Chronic Regulatory Compliance Issues Causing Shortages, Safety Problems

Chronic regulatory lapses at manufacturing facilities are exacerbating drug shortages and patient safety issues, claims a new report published in The New York Times.

The report chronicles the huge number of issues-some of them particularly egregious-that have occurred in recent years at facilities responsible for manufacturing pharmaceutical products. The problem is especially prominent at facilities that manufacture sterile injectable drugs, which have experienced widespread shortages in the last two years.

It's easy to see why those shortages have occurred, explained The Times. "In the last three years, six of the major manufacturers of sterile injectable drugs … have been warned by the Food and Drug Administration (FDA) about serious violations of manufacturing rules."

Four of those facilities have closed or reduced their production capacities, leading to widespread shortages for some essential injectable anti-cancer drugs like Doxil.

But the problems go far beyond just injectables. As noted by The Times and a congressional report, "Nearly a third of the industry's manufacturing capacity is off line because of quality issues."

The problems vary depending on the facility, said experts consulted in the article. Some of the factories are old and in need of repair. Others-generic manufacturers, mostly-don't have the funding to make required upgrades to their facilities due to low profit margins. Some just don't have good quality manufacturing plans in place or are short-staffed due to layoffs.

But the problems have been far from minor. Barrels of human urine, rusty tools used in manufacturing and insects in manufacturing areas have all been found at facilities in the last three years. Worse, FDA inspectors have found products contaminated with mold, fungus, bacteria, human hair and insects-all of which could cause severe adverse events or death.

While some facilities are scrambling to upgrade their facilities in the wake of FDA's crackdown on poor manufacturing practices, the costs are tremendous and the timeline long. Ohio-based Ben Vanue, whose facility was suspended after FDA found significant violations of current good manufacturing practices (cGMP), has invested hundreds of millions of dollars to bring its facility up to standards, but the entire process could take as long as five years.

In the meantime, shortages are likely to persist, which could pose a different set of problems. Such shortages have been associated with the rise of compounding pharmacies, which have been used to fill gaps left by more established manufacturers. Those facilities, however, are not as tightly regulated by FDA, and one-Massachusetts-based New England Compounding Center-has been blamed for a massive outbreak of meningitis that has sickened hundreds and killed 19 patients injected with one of its products. In working to fix one problem, critics argue, FDA may have inadvertently caused even worse ones.

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