E 1158 CONGRESSIONAL RECORD — Extensions of Remarks June 6, 1995

The bill offers authority and strong encouragement to the Agency to use third parties—

unbiased, independent panels under FDA supervision—to approve and oversee early stage

trials of new drugs and devices.

The bill relaxes some restrictions now barring the exchange of scientifically valid material—professional journal articles, medical textbook excerpts, research compendia—between

manufacturers, clinicians, and health insurers.

This change will make it easier for knowledgeable observers to receive information on promising, though unapproved, new uses of drugs

and devices which have already been approved by the FDA for at least a single use.

At the same time, the legislation gives the

Agency authority to require that persons disseminating these articles provide appropriate

supportive scientific data and respond on its

balance.

The bill fundamentally revamps and modernizes FDA review processes for biologics,

therapeutics which are manufactured or propagated through bioengineering.

The bill offers reasonable relaxation on current restrictions on the export of drugs or devices which are not approved by the FDA, but

which meet the importing nation’s approval regime. This flexibility would be limited to exports to member nations of the World Trade

Organization.

The bill modifies current reporting and approval requirements for minor manufacturing

changes in devices of low to moderate risk. In

essence, a manufacturer would be required to

report, but not obtain prior approval for manufacturing changes which would improve the

product’s quality. This would allow manufacturers to make swift, useful, and perhaps even

lifesaving changes in products without having

to wait out an FDA approval decision.

Mr. Speaker, there is no doubt in my mind

that the FDA is a premier public health care

agency with many extraordinarily dedicated

employees. This Agency has a crucial health

and safety mission that this Congress must

not allow to be undermined.

But I firmly believe that these vital safety

missions can be preserved, and better products can be brought to consumers more rapidly and at lower cost, through the modest reform proposals contained in this legislation.

It’s time to make a good agency better. I

urge my colleagues to support H.R. 1742, the

FDA Modernization Act of 1995.

TRIBUTE TO MARY CAPERTON

fBINGHAM

HON. MIKE WARD OF KENTUCKY

IN THE HOUSE OF REPRESENTATIVES

Tuesday, June 6, 1995

Mr. WARD. Mr. Speaker, it is a distinct

honor for me to pay tribute today to a truly remarkable individual who recently passed

away, Mary Caperton Bingham of Louisville,

KY.

Mary Bingham and her husband Barry Bingham, Sr. met in their college days at Radcliffe

and Harvard, respectively, and together built a

media powerhouse which included The Courier-Journal newspaper of Louisville until it was

sold in 1986. However, the Bingham publishing empire, which began in 1918 with the purchase of The Courier-Journal and The Louisville Times by Robert Worth Bingham, is not

the most remarkable aspect of Mary Bingham’s life—the attribute which most accurately

describes the way she lived her life is her generosity.

In only a 9-year timespan, from the time of

the sale of the Bingham media properties,

Mary and Barry Bingham, in contributing almost $60 million to education and arts funds

throughout Kentucky, came close to achieving

their goal of ‘‘giving it all away’’ before their

deaths. In rural Kentucky, Mary Bingham

founded bookmobiles to encourage children to

read and value their education—education and

the arts were central to Mary Bingham’s philosophy of what made a civilization great, and

to this end she dedicated many years of her

life. She donated money to many social

causes, environmental funds, historic preservations, health care facilities, and community

developments. Along with this money came

her insightful wisdom and expert counsel.

Throughout her life, Mary Bingham was a

woman far ahead of her times who did not

hesitate to let her views be heard and you

may rest assured that when she spoke, people listened and they appreciated her advice.

My hometown city of Louisville now offers

one of the most extensive arts programs in the

Nation, including the Kentucky Center for the

Arts and the Actors Theatre of Louisville,

which could not have been possible without

the efforts of Mary Bingham.

The city of Louisville, the Commonwealth of

Kentucky, and indeed the entire Nation lost

one of our most dedicated and generous citizens and we will truly miss her civic contributions, her insightful knowledge and counsel,

her dedication and endurance, and her grace

and beauty.

