[Congressional Record Volume 143, Number 128 (Tuesday, September 23, 1997)]
[Senate]
[Pages S9771-S9772]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  The Senate continued with the consideration of the bill.
  Mr. JEFFORDS. What is the pending business?
  The PRESIDING OFFICER. There is now to be 4 hours of debate equally 
divided on S. 830. The Senator from Vermont controls half that time.
  Mr. JEFFORDS. I yield to the Senator from Utah 5 minutes.
  The PRESIDING OFFICER. The Senator from Utah.
  Mr. HATCH. Mr. President, I ask unanimous consent that the Record 
reflect the fact that amendment No. 1182, as modified, which was 
adopted was a Hatch-Wyden amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. HATCH. Mr. President, there is an old saying, ``No good deed goes 
unpunished.'' And it applies only too well to those who tackle the job 
of shepherding the FDA legislation through Congress.
  The legislation we are debating today has its foundation in the last 
Congress. From my experience, I know that FDA bills are inherently 
contentious and complicated--and that would be true even if my friend 
from Massachusetts, Senator Kennedy, was not on the Labor Committee. 
Sometimes I believe that it was this FDA bill that drove our good 
friend Nancy Kassebaum out of the Senate.
  So we should all take off our hats and thank Jim Jeffords for his 
efforts in forging this important compromise bill. The overwhelming 
votes on cloture and on the motion to proceed are testament to the fact 
that S. 830 is a solid piece of bipartisan legislation that will 
benefit the American public for years to come.
  Every Member of this body understands only too well the necessity of 
having good staff. Our staffs work long hours in order to resolve very 
difficult issues. I commend the work of all of the staff involved in 
the development of this bill. I will defer to tradition and allow the 
chairman and ranking member to single them out when the bill achieves 
its final passage.
  However, I do want to depart from tradition for a moment to 
compliment the work of Senator Jeffords' point person on FDA reform, 
Jay Hawkins. It is always safe to bet against the passage of FDA 
legislation, but Jay joined the Labor Committee this past winter and 
hit the ground running and has helped the chairman in crafting and 
bringing S. 830 through the committee and onto the floor.
  Jay has worked hard, listened patiently to diverse viewpoints, 
identified and solved problems, and has exhibited sound judgment and 
tremendous energy throughout this process.
  Unfortunately for Jay and his family, on August 20, his mother, Mrs. 
Donna Lotz Hawkins, died after a long battle with cancer. Jay's mom was 
a mountain climber, ocean swimmer, and distance runner who had many 
friends that will deeply miss her.
  The loss of a parent can never be replaced. While I never met Jay's 
mom, as a parent I know that she must have been extremely proud of her 
son for all of his important work in the Senate.
  It is only fitting that this bill, which has so much of Jay's 
imprint, promises to speed the development of the next generation of 
cancer treatments.
  I just wanted to take these few moments to salute Jay and the 
chairman for their considerable efforts on the FDA bill, and I want to 
extend my condolences to the Hawkins family on the loss of his mother.
  I yield the floor.
  Mr. D'AMATO addressed the Chair.
  The PRESIDING OFFICER. Who yields time?
  Mr. JEFFORDS. I yield 5 minutes to the Senator from New York.
  Mr. D'AMATO. I thank the chairman and ask unanimous consent that I 
may proceed as in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The remarks of Mr. D'Amato pertaining to the introduction of S. 1203 
are located in today's Record under ``Statements on Introduced Bills 
and Joint Resolutions.'')
  Mr. KENNEDY. Mr. President, I yield such time as the Senator from 
Rhode Island might use.
  The PRESIDING OFFICER. The Senator from Rhode Island.
  Mr. REED. We have made great progress with respect to the Food and 
Drug Administration [FDA] bill. That is a tribute to Chairman Jeffords 
and the ranking member, Senator Kennedy from Massachusetts, and all the 
members of the committee and the Members of the Senate participating in 
this debate.
  However, there remains at least one issue of concern, one issue that 
was a subject of extensive debate today. That issue is a provision 
regarding the 510(k) approval process for class I and class II devices. 
As I mentioned previously, these class I and class II devices are 
serious medical devices. This is not a Band-Aid or gauze. These are 
lasers or biopsy needles or many other complicated, necessary medical 
devices.
  As a result, we cannot, I think, assume that this is a small or 
inconsequential issue we are debating. It is a very important issue.
  Essentially, the legislation that is before the Senate today limits 
the FDA from looking behind the stated use on the label presented by 
the manufacturer when they request approval to put a new product on the 
market. It is important, in certain cases, to make such a searching 
review beyond the proposed use by the manufacturer. It is particularly 
important in the case where there is strong suspicion that the label is 
either misleading or fraudulent or false. Although my amendment was not 
favorably considered earlier today, it would have given the authority 
to the FDA to look beyond the label in cases where they could show--and 
this is a very high standard of proof--that the label was false or 
misleading.
  There is no other provision in this new legislation that would give 
the FDA such authority. Indeed, one could ask why the proponents of 
this legislation deliberately chose to remove the FDA's authority and 
to effectively prevent the FDA from conducting a thorough review of 
medical devices as they come on the market.
  I have outlined, as many of my colleagues have, the detailed reaction 
of several sections of the FDA law. It is complicated, arcane 
legislative language.
  I have tried to think of a more homely and mundane example which 
might illustrate the dilemma the FDA would be facing as it contemplates 
this new legislation. If the FDA were in the position of not approving 
medical devices but approving, for example, land transportation 
vehicles, they might be confronted with an existing model, perhaps a 
Ford Mustang. And say, for example, a new product such as an F-16 
fighter plane is presented for review.

