S6494 CONGRESSIONAL RECORD— SENATE May 11, 1995 

AMENDMENT NO. 769

The PRESIDING OFFICER. Under 

the previous order, the Senate will now 

resume consideration of amendment 

No. 769 offered by the Senator from Arizona [Mr. KYL]. 

Mr. CHAFEE. Mr. President, I move 

to table the Kyl amendment and ask 

for the yeas and nays. 

The PRESIDING OFFICER. Is there a 

sufficient second? 

There is a sufficient second. 

The yeas and nays were ordered. 

The PRESIDING OFFICER. The 

question is on agreeing to the motion 

to lay on the table amendment No. 769. 

The yeas and nays have been ordered. 

The clerk will call the roll. 

The legislative clerk called the roll. 

The result was announced—yeas 79, 

nays 21, as follows: 

[Rollcall Vote No. 162 Leg.] 

YEAS—79 

Abraham 

Akaka 

Baucus 

Bennett 

Biden 

Bingaman 

Bond 

Boxer 

Bradley 

Breaux 

Bumpers 

Burns 

Chafee 

Coats 

Cohen 

Conrad 

Coverdell 

D’Amato 

Daschle 

DeWine 

Dodd 

Dole 

Dorgan 

Exon 

Faircloth 

Feinstein 

Ford 

Frist 

Glenn 

Gorton 

Graham 

Grams 

Grassley 

Gregg 

Harkin 

Hatch 

Hatfield 

Heflin 

Helms 

Hollings 

Hutchison 

Inouye 

Jeffords 

Johnston 

Kassebaum 

Kennedy 

Kerrey 

Kerry 

Lautenberg 

Leahy 

Levin 

Lieberman 

Lugar 

Mack 

McConnell 

Mikulski 

Moseley-Braun 

Moynihan 

Murray 

Nunn 

Packwood 

Pell 

Pressler 

Pryor 

Reid 

Roth 

Santorum 

Sarbanes 

Shelby 

Simon 

Simpson 

Smith 

Snowe 

Specter 

Thomas 

Thompson 

Thurmond 

Warner 

Wellstone 

NAYS—21 

Ashcroft 

Brown 

Bryan 

Byrd 

Campbell 

Cochran 

Craig 

Domenici 

Feingold 

Gramm 

Inhofe 

Kempthorne 

Kohl 

Kyl 

Lott 

McCain 

Murkowski 

Nickles 

Robb 

Rockefeller 

Stevens 

So the motion to lay on the table the 

amendment (No. 769) was agreed to. 

Mr. PRYOR. Mr. President, seeing no 

other Members of the Senate seeking 

recognition at this time, I would like 

to ask unanimous consent that I may 

be allowed to speak as in morning business, not to exceed 12 minutes. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

f 

COMMENDATION TO FORMER 

PRESIDENT BUSH 

Mr. PRYOR. Mr. President, I thank 

the Chair for recognizing me and I 

thank the distinguished managers for 

allowing me to speak. 

Mr. President, this morning’s Washington Post and many television and 

radio news programs throughout America and perhaps the world, reported on 

what I would like to call a portrait in 

courage, and the person standing tall 

in that portrait was none other than 

former President George Bush. 

Like many of my friends and family 

in Arkansas, former President Bush is 

a gun enthusiast. He is a long-time 

member of the National Rifle Association. 

But like many other NRA members, 

President Bush was deeply offended by 

a recent NRA fundraising letter signed 

by Mr. Wayne LaPierre, the NRA’s executive vice president. The LaPierre 

letter referred to several law enforcement officials: ‘‘Jack-booted thugs who 

harass, intimidate, even murder lawabiding citizens.’’ The NRA referred to 

Federal agents ‘‘wearing Nazi bucket 

helmets and black storm trooper uniforms to attack law-abiding citizens.’’

This irresponsible, inflammatory 

NRA fundraising letter incited the 

former President of the United States 

to the point that he wrote NRA President Thomas Washington to resign his 

NRA membership. 

Former President Bush’s letter reads 

as follows: 

Your broadside against Federal agents 

deeply offends my own sense of decency and 

honor and it offends my concept of service to 

our country. 

President Bush continues in his letter: 

It indirectly slurs a wide array of government law enforcement officials who are out 

there day and night, laying their lives on the 

line for all of us. 

