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Equally concerning should be the fact that a majority of pharmaceuticals are being produced in countries with lax regulatory controls. And the regulatory cont

Equally concerning should be the fact that a majority of pharmaceuticals are being produced in countries with lax regulatory controls. And the regulatory controls elsewhere leave much to be desired. It took the FDA years to figure out that widely used blood pressure medications were being contaminated with a carcinogen. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan https://www.fda.gov/drugs/drug-safety-and-availability/fda-u...

consumer451 3y ago
From a few years back, I recall that an Israeli company was going to give us affordable consumer chemical scanners. Anyone remember what happened to that company and technology?
- jqpabc123 3y ago
  This might work to detect certain base elements like lead. But I doubt this will work reliably with pharmaceuticals. These are complex chemicals. A slight variation in composition can be the difference between medicine and carcinogen. To reliably automate testing for every possible variation would be virtually impossible without producing so many false positives as to be essentially useless.
  - consumer451 3y ago
    I just found the company that I was thinking of, they still exist but only in b2b, but only in a very specific niche. They have scaled way back from their original ambition. They seem to have had consumer tech already,[0] and rolled it back for reasons which I do not understand. > Our patented solution combines two integrated technological components, the revolutionary SCiO Sensor, and our powerful cloud. Together these disruptive technologies provide a comprehensive end to end solution that gives you everything your business needs for instant material analysis.[1] A consumer product no longer exists, even though one was originally delivered. This could be an issue of going up-market first, scaling issues, or if I believed in conspiracies like "killer acquisitions,"[2] then I might imagine that this technology would be inconvenient for many industries if end consumers had the spectrographic data in hand. This inconvenience might be a bunch of people complaining about compounds which were not dangerous, or it might democratize the testing that the FDA should be doing, and show dangerous contamination in many consumer products, especially in the food category. [0] https://theindexproject.org/post/scio https://theindexproject.org/post/scio [1] https://www.consumerphysics.com/ https://www.consumerphysics.com/ [2] https://www.google.com/search?q=%22killer+acquisition%22 https://www.google.com/search?q=%22killer+acquisition%22 https://www.timesofisrael.com/scanner-identifyng-foods-calorie-ingredient-count-honored-by-world-body/ https://www.timesofisrael.com/scanner-identifyng-foods-calor...
alephnerd 3y ago
> that a majority of pharmaceuticals are being produced in countries with lax regulatory controls The US FDA has an on-site presence in every major exporting country to the US [0] If I have a line of generic drugs I manufactured in India or China that I want to sell in the US, they will have to be tested by the FDA office in those countries in order to get past customs. If those companies do not comply or break FDA regulations, they face US level fines and can even see valuations collapse [1] [0] - https://www.fda.gov/about-fda/office-global-policy-and-strategy/office-global-operations https://www.fda.gov/about-fda/office-global-policy-and-strat... [1] - https://www.reuters.com/business/healthcare-pharmaceuticals/indias-dr-reddys-shares-fall-observations-us-regulator-2023-12-11/ https://www.reuters.com/business/healthcare-pharmaceuticals/...
- toomuchtodo 3y ago
  https://www.bloomberg.com/news/features/2023-12-05/pentagon-is-skeptical-of-cheap-generic-drugs-approved-by-the-fda https://www.bloomberg.com/news/features/2023-12-05/pentagon-... | https://archive.today/ubLmg https://archive.today/ubLmg ("The Pentagon Wants to Root Out Shoddy Drugs. The FDA Is In Its Way.") > They’ve saved taxpayers and consumers hundreds of billions of dollars a year. But recalls related to drug manufacturing quality doubled in the US from 2018 to 2022. With almost 80% of FDA-registered generic production facilities located overseas, years can pass between inspections. Profit margins on generics are so thin that there are often only one or two suppliers of vital medications. As a result, quality issues are fueling shocking shortfalls in supply, which a US Senate committee will examine on Tuesday. Shortages in the US reached near-record highs this year and left cancer patients, among others, waiting for life-saving treatments. Generics are supposed to be affordable and safe. Instead, they’re cheap — but sometimes dangerous. > Concern about the nation's drug supply has reached the point that big hospitals, the Defense Department and Congress are raising questions about the FDA's ability to monitor it. The Pentagon in August chose an independent lab with which the FDA has publicly feuded, Valisure LLC, to test some of the generics available to millions of military personnel and their families, two years after Kaiser Permanente, a health system serving 12.7 million in the US, started a similar program with the lab. > The efforts have run headlong into a major roadblock: the FDA itself. One might assume the US drug regulator, which dates to the 19th century Division of Chemistry, leads the mission of testing drugs. In fact, the FDA resists the idea of grading drugs by quality and rarely conducts tests of its own. Agency officials sought to block the Pentagon's nascent study, cast doubt on Valisure's methods and, according to multiple government officials, soured a Biden administration effort this year to introduce third-party testing more widely. I would be wary about trusting current FDA oversight and governance implementations overseas, especially in India due to geopolitical concerns (prioritizing the relationship over robust testing). The above piece dives into detail.

