AAM releases drug shortage white paper
The Association for Accessible Medicines has released a white paper on drug shortages.
The AAM noted in the paper that generic medicines are the backbone of the U.S. prescription drug market, supplying more than 9 out of every 10 prescriptions. And the availability of generic medicines overall is remarkably stable—even during challenges such as the COVID-19 pandemic. Nonetheless, drug shortages, which hit crisis proportions between 2010 and 2011, can be a challenge for manufacturers, providers, and patients.
Pointing out that due to aggressive efforts by industry and the Food and Drug Administration, the incidence of shortages has declined, AAM said that recent reports suggest a rise in shortages in 2023. Drug shortages are not limited to generic markets. They affect roughly 3% of brand-only markets and 4-6% of generic/brand and generic-only markets.
Nonetheless, evidence suggests that some generic drugs may be particularly susceptible to drug shortages, due to challenges facing the generic marketplace, AAM said.
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AAM continued, “Manufacturing generic drugs is a highly competitive, low-margin industry. External measures including disruptions in the supply chain, regulatory delays or changes in competitive intensity can make producing certain products financially unsustainable. In fact, the risk of drug shortages is increasing as the long-term sustainability of generic manufacturing faces threats. Generic prices are decreasing, drug purchasers are becoming more concentrated, new generics are not adopted as quickly, some generics are never launched due to limited commercial opportunities and registered manufacturing sites are declining.”
AAM noted that these changes force generic manufacturers to reconsider production of lower-margin, often older, medicines to ensure continued financial sustainability of the overall pipeline.
AAM also pointed out that generic product discontinuations have numbered over 3,000 since 2010 and appear to be on the rise and added that recent reports suggest a rise in shortages in 2023.
[Read more: AAM report: Middlemen increasingly block patient access to new generics]
Moreover, AAM said, “ At the core, shortages reflect challenges to the long-term sustainability of generic medicines. While each drug shortage is unique, most stem from the increasing fragility of the generic drug market. This fragility is caused by market and pricing factors that undermine the sustainability of low-cost generic manufacturing and government policies that compound challenging market dynamics. These leave generic markets vulnerable to shortage, often as a result of regulatory and manufacturing challenges. The result can strain supply chains and leave providers without sufficient supply for patients."
To access the white paper online visit here.