Mr. President, I am asking unanimous consent that an excerpt from the 

story in the Washington Post about 

President Bush resigning his membership from the National Rifle Association be printed at this point in the 

RECORD. 

There being no objection, the material was ordered to be printed in the 

RECORD, as follows: 

But his resignation letter was more personal than political. 

‘‘Al Whicher, who served on my [Secret 

Service] detail when I was vice president and 

president, was killed in Oklahoma City,’’

Bush wrote. ‘‘He was no Nazi. He was a kind 

man, a loving parent, a man dedicated to 

serving his country—and serve it well he did. 

‘‘In 1993, I attended the wake for ATF 

agent Steve Willis, another dedicated officer 

who did his duty. I can assure you that this 

honorable man, killed by weird cultists, was 

no Nazi.’’ Willis was one of four federal 

agents killed in the initial February 1993 

raid on the Branch Davidian compound near 

Waco, Tex. 

‘‘John Magaw, who used to head the [Secret Service] and now heads ATF, is one of 

the most principled, decent men I have ever 

know,’’ Bush wrote. ‘‘He would be the last to 

condone the kind of illegal behavior your 

ugly letter charges. The same is true for the 

FBI’s able Director Louis Freeh. I appointed 

Mr. Freeh to the federal bench. His integrity 

and honor are beyond question.’’

The letter concluded, ‘‘You have not repudiated Mr. LaPierre’s unwarranted attack. 

Therefore, I resign as a life member of NRA, 

said resignation to be effective upon your receipt of this letter. Please remove my name 

from your membership list. Sincerely, 

George Bush.’’

f 

GATT AND GENERIC DRUGS 

Mr. PRYOR. Mr. President, when we 

in Congress voted on the GATT treaty 

recently, we all knew that we were 

breaking down trade barriers and leveling the playing field in international 

trade. 

Make no mistake, I believe that 

Americans will benefit from this agreement when it is implemented in June. 

But never, Mr. President, in our 

wildest dreams or imagination, would 

we have ever thought we were voting 

to give special treatment and a $6 billion windfall to the prescription drug 

industry on one hand and higher drug 

prices to American consumers on the 

other. Yet that is exactly what is happening. 

Mr. President, here is what has happened to bring us to this point today. 

Last year, the United States agreed 

under GATT to a new patent law, good 

for 20 years from filing. Our old patents 

were for 17 years, the effective date 

from their date of issue. 

We also agreed under GATT to give 

existing patents the longer of the two 

patent terms. This extension applies to 

all industries. 

At the same time, we knew that generic companies of all kinds all over 

America had already made significant 

investments based upon old patent expiration dates. These companies were 

prepared to introduce their competitively priced drug products just as the 

brand-name monopolies end. 

We did not want to jeopardize the 

jobs and the factories which were at 

stake. So we decided under GATT to 

adopt a formula under which these generic companies could proceed with the 

introduction of their products if they 

paid the patent holders ‘‘equitable remuneration’’ for the period of time left 

on their patents. 

Mr. President, here is where this 

story really begins. It just so happens 

that over 100 prescription drugs now 

protected by patents will be getting 

extra patent life under GATT. 

For example, Glaxo’s patent for the 

world’s best selling drug, Zantac, 

would have run out December 5, 1995, 

but will now last until 1997. Generic 

drug companies have already spent 

millions of dollars to prepare to market lower cost, equivalent drugs on 

that date, giving consumers of America 

a tremendous price break. 

But a small handful of brand-name 

pharmaceutical companies have objected. They are saying, ‘‘Thank you 

for the extra patent life. We really appreciate that part of GATT. But you 

should know there is an obscure provision in U.S. drug law which we think 

protects us from the rest of the GATT 

treaty. We are sorry our generic competitors have invested heavily in their 

business, but they do not deserve the 

protections that are rightfully theirs 

under GATT. So we guess we will not 

have any competition for quite some 

time.’’

mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS

May 11, 1995 CONGRESSIONAL RECORD— SENATE S6495 

This is what they have told the Food 

and Drug Administration. The pharmaceutical manufacturers have even 

threatened litigation against the Food 

and Drug Administration. 

I am deeply concerned, Mr. President, because if they get their way at 

this time, they gain a multibillion dollar windfall—alone among the dozens 

of other industries and thousands of 

other companies complying rigidly 

with the GATT treaty. 

