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NEWS & ANALYSIS
Nature Reviews Drug Discovery | Published online 2 Feb 2017; doi:http://dx.doi.org/10.1038/nrd.2017.14
Web End =10.1038/nrd.2017.14
2016 FDA drug approvals
FDA approval count fell last year, despite a steady regulatory filing rate.
Asher Mullard
After 2 years of sky-high approval numbers, the class of 2016 FDA approvals is smaller than average. The agencys Center for Drug Evaluation and Research approved 22 drugs in 2016 (TABLE 1), down from the 19-year high of 45 in 2015 (FIG. 1).
This makes the class size below the 5-year and 10-year averages (35 and 29, respectively). But,rather than indicating a new crisisin pharmaceutical productivity, the FDAs outgoing Director of the Office of New Drugs John Jenkins urged analysts to look at these approvals from beyond the context of a single calendar year.
The numbers are down thisyear for approvals, but I dont think thats the best metric for the success of either the FDA or industry, says Jenkins, who retired from the FDA in January (see http://www.nature.com/nrd/journal/v16/n2/full/nrd.2017.2.html
Web End =Nat. Rev. Drug Discov. http://www.nature.com/nrd/journal/v16/n2/full/nrd.2017.2.html
Web End =16, 8081; 2017 ). Some of this is just a timing issue of when things were submitted and when their goal dates were.
For example, the agency approved five drugs in 2015 that actually had approval action dates in 2016: had the agency acted on the scheduled Prescription Drug User Fee Act (PDUFA) dates, the gap between last years high and this years low would be narrower.
The number of drugs submitted for review at the FDA is also stable, he points out. As of mid-December, pharmaceutical and biotech companies had filed 36 new drug applications (NDAs) and biologics licence applications (BLAs) with the agency. Companies submitted 40 and 41 submissions over the full year in 2015 and 2014, respectively.
A key driver of the low 2016 approval count, instead, was an increase in the number of drugs that the agency rejected. Whereas the FDA issued only 2 complete response letters in 2016, it issued 14 in 2016
(TABLE 2). A key reason for many of these rejections was sponsors failure to comply with good manufacturing practice regulations.
The EMA also approved fewer drugs in 2016 than in previous years (see http://www.nature.com/nrd/journal/v16/n2/full/nrd.2017.17.html
Web End =Nat. Rev. Drug Discov. 16, 77; http://www.nature.com/nrd/journal/v16/n2/full/nrd.2017.17.html
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