[Congressional Record Volume 143, Number 148 (Wednesday, October 29, 1997)]
[Extensions of Remarks]
[Pages E2120-E2121]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




       LOOK OUT CONSUMERS: PHARMACEUTICAL RIP-OFF BEING PROPOSED

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                      Wednesday, October 29, 1997

  Mr. STARK. Mr. Speaker, following is the testimony of Immunex Corp. 
from an October 21, 1997 hearing before the Senate Approrpriations 
Subcommittee on Labor-HHS-Education.
  It describes why a proposal by a number of drug manufacturers to 
extend the patent exclusivity on their drugs is a bad deal for 
consumers and America. Everyone is for increased research on the cure 
to illnesses--but charging sick people more for existing medicines 
while the corporations pocket most of the monopoly windfall for profits 
is a lousy deal.
  The end of a Congress is a dangerous time, when last minute 
sweetheart deals get added to ``must pass'' legislation. The last time 
a pharmaceutical company tried this was an anonymous amendment to the 
Kennedy-Kassebaum law to provide special patent protection to Lodine. 
the result was a national outcry and special action to strip the 
``gift'' out of the bill.
  Keep your eyes open everyone--we may be facing the same robbery 
attempt again.

Statement by Scott Hallquist, Senior Vice President and General Counsel 
Immunex Corporation, Before The Subcommittee on Labor, Health and Human 
     Services, Education, Committee on Appropriations, U.S. Senate

                           October 21, 1997.

       Mr. Chairman and Members of the Subcommittee: On behalf of 
     the employees and stockholders of Immunex Corporation, I am 
     grateful to the Subcommittee for affording me the opportunity 
     to present Immunex's views about the proposed demonstration 
     project to fund biomedical research through extensions of 
     market exclusivity for approved drugs. If implemented, this 
     proposal would deprive our company of the ability to provide 
     an important cancer drug to patients. Using this drug as an 
     example, I will illustrate for the Subcommittee the punitive 
     and anticompetitive impact of the proposed demonstration on 
     private sector research, health care expenditures, the 
     federal Medicare budget, and patient access to affordable 
     drug therapies.
       Immunex is a research-based biopharmaceutical company 
     headquartered in Seattle, Washington. We have approximately 
     900 employees throughout the U.S. Our mission is to develop 
     innovative treatments for patients with serious medical 
     needs. Since the company was founded sixteen years ago, we 
     have spent $483 million on research and development--
     approximately one-half of the company's revenues over that 
     same period of time. In 1996, our total research investments 
     exceeded $100 million.
       Immunex markets seven products in the U.S. All are used in 
     the treatment of cancer or to temper the side effects of 
     cancer therapy. As one example, we received FDA approval to 
     market a chemotherapy drug called Novantrone for the 80,000 
     men who suffer from advanced hormone refractory prostate 
     cancer. Until Novantrone received clearance, there were few 
     treatment options for these patients. In addition to the 
     development of innovator drugs like Novantrone, Immunex has 
     developed a generic form of paclitaxel, a chemotherapeutic 
     agent used to treat metastatic ovarian and breast cancers 
     that have not responded to first line therapies. We intend to 
     market this drug as soon as the exclusivity period granted to 
     Brisol-Myers Squibb for its brand, Taxol, expires.
       Thus, we are able to consider the proposed demonstration 
     project from a unique perspective--that of a company that is 
     fiercely committed to research and development, that develops 
     and markets innovator drugs, and that also has an interest in 
     generics. In our view, the proposed demonstration runs 
     counter to sound public policy and would not achieve its 
     stated objectives.
       Proponents of the demonstration offer two principal 
     justifications: 1) five years of market exclusivity is not 
     sufficient to provide adequate incentive for companies to 
     conduct research to develop new drugs; and 2) the 
     demonstration would provide a source of revenue needed to 
     maintain support for NIH research. Unfortunately, the 
     proposal fails on both counts.
       Perhaps there should be a reexamination of the purpose and 
     effect of the Waxman-Hatch market exclusivity law. But the 
     appropriations process is not the proper forum for that 
     debate. It requires the same level of scrutiny and 
     consideration that was applied when the law was first 
     adopted. This is particularly true in light of the anti-
     competitive nature of the demonstration and its likely 
     adverse impact on patient access to lifesaving therapies. 
     Moreover, the proposed demonstration does nothing to 
     incentivize new drug development since it would extend, by up 
     to five additional years, market exclusivity for existing 
     drugs only. It actually would deter research to develop new 
     formulations of drugs that qualify for the additional 
     protections. Simply put, other companies that otherwise might 
     produce new versions with fewer side effects, easier delivery 
     systems, or greater efficacy would be unable to receive 
     approval and would have no incentive to conduct the research 
     necessary to achieve these kinds of breakthroughs. Depriving 
     patients in this