Even worse, consumers now are going 

to have to pay double for these drugs. 

They will have to pay twice, Mr. President, as consumers and as taxpayers. 

The Federal Government and the State 

governments are going to pay an extra 

$1.25 billion for prescription drugs for 

older Americans under Medicare, veterans, low-income families and children, as well as the active duty military. 

That will come out of our tax dollars. 

The American taxpayers will thus be 

paying more taxes so that a few brandname drug companies can make more 

profits and block competition in the 

marketplace— forcing the American 

consumer to continue paying the highest drug prices in the world today. 

Most important, I think, will be the 

effect on older Americans, Americans 

on fixed incomes, and Americans without adequate health insurance. They 

will feel the hurt of these soaring drug 

prices even more. 

Mr. President, this chart is fascinating because it demonstrates very 

clearly that two of our best-selling 

drugs on the market are about to run 

out of patent protection, and should 

have generic competition by the end of 

this year. 

Zantac, for example, is the leading 

drug for ulcers. It is manufactured by 

Glaxo. For a typical 2-month supply, 

the brand-name is $180. For a generic 

supply of 2 months, the cost is about 

$90. What we are going to see is, under 

GATT, an unintended consequence. 

Glaxo is going to receive a 19-month 

extension on their patent. This drug’s 

price is not going to go down. There 

will be no generic competition with 

Zantac. We will see Zantac continue to 

soar in price. In fact, Glaxo is anticipating over a $1 billion windfall, because of this unintended consequence 

in GATT. 

Do you think this brand-name drug, 

Zantac, is going to go down in price? 

Last year, Zantac’s price grew 11⁄2

times faster than inflation. The price 

for Zantac since 1989, only 6 short years 

ago, has increased 40 percent. What do 

you suppose is going to happen to that 

price if Zantac gains more than a year 

and a half of additional uncontested 

market exclusivity? 

Mr. President, the intent of GATT, of 

course, was not to harm American consumers. The goal was to improve their 

standing in the world economy. The 

prescription drug marketplace today is 

one area where the American consumer 

has been particularly exploited as we 

have historically paid the highest price 

for drugs while subsidizing lower drug 

prices for consumers around the world. 

This is why five of my colleagues and 

I have written to the Food and Drug 

Administration, asking the Food and 

Drug Administration to make the right 

decision—and that right decision is to 

allow generic drugs to come to the 

marketplace, offering competition to 

brand-named drugs which are about to 

receive an enormous unexpected and 

undeserved windfall. 

This is a textbook case of a loophole 

resulting in an unwarranted windfall. 

No single industry deserves special 

treatment under GATT and today the 

pharmaceutical manufacturers of 

brand-name products are getting that 

special treatment at the expense of the 

American consumer. Should the Food 

and Drug Administration fail to provide the proper solution to this problem, I will immediately proceed with 

legislation to remedy this economic 

and this moral wrong. And I am hopeful my colleagues will join me. 

Mr. President, I ask unanimous consent that an article appearing in Business Week magazine dated May 15, 1995, 

be printed in the RECORD, as well as 

letters to Dr. David Kessler, Commissioner of the Food and Drug Administration, from consumer, patient, health 

care, and trade groups supporting our 

concerns. These groups include the National Organization for Rare Disorders; 

Families USA and the Gray Panthers; 

AmeriNet, of St. Louis, MO, and Premier Health Alliance, of Westchester, 

IL; the National Association of Chain 

Drug Stores and the National Pharmaceutical Alliance. 

There being no objection, the material was ordered to be printed in the 

RECORD, as follows: 

[From Business Week, May 15, 1995] 

A PATIENT MEDICINE CALLED GATT—FOR

MAKERS OF BRANDED DRUGS, IT COULD

PROVE A POWERFUL TONIC

(By John Carey) 

It wouldn’t be surprising if Robert J. Gunter took a dose of his own medicine. President of generic drugmaker Novopharm USA 

Inc., he has spent five years gearing up to 

produce a generic version of Glaxo Holdings 

PLC’s blockbuster ulcer drug, Zantac. He 

even invested $40 million in a plant in Wilson, NC., built to pump out the low-cost 

version as soon as Glaxo’s first patent expired in December. 

