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FDA drug approval should include a clause that requires a certain production rate per quarter along with an ongoing adjustment based on the number of prescripti
by breput 3y ago
FDA drug approval should include a clause that requires a certain production rate per quarter along with an ongoing adjustment based on the number of prescriptions.
If the applicant misses the production rate for one quarter, they agree to work with a second source drug producer to prepare for production. If they miss the next quarter's quota, the second source is allowed to sell the drug for no less than three years.
- refurb 3y agoIt takes a long time to move production facilities. Even if the original company decides to move production to another facility, it can take 6-12 months to run test batches, tests and submit it all to the FDA for approval. I’m not sure drug companies need much incentive to not have supply issues. That’s lost sales. If you dig into the actual causes it’s usually because of DEA limits (Adderal) or massive off-label use (Wegovy) or the fact that the drug is generic and the margins as so small nobody is all that interested in selling it.