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The American Society of Hospital Pharmacists, the national professional
society of pharmacists practicing in hospitals and other settings of
organized health care, is writing to urge speedy consideration of the
above referenced legislation.

Our members have a strong interest in this legislation: they wish to see
an increased rate of development of new drug products and new forms of
drug delivery and they also wish to see the cost of drugs reduced.
H.R. 3605 accomplishes this by providing patent term extension to newly
developed drugs and by permitting post-1962 drugs, already shown to be
safe and effective, to be marketed without duplicitous clinical testing.
Although we do not know what the pharmaceutical industry will do with this
new incentive for research, we do know that well over 100 drugs will be
available for the new approval process; consumer savings and reduced
health care costs will be the result.

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National Council of Senior Citizens

925 15th Street, N.W. Washington, DC 20005 Phone (Area Code 202) 347-8800

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As you know, the National Council of Senior Citizens has
long been opposed to any legislation extending the patent period
for prescription drugs. We have pointed out the impact it will
have on elderly consumers and questioned the Pharmaceutical
Manufacturers Association's contention that higher profits auto-
matically mean more research. On the other hand, we have actively
supported Representative Waxman's legislation to accelerate the
approval process for bringing generic drugs to market. It has
been estimated that consumers stand to save $1 billion over the
next 12 years should this legislation be enacted and senior
citizens make up a large percentage of these consumers.

We now know that a compromise on these two issues has been
reached which combines elements of both legislative proposals.
After a careful review of the compromise, NCSC has determined
that it is in the best interest of our members to support it.
We do so with some reluctance, and the hope that drug companies
benefiting from a longer patent period will invest their higher
profits in drug research.

Senior citizens do stand to benefit greatly from an abbreviated new drug application process. One-half of the top ten selling drugs, many of which are consumed by the elderly, could soon be available in generic form. Examples include: INDERAL for cardiac conditions, DYAZIDE and LASIX for high blood pressure and INDOCIN for arthritis.

Therefore, on behalf of our 4,500 clubs and the 4,000,000 seniors we represent, I urge you to support the ANDA/Patent Term Extension bill as is. Any attempt to amend the legislation will not only jeopardize our support, but also undermine the entire compromise package.

Thank you.

JC/S/1c4

Sincerely,

Jacob Cloynan

Jacob Clayman

President

First Vice President, Dr. Mary C. Mulvey, Providence, Rhode Island
Third Vice President, Einar O. Mohn, Menlo Park, California
Secretary-Treasurer, J. Al Rightley, Rochester, Michigan

Second Vice President, George J. Kourpias. Washington, D.C. Fourth Vice President, Dorothy Walker, Detroit, Michigan General Counsel, Robert J. Mozer, New York

INTERNATIONAL UNION, UNITED AUTOMOBILE, AEROSPACE & AGRICULTURAL IMPLEMENT WORKERS OF AMERICA-UAW

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It is our understanding that the House may take up the Abbreviated New Drug Applications (ANDA) - Patent Term Extension legislation next week. The UAW believes this bill represents a reasonable compromise, which will provide significant benefits both to consumers and to drug manufacturers. The UAW therefore urges you to support this important, bipartisan legislation, and to oppose any weakening amendments.

The legislation would accomplish two basic objectives. First, the ANDA provisions would extend the procedures which are currently used to approve generic copies of pre-1962 drugs to post-1962 drugs. Currently there are no procedures for approving generic copies of post-1962 drugs. This has greatly inhibited the development of generic equivalents for many of the most popular drugs on the market. Under the proposed legislation, generic copies could immediately be developed on over 150 drugs that have been approved since 1962, at a savings to consumers of approximately $1 billion over twelve years.

The UAW has long been a supporter of measures which would increase the availability of generic drugs. We believe the ANDA provisions would greatly expand the availability of generics, and thus provide substantial saving to all consumers, and especially to the elderly who often must spend a large portion of their limited resources on drugs.