Now, Gunter finds himself in the middle of 

stomach-churning patent battle. Glaxo and 

other brand name pharmaceutical giants are 

claiming that the General Agreement on 

Tariffs & Trade (GATT), signed by President 

Clinton in December, extends many of their 

patents, Zantac’s among them. More important, they argue, the extended patent term 

gives them extra months—even years—of 

protection from competing generics. 

While the case relies on complicated legal 

arguments, it boils down to whether provisions in GATT supersede a 1984 law that prevents the Food & Drug Administration from 

approving generics until the patent on a 

name brand expires. If the arguments prevail, more than 100 brand-name products will 

win an average of 12 months each of extra 

patent protection (table). A new study from 

the University of Minnesota estimates that 

the extra protection could give the 

drugmakers a windfall of $6 billion over the 

next 20 years. ‘‘That’s obscene,’’ fumes Senator David H. Pryor (D-Ark.). ‘‘American 

consumers are going to pay the bill.’’ 

‘‘EUREKA’’ MOMENT

Pryor, a handful of other lawmakers, and 

the generics companies are fighting back. On 

Apr. 27, Pryor and five other senators asked 

the FDA to reject the brand-name companies’ interpretation of GATT. Vows 

Novopharm’s Gunter: ‘‘If the pharmaceutical 

industry thinks generics will roll over and 

play dead on this, they have another think 

coming.’’ The FDA’s decision is expected 

within weeks, but the wrangling won’t end 

then. FDA officials and executives on both 

sides predict that whatever the FDA decision, the loser will take the issue to court. 

The high-stakes controversy wasn’t anticipated when GATT was approved late last 

year. The agreement harmonized U.S. law 

with the rest of the world’s by changing patent terms to 20 years from the initial filing 

instead of 17 years after being granted. Most 

companies thought the change applied only 

to new patents, but soon after passage, 

Glaxo’s lawyers had a ‘‘eureka’’ moment. 

Poring over the legislation, ‘‘we realized 

that for many of our existing products, patent life would be extended,’’ says associate 

general counsel Marc Shapiro. 

As a result, any patent that took under 

three years to win approval would have 

longer protection. Since the U.S. Patent Office took only 17 months to grant the first of 

two key patents on Zantac, the change 

would give the company an additional 19 

months of protection for its top-selling drug. 

But even as GATT changed patent terms, 

Congress tried to prevent harm to rivals that 

had been counting on the original expiration 

dates. Lawmakers inserted a clause permitting a company to introduce a competing 

product on the original patent expiration 

date if the company had made significant 

prior investments and if it paid the patent 

holder a royalty or some other form of ‘‘equitable remuneration.’’ While Jeremiah 

McIntyre, counsel for generic drugmaker Geneva Pharmaceuticals Inc., calls that ‘‘a fair 

balance,’’ on the theory that it’s better to 

pay a royalty than not be allowed into the 

market at all, the provision would squeeze 

generic drugmakers’ already thin profit margins. 

OVERSIGHT? 

Meanwhile, Glaxo, Bristol-Myers Squibb 

Co., and other brand-name companies are arguing that this escape clause shouldn’t even 

apply to the drug industry. The reason, they 

say, is that it clashes with provisions in a 

1984 U.S. generic-drug law that prevents the 

FDA from approving a generic drug until the 

brand-name patent expires. Unlike other instances where Congress amended existing 

laws to conform with GATT, it failed to resolve this conflict—implying an intent to 

keep existing law intact, says Glaxo’s Shapiro. Pryor and others plead simple oversight. But the big drugmakers insist on 

claiming what they see as theirs. 

In the coming fight, generic drugmakers 

face an uphill struggle. ‘‘We have to be better organized, and spend more money to get 

our message across,’’ says Bruce Downey, 

CEO of Barr Laboratories Inc., a generic 

drugmaker in Pomona, N.Y. As policymakers 

focus once again on rising health-care costs, 

the generic companies do have one potent 

message: If the brand-name companies win, 

Americans will pay billions more for drugs. 

Faced with the prospect of dramatically 

higher costs, ‘‘I can’t believe the [FDA] 

won’t make the right choice,’’ says Lewis A. 

Engman, president of the Generic Pharmaceutical Industry Assn. Robert Gunter can 

only hope he’s right. 

mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS

S6496 CONGRESSIONAL RECORD— SENATE May 11, 1995 

A WINDFALL IN THE MAKING

Pharmaceutical makers are seeking an average of 12 months’ extra protection from generic competitors for more than 100 drugs. 

