[Congressional Record Volume 141, Number 91 (Tuesday, June 6, 1995)]
[Extensions of Remarks]
[Pages E1157-E1158]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


      INTRODUCTION OF H.R. 1742, THE FDA MODERNIZATION ACT OF 1995

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                             HON. RON WYDEN

                               of oregon

                    in the house of representatives

                          Tuesday, June 6, 1995
  Mr. WYDEN. Mr. Speaker, the technology of drugs and medical devices 
has reached a new frontier. Through emerging sciences such as 
bioengineering we can anticipate truly monumental breakthroughs in the 
way we treat, and conquer, dread diseases which for centuries have 
plagued mankind.
  It is crucial, absolutely critical, that the Federal regulatory 
system so integral to the development and commercialization of these 
new products change, improve, and advance in step with this 
technological revolution.
  In support of this effort, I am today introducing H.R. 1742, the Food 
and Drug Administration Modernization Act of 1995. This bill offers 
reasonable, progressive, and user-friendly approaches toward making the 
FDA drug and device approval process more efficient and cost effective.
  Most importantly, it accomplishes these goals while preserving the 
Agency's critical mission to assure the safety and effectiveness of new 
drugs and medical devices.
  It ensures that our multibillion-dollar medical products industry 
continues as the preeminent international competitor.
  Here are the salient features of this legislation:
  The bill grants the agency authority to grant early, conditional 
approvals for promising drugs and devices which appear to be effective 
in fighting serious or life-threatening disease. Full and final 
approval would rest upon the manufacturer's ability to demonstrate that 
the initial promise of effectiveness was proven out in broader use.
  [[Page E1158]] The bill offers authority and strong encouragement to 
the Agency to use third parties--unbiased, independent panels under FDA 
supervision--to approve and oversee early stage trials of new drugs and 
devices.
  The bill relaxes some restrictions now barring the exchange of 
scientifically valid material--professional journal articles, medical 
textbook excerpts, research compendia--between manufacturers, 
clinicians, and health insurers. This change will make it easier for 
knowledgeable observers to receive information on promising, though 
unapproved, new uses of drugs and devices which have already been 
approved by the FDA for at least a single use. At the same time, the 
legislation gives the Agency authority to require that persons 
disseminating these articles provide appropriate supportive scientific 
data and respond on its balance.
  The bill fundamentally revamps and modernizes FDA review processes 
for biologics, therapeutics which are manufactured or propagated 
through bioengineering.
  The bill offers reasonable relaxation on current restrictions on the 
export of drugs or devices which are not approved by the FDA, but which 
meet the importing nation's approval regime. This flexibility would be 
limited to exports to member nations of the World Trade Organization.
  The bill modifies current reporting and approval requirements for 
minor manufacturing changes in devices of low to moderate risk. In 
essence, a manufacturer would be required to report, but not obtain 
prior approval for manufacturing changes which would improve the 
product's quality. This would allow manufacturers to make swift, 
useful, and perhaps even lifesaving changes in products without having 
to wait out an FDA approval decision.
  Mr. Speaker, there is no doubt in my mind that the FDA is a premier 
public health care agency with many extraordinarily dedicated 
employees. This Agency has a crucial health and safety mission that 
this Congress must not allow to be undermined.
  But I firmly believe that these vital safety missions can be 
preserved, and better products can be brought to consumers more rapidly 
and at lower cost, through the modest reform proposals contained in 
this legislation.
  It's time to make a good agency better. I urge my colleagues to 
support H.R. 1742, the FDA Modernization Act of 1995.


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