David R. Henderson  

Hooper on Personalized Drugs vs. the FDA

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My sometimes co-author Charley Hooper has an interesting post on how FDA regulation will hobble the shift to personalized drugs. Two key paragraphs:

If each drug takes $1 billion to reach the market and 10 million people use it over its patent protected lifetime, then each patient contributes, on average, $100 to the development of that drug. If we keep shrinking the denominator, then the economics become more difficult. Taken to the extreme of personalized medicine, with one specific drug for each person, we cannot expect that one person to cover the $1 billion development cost. Even if the development cost drops to $1 million per new drug, the economics won't work.

I think the average development cost would need to drop to $10,000 per drug to be reasonable. To reach this price, we would need to exclude the FDA completely--allow drugs to be marketed without prior FDA approval--or allow the FDA to approve the process of drug development instead of each specific drug. With this arrangement, the FDA would evaluate and approve the process of developing personalized medicines, but would then stand aside and let the drug companies deal directly with patients, physicians, and managed care organizations.

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mike shupp writes:

Blink! You're ignoring something here -- the whole point of personalized medicine is that conventional FDA testing will not work.

Here's a magic pill,let's say, which cures your stomach cancer, based upon your individual set of genes. It'll work for you and nobody else in the entire world. It's absolutely pointless to test the effectiveness of this on people with a different set of genes -- which rules out basically the rest of the human race. True, the FDA might want to ensure that the magic pill actually contains an anti-cancer medicine rather than sugar or strychnine, but this is a pretty minor task.

In other words, the elaborate and expensive testing associated with the FDA would go away with individualized medicine because it was no longer appropriate, and this would be obvious to every medical and legal authority in sight. You're not talking about the sort of legal challenge that has to go to the Supreme Court.

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