FDA generic drug approvals rose in 2023 as US drug prices surge 35% 

  USA— In its 2023 Annual Report, the US Food and Drug Administration (FDA) Office of Generic Drugs highlighted advancements in the quantity of approved generic medications and outlined the criteria applicants needed to fulfill for their applications to be approved.  

Additionally, the FDA detailed several measures aimed at improving the accessibility of generic medications. 

The report revealed that in 2022, the FDA issued 1,493 complete response letters and approved 956 generic pharmaceuticals, representing an improvement over the 914 approvals and 1,775 complete response letters issued in 2022. 

Notably, the year saw the approval of the first generic versions of Vyvanse (lisdexamfetamine dimesylate) and Pfizer’s Xeljanz (tofacitinib citrate), marking significant milestones in generic drug availability. 

Despite these advancements, concerns persist regarding rising drug prices in the US pharmaceutical market. 

Reuters research found that pharmaceutical companies introduced new drugs in 2023 at prices that were 35% higher than in 2022, attributed partly to costly therapies for rare diseases like muscular dystrophy. 

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The median yearly list price for a new drug surged from US$222,000 to US$300,000 in 2023, according to Reuters’ analysis. 

Moreover, the FDA approved more than half of the new drugs in 2023 for orphan diseases, affecting fewer than 200,000 people in the US. 

This trend, though slightly higher than in previous years, raises questions about pricing rationale, especially when benefits may not justify the exorbitant costs. 

The analysis excluded immunizations and rarely used medications, focusing on 47 pharmaceuticals. 

Notably, the most expensive drug, Regeneron’s Veopoz for CHAPLE illness, carries an annual price tag of US$1.8 million, while TheracosBio’s Brenzavvy, a diabetes medication, is priced at US$576 annually. 

TheracosBio’s innovative pricing strategy aims to disrupt the conventional drug contracting model by offering Brenzavvy at a significantly lower price than competitors, signaling potential shifts in market dynamics. 

Meanwhile, gene therapies and treatments for diseases like sickle cell disease and muscular dystrophy command staggering prices, starting at US$2.2 million and reaching US$3.2 million, respectively. 

The US pharmaceutical market benefits from various incentives for innovation in rare diseases, including fee exemptions, market exclusivity, direct R&D financing, and tax breaks. 

While these incentives drive innovation, concerns persist about affordability and therapeutic competition. 

Ultimately, efforts to balance innovation incentives with affordability remain crucial to ensure sustainable access to life-saving medications for all patients.