Pharmaceutical Research Companies and Developing 132 Biotechnology Medicines

approvals per year. This rate clearly has to be sharply increased to keep up with industry's growing activity in
biotechnology research."
The regulatory obstacles facing biopharmaceuticals are
"formidable," said John F. Beary, III, M.D., PMA's Senior Vice
President for Science and Technology. He said the survey found
that 8 of the 58 monoclonal products in development are awaiting
approval at FDA for such life-threatening diseases as heart and
liver transplant rejection, cancer and septic shock. FDA's sole
approval of a monoclonal antibody was in 1986.
The PMA survey also included an analysis of the 3,378
biotechnology patents issued in 1990. It found that two-thirds
of the patents were of U.S. origin. American corporations
received 40 percent of the health care patents, the largest
single share. U.S. companies also received 47 percent of the
health care patents that used genetic engineering.
The Pharmaceutical Manufacturers Association is a nonprofit
scientific and professional organization of more than 100 member
companies that discover, develop and produce most of the
prescription drugs used in the United States.
(Copies of the report are available by writing to Editor, "Biotechnology Medicines in Development," Communications Division,
Pharmaceutical Manufacturers Association, 1100 15th Street, N.W.,
Washington, D.C. 20005.)