[[Page S9772]]

 Both can move over the ground, both of them are fairly fast, and both 
of them have certain similar aerodynamic capacities. Both of them can 
carry passengers. So one could make the argument that the F-16 could be 
substantially equivalent in use as a ground transportation vehicle.
  But I think anyone would have to say, upon looking at both of these 
devices, that there is a strong suggestion the F-16 can be used for 
something else. If the FDA, or in this example, the hypothetical 
agency, did not have the authority to ask the simple question: Will it 
be used to fly and can it fly? The hypothetical agency may not be doing 
the job.
  That is a homely example to illustrate that the FDA is frequently 
confronted with devices that are presented as being substantially 
equivalent to existing devices. These new devices may be similarly 
labeled to that existing device, but they have the potential for other 
uses. If it is obvious that the device is for uses not listed on the 
label, the FDA should have the authority to make an inquiry into those 
other uses.
  In fact, my suspicion is that in the development of new medical 
devices there is a long history of starts and stops. A history of 
contact with other individuals, many researchers working together, 
exploring different uses and alternatives, different materials. In that 
process, it is very likely that other issues are contemplated, 
evaluated and perhaps designed into the device.

  Today we have a system where there is more incentive for approaching 
the FDA with a petition of a 510(k) approval because that is the 
fastest way to the marketplace. Even if there were uses that were 
discussed and contemplated, even if there are obvious uses that might 
become part of common practice, those may be dismissed in order to get 
this through the system quickly.
  What we have done today by not adopting my amendment is effectively 
prohibit the FDA from making that searching inquiry into possible uses. 
The consequences can be severe to the public health.
  Despite all of these issues we have discussed, this bill represents 
significant progress on many fronts. We are very, very close. I hope in 
the ensuing conference--or before we go to conference--that we could 
address this particular issue. It is an issue that has been highlighted 
by Secretary Shalala. It has been highlighted with respect to the 
potential for a Presidential veto. I hope we don't reach that point.
  The hard work that has been done over many months by my colleagues, 
the hard work of many representatives of the industry, and the hard 
work of public health advocates I think will lead us, if we can get 
over this hurdle, to a bill that we will all be proud of.
  In conclusion, today we have spent some time discussing the industry. 
We have spent some time discussing the FDA. There have been criticisms 
by Members with respect to both the industry and the FDA. Our job at 
this point is not to demonize or deify anyone. It is to get good laws 
passed. I believe this legislation can be approved and can succeed.
  I note the majority leader is standing by, and I yield back my time.

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