Have FDA’s Generic Approvals Helped With Competition? Researchers Say Too Early to Tell

Regulatory NewsRegulatory News
| 11 October 2019 | By Michael Mezher 

Amid increasing abbreviated new drug application (ANDA) approvals, efforts by the US Food and Drug Administration (FDA) to promote generic drug development in areas where competition is lacking and for shortage-prone drugs have yet to make a noticeable impact, according a paper published in JAMA Network Open on Friday.
Since 2017, FDA has stepped up its efforts to promote generic drug competition by offering priority reviews for certain ANDAs, a new competitive generic therapy (CGT) designation and by providing a list of drugs that lack generic competition.
The agency has also looked to increased generic competition as a means of preventing drug shortages and has taken steps to facilitate the development of complex generics, which have been a particularly challenging area of development for generic drugmakers.
Recent Generic Approvals
From July 2016 to December 2018, FDA approved 1832 ANDAs for some 533 different active pharmaceutical ingredients. For the most part, the number of ANDAs approved each quarter rose between Q3 2016 and Q4 2017, but more than halved from the previous quarter in Q1 2018 before continuing to rise for the remainder of 2018.
One-fifth (20.4%) of the ANDAs approved during this period were found to have limited competition at the time of approval, meaning there were two or fewer manufacturers making the same generic at the time of approval.
Two-fifths (39.1%) of the ANDAs were for products that experienced a shortage within the preceding five years and one-fifth (19.2%) were for complex generics.
The bulk of the ANDAs referenced products initially approved from 1995-2004 (41.5%), with roughly 20% referencing products either approved from 2005-2015 or prior to 1984.
The authors point out that while the number of ANDAs approved during this period trended upwards, the number of products approved with limited competition or that had experienced a recent shortage remained flat.
“Although our results suggest that there have not yet been noticeable effects of the FDA’s initiatives to expand approvals for generic drugs at risk for price spikes and shortages, ANDAs take time for the manufacturer to prepare and then another 6 to 12 months for regulatory review,” the authors note, adding that addressing competition and shortages will require continued attention from the agency.
However, it may still be too early to tell the impact of FDA’s priority ANDA and CGT programs. According to FDA’s most recent quarterly report for both programs, the number of priority ANDAs and CGT designated products awaiting FDA action have swelled in the two preceding quarters, with more approvals likely as the goal dates for those applications approach.


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