The Manufacturing Issues That Continue to Contribute to Drug Shortages

Drug shortages remain a difficult to fix issue for the pharma industry and are an issue that can have devastating results. Often times, shortages hit because of an increased demand for the medication, leaving patients waiting for gaps in the supply chain to be filled.

Pharmaceutical Executive spoke with Marc Wagner, an FDA and life sciences attorney at Fox Rothschild, about the manufacturing and regulatory pressures that contribute to drug shortages. According to him, these shortages happen for a variety of reasons and there is single fix.

Instead, there are multiple steps the industry must take to prepare for increases in demand and pipeline disruptions. A major issue is the industry’s dependence on overseas production, which leaves the supply open to global pressures. According to Wagner, a majority of generic drug products are manufactured outside of the US, meaning that these sites may not be unable to pick the slack.

Pharmaceutical Executive: What manufacturing issues continue to contribute to drug shortages?
Marc Wagner: Drug shortages are a multifactorial systems failure driven by many different factors — overseas dependencies, manufacturer incentives including pricing and reimbursement, and regulatory burdens among them. But to directly answer the question of why manufacturing issues contribute to drug shortages, I think we first need to take a step back and define what a drug shortage actually is, because that definition shapes everything we see in the drug shortage marketplace.

The answer largely depends on who you ask. The FDA maintains its own definition of a drug shortage — and as of today, the FDA lists 70 drugs as currently in shortage. The American Society of Health-System Pharmacists tracks drug shortages separately, and according to their metrics, the number is 188. That is a dramatic difference — one organization is reporting more than twice as many shortages as the other. Getting clear on the definition is therefore critical to understanding the dynamics and the true scope of the problem.

As for the manufacturing issues that contribute to shortages: quality control failures are a significant driver. But compounding that, as I mentioned, is our dependence on overseas sources for raw materials, active pharmaceutical ingredients, and in some cases finished dosage products. Complex global supply chains, combined with manufacturing quality challenges, can all converge to create or worsen drug shortages.