Second, the patent term extension provisions would extend the patents which manufacturers have on various drugs. However, the bill places outer limits on the permissible patent extensions, as well as the total period of time a drug may be under patent. With these safeguards, the legislation, in our judgment, strikes a reasonable balance between the needs of the drugs manufacturers and consumers.

Opponents of the ANDA-Patent Term Extension legislation may attempt to offer.
a number of amendments on the House floor. These amendments would have the effect
of delaying or restricting the availability of generic drugs, and thus would wind up
imposing increased costs on all consumers. In our judgment, this would undermine the
carefully constructed compromise between the interests of consumers and drug
manufacturers which has been embodied in the ANDA-Patent Term Extension legislation.
The UAW therefore urges you to oppose all amendments and to vote for the bill.

Your consideration of our views on this important legislation will be appreciated.
Thank you.

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MERICAN

STATE

EDERATION

AFL-CIO

MUNICIPAL

EMPLOYEES

AFSCME.

American Federation of State, County and Municipal Employees

1625 L Street, N.W., Washington, D.C. 20036
Telephone (202) 429-1000

Telex 89-2376

August 2, 1984

Gerald W. McEntee
President

William Lucy Secretary Treasurer

Vice Presidents

Ronald C. Alexander
Columbus, Ohio

Dominic J. Badolato
Berlin, Conn

Joseph Bolt
Richmond, Ind

Joseph M. Bonavita
Boston, Mass.

Robert A. Brindza

Columbus, Ohio Ernest B. Crofoot Baltimore, Md.

Steve Culen Chicago, Ill Lawrence V. DeCresce

Columbus, Ohio

Albert A. Diop New York, NY. Danny Donohue Hauppauge, NY

James Glass Lansing, Mich

Victor Gotbaum

New York, NY

Blondie P. Jordan
Orlando, fla

Edward J. Keller
Harrisburg, Pa

Joseph J. Kreuser

Menomonee Falls, Wisc

Faye D. Krohn

Kasota, Minn.

Marilyn LeClaire

Columbiaville, Mich.

George Masten
Olympia, Wash

Joseph E. McDermoll
Albany, NY

William L. McGowan
Albany, NY.

Donald G. McKee
Des Moines, Iowa

Jack Merkel
Trenton, N.J

Bettye W. Roberts
New York, NY.

Russell K. Okata
Honolulu, Hawaii

George E. Popyack Redwood City, Calif.

Earl Stout
Philadelphia, Pa

Garland W. Webb
Baton Rouge, La.

Maynard White
Houston, Texas

Dear Representative:

Next week the House will consider H.R. 3506, the ANDA-Patent Term Extension bill. AFSCME urges you to support this bill without any weakening amendments.

The bill that you will consider is a carefully designed compromise. We believe that this bill is needed to place less expensive generic drugs on the market. bill will be of great benefit to all consumers particularly to senior citizens

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The

and in the years ahead. FDA has estimated the consumer savings to be $1 billion over the next decade. There will be increased competition in government contracts and there will therefore be a savings to the Federal and state governments in the delivery of health care.

The passage of any amendments to this bill could negate a very delicate compromise in the present bill. We urge you to vote against any amendments and for final passage.

WBW:mlm

in the public service

Sincerely,

Wears whe

William B. Welsh

Director of Legislation

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The American Association of Retired Persons would like to thank you for your efforts on behalf of H.R. 3605, the Drug Price Competition Act.

Because this bill will facilitate the availability of low priced generic drugs to consumers, AARP has endorsed this compromise legislation. Our position has been that since H.R. 3605 is already a compromise, we would oppose any efforts to weaken it through amendment by either creating obstacles to approval of generic drugs or by insulating brand name companies from competition with additional patent extension. You are to be commended for your leadership in opposition to such amendments in the Judiciary Committee.

We are hopeful for quick passage of H.R. 3605 on the House floor as reported out of the Committee, and are confident that we can rely on your continued support. Once again, your thoughtful

attention to this matter is appreciated.

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Notional Headquarters 1909 K Street NW Washington DC 20049 (202) 872 4700

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