[Dollars in millions] 

Drug Company/Use 

Months of 

added protection 

Potential extra 

revenues because of lack of 

generic alter- native 

ZANTAC—Glaxo/ulcers .............................. 19 $1,000 

MEVACOR—Merck/cholesterol-lowering .... 19 448 

DIFLUCAN—Pfizer/antifungal agent ......... 20 410 

PRILOSEC—Merck/ulcers .......................... 17 586 

CAPOTEN—Bristol-Myers Squibb/hypertension .................................................. 6 101 

Data: Prime Institute, University of Minnesota. 

NATIONAL ORGANIZATION FOR

RARE DISORDERS, INC., 

New Fairfield, CT, April 13, 1995. 

Hon. DAVID KESSLER, 

Commissioner, Food and Drug Administration, 

Rockville, MD. 

DEAR DR. KESSLER: The National Organization for Rare Disorders, Inc. (NORD) is deeply concerned with the FDA’s pending interpretation of the General Agreements on Tariffs and Trade (GATT) implementing legislation as it applies to pharmaceutical drug 

patents. 

The branded pharmaceutical industry (represented by PhRMA) is seeking an extension 

of patents solely based on their desire to 

maximize profits. If these companies succeed 

in their attempt to limit consumer access to 

more affordable ‘‘generic’’ products, then 

millions of Americans will have no choice 

but to pay more for already over-priced 

drugs. NORD believes that Congress never 

intended to force American consumers to 

pay even higher prices for their prescription 

drugs. 

While such patent extensions would significantly increase the cost of our Medicaid program, please consider the even greater burden this would place upon the millions of 

Americans who are refused health insurance—and in turn prescription drug coverage—because they are afflicted with a rare 

‘‘orphan’’ disease. 

GATT was intended to improve the welfare 

of American consumers through international trade—including the needs of patients who desperately rely on access to 

more affordable drugs. GATT was never intended to provide special treatment to any 

segment of the pharmaceutical industry. 

Sincerely, 

ABBEY S. MEYERS, 

President. 

FAMILIES USA FOUNDATION, 

Washington, DC, April 10, 1995. 

Dear Senator/Representative: 

We understand that the FDA is currently 

reviewing its position on GATT language as 

it applies to the extension period on drug 

patents. If GATT rules are retrospectively 

applied to previously filed or issued patents, 

the average patent extension for currently 

marketed drugs would be more than 12 

months. The FDA is considering regulations 

that would withhold approval of generic 

drugs covered by ‘‘GATT-extended’’ patents 

until the extension period has ended. This 

would force the American public to pay higher prescription drug prices. 

Families USA recently studied price increases in the top-selling drugs used by 

Americans. In our report, Worthless Promises: 

Drug Companies Keep Boosting Price, we found 

that the prices consumers pay for the most 

commonly purchased drugs continue to increase faster than general inflation. Drug 

price increases are particularly harmful to 

senior citizens who have the greatest needs 

for drugs and are most likely to pay for them 

out of pocket. 

Several of the brand-name drugs that could 

receive patent extensions are among the topselling drugs used by Americans. Among the 

drugs whose patents would be extended are: 

Zantac, the top-selling drug used by Americans, which increased in price 38% from 1989 

to 1994; Capoten, a blood pressure medicine 

which increased in price 65.3% from 1989 to 

1994 and 4.9% last year; Pepcid, an ulcer medicine that increased in price 31.3% from 1989 

to 1994; Mevacor, a cholesterol medicine 

which increased in price 27.8% from 1989 to 

1994; and Prilosec, an ulcer medicine that increased in price 4.2% last year, and increased 

in price 7.5% (2.4 times as fast as inflation) 

in the year 1991 to 1992. 

Generic drug products typically enter the 

market at prices 25% less than patented 

brand, and their prices are even less compared to the brand-name drug as generics 

further penetrate the market. Consumers 

desperately need relief from high drug 

prices. 

A recent study by PRIME institute found 

that the extension would cost Medicaid 

about $1 billion. Federal and state governments will face more than $1.25 billion in 

added costs without generic drugs entering 

the marketplace. 

We ask you to examine this issue and encourage the FDA to delay any ruling until 

the problem is fully investigated. 