TRIBUTE TO THE MARISSA HISTORICAL AND GENEALOGICAL

fSOCIETY

HON. JERRY F. COSTELLO OF ILLINOIS

IN THE HOUSE OF REPRESENTATIVES

Tuesday, June 6, 1995

Mr. COSTELLO. Mr. Speaker, I rise today to

bring to the attention of my colleagues a historical structure in Marissa, IL, which stands

as a monument to education and pride for

southwestern Illinois.

I recently had the privilege to attend a dedication ceremony sponsored by the Marissa

Historical and Genealogical Society in Marissa

on May 21. Several months ago, the society’s

president, Don Jones, began working on a

project to have this building declared a national historical place.

By gathering historic documents, Mr. Jones

and other members of the society prepared

their application to the National Park Service

and the U.S. Department of the Interior for historical designation.

I am pleased to tell my colleagues that the

Marissa Academy Building, located in the village park, received a certificate announcing its

listing on the National Registry of Historic

Places effective October 28, 1994.

According to a recent edition of the Marissa

Journal-Messenger, the academy was started

in 1886 and served students originally as a

preparatory school. It was used until 1900,

when classes shifted to Marissa Township

High School. Later, it was used again as a

school while the new elementary school was

being built.

Over time the building’s structure degraded,

and since it was the last academy building in

Illinois, the community rallied to have it restored. In 1969, the village leased the building

to the Marissa Historical and Genealogical Society. It is now a library and museum open to

the public.

Mr. Speaker, I want to congratulate the

Marissa Historical and Genealogical Society

for its hard work in making the Marissa Academy Building one of our Nation’s newest addition to the National Register of Historic Places.

It was a privilege for me to participate in the

commemoration of this public recognition, for

a building that will stand as a learning and historical tool for generations to come.

IN RECOGNITION OF THE CARMEL

REPUBLICAN COMMITTEE’S BALfANCED BUDGET RESOLUTION

HON. SUE W. KELLY OF NEW YORK

IN THE HOUSE OF REPRESENTATIVES

Tuesday, June 6, 1995

Mrs. KELLY. Mr. Speaker, I rise today to

commend to my Republican colleagues the

following resolution of support issued by the

town of Carmel’s Republican Committee. This

resolution demonstrates the strong public support for Republican-elected officials, who are

working to achieve the important goals of the

Contract With America. Our fight to reduce the

Federal budget deficit, to have a balanced

budget and reduce and consolidate Government services has not gone without recognition from the American people.

Therefore, I join with the spirit of this resolution in applauding the energy put forth by my

colleagues in addressing the many reformminded issues facing this Congress. Mr.

Speaker at this time, I insert the full text of the

Carmel resolution into the RECORD.

Whereas, through liberal reporting by TV

and newspaper media an obvious attempt has

been made to undermine the positions held

by our Republican State and Federal Officials on issues of budget deficit reduction,

balanced budgets, consolidation of government services and welfare reform; and

Whereas, due to media’s liberal reporting

of these issues the Town of Carmel, Putnam

County, State of New York, Republican Committee desires to counteract effects of said

liberal reports supporting special interest

groups; now,

Therefore, be it resolved, the Town of Carmel Republican Committee membership of

ninety-two hereby pledges its support to

NYS Governor George Pataki, Senate Majority Leader Joseph Bruno, Assembly Minority

Leader Clarence Rappleyea, Senator Vincent

Leibell, III; 37th District, Assemblyman Willis Stephens, Jr.; 91st District, and U.S. Senate Majority Leader Robert Dole, U.S. House

Majority Leader Dick Armey and Speaker

Newt Gingrich, NYS U.S. Senator Alfonse

D’Amato and NYS U.S. 19th District Congresswoman Sue Kelly toward achieving

their goals to alleviate the overwhelming

tax burden through enactment of balanced

budgets, consolidation and reduction of government services and welfare reform and

‘‘Contract with America’’; and,

Be It Further Resolved, that the Chairman

of the Town of Carmel, Putnam County, New