The Wall Street Journal reported that while record numbers of generic drugs for cancer, cardiovascular disease and other conditions have received FDA approval in recent years, many of the treatments have not reached the market.
"It's very troublesome," commented Ameet Sarpatwari of Harvard Medical School whose research includes pharmaceutical regulation, adding "prompt generic entry is the one known solution to lowering drug prices."
Industry officials and other researchers say delays in launching generic drugs sometimes stem from businesses changing their strategies, but they mostly blame protracted legal tie-ups, such as brand-name drugmakers aggressively defending their products by filing additional patents and suing generic-drug companies.
The FDA has approved 2492 generic versions of 617 brand-name drugs since 2016, with the pace of approvals increasing after the agency began its effort in 2017 to speed up the review of generic-drug applications.
However, less than two-thirds of generic drugs approved between 2016 and 2018, or 1249 products, were launched into the market. Meanwhile, through June, just 30% of the 442 approvals this year are now available on the market, while about 40% of last year’s 689 approvals have not been launched.
An FDA spokesman said the agency's efforts to speed up approvals has resulted in a better overall generic program. He added the FDA is encouraged by a "strong pipeline" of applications, but noted that companies decide whether to ultimately launch their products.
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