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If you want to see where this kind of free-wheeling approach to cGMP certification and product quality gets you - just take a look at the developing world, wher

If you want to see where this kind of free-wheeling approach to cGMP certification and product quality gets you - just take a look at the developing world, where big-name generics manufacturers knowingly dump subpar-quality (or even outright dangerous or ineffective) drugs on the market with impunity. This leads to all sorts of unsavory outcomes, and puts healthcare providers in the position of resorting to incredibly unscientific approaches to dosage management (it's not uncommon for physicians in such cases to recommend dosages many times in excess of what's recommended due to extremely poor active ingredient potency, based mainly on strictly qualitative feedback from patients). It effectively reduces the pharmaceutical market to a guessing game. The quality issues seen in the developing world are also directly linked to antibiotics usage practices that directly contribute to development of resistant strains of bacteria.

wooby 6y ago
It is my understanding that malnutrition, clean water, and access to education/information are foremost among the problems of the developing world, and it's not at all clear to me that regulating medication in those countries would improve anyone's situation measurably. For my part, here in the "developed" world, I have a family member with a rare autoimmune condition, and access to comparatively few medications. Those that are available are very expensive and not covered by any insurance. There is little competition between their manufacturers. Because it costs at least 1.4B to bring a drug to market, and because of the rarity of her illness, it's unlikely any company will pursue new research. Thanks to the FDA's inordinately expensive approval process, no company is incentivized to bring a drug to market with an upside of <= 1.4B, regardless of how many people it could help.

wooby 6y ago

It is my understanding that malnutrition, clean water, and access to education/information are foremost among the problems of the developing world, and it's not at all clear to me that regulating medication in those countries would improve anyone's situation measurably. For my part, here in the "developed" world, I have a family member with a rare autoimmune condition, and access to comparatively few medications. Those that are available are very expensive and not covered by any insurance. There is little competition between their manufacturers. Because it costs at least 1.4B to bring a drug to market, and because of the rarity of her illness, it's unlikely any company will pursue new research. Thanks to the FDA's inordinately expensive approval process, no company is incentivized to bring a drug to market with an upside of <= 1.4B, regardless of how many people it could help.