Regulators, pharma and other key stakeholders discussed a host of burning issues around inspections and quality systems at a recent summit in India, including the need for senior management oversight of facilities to ensure “sustainable compliance.”
Shortages Getting More Complex
Patrizia Cavazzoni, director of the US FDA's Center for Drug Evaluation and Research, noted that depending on the precipitating events, some drug shortages can endure for months to years - for instance plant remediations and agency approvals.
Over 60% of shortages are largely due to product quality problems at the manufacturing level. Some of the shortages are more complex, tend to last longer and are also more challenging and take more effort to mitigate, Cavazzoni said.
On cisplatin shortages in the US, she stated that a firm that was responsible for over 50% of cisplatin supply had some major quality issues and decided to shut down production, leading to the current shortfall.
“In addition, the shortages of cisplatin led to a ripple effect as demand for the second-line treatment carboplatin increased, but the manufacturers were unable to meet demand,” she added.
Referring to an overall gap in manufacturing capacity for critical drugs in the US and globally, particularly for sterile injectable drugs, Cavazzoni also pointed to some “deeply rooted economic reasons” for this shortfall, which include the lack of incentives currently for generic manufacturers to manufacture products over the market demand, so that “we have the safety buffer in case some disruptions in the supply chain were to happen.”
This can lead to supply disruptions, which can ultimately result in shortages. Disruptions can be caused by unforeseen events including “geopolitical concerns” or financial pressures could lead to manufacturing site closures/firm bankruptcies.
Other experts have in the recent past highlighted the declining return on invested capital for the 24 top manufacturers in the US generic drug market. Data from S&P’s Capital IQ indicated that the median return fell from 13% in 2015 to 5% in 2022. (Also see "Why Generic Drug Manufacturing Is Faltering And Ways To Bolster It" - Pink Sheet, 2 June, 2023.)
