[Congressional Record Volume 144, Number 145 (Tuesday, October 13, 1998)]
[Extensions of Remarks]
[Pages E2121-E2122]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 CLARITIN AND SPECIAL INTEREST LOBBYING

                                 ______
                                 

                          HON. HENRY A. WAXMAN

                             of california

                    in the house of representatives

                       Tuesday, October 13, 1998

  Mr. WAXMAN. Mr. Speaker, as all of my colleagues know, this is the 
time of year when special interests come out in force to take advantage 
of our busy schedule. They try to slip last-minute riders into 
conference reports and sneak lucrative patent extensions into crucial 
appropriations bills. If history is any guide, a number of 
pharmaceutical companies are at the very head of this unsavory pack.
  You may recall that, in the dead of night, someone smuggled a drug 
patent extension into the conference report of the 1997 Kennedy-
Kassebaum Health Care Reform Act. Neither Senator Kennedy nor Senator 
Kassebaum were informed of this corporate giveaway. Only public protest 
prevented the drug company from scoring a multimillion dollar coup at 
the expense of consumers.
  It is the widespread rumors about a similar effort that have brought 
me here. I want to alert my colleagues to the efforts of Schering-
Plough to sneak a backdoor patent extension onto the continuing 
resolution.
  For many years, Schering has sought to extend its patent protections 
for Claritin, a prescription antihistamine with over $900 million

[[Page E2122]]

in annual U.S. sales. Last year, Schering lobbied the Senate for an 
amendment to omnibus patent reform legislation granting outright five-
year patent term extensions for a number of drugs, including Claritin. 
In 1996, Schering tried unsuccessfully to attach Claritin patent 
extensions to the omnibus appropriations bill, the continuing 
resolution and the agriculture appropriations bill. In the first half 
of that year alone, Schering spent over $1 million in lobbying the 
Congress.
  Schering's proposal is a terrible deal for consumers. It would 
require the Patent Office to adjudicate patent extensions for drug 
companies who have experienced regulatory delays at FDA. In reality, it 
is a backdoor opportunity for companies to undercut the scientific 
judgment of the FDA and its expert advisory committees.
  What Schering calls ``regulatory delay'' is the time needed by our 
public health agencies to ensure drug safety and efficacy. Often, a 
company will cause its own delays through miscalculations, 
complications in its research and new questions about its products. 
Schering claims that the approval of Claritin was subject to regulatory 
delay. The company never mentions that its delay resulted from the 
unexpected discovery that Claritin might cause cancer.
  Mr. Speaker, putting the Patent Office in the position of trying to 
second guess the FDA and its expert advisors on Claritin's possible 
carcinogenicity would be like having the IRS deciding which research 
proposals should be funded by NIH.
  This proposal would also burden the Patent Office with meritless 
cases like Claritin. The Patent Office has limited resources and 
crucial responsibilities. It does not have time to coddle companies 
like Schering when patents for breakthrough technology are awaiting 
approval.
  Even worse, this proposal would cost taxpayers millions of dollars in 
additional health care spending for Medicaid, Veterans health programs, 
the Defense Department and Public and Indian Health Services. Private 
insurers and HMOs will have to pay higher prices for drugs like 
Claritin. And ordinary consumers, especially older Americans, will have 
to pay much more out of pocket for their medicines.
  Let me make a final point about this proposal. I am the coauthor of 
the 1984 Waxman-Hatch Act. The Act grants patent extensions to drug 
companies for the patent time expended obtaining FDA approval. One of 
the points of the 1984 Act was to stop companies like Schering from 
lobbying Congress for patent extensions. It has been very successful, 
with the exception of rogue companies like Schering.
  In fact, I seriously doubt that Schering has told anyone that it 
already received a 2-year patent extension under this law. The company 
just wants another pass at the trough.
  Lobbying efforts like Schering's are bad for the consumer. They also 
do harm to the 1984 Act, which strikes a balance between promoting 
innovation and ensuring that consumers have timely access to affordable 
medicines. Senator Hatch and I have publicly emphasized that revisions 
to the 1984 Act be made in a careful, deliberative process to preserve 
that balance. Dropping the Schering proposal onto the CR without 
notice, without committee proceedings, and without publicity is the 
exact opposite of what we meant.
  For these reasons, I urge my colleagues to oppose Schering-Plough's 
proposal, wherever it should appear in these final days of the session. 
It would cost taxpayers millions, hurt consumer choice, distract the 
Patent Office, undercut the FDA and do violence to the need for 
committees of jurisdiction to deliberate carefully over these important 
issues.

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