Sincerely, 

JUDITH G. WAXMAN, 

Director, Government Affairs. 

GRAY PANTHERS PROJECT FUND, 

Washington, DC, April 20, 1995. 

Hon. DAVID KESSLER, 

Commissioner, Food and Drug Administration, 

Rockville, MD. 

DEAR DR. KESSLER: I am writing to you because we understand the FDA is reviewing 

its position on the language in GATT as it 

applied to extension periods on prescription 

drug patents. We understand that FDA is 

considering regulations that would prohibit 

the entry of generic drugs in the marketplace during this GATT extension period. 

It is our position that this action would 

force the American public to pay higher 

prices for prescription drugs. It also seems to 

us, that the primary purpose of GATT is to 

create level playing fields and the best product at the lowest price to consumers. This 

action is contrary to that principle. 

Many of the brand-name drugs that could 

receive extended patent protection are some 

of the most widely prescribed drugs used by 

Americans—especially the senior population. 

And these drugs continue to cost more and 

more each year. In a recent study by PRIME 

Institute of the University of Minnesota 

found that Medicare alone would incur about 

1 billion added costs without the availability 

of generic drugs. 

A generic prescription drug usually enters 

the marketplace at up to 25 percent less than 

the branded drug. To those individuals living 

on fixed incomes who already faced with rising health costs, the option to choose generic is very important. 

Dr. Kessler, I trust that you will further 

investigate this issue and seriously consider 

the negative impact that prohibiting the 

availability of generic drugs on the American consumer. 

Sincerely, 

DIXIE HORNING, 

Executive Director. 

AMERIVET, 

St. Louis, MO, April 25, 1995. 

Hon. DAVID KESSLER, 

Commissioner, Food and Drug Administration, 

Rockville, MD. 

DEAR DR. KESSLER: The FDA is currently 

deliberating on an important issue that 

could force the American public to pay millions of dollars in higher prescription drug 

costs. The debate is over the interpretation 

of GATT legislation language as it pertains 

to patents on prescription drugs. This language extends the life of patents on a number of the country’s most widely prescribed 

drugs, potentially generating a windfall to 

pharmaceutical companies at the expense of 

the American public. 

As a group purchasing organization, the 

economic impact of the GATT patent extension and the projected cost to consumers is 

of great concern to us. We strongly urge you 

to do all you can to make available to consumers the generic drugs that may be delayed in reaching the market if the patents 

on brand-name drugs are extended. 

As you realize, if a provider has a generic 

equivalent to substitute, the patient receives 

a cost savings over the brand-name drug. 

The cost to consumers for the currently marketed brand-name drugs is substantial, projected to be as high as $6,000,000, over potential generic equivalents. The cost will be incurred by the American public as well as 

Medicare, federal and state governments, 

employers, private insurers, and managed 

care firms. 

We request that you seriously consider the 

enormous financial burden to the American 

public that would result from legislature 

preventing generic drugs from entering the 

marketplace during the GATT extension. We 

fully support your efforts in persuading the 

FDA to make lower-cost generic drugs available to consumers upon existing brand patent expiration. 

Sincerely, 

JOSEPH W. MULROY, 

President. 

PREMIER HEALTH ALLIANCE, INC., 

Westchester, IL, April 14, 1995. 

Hon. DAVID KESSLER, 

Commissioner, Food and Drug Administration, 

Rockville, MD. 

Re GATT Extension Period and Drug Patents 

DEAR HONORABLE KESSLER: It has been 

brought to my attention that certain language in the recently approved GATT legislation may have a negative impact on the 

price Americans will pay for prescription 

drugs in the near future. It is also my understanding that the branded pharmaceutical 

industry is currently pressuring FDA to 

make a ruling that would prevent generic 

drugs from entering the marketplace during 

this extension period—a decision that would 

place an enormous financial burden on the 

American health care system and public 

through higher priced drugs. 

It is my firm belief that Congress did not 

intend for brand name pharmaceutical companies to be the recipient of a $6 billion financial windfall during this GATT extension 

period to be subsidized by health care providers and the American public. 

This ‘‘unintended consequence’’ of the 

GATT language should not be passed on to 

hospitals and physicians that already are aggressively seeking ways to reduce healthcare 

costs, as well as private citizens. 

