As Coronavirus fears grow, so do fears of dependency on overseas Rx
As the Trump Administration bungles its Coronavirus response and questions loom about US preparedness, red lights are flashing over the profound fragility of our Rx supply. It's bad now, and likely to get worse. So where are we? back in August, (pre-Coronavirus), United States Department of Defense testified that US dependence on Chinese-sourced Rx ingredients was a national security risk: https://bit.ly/399NvdG. Coronavirus exacerbates our vulnerability in every way.
On Thursday, the FDA announced the first Coronavirus-related Rx shortage: https://on.wsj.com/2I6qBry. But Rx shortages not the only problem. On 2/24, the FDA acknowledged it can't send inspectors to China, but tried to reassure the public: it would request data from plants there “in advance or in lieu of” inspections. All good, right? https://bit.ly/399Waga.
The FDA's foreign inspection program is already threadbare and ineffective, as this US Government Accountability Office report confirmed in December: https://bit.ly/394om41. We need drugs. But we also need inspections: aggressive, unannounced ones. It's clear that much of the data coming from Rx plants in India and China is not worth the paper it's written on. So how can the FDA's Coronavirus workaround of more data satisfy anyone? https://nyti.ms/2I51XYu.
We sleepwalked into dependence on foreign-sourced Rx. Never found a proper way to safeguard quality. Never built in redundancy. Coronavirus has now revealed the edge of the cliff we've been standing on 4 years, which I expose in #BottleofLies: https://amzn.to/383oQWM.
It is frightening that the industry has allowed this dependency on such unreliable and uncontrollable sources to proliferate. It is past the time that the government takes appropriate steps to lessen that dependency and re-establish our confidence in quality drug products. To that end, senators Menendez (D-NJ) and Blackburn (R-TN) have introduced a bipartisan bill to encourage the manufacture of APIs in the US. If APIs come back, aren't finished dosage forms bound to follow? We should all support this bill. MASA.
A Business Attorney and University Instructor who has experience in ALL areas of Business Law, including International relations. My legal advice is based on your business growth goals.
5 年India just restricted export of 26 APIs due to the coronavirus. We can debate the scientific rationale behind that decision, but the truth will be realized by the impact on patients around the world who will not get their meds because supply chains are being threatened rather than the threats being managed.
Almost all countries in the world (not only in the US and including India) rely on Rx/Generic medicine that often represent over 70-80% of total medicine consumption. Yet it may very well be that 95% of it bares a piece of Chinese dependency anywhere in their complex route of synthesis of intermediates, side-chains, active ingredients or formulations. This is very unhealthy and alarming indeed.
Proven Pharma/Biotech CDMO Executive, Veteran, and Faith Driven Investor - Working, Raising Funds and Riding for Great Companies and Ministries which Elevate!
5 年This should be a major topic of discussion at DCAT. Supply chains have been vulnerable for so long - pity it takes something like Corona to provide a wake up call.