The federal government requires pharmaceutical companies to prove that their drugs are both safe and effective before putting them on the market.
The thinking behind the FDA's two-hurdle approach is that ineffective drugs cost money and impose an opportunity cost: While the ineffective drug is being used, potentially effective ones are not.
Researchers who have studied the 1962 law, known as the Kefauver-Harris Amendments, have concluded that before it was enacted, ineffective drugs were a small percentage of the market and therefore not much of a problem.
Further, the Kefauver-Harris Amendments dramatically increased the time and cost of getting new drugs approved.
To understand how little the FDA's two-hurdle approach contributes, consider Merck's Keytruda, which has recently become one of the hottest drugs on the market.
Does the FDA, which approved Keytruda as safe and effective for melanoma, know which patients will benefit from it? No. The potential benefits described on the drug's label are what happened to strangers in another time and place.
If you were diagnosed with Covid-19 today, would you choose to take nothing? Or would you want a safe drug that has shown some potential against the virus? We suspect the great majority of Covid-19 patients would choose the latter option.
https://www.wsj.com/articles/fda-shouldnt-keep-safe-drugs-off-the-market-11585175286?mod=hp_opin_pos_3
The thinking behind the FDA's two-hurdle approach is that ineffective drugs cost money and impose an opportunity cost: While the ineffective drug is being used, potentially effective ones are not.
Researchers who have studied the 1962 law, known as the Kefauver-Harris Amendments, have concluded that before it was enacted, ineffective drugs were a small percentage of the market and therefore not much of a problem.
Further, the Kefauver-Harris Amendments dramatically increased the time and cost of getting new drugs approved.
To understand how little the FDA's two-hurdle approach contributes, consider Merck's Keytruda, which has recently become one of the hottest drugs on the market.
Does the FDA, which approved Keytruda as safe and effective for melanoma, know which patients will benefit from it? No. The potential benefits described on the drug's label are what happened to strangers in another time and place.
If you were diagnosed with Covid-19 today, would you choose to take nothing? Or would you want a safe drug that has shown some potential against the virus? We suspect the great majority of Covid-19 patients would choose the latter option.
https://www.wsj.com/articles/fda-shouldnt-keep-safe-drugs-off-the-market-11585175286?mod=hp_opin_pos_3
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