[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]

 
                  MEDICAL DEVICE USER FEE ACT OF 1994

                                 ______


                          HON. JOHN D. DINGELL

                              of michigan

                    in the house of representatives

                         Tuesday, July 12, 1994

  Mr. DINGELL. Mr. Speaker, I am pleased to join my colleague Mr. 
Waxman in introducing the Medical Device User Fee Act of 1994.
  This legislation authorizes the collection of fees by the Food and 
Drug Administration [FDA] for the purpose of improving the medical 
device review process. These fees will make it possible for FDA once 
again to meet the 90- and 180-day deadlines set by the Congress for the 
review of substantial equivalence and pre-market-approval applications, 
most particularly through providing the resources needed to hire new 
personnel, additional to those already employed by the Agency.
  Many in the device industry have told us that delays in processing 
their applications cost their companies substantial losses. Thus, they 
believe that user fees are an acceptable investment if they are linked 
to FDA meeting these timeframes for new applications and to eliminating 
the backlog of applications pending action by the Agency.
  Fees would be collected from companies who apply to FDA for medical 
device pre-market approvals [PMA]; for a determination of substantial 
equivalence of devices covered by the requirements of section 510(k) of 
the Food, Drug, and Cosmetic Act; or for approval of supplements to PMA 
applications. The fees will be no higher than necessary to meet the 
agency's actual needs and will be dedicated to the medical device 
review process and specific related activities.

  In developing this legislation, we looked to the Prescription Drug 
User Fee Act (Public Law 102-571) as a model for basic principles. 
However, we also recognized that the medical device industry is 
different from the prescription drug industry in a number of 
significant ways. We worked with representatives of the industry--both 
large and small companies and associations--in crafting the 
legislation. However, we are well aware that we have not heard from 
each and every segment of this large and diverse industry. Thus, some 
unique perspectives of specific portions of the industry may not be 
represented in the bill we introduce today.
  I want to emphasize, Mr. Speaker, that we remain receptive to hearing 
additional points of view about the structure of this user fee program, 
and we will try to accommodate them.
  One particular component of the device industry which has 
communicated its concerns is in vitro diagnostics manufacturers. These 
companies develop and produce tests and reagents used by health care 
providers and clinical laboratories for screening and diagnosis. For 
instance, they manufacture tests and reagents used in measuring blood 
cholesterol levels, doing blood screening, testing for allergies and 
infections such as hepatitis and HIV. Many of these companies are 
small, but manufacture a range of inexpensive devices. Thus, they are 
justifiably concerned about the impact of user fees on their business. 
We are looking carefully at their questions and concerns, to determine 
the best approaches to resolving them.
  Mr. Speaker, over the last several years, my Oversight and 
Investigations Subcommittee has thoroughly examined the management and 
operation of FDA's Center for Devices and Radiological Health. The 
subcommittee report, ``Less Than the Sum of Its Parts,'' details the 
results of this investigation and makes a number of recommendations for 
change, especially in the Center for Devices and Radiological Health 
[CDRH]. Some of these recommendations have been implemented by the new 
management of the center, and progress is being made. This is a 
positive sign, but we are not out of the woods. We expect FDA to 
continue to improve its management, operations, and policies related to 
medical device review, approval, and regulation.
  Without sufficient resources, however, FDA will continue to swim 
upstream. With our enormous Federal deficit and intense demands for 
funding from many worthy programs, we simply do not have funds 
available to enhance FDA's budget. User fees are not the answer to all 
of the problems identified by our investigation or experienced by the 
medical device industry, but they are a key component of the solution. 
I urge my colleagues to support this legislation as a responsible and 
necessary approach to improving the medical device review process and 
enhancing FDA's ability to do the job we want the agency to do.

                          ____________________