[[Page E2121]]

     way goes well beyond current market exclusivity policy.
       The projected revenue stream to NIH is another fallacy. As 
     illustrated in the Taxol example below, the cost to the 
     government of extending exclusivity periods under this 
     demonstration would far exceed the projected $750 million of 
     new revenue for NIH. It also is important to note that the 
     proposed ``royalty'' would not be absorbed by the 
     pharmaceutical companies but would be passed on to patients, 
     private insurers, and government health care programs in the 
     form of higher prices for drugs that are shielded from 
     competition. A tax on sick and dying patients is an 
     inappropriate and unnecessary way to fund biomedical 
     research.
       Conservatively, at least 21 drugs would receive protection 
     under the demonstration. But one drug, Taxol, presents the 
     most egregious case study on why the demonstration would be a 
     horrible investment for taxpayers and a setback for cancer 
     patients.
       The active ingredient in Taxol is the anticancer compound 
     paclitaxel. It was discovered, formulated, and introduced 
     into human clinical trials by the National Cancer Institute 
     using federal funding. As a result of a cooperative research 
     and development agreement, or CRADA, Bristol-Myers Squibb was 
     granted exclusive rights to the NCI paclitaxel research, 
     continued the clinical trials of Taxol, and obtained FDA 
     approval in December 1992. In return for its investment, 
     Bristol received five years of marketing exclusivity under 
     the Waxman-Hatch Act. This term of exclusivity is 
     scheduled to expire on December 27, 1997.
       Taxol is an expensive drug. A basic treatment costs a 
     cancer patient more than $2,000. Taxol pricing was the 
     subject of a negotiated agreement between NIH and Bristol 
     following a House subcommittee hearing in 1991 at which a 
     senior Bristol executive testified that the drug ``is neither 
     patented nor patentable; therefore, we do not have exclusive 
     intellectual property rights to Taxol.'' Taxol's high price 
     and five years of marketing exclusivity were part of the 
     bargain that Bristol struck with the government.
       The bargain paid off for Bristol. Bristol does not 
     separately report U.S. Taxol sales, but the market research 
     firm IMS America estimated U.S. Taxol sales for 1996 alone to 
     total $519 million. Other firms have estimated them to be as 
     high as $590 million. In August of this year, Bristol 
     reported worldwide Taxol sales of $813 million and sales in 
     the first half of 1997 of $444 million. Taxol is well on its 
     way to becoming a billion dollar drug and certainly needs no 
     additional legislative preference to ensure its success.
       Four years ago, Immunex began working with paclitaxel. We 
     have a supply arrangement with an innovative Colorado 
     company, Hauser, Inc., that pioneered paclitaxel 
     manufacturing processes when NCI research on paclitaxel first 
     began. Immunex and Hauser each have invested heavily to 
     prepare stockpiles of bulk drug for formulation and sale. 
     Hauser also has developed a manufacturing process based on 
     renewable biomass that can assure continued supplies of 
     paclitaxel. In undertaking this effort, we relied upon the 
     Waxman-Hatch law and have every intention of introducing on 
     the market a competitive paclitaxel product in the U.S. upon 
     the expiration of Bristol's initial exclusivity period for 
     Taxol. Several other companies have expressed the same 
     intent.
       The positive impact of generic competition to Taxol is 
     occurring in Canada where Immunex has introduced a 
     competitive paclitaxel injection product. The prices for 
     Taxol in Canada are already declining as the market adjusts 
     to competition. Whereas a breast cancer patient in the U.S. 
     pays $183 for a vial of Taxol, her Canadian counterpart is 
     able to obtain the competitive product for less than $100 
     (U.S. dollars).
       NCI has indicated its expectation that generic competition 
     for Taxol will occur upon the expiration of Bristol's initial 
     term of exclusivity. In a letter to Senator Ben Nighthorse 
     Campbell, dated February 26, 1997, Alan Rabson, Deputy 
     Director of NCI, discussed the Bristol CRADA and stated, ``. 
     . . [N]ew anti-cancer indications for paclitaxel that 
     hopefully will arise from research under the extended CRADA 
     may increase market opportunities for generic manufacturers 
     of paclitaxel once they are able to enter the market in 
     January, 1998.''
       Nevertheless, Bristol continues to pursue efforts to obtain 
     extensions of its Taxol exclusivity. At one point, Bristol 
     was seeking a two-year extension. To better understand the 
     economic impact of such an extension, Immunex commissioned a 
     study by an independent economic research firm, National 
     Economic Research Associates (``NREA''). NERA estimated that 
     a two-year extension would cost the U.S. health care system 
     in excess of $1 billion and would cost the Medicare program 
     alone $288 million.
       The proposed demonstration would provide not two, but five 
     years of additional exclusivity to Bristol for Taxol. In 
     exchange, NCI would receive a mere three percent royalty. 
     Based upon the approximately $500 million in U.S. sales now 
     recorded by Bristol, NCI would receive about $15 million in 
     royalties in the first year. Comparing the estimated Medicare 
     cost impact of a two-year extension with two years worth of 
     royalty payments under the demonstration, taxpayers would 
     spend an extra $10 on Medicare for every $1 invested in the 
     demonstration. When one considers the over $1 billion in 
     added costs to all federal health programs and private sector 
     plans, the taxpayer cost balloons to nearly $30 for every one 
     dollar spent with regard to Taxol alone. The numbers are even 
     more astounding when all drugs covered by the demonstration 
     are taken into account.
       The sweeping protections granted to certain drugs under the 
     proposal actually would deter other companies from 
     researching and developing new formulations of paclitaxel or 
     new methods of using and administering this anticancer 
     compound, since any drug application relating to this active 
     compound (even new drug applications directed to uses, 
     indications, or formulations that are not researched or 
     developed by Bristol or included in Taxol labeling) would be 
     frozen for five years.
       Thus, the proposed demonstration actually would cost the 
     federal government billions of dollars that otherwise could 
     have been dedicated, at least in part, to NIH research. It 
     would discourage important research, deny patients access to 
     lower-cost drugs, impose a hidden tax on the sick, and 
     adversely impact companies that have made significant 
     investments in researching new uses for drugs that are 
     reaching the end of their exclusivity periods.

     

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