I am personally asking you to seriously 

consider the negative implications that 

would result from legislation preventing generic drugs from entering the marketplace 

during the GATT extension. The access to 

generic drugs is vital to those Americans 

who need them the most and I trust you will 

mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS

May 11, 1995 CONGRESSIONAL RECORD— SENATE S6497 

delay any ruling until further investigation 

into this matter has been made. 

Yours truly, 

BILL MAGRUDER, 

Vice President, Pharmacy Program. 

NATIONAL ASSOCIATION OF

CHAIN DRUG STORES, 

Alexandria, VA, April 26, 1995. 

Hon. DAVID KESSLER, 

Commissioner, Food and Drug Administration, 

Rockville, MD. 

DEAR DR. KESSLER: On behalf of the National Association of Chain Drug Stores 

(NACDS), I am writing to strongly urge that 

the Food and Drug Administration (FDA) 

recognize pre-GATT patent expiration dates 

for pharmaceuticals, and allow the approval 

of ANDAs for generic prescription pharmaceutical preparations where the sponsor of 

such application has made a ‘‘substantial investment’’ in the product prior to June 8, 

1995, the date of implementation of the General Agreement on Tariffs and Trade 

(GATT). We understand that the FDA is currently considering whether GATT’s implementing legislation provides such statutory 

authority. NACDS believes that it does. 

NACDS represents America’s chain drug 

store industry, and includes more than 160 

chain companies in an industry that operates 30,000 retail community pharmacies. 

Chain pharmacy is the largest component of 

retail pharmacy practice, providing practice 

settings for more than 66,000 pharmacists. 

Our membership base fills over 60 percent of 

the more than two billion prescriptions dispensed annually in the United States. 

We understand and support the importance 

of having generic prescription drugs available to consumers as soon as possible. Everyday, the availability of generic drugs enables 

the pharmacists who practice in our stores 

to help reduce overall prescription medication costs for populations that do not have 

prescription drug insurance. Among those 

who benefit from access to generic drugs are 

millions of older Americans and working 

poor, publicly-funded prescription drug programs such as Medicaid, and other third 

party prescription drug plans. 

The impact that a misapplication of the 

GATT implementing legislation could have 

on the American public is significant. A recent study by the PRIME Institute at the 

University of Minnesota found that GATT 

provisions could result in an additional $6 

billion in prescription drug expenditures in 

the United States because of the additional 

patent protections granted to brand name 

products, and the relative unavailability of 

lower-cost generic versions. 

In summary, NACDS believes that the 

GATT agreement should not preclude the 

manufacturers of generic prescription drugs 

from bringing their products to market during the period of extended patent protection 

provided by GATT for brand name prescription drug products. 

Sincerely, 

RONALD L. ZIEGLER, 

President and Chief Executive Officer. 

NATIONAL PHARMACEUTICAL ALLIANCE, 

Alexandria, VA, April 26, 1995. 

Hon. DAVID PRYOR, 

U.S. Senate, Washington, DC. 

DEAR SENATOR PRYOR: The National Pharmaceutical Alliance (NPA) is an association 

of over 165 manufacturers and distributors of 

pharmaceutical preparations for human and 

veterinary use. Our members are dedicated 

to providing safe and affordable alternatives 

to the American public whenever health 

needs dictate the use of pharmaceutical 

products. 

In December of last year, the congress ratified the Uruguay Round Agreements Act 

[P.L. 103–465] (URAA) of the General Agreement on Trade and Tariffs (GATT). This 

agreement created some fundamental 

changes to be made in U.S. patent law. The 

new law provides for patents to be in force 20 

years from the date of application as opposed 

to the historical law of the United States 

which provided for patents to be in force for 

17 years from date of approval. Congress, realizing that such a change would cause a financial hardship on companies that expected 

to enter the marketplace at the expiration of 

the old patent date, provided a remedy to 

allow competing products on the market. 

Under H.R. 5110, the implementing language of GATT, companies that could show 

that a substantial investment had been made 

in a product could enter the marketplace at 

the pre-GATT expiry date. The respective 

companies then would work out an ‘‘equitable remuneration’’ during the life of the 

patent extension. This remedy will work for 

every industry except the generic pharmaceutical industry due to its regulation by the 

Food and Drug Administration. Since approvals for Abbreviated New Drug Applications (ANDAs) are governed by the Drug 

Price Competition and Patent Term Restoration Act of 1984, known as Hatch/Waxman, 

failure to change its provisions could prevent 

the FDA from granting approvals until after 

the patent extension has expired. We do not 

believe that Congress intended to treat the 

drug industry differently that other industries. 

