24 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m
Generic Pharmaceuticals
G
eneric pharmaceuticals now account for more than 90%
of all prescriptions issued in the United States. However,
the generic pharmaceuticals' pipeline f low is anything
but smooth. A report issued on Aug. 7, 2019 by the US
Government Accountability Office (GAO) (1) traces part of the prob-
lem to issues with FDA review. The study found that FDA approved
only 12% of the 2030 generic-drug abbreviated new drug applica-
tions (ANDAs) submitted between 2015 and 2017 during the first
review cycle (Figure 1). Often, this could be traced to incomplete
applications and quality problems with the drug or issues found
during site inspections. In addition, reviews of complex formulations,
notably ophthalmic therapies, were often held up.
However, GAO also found that FDA reviewer comments varied in
clarity and substance. Applicants that had filed incomplete ANDAs
in the past were also found to be at higher risk of having their appli-
cations rejected during the first cycle, GAO's analysis found. Another
problem was that labeling changes required for the equivalent name
brand drug were often made late in the ANDA review cycle, delaying
approval of the generic.
FDA recently introduced changes designed to improve commu-
nication between reviewers and applicants and developed templates
designed to help make the review process more consistent, the re-
port noted. However, GAO recommends that the agency take ad-
ditional steps to improve the consistency of reviewer comments
and that it also looks into the timing required for brand-name drug
labeling changes.
Generics: Getting Beyond
"File First, Figure it Out Later"
Agnes Shanley
A GAO report analyzes some
of the reasons why so few
generics are approved the
first time around. NIPTE has
proposed a program that
would address these issues.
Surapong
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