4 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m
Regulatory Update
I
n a February 2020 report (1), FDA's Office of Pharmaceutical Qual-
ity (OPQ) noted that, "Quite simply, the quality of our drug sup-
ply is better than ever before." OPQ, which was launched in 2015
to oversee quality standards for all innovator and generic drugs
marketed in the United States, noted a number of achievements in
2019, including 357 inspections for application approval and nearly
200 quality assessments of applications expedited by OPQ to avert
potential drug shortages for patients.
In noting other progress, FDA reported that the sixth continuous
manufacturing application—one to meet a medical need for cystic
fibrosis patients—was approved in three months, compared with a
typical approval time of nearly 10 months.
Public perceptions about drug quality can be off target from
reality. A 2019 survey conducted by FDA and WebMD found that
nearly one-quarter of physicians surveyed believed an advertise-
ment for a drug was an indicator of quality. However, nearly half
of the physicians responding to that survey said drugs manufac-
tured 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.
Regulatory enforcement, as normal
Through early March 2020, FDA reported eight drug recalls, includ-
ing four related to nitrosodimethylamine 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 ALEXLMX
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STOCK.ADOBE.COM
A "New Normal" for Quality?
Rita Peters
With FDA offshore
inspections on hold, will the
US drug supply maintain its
quality standards?