1990 Annual Report

BIOLOGICAL SECTION
The Biological Section sponsored the first in a series of workshops with FDA, which dealt
with biotechnology in 1989. The Section also formed a joint working group on electronic submissions
with FDA to facilitate the development of Computerized Product License Applications. In addition, the
Section's Division on Vaccines and Allergenics worked with the FDA and the Centers for Disease Control
on the selection of strains for influenza virus vaccines.
The Section-which works closely with the FDA's Center for Biologics Evaluation and Research
in many areas-concentrates on such issues as vaccines and immunizations; blood and blood products;
biotechnology subjects and product development; alternatives to animal toxicity testing;
sterility and microbiological control; computer-assisted product license application: review; and coordination of drug safety and toxicity with the FDA and the U.S. PharS macopeial Convention.
The Section is composed of microbiologists, biochemists, chemists, virologists,
pharmacologists, veterinarians and regulatory affairs experts.
PMA STAFF LIAISON PMA BOARD LIAISON
Thomas L. Copmann, Ph.D. Klaus Heinz Risse, Ph.D.
Assistant Vice President for
Biotechnology and Biologics
FINANCIAL SECTION
The Financial Section dealt with a number of issues ranging from the standards for corporate
accounting for post-retirement benefits to revisions in the U.S. tax laws that would substantially affect
the domestic and international operations of member companies.
The Board of Directors in late 1989 approved the creation of a Caribbean Basin fund as recommended by the Section and asked it to develop an equitable investment formula for both pharmaceutical
and non-pharmaceutical companies using funds generated under Section 936 of the Internal Revenue
Code. Such a fund vehicle will be established in 1990.
The Section submitted comments to the Internal Revenue Service on recommendations made
in a Treasury Department/IRS study on intercompany pricing of intangibles for federal tax purposes. In
addition, the Section gave renewed attention to Section 936, under which member companies have used
tax incentives to invest extensively in Puerto Rico to help build the Commonwealth's economy.
The Financial Section advises the Board of Directors on
a broad spectrum of financial issues in the accounting, funding
and tax areas. The Section is composed of Chief Financial Officers
I Vand other financial executives, including treasurers, controllers,
fiscal specialists and tax counsels.
PMA STAFF LIAISON PMA STAFF LIAISON PMA BOARD LIAISON
Edwin C. Mulcahy Albert C. Saunders Duane L. Burnham
Deputy General Counsel Legilive Counsel

1990-91 CHAIRMAN
C. Searle Wadley
Abbott Laboratories

1990-91 CHAIRMAN
Francis H. Spiegel, Jr.
Merck & Co., Inc.

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