[Congressional Record Volume 141, Number 6 (Wednesday, January 11, 1995)]
[Extensions of Remarks]
[Page E80]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                   LEGISLATION TO SAVE AMERICAN JOBS

                                 ______


                              HON. JAY KIM

                             of california

                    in the house of representatives

                      Wednesday, January 11, 1995
  Mr. KIM. Mr. Speaker, I rise today to introduce legislation which 
will save the jobs of thousands of American workers.
  As many of my colleagues know, the medical device industry is one of 
the most dynamic industries in the United States. The statistics bear 
this point out: In 1993, the U.S. medical device industry produced 
nearly 40 billion dollars worth of goods and employed approximately 
270,000 workers in high-skill, high-wage jobs. U.S. medical device 
firms also exported almost $10 billion worth of goods in 1993, 
capturing 53 percent of the worldwide device market.
  However, like other U.S. industries in the past, our position of 
world dominance in this industry is being threatened. The medical 
device industry is facing increasingly fierce competition from many 
foreign nations, especially Japan, Germany, and France.
  Given this situation, one would think that our Government would be 
doing all it could to help device manufacturers retain their position 
as world leaders. Unfortunately, the opposite is true: In their fight 
for survival against these foreign competitors, our own Government has 
put U.S. companies at a serious competitive disadvantage.
  Under current law, any company wishing to export a class III medical 
device must obtain separate export approval from the FDA--a process 
which is complex, expensive, and which can take months to complete. 
Surprisingly, U.S. companies are required to complete this export 
approval process even if the export product is not intended for sale in 
this country and has already
 been approved by the country to which it is being exported.

  Because of this FDA redtape, U.S. device companies who want to export 
face a double hurdle: They must satisfy both the U.S. Government and 
the government of the country to which they wish to export. This 
situation creates a strong incentive for American companies to move 
overseas, where they do not face this kind of unnecessary redtape.
  This incentive is already having devastating effects: In a recent 
survey of device company CEO's 40 percent said that their companies had 
reduced employment as a result of regulatory delays, and 22 percent 
said that they had already moved jobs offshore due to unnecessary FDA 
regulation. In other words, the result of this FDA regulation is lost 
American jobs.
  The legislation I am introducing today, the Medical Device Export 
Promotion Act, could help save these jobs.
  This legislation would direct the FDA to give automatic export 
approval to class III medical devices which have been approved for 
import by members of the European Community or Japan. These countries 
are our two most important export markets and have device approval 
processes which are internationally recognized as being safe and 
effective. The bill would also allow U.S. companies which have gained 
approval for import into Europe and Japan to export worldwide without 
FDA interference. Finally, the bill would not allow companies to export 
products which have been banned in this country.
  In short, this legislation represents the best of both worlds: It 
would allow 85 to 90 percent of U.S. medical devices to be freely 
exported without allowing U.S. companies to dump inferior products on 
the world market.
  In doing so, this legislation would eliminate many of the 
bureaucratic hurdles that U.S. companies must currently overcome in 
order to export medical devices. In doing so, this legislation will 
eliminate the incentives for companies to move overseas to avoid such 
unnecessary regulation and, as a result, will save American jobs. For 
this reason, I urge my colleagues to support the Medical Device Export 
Promotion Act and ask for its timely consideration by this body.
  American workers are counting on us. It is time to act.
  

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