4 BioPharm International eBook March 2020 www.biopharminternational.com
Is There a "New Normal"
for Drug Quality?
With some FDA inspections on hold,
will the US drug supply maintain its quality standards?
I
n a February 2020 report (1), FDA's Office of
Pha r maceut ica l Q ua lit y (OPQ ) noted t hat,
"Quite simply, the quality of our drug supply
is better than ever before." OPQ , which was
launched in 2015 to oversee quality standards
for all innovator and generic dr ugs marketed in
the United States, noted a number of achievements
in 2019, including 357 inspections for application
approval and nearly 200 quality assessments of appli-
cations expedited by OPQ to avert potential drug
shortages for patients.
Public perceptions about drug quality can be off tar-
get from reality. A 2019 survey conducted by FDA and
WebMD found that nearly one-quarter of physicians
surveyed believed an advertisement for a drug was an
indicator of quality. However, nearly half of the physi-
cians responding to that survey said drugs manufactured
abroad were of lower quality than those manufactured in
the United States. That assessment is troubling, in light of
the number of APIs that are manufactured offshore and
disruptions to quality oversight efforts.
WARNING LETTERS
REPORT FAMILIAR VIOLATIONS
Through early March 2020, FDA reported eight drug
recalls, including four related to nitrosodimethyl-
amine impurities (2), an ongoing concern traced to
quality problems with the manufacture and testing of
APIs manufactured overseas.
On the compliance front, FDA's Center for Drug
Evaluation and Research—through mid-March 2020—
issued 12 warning letters to facilities in China, India,
tomertu
-
Stock.adobe.com
RITA PETERS
Regulatory Sourcebook Regulatory Update
