[Congressional Record Volume 148, Number 105 (Monday, July 29, 2002)]
[Senate]
[Pages S7460-S7461]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                               FTC REPORT

  Mr. HATCH. Mr. President, my staff just attended a non-embargoed 
briefing conducted by the Federal Trade Commission. It is our 
understanding that tomorrow the FTC will transmit to the Congress and 
the American people a copy of its comprehensive study of the 
pharmaceutical industry with respect to litigation involving the two 
major components of the pending legislation: first, the report examined 
the use and abuses of the statutory 30-month stay. Second, the report 
examines how the 180-day marketing exclusivity rule has been the source 
of collusive arrangements between pioneer and generic firms.
  I will be very interested to study the full report when it released 
tomorrow morning.
  Let me say this tonight. First, I want to commend Chairman Muris and 
the other FTC Commissioners for undertaking this important study. I 
would also like to acknowledge the efforts of the FTC staff including, 
Maryann Kane, Mike Wroblenski and Sarah Browers for their work on this 
report.
  It is my understanding that the key recommendations contained in the 
report are somewhat at odds with the legislation on the floor.
  It is my understanding the first FTC recommendation, consistent with 
the position that I took at the Health Committee hearing May 8 and my 
floor statements the past two weeks, will basically say that there 
should only be one automatic 30-month stay per drug product per ANDA to 
resolve challenges to patents listed in the FDA Orange Book prior to 
the filing date of the generic drug application.
  Senator Gregg took this position in the HELP Committee and I commend 
him for his work to strengthen the bill.
  Clearly, as I have laid out in some detail in earlier speeches, the 
Edwards-Collins substitute delves into areas way beyond this 
recommendation.
  I also understand the second FTC recommendation, which touches upon 
the so-called reverse payment agreements whereby generic firms are paid 
not to market generic drugs, will suggest that the Congress pass 
legislation to require brand-name companies and first generic 
applicants to provide copies of certain agreements to the FTC.
  This is exactly what Senator Leahy's bill, S. 754, the Drug 
Competition Act, requires. As I discussed in my previous statements, I 
voted for Senator Leahy's bill in the Judiciary Committee and worked 
with him to refine the final language. In my view, S. 754 contains a 
much more measured--and certainly more comprehensible--approach than 
does the Edwards-Collins substitute.
  Because the staff briefing just occurred and the full report will be 
issued tomorrow, I am not prepared tonight to give you my full 
evaluation of the FTC report. But I can say that the major 
recommendations of the FTC appear to be somewhat at odds with key 
provisions of the legislation that is pending on the floor, the 
Edwards-Collins substitute to S. 812.
  I look forward to examining the data collected by the FTC and 
analyzing the report's two major recommendations and its several 
subsidiary recommendations.
  Frankly, I think that it would be appropriate for the relevant 
committees, the Judiciary Committee, the Commerce Committee, and HELP 
Committee, to have the opportunity to examine this comprehensive study 
before we adopt legislation in this area.
  I will be interested to learn if the sponsors of the bill on the 
floor would be open to a process that will allow a careful evaluation 
of what the FTC study reveals and will not just act to ram this 
legislation through in the last week before August recess.
  I have lodged my concerns about the way this bill so hastily was 
adopted by the committee and appeared on the floor, and urged that we 
take the time necessary to get this legislation right.

[[Page S7461]]

  The Hatch-Waxman Act is an important consumer bill that has helped 
save about $8 billion to $10 billion each year since 1984. So we should 
not be playing around with this bill, especially without the benefit of 
carefully studying this this soon-to-be-released FTC report.
  Once again, I urge my colleagues to do the right thing and give us an 
adequate opportunity to factor in this FTC study.
  It would be advisable to spend the time before the recess to adopt 
trade promotion authority rather than to continue to struggle with the 
hastily crafted and not fully vetted Edward-Collins substitute.
  In that regard, I pay specific tribute to our colleague, Senator 
Baucus, who represented the Senate so well in the trade conference that 
occurred Thursday evening and early Friday morning. I was a member of 
the conference committee. Senator Baucus did himself proud, did our 
body proud, did a very good job, as did Chairman Thomas. Those two 
worked very well together to come up with what is landmark legislation 
to help our economy move forward. It is one of the reasons I think the 
stock market turned around today. It is not the only reason. I think we 
would have another reason if we would treat the Hatch-Waxman language 
with the care and treatment it deserves before we go off half cocked to 
enact a bill before we examine the FTC study and its recommendations.
  I am grateful I serve on the Finance Committee with Senator Baucus 
and Senator Grassley, both of whom did a good job in this last 
conference on trade promotion authority. I also am very pleased one of 
my long-term friends in the Congress has been Chairman Bill Thomas in 
the House. It is a tough job being chairman of the Ways and Means 
Committee. It is a very divided committee in many respects; yet it 
works very well. There is no one in this Congress who does a better job 
on health care issues than Chairman Thomas.
  All of them deserve credit, as do the ranking members, Charlie 
Rangel, without whom this agreement probably could not have come to 
pass, a man for whom I have tremendous respect; and, of course, Senator 
Grassley in our body who has worked so well with Senator Baucus on so 
many pieces of legislation that mean so much to our economy and our 
country.
  These are important issues. I have given some rather lengthy speeches 
on the Hatch-Waxman issue and even some lengthy speeches on the trade 
promotion authority. I was one of those in the Finance Committee who 
pushed very hard to get the trade promotion bill on the floor and get 
us to conference. I express my regard for all concerned. I hope we can 
resolve this matter on the floor this week, but I believe trade 
promotion authority deserves even greater precedence than what we are 
trying to do in the underlying bill S. 812. If we act on the underlying 
bill, it ought to be done in a thoughtful fashion. It should not be 
done just politically. We ought to pay attention to the experts at FTC 
and elsewhere who have spent so much time on the issue.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Pennsylvania is recognized.

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