If the 109 generic pharmaceutical products 

inversely affected by GATT are kept off the 

market, the result could be an increased cost 

to the American consumer of over $6 billion 

and a cost of over $1.2 billion to Federal and 

State governments in higher Medicare and 

Medicaid costs. In 1995 alone, drugs such as 

alclometrasone dipr. (Alclovate), captopril 

(Capoten), and ranitidine HC1 (Zantac) could 

be unavailable to consumers in a generic 

version. Zantac alone could represent an additional cost to the consumers in excess of $1 

billion during the time of the patent extension. At a time when both healthcare costs 

and government budgets are strained to the 

limit, it makes no sense for government to 

take any action that would fuel the growth 

in these expenditures. 

In the ten years since its passage, the 

Hatch/Waxman legislation has done remarkably well at balancing the interests of proprietary drug companies and the generic 

drug industry. The public also has come to 

not only expect, but to rely upon, timely access to high quality, low cost alternatives to 

monopolistic priced name brand drugs. 

NPA is pleased to see that members of 

Congress, such as yourself, are taking steps 

to correct this inequity in the law. Your actions are to be applauded and your decision 

to stand up for the American consumer is appreciated. 

Sincerely, 

CHRISTINE SIZEMORE, 

f 

Executive Director. 

INTERSTATE TRANSPORTATION OF 

MUNICIPAL SOLID WASTE ACT 

The Senate resumed consideration of 

the bill. 

The PRESIDING OFFICER (Mr. 

THOMAS). The pending business is the 

Jeffords amendment No. 867. 

The Senator from Michigan. 

Mr. LEVIN. Mr. President, I ask 

unanimous consent I be allowed to proceed as in morning business for 3 minutes. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. The Senator 

may proceed. 

THE NATIONAL RIFLE 

ASSOCIATION 

Mr. LEVIN. Mr. President, our friend 

from Arkansas has brought to our attention the fact that former President 

Bush has decided to resign from the 

National Rifle Association because of 

its refusal to repudiate some statements which were made by a vice president of NRA in a fundraising letter. I 

join Senator PRYOR in commending 

former President Bush for his action. I 

am sure it is a difficult one for the 

President, as a decades-long member of 

the NRA and as someone who believes 

in so many of its programs and efforts 

to protect rights under the second 

amendment. 

But what President Bush reacted to 

is what I think most Americans who 

have read this letter reacted to, which 

is a statement by Mr. LaPierre, among 

others, that the Clinton administration 

has authorized law enforcement personnel to murder law-abiding citizens. 

Those are the words in the letter. It 

is an outrageous allegation about any 

American President or any American 

administration. I do not think 1 percent of the members of the NRA believe that the Clinton administration 

has authorized its agents, its Treasury 

agents, its FBI agents, its law enforcement agents, to murder law-abiding 

citizens. I wrote a letter to Tom Washington, whom I know. He is a resident 

of Michigan who was president of the 

National Rifle Association, urging him 

to retract that statement and some 

other allegations in that letter which 

are, I think, equally offensive, but at 

least that statement. 

In his response to me, which I put in 

the RECORD yesterday or the day before 

yesterday, he really did not respond to 

the request. He simply acknowledged 

that sometimes fundraising letters 

have exaggerated rhetoric. But this is 

not a case of just exaggerated rhetoric. 

This is an allegation by one of the Nation’s largest organizations that this 

administration has given the go-ahead 

to law enforcement personnel to murder—I am using the word murder because that is exactly the word that 

they used; indeed the letter underlines 

it, italicizes it, emphasizes it—to murder law-abiding citizens. 

I do not think, again, anybody on 

this floor would think there is truth to 

that statement. I do not think 1 percent of the members, as I said, of the 

NRA believes there is truth to that 

statement. It is that kind of a statement, of a wild statement, of an irresponsible statement by a major organization, which is creating an unacceptable climate in this country, I believe. 

Is it the only statement? Of course not. 

Others have made outrageous statements, too. Do they have a right to 

make that statement under the first 

amendment? They do. I will defend it. 

mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS