FDA announces record generic approvals in 2019
The US Food and Drug Administration (FDA) has announced record approvals of generic drugs in 2019, amid growing pressure over drug prices in the US.
According to acting FDA commissioner Ned Sharpless, the agency approved 1,171 new generic drugs during the 2019 fiscal year.
The figures, consisting of 935 full approvals and 236 tentative approvals, mark a new record for a full fiscal year. In 2018, the FDA approved 971 generics in total.
The past fiscal year also saw approvals of 125 generics for drugs which previously had no generic competition. These included the first generic of Narcan, a naloxone hydrochloride nasal spray used to treat opioid overdose.
“We’re encouraged to see that the pipeline of generic drug applications is strong and that there is ongoing interest in the development of generic versions of complex drugs and of other drugs with inadequate generic competition,” Sharpless said.
High drug prices and a lack of generic competition have been a source of controversy in the US in recent months.
In May, 44 US states filed a lawsuit against major pharmaceutical companies including Teva, Sandoz, Mylan, and Pfizer accusing Big Pharma of conspiring to “manipulate prices and reduce competition” in the generic drugs market.
The complaint alleged that the companies had discreetly agreed not to compete with each other in certain markets, avoiding competition that would have otherwise resulted in “significant price erosion and great savings to the ultimate consumer”.
Earlier this month, California banned so-called “pay-for-delay” deals, whereby a pharmaceutical company settles patent litigation with a competitor in order to keep generics off the market.
Under California state law, these deals are now considered anti-competitive. The reforms came as part of new legislation, AB824, which is aimed at reducing drug prices.
Teva agreed to pay $69 million to the state of California in July over alleged pay-for-delay deals.
The FDA is now pressing ahead with efforts to bring more generics to market.
“In the coming months, we plan to publish additional guidances and take other important policy steps to assist generic drug applicants, including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers,” Sharpless said.
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