consumer451 3y ago

From a few years back, I recall that an Israeli company was going to give us affordable consumer chemical scanners. Anyone remember what happened to that company and technology?

jqpabc123 3y ago
This might work to detect certain base elements like lead. But I doubt this will work reliably with pharmaceuticals. These are complex chemicals. A slight variation in composition can be the difference between medicine and carcinogen. To reliably automate testing for every possible variation would be virtually impossible without producing so many false positives as to be essentially useless.
- consumer451 3y ago
  I just found the company that I was thinking of, they still exist but only in b2b, but only in a very specific niche. They have scaled way back from their original ambition. They seem to have had consumer tech already,[0] and rolled it back for reasons which I do not understand. > Our patented solution combines two integrated technological components, the revolutionary SCiO Sensor, and our powerful cloud. Together these disruptive technologies provide a comprehensive end to end solution that gives you everything your business needs for instant material analysis.[1] A consumer product no longer exists, even though one was originally delivered. This could be an issue of going up-market first, scaling issues, or if I believed in conspiracies like "killer acquisitions,"[2] then I might imagine that this technology would be inconvenient for many industries if end consumers had the spectrographic data in hand. This inconvenience might be a bunch of people complaining about compounds which were not dangerous, or it might democratize the testing that the FDA should be doing, and show dangerous contamination in many consumer products, especially in the food category. [0] https://theindexproject.org/post/scio https://theindexproject.org/post/scio [1] https://www.consumerphysics.com/ https://www.consumerphysics.com/ [2] https://www.google.com/search?q=%22killer+acquisition%22 https://www.google.com/search?q=%22killer+acquisition%22 https://www.timesofisrael.com/scanner-identifyng-foods-calorie-ingredient-count-honored-by-world-body/ https://www.timesofisrael.com/scanner-identifyng-foods-calor...

alephnerd 3y ago

> that a majority of pharmaceuticals are being produced in countries with lax regulatory controls The US FDA has an on-site presence in every major exporting country to the US [0] If I have a line of generic drugs I manufactured in India or China that I want to sell in the US, they will have to be tested by the FDA office in those countries in order to get past customs. If those companies do not comply or break FDA regulations, they face US level fines and can even see valuations collapse [1] [0] - https://www.fda.gov/about-fda/office-global-policy-and-strategy/office-global-operations https://www.fda.gov/about-fda/office-global-policy-and-strat... [1] - https://www.reuters.com/business/healthcare-pharmaceuticals/indias-dr-reddys-shares-fall-observations-us-regulator-2023-12-11/ https://www.reuters.com/business/healthcare-pharmaceuticals/...

toomuchtodo 3y ago
https://www.bloomberg.com/news/features/2023-12-05/pentagon-is-skeptical-of-cheap-generic-drugs-approved-by-the-fda https://www.bloomberg.com/news/features/2023-12-05/pentagon-... | https://archive.today/ubLmg https://archive.today/ubLmg ("The Pentagon Wants to Root Out Shoddy Drugs. The FDA Is In Its Way.") > They’ve saved taxpayers and consumers hundreds of billions of dollars a year. But recalls related to drug manufacturing quality doubled in the US from 2018 to 2022. With almost 80% of FDA-registered generic production facilities located overseas, years can pass between inspections. Profit margins on generics are so thin that there are often only one or two suppliers of vital medications. As a result, quality issues are fueling shocking shortfalls in supply, which a US Senate committee will examine on Tuesday. Shortages in the US reached near-record highs this year and left cancer patients, among others, waiting for life-saving treatments. Generics are supposed to be affordable and safe. Instead, they’re cheap — but sometimes dangerous. > Concern about the nation's drug supply has reached the point that big hospitals, the Defense Department and Congress are raising questions about the FDA's ability to monitor it. The Pentagon in August chose an independent lab with which the FDA has publicly feuded, Valisure LLC, to test some of the generics available to millions of military personnel and their families, two years after Kaiser Permanente, a health system serving 12.7 million in the US, started a similar program with the lab. > The efforts have run headlong into a major roadblock: the FDA itself. One might assume the US drug regulator, which dates to the 19th century Division of Chemistry, leads the mission of testing drugs. In fact, the FDA resists the idea of grading drugs by quality and rarely conducts tests of its own. Agency officials sought to block the Pentagon's nascent study, cast doubt on Valisure's methods and, according to multiple government officials, soured a Biden administration effort this year to introduce third-party testing more widely. I would be wary about trusting current FDA oversight and governance implementations overseas, especially in India due to geopolitical concerns (prioritizing the relationship over robust testing). The above piece dives into detail.