"Do I contradict myself? Very well, I contradict myself. I am vast. I contain multitudes." -Walt Whitman

:malicious user:

Wednesday, May 12, 2004

On drug development and regulation
On average, of every 7,500 screened molecules, only 1 is approved for use. Of these, only 30% will produce a profit. The average estimated cost for developing a drug in 2001 was $802M. In the last 25 years the cost of research & development has increased from 2 billion dollars to over 30 billion dollars. Even given the relative worth of the dollar, that is still a substantial cost increase.

One reason for this increase is certainly the cost to the sponsor to comply with government regulations. Since 1980 the FDA has enacted no less than six major Acts that impact prescription drugs. One of these, the Prescription Drug User Fee Act of 1992, required drug manufacturers to pay fees to the FDA for the evaluation of new drug applications.

There is also a heavy price to market prescription drugs, in an increasingly competitive industry. In the last six years, 15 of the top 25 major companies have participated in merger/acquisition discussions. Over the last 20 years, 42% of the pharma industry has been consolidated into six giants. There is fierce competition (in a era of diminishing discoveries) to discover, develop, and market new drugs first. Sales reps in pharma are very well paid.

But back to regulation.

Is there too much regulation in the public health arena for our own good? Probably. Historically, the major regulatory actions have resulted from incidents involving human deaths. These regulations exist to serve the public health. However, there is also a history of adversarial relationships between the FDA and other agencies, including the USDA. Sometimes this push and shove results in overregulation, and waste. As an example, baked beans with bacon are inspected by the USDA; baked beans with pork are inspected by the FDA. This type of double effort results in increased costs for the manufacturers, the government, and of course to the consumer/taxpayer.

Is massive deregulation in order? Certainly not blanket deregulation instigated by torch-carrying mobs. Regulations in their best incarnation serve to protect the public health, promote fair opportunity and competition among both brand-name and generic manufacturers, and speed the time to market for drugs. Selective deregulation that considers the economic impact of a law upon the consumer and weighs it against the health risks addressed by the law is, one hopes, a feasible approach.

Thanks. Here's the soapbox back.
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i used to be disgusted. now i try to be amused.
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