[Congressional Record Volume 143, Number 69 (Thursday, May 22, 1997)]
[Extensions of Remarks]
[Page E1043]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


        THE MEDICAL DEVICE REGULATORY MODERNIZATION ACT OF 1997

                                 ______
                                 

                            HON. JOE BARTON

                                of texas

                    in the house of representatives

                         Thursday, May 22, 1997

  Mr. BARTON of Texas. Mr. Speaker, I rise today to introduce the 
Medical Device Regulatory Modernization Act of 1997, along with my 
colleague, Congresswoman Anna Eshoo. This legislation will improve and 
streamline the Food and Drug Administration's [FDA] regulation of 
medical devices. This is a bipartisan initiative to provide additional 
resources to the FDA for reviewing innovative devices and modernizing 
FDA regulation of the device industry.
  Currently, the FDA limits choice, access, and opportunities for 
patients. As the rest of the country moves into the 21st century, we 
must make sure the FDA moves with us. When the lives of millions of 
people are hanging in the balance, inefficiency doesn't cut it. For 
example, if the FDA had approved the drug interleukin-2 as quickly as 
it had been approved in Europe, the lives of 3,500 kidney cancer 
patients might have been saved. If the FDA had approved the drug 
misoprostal, which helps to treat gastric ulcers, up to 15,000 deaths 
might have been prevented.
  The Medical Device Regulatory Modernization Act of 1997 sets forth a 
formal mission statement to provide reasonable assurance of safety and 
effectiveness and to review devices in a manner that does not unduly 
impede innovation or product availability. In regards to 
investigational device exemptions [IDE's], the bill would require that 
the FDA set clear terms under which doctors could use devices in 
clinical trials for other compassionate purposes. It will require FDA 
officials to meet with medical device applicants early in the IDE 
process to clarify company goals and agency expectations.
  This legislation would also allow the FDA to recognize national and 
international performance standards by publishing them in the Federal 
Register and allowing companies to self-certify to the standards. 
Penalties would be levied for falsification of data, and certification 
data would be available for FDA inspection.
  Under our bill, the uses of a device specified by the FDA during 
clinical trials must be consistent with FDA expectations of uses during 
the premarket approval [PMA] process, unless the agency determines 
there could be harm to public health.
  The bill also calls for independent review for most class I and II 
devices, except for permanently implantable or life-sustaining 
products. This frees FDA resources from reviewing less complex new 
devices so these products could reach consumers sooner, allowing the 
FDA to devote more personnel to reviewing cutting-edge technologies and 
get those devices to the market quicker.
  The FDA was formed in 1927 to enforce the 1906 Pure Food and Drug 
Act. Safety was important then and is just as important today. But 
delay does not mean safety. The current practices of the agency do not 
enable the FDA to benefit patients and consumers because decisions 
simply take too long. Congress needs to act, and as a result patients 
will receive much needed medication and medical devices more quickly.
  Mr. Speaker, I urge the Members of this body to join Congresswoman 
Eshoo and I in supporting this important piece of legislation to 
streamline and improve the Food and Drug Administration's regulation of 
medical devices.

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