
Why Drug Shortages Average 5+ Years: PharmTech Explained
USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.
There are fewer drug shortages in the United States, but the ones that remain are getting harder to fix. The latest episode of PharmTech Explained argues that the cause is less a manufacturing mystery than an incentive problem. USP's
The persistence is linked to a market that does not pay for reliability. Hospital contracts typically run 1 to 3 years with no minimum volume commitments. Rebates, inflation penalties, and state price-gouging laws keep generic injectable prices low even when supply tightens. Ron Piervincenzi, CEO, USP, calls the result a collective action challenge. When a low-cost supplier without resiliency safeguards fails, the shortage reaches every purchaser, including those buying from a high-quality source. “So the collective problem isn't just, ‘I don't wanna pay for something if I don't get what I need,’ it's also just, ‘I can't solve it on my own, and so I'll wait to see when we solve it together,’” he says.
Sterile injectables show this most clearly. Their shortages last a median of 4.6 years, compared with 1.6 years for oral drugs.
Reshoring is not a simple fix either: US plants make 21% of oral solid volume but 58% of the oral solid volume in shortage. Much of the risk sits further upstream. 44% of drugs in shortage rely on at least one key starting material made in only one country, a concentration USP tracks through its
Possible solutions come in the form of 3 priorities for manufacturers. They should map supply chains down to starting materials, make reliability visible to buyers, and treat quality as a commercial asset rather than a compliance cost. USP is developing
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