kennedy 
has played in the drafting of this legislation and in enacting user 
fees for prescription drugs. Today he will be introducing a bill in the 
Senate that is identical to the device user fee bill that I am 
introducing today.
  Mr. Speaker, in this bill, we have attempted to achieve a user fee 
structure that is fair and equitable. In particular, we have been very 
sensitive to the interests of small business, especially startup 
companies. We will continue to work on these and other issues as the 
bill is considered during the legislative process.
  I am pleased to announce that the bill is supported by the Health 
Industry Manufacturers Association, the National Electrical 
Manufacturers Association, and many companies in the device industry. 
It is my hope that it can be enacted this year.
  I ask unanimous consent that the text of the bill may be printed in 
the Record.

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