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

S6498 CONGRESSIONAL RECORD— SENATE May 11, 1995 

They may have a right to make that 

statement, but that does not make it 

right to make that kind of a statement. It should be retracted. 

I commend President Bush and I hope 

other members of the NRA, in one way 

or another, would let their leadership 

know that kind of rhetoric is unacceptable about an American administration. Like any other administration, it, 

I am sure, has agents who make mistakes from time to time. There is a 

place to rectify them. It is called a 

court. But to make that allegation 

from an organization the size of the 

NRA I think is unacceptable, it is irresponsible, and it still should be retracted. 

I thank my friend from Arkansas for 

his continuing effort to try to bring 

some kind of calmer normalcy into the 

general climate in this country. 

I yield the floor. 

Mr. LOTT. Mr. President I just want 

to observe that the managers of the 

pending legislation I understand are 

working on some agreements hopefully 

that will make it possible to wrap up 

this legislation before the day is out. 

Therefore, at this time, I suggest the 

absence of a quorum. 

The PRESIDING OFFICER. The 

clerk will call the roll. 

The bill clerk proceeded to call the 

roll. 

Mr. COATS. Mr. President, I ask 

unanimous consent that the order for 

the quorum call be rescinded. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

Mr. COATS. Mr. President, I would 

like to ask the Chair what the pending 

business is. 

The PRESIDING OFFICER. The 

pending business of the Senate is the 

Hatch amendment numbered 755. 

Mr. COATS. I suggest the absence of 

a quorum. 

The PRESIDING OFFICER. The 

clerk will call the roll. 

The assistant legislative clerk proceeded to call the roll. 

Mr. ROTH. Mr. President, I ask unanimous consent that the order for the 

quorum call be rescinded. 

The PRESIDING OFFICER (Mr. 

GREGG). Without objection, it is so ordered. 

f 

THE NUCLEAR NONPROLIFERATION TREATY 

Mr. ROTH. Mr. President, just a couple of hours ago, the Nuclear Non-Proliferation Treaty—the single most important component of the international 

effort to prevent the spread of nuclear 

weapons—was enshrined for all time by 

an overwhelming decision made by 

more than 170 countries party to the 

treaty. The decision to make the NPT 

permanent was accomplished without 

any conditions or qualifications. 

This is a truly historic day in our ongoing efforts to make ours a safer and 

more peaceful world. The security of 

all countries, weapons States and nonweapons States alike, has been 

strengthened. 

The NPT has established the norm 

prohibiting the further acquisition of 

nuclear weapons. Indefinite extension 

of the NPT will help improve the climate of trust conducive to more restrictive controls over weapons-grade 

nuclear materials and related technologies and activities. It also provides 

momentum for addressing the dangers 

posed by other weapons of mass destruction. 

Making the NPT permanent, of 

course, will not end the global nuclear 

proliferation threat. Treaty membership is never a guarantee of compliance. Yet, when backed by strong national policies, the NPT advances the 

security interests of all countries. Indeed, it has helped to keep the number 

of declared nuclear weapons States and 

so-called ‘‘threshold’’ States at five 

and three respectively. 

Clearly, the world remains a dangerous place. Iran, North Korea, and 

the theft of fissile materials present 

immediate nuclear proliferation perils. 

Much progress on controls over other 

weapons of mass destruction remains 

to be made. Moreover, as the tragic 

bombing in Oklahoma has shown, determined terrorists can accomplish 

their contemptible intentions with 

even the crudest of weapons. 

But today is a time for celebration. 

We have achieved a critical victory in 

making the post-cold-war period safer 

and more secure. This is a victory for 

all the world’s people. I believe this 

body deserves a measure of credit for 

the unanimous adoption of a resolution 

in March calling for permanent, unconditional extension of the NPT. It is 

also a testament to the hard work of 

Tom Graham who took the lead in the 

negotiations. The chairman of the conference held in New York, the Honorable Jayantha Dhanapala of Sri Lanka, 

also deserves our thanks for his particularly skilled leadership. Happily, 

Mr. Dhanapala will be returning to 

Washington within a few days to resume his post as Ambassador of his 

country to the United States. 

Mr. President, I suggest the absence 

of a quorum. 

The PRESIDING OFFICER. The 

clerk will call the roll. 

The legislative clerk proceeded to 

call the roll. 

Mr. THURMOND. Mr. President, I 

ask unanimous consent that the order 

for the quorum call be rescinded. 

The PRESIDING OFFICER. Without 

objection, it is so ordered. 

f 

THE NON-PROLIFERATION TREATY 

AND U.S. SECURITY 

Mr. THURMOND. Mr. President, 26 

years ago, the Senate provided its advice and consent to ratification of the 

Nuclear Non-Proliferation Treaty 

[NPT]. In considering the treaty, 

Chairman Fulbright prevailed on the 

Members of the Senate to ratify the 

NPT, because without it, the world 

would face a wide array of potential 

nuclear horrors—such as developing 

nations acquiring nuclear weapons to 

elevate their status or national power; 

regional powers resorting to the use of 

nuclear weapons to settle their differences; or ethnic or religious differences being settled with nuclear 

weapons. He foresaw a world where 

major powers like the United States 

might be held hostage by small, poor 

countries who possess a few nuclear 

weapons and the means to deliver 

them, or, become drawn into a nuclear 

confrontation brought about by these 

small nations through a miscalculation 

or an accident. 

At the time the NPT was negotiated 

there were relatively few countries who 

had tested or possessed nuclear weapons. Those countries were the United 

States, the United Kingdom, Russia, 

France, and China. They became 

known as the nuclear weapons states. 

All other states who did not possess or 

had not tested nuclear weapons became 

known as non-nuclear weapons states. 

Back in 1969, when the Senate voted 

to provide its advice and consent to 

ratification of the NPT, I was one of 

the 15 members who voted against ratification of the treaty. I voted against 

it because I had grave reservations 

about the treaty’s goals and whether 

they could be achieved. I was concerned that if the United States ratified the NPT, it would be unable to fulfill its NATO responsibilities and commitments. I feared that the NPT would 

also foreclose the ability of NATO 

members to participate fully in the operations of the Alliance. Lastly, I was 

concerned that the nuclear weapons 

states, and in particular, the United 

States, would bear the huge costs of 

transferring nuclear technology for 

peaceful uses to the non-nuclear weapons states. 

Mr. President, the overall goal and 

purpose of the NPT is to stop the 

spread of nuclear weapons, and to prohibit the transfer, or acquisition and 

manufacture of nuclear weapons by 

non-nuclear weapons states. However, 

there are no enforcement mechanisms 

to prevent a non-nuclear weapons state 

from becoming a nuclear weapons state 

in the NPT. There are no sanctions for 

violations of the treaty. While the NPT 

requires the parties to pursue negotiations to end the nuclear arms race and 

bring about nuclear disarmament, the 

NPT cannot force an end to the race 

for nuclear weapons, nor can it force 

the destruction of all nuclear weapons. 

For that matter, the NPT cannot ensure that parties to the Treaty, whether nuclear weapons states or non-nuclear weapons states, do not withdraw 

from the Treaty if they decide they 

wish to acquire or develop a nuclear arsenal for their own national security 

reasons. In fact, the NPT has a withdrawal clause. 

The NPT only covers countries that 

have ratified the Treaty. For example, 

take the so-called threshold states 

which have developed nuclear weapons, 

mmaher on MIKETEMP with SOCIAL SECURITY NUMBERS