Delays Facing Use of New Drugs Not All Due to FDA Testing
Watkins, Robert, THE JOURNAL RECORD
American pharmaceutical companies invested $4.6 billion on research last year while earning $36.1 billion in sales, an all-time high research-to-spending ratio.
In the process, the companies won final approval from the federal Food and Drug Administration to market 20 new prescription products. Some of the clinical studies leading to FDA clearance of the approved drugs were done here in Oklahoma City.
After all that investment, however, the continuing disappointment - for the companies in particular - is the length of time it takes to run the FDA gauntlet enroute to market. It's a question that has nagged physicians and patients alike. Patients who may need the new therapies, it is said, are the real losers.
Dr. Malcolm Robinson, chief of the department of medicine at Presbyterian Hospital and director of drug research at the hospital, says the average time span from his investigative work here and final clearance is about three years.
Pharmaceutical companies invest $2 million a year for drug research at Presbyterian, but the hospital supports it own research activities with an additional $250,000.
From the president of the American Pharmaceutical Manufacturers Association comes this assessment of the time problem:
"America's leadership in pharmaceutical innovation. . .may be at stake if we do not reduce the time required for new drug development and approval."
Gerald J. Mossinghoff, the association's president, also observes that American physicians and patients simply are not at the head of the line for new drugs and therapies.
"That," he argues, "could have tragic implications, now and in the future."
Despite the complaints of painful slowness in the American system, Mossinghoff doesn't lay all the blame at the feet of FDA's scientists, whose awesome task it is to wade through huge stacks of data as they evaluate the claims of efficacy and safety offered by the investigators. …