ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Sunday, January 19, 1997 TAG: 9701170048
SECTION: BUSINESS PAGE: 5 EDITION: METRO
DATELINE: NEW YORK
SOURCE: STEVE SAKSON THE ASSOCIATED PRESS
The Food and Drug Administration smashed its record for approving new drugs in 1996, including groundbreaking treatments for AIDS, neurological diseases like multiple sclerosis and five kinds of cancer.
The FDA approved 53 new chemical entities - drugs never before used - compared with 28 in 1995 and well above the record of 30 set in 1985 and 1991. As in every year, numerous existing medicines were approved for new uses.
The agency, drug industry and Wall Street analysts all credited a new system of ``user fees'' passed by Congress in 1992.
``The companies agreed to pay the FDA for reviewing their applications in exchange for faster approvals,'' said Mariola Haggar, a drug industry analyst with Deutsche Morgan Grenfell in New York.
However the industry isn't celebrating just yet. A spokesman complained last week that the FDA makes companies do more extensive research prior to filing an application - so the number of years between the initial discovery of a drug in a lab to a sale at the corner pharmacy hasn't changed.
Don McLearn, an FDA spokesman, said the user fees allowed the agency to boost its drug review staff by 600 in the past four years, and it shows.
McLearn said the agency took roughly 14 months to approve new drug applications in 1996, down from nearly 16 months in 1995.
``You used to have things waiting in queue for when someone was available,'' said McLearn.
The FDA, long criticized for approving drugs more slowly than its European counterparts, is now faster, he said.
However, Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, said the FDA now requires companies to test their drugs on more people than in the past.
``In our view, one of the effects of that has been to make the process more cumbersome and delay development times,' he said.
For this reason, it still takes about 81/2 years from the start of human experiments to final marketing approval and that time span hasn't changed since 1990, said Homer.
The industry has asked the FDA to loosen its research requirements, but the agency has balked, saying the requirements ensure that drugs are truly effective and safe.
Among the most important new drugs of the year are the well-known AIDS drugs called protease inhibitors. When combined in a cocktail of older medicines, they have substantially reduced the level of virus in patients and, at least temporarily, improved their health.
Merck & Co.'s protease inhibitor, Crixivan, was approved by the FDA in March, after a review of about 11/2 months, also a record. Norvir, a protease drug by Abbott Laboratories was approved in just over two months.
Among the cancer drugs approved were Hycamtin for cancer of the ovaries that has spread, and Camptosar for difficult cases of colorectal cancer, both by SmithKline Beecham PLC. Also approved was Taxotere, a chemotherapy treatment by Rhone-Poulenc Rorer for advanced breast cancer in which other drugs have failed. Gemzar, by Eli Lilly & Co., treats advanced pancreatic cancer and Nilandron, by Pharmacia & Upjohn Inc., treats advanced prostate cancer.
Ira Loss, an analyst with HBSC Washington Analysis, said that starting in 1989, the FDA began to focus more aggressively on serious diseases with few treatments.
``This mind set, that started with AIDS, has now moved on to cancer and I'm sure it exists for Alzheimer's disease and other neurological diseases in which the drugs currently available are not cures,'' Loss said.
In 1996, the agency approved Aricept, a drug to treat dementia related to Alzheimer's that was developed by Eisai Pharmaceuticals of Japan and is sold in this country by Pfizer Inc.
Two drugs that treat the paralytic episodes of multiple sclerosis were also added, Avonex by Biogen Inc., and Copaxone, by Teva Pharmaceuticals of Israel.
Among prescription drugs that were converted to over-the-counter use, nicotine gum and skin patches were the most prominent. Pharmacia & Upjohn got permission to sell its Rogaine hair regrowth drug without a prescription and is working on a more effective version.
The biggest research disappointments were drugs that were supposed to treat Lou Gehrig's disease, the paralyzing and fatal neurological affliction known scientifically as amyotrophic lateral sclerosis.
Amgen Inc. said this month that its drug BDNF, or brain-derived neurotrophic factor, failed in a test of more than 1,000 patients. Earlier in the year, Myotrophin, a drug by Cephalon Inc., failed in European tests after tests in the United States showed it slowed progression of the disease. Further testing was ordered by the FDA.
Major new drugs that are near final approval include Fareston, by Schering-Plough for advanced breast cancer, Serlect by Abbott Labs for schizophrenia, and the abortion pill RU-486, being developed by the nonprofit Population Council.
LENGTH: Medium: 92 lines ILLUSTRATION: GRAPHIC: Chart by AP.by CNB