Thursday, October 14, 2004


We had a very good talk on the Pharmaceutical Industry today by Dr. Kevin Swiss, a consultant for the FDA (US Food and Drug Administration). In conjunction with the Drug Discovery course I am taking, it offered everyone a 'semi-insider's' perspective of the pharma world.
Undoubtedly, the Phrama industry is the most controlled system on the planet. I won't be surprised if some people think of the FDA as a combination of Hitler, Ghenghis Khan and Pol Pot. I have reason to think that it's even more regulated than the Department of Homeland Security's immigration procedures. The tortuous route that a drug takes through the process of discovery until when it actually gets marketed as a blockbuster entity is basically imagination in a straitjacket. Moreover, this process is essentially a game of snake and ladders. At any point, and even after it has made it into the market, a drug can get recalled and forgotten quickly into oblivion. Some of the more interesting facts which juggle mind boggling numbers (That is, mind boggling for us. The drug people are blissfully at ease with these, just like the politicians):

1. An average good drug takes 10-15 years to appear on the market. The average cost has been acknowledged to be about 800 million dollars.

2. The drug companies have to file a 'New Drug Application' (NDA) after they finish with the initial trials, so that the drug can proceed to large scale trials. This consists, on an average of 300,000 pages of material, a truckload roughly equivalent to two thousand PhD. theses.

3. Everytime a drug gets recalled, the drug companies lose about 3 million$ per day.

4. Requirements for impurity detection in drugs are hideous for the researchers. As less as 1 ppb (part per billion) of impurities may be unacceptable.

Given these facts and many more, it's not surprising that more and more drugs are choking in the pipeline every year. This, coupled with the inherent difficulties of discovering newer drugs, is taking it's toll on the number of new drugs making it to our homes. The system seems to have been caught up in an endless loop; the difficulties in new drug production raising the price of drugs, and the price putting pressure on the political system. Not surprisingly, there's a lot of politics involved at every stage. The pressure on corporates at drug companies is enormous. It's all a grand scheme, literally hanging by the thread of life and death. Given all this, I would really think that it may be better to actually become an administrator with the FDA than a manager or researcher with a big drug company. That way, even if you are paid less, you get to dictate the terms to the actual 'doers' and can get a vicarious feeling of glee and power...


Blogger Sumedha said...

Hmm..I have heard some horror stories about inadequately tested drugs. But I guess the FDA should draw a line somewhere. Nothing is perfect :-)

5:00 PM  

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