PB, Just on the FDA saving us from ourselves and doctors. They are boasting about taking over a year to approve products. Working backwards from the number of people suffering the problems which these products will help, we could work out the number of people who died due to the delays. Fiddling around with strategies to maximize approval times as you mentioned in your last post instead of aiming at maximum human benefits is a joke. The drugs are meant to treat disease, not cure bureaucracy and feed the approvals system with millions of dollars.
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The Food and Drug Administration said it sped up drug approvals in 1997 by as much as 20 percent. Management reforms and new laws to modernize the whole agency helped speed 35 major new approvals to market. The median approval time for last year's 121 new original drugs was 14.4 months, six percent shorter than the 15.4 months in 1996.
Ten of the major approvals were for products containing substances new to the American market. The median time for first-time approvals in 1997 was 12 months, 20 percent shorter than the median time of 15.08 months required for such approvals in 1996.
It said the most significant new approvals were for BeneFIX, a bloodclotting factor approved in February and made by Genetics Institute Inc which uses the body's own immune system to prevent rejection of kidney transplants.
It also named Carticel, Genzyme's new process for repairing knee cartilage using a patient's own cells, Genetics Institute Inc's Neumega, which uses a hormone called interleukin-11 to help cancer chemotherapy patients and Infanrix, SmithKline Beecham's new diphtheria, tetanus and pertussis (DPT) vaccine for babies and small children.
Drugs that got priority approval included Viracept, Agouron's new protease inhibitor for HIV which got okayed in less than three months and Evista, Eli Lilly and Co's new osteoporosis drug, cleared in less than six months.
The remaining major biological approvals included software to enhance the safety of blood products, expanded indications for approved products and new manufacturing methods and technologies to improve the safety of biologics,it said.
The Prescription Drug User Fee Act requires the FDA to act on new drug applications within 10 months by 2002.
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Oh, the lawmakers are getting their cut of the cake too, passing laws to ensure human freedom from TOO much bureaucracy while creating the bureaucracy in the first place. I hope the courts and lawyers are getting their cut of the cake.
Your cynical servant,
Maurice |
