22 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m
Drug Safety
pandemic issues. For example, hurricanes and other
natural disasters have demonstrated that single sourc-
ing can be problematic. If a manufacturing or sourc-
ing facility is damaged and there is no other alterna-
tive, shortages happen.
VanTrieste (Civica RX): In identifying risks, we should
ask: which products are essential, which have a history
of shortages, which ones are produced largely within
a single country or geography? Drugs that seem espe-
cially vulnerable include penicillin and cephalosporin
antibiotics. These are absolutely essential to modern
medicine—from out-patient prescriptions to intensive
care medicine—and we no longer make them in the
US. What's more, global production is heavily con-
centrated in China. And in a future pandemic, trade
war, or another event, we could be left with no source
to serve our own population.
The role of regulatory authorities
PharmTech: What role do/can governments or regula-
tory authorities play in addressing drug shortages?
Patel (Clarkston Consulting): In general, the industry
will rely on FDA more heavily to open up channels
for collaboration and communication both between
the regulatory authorities and manufacturers and
also amongst manufacturers together.
VanTrieste (Civica RX): Government has an impor-
tant role to play in identifying the products most
at risk or most essential to have on hand, ensur-
ing there is adequate inventory in the system and
adequate manufacturing redundancy, creating
public-facing quality data, and (in some cases)
making targeted investments to shore up domes-
tic manufacturing capacity. Since the start of the
pandemic, FDA has developed an essential drugs
list and the government has made some targeted
investments, including an end-to-end domestic
manufacturing capacity through a project that
Civica has partnered on with Phlow Corporation.
The White House and Congress have proposed to
make additional investments to further shore up
supply chains.
Predictions for the future
PharmTech: Any predictions for trends in drug
shortages or the supply chain going forward?
VanTrieste (Civica RX): What we can say is that the
risk factors that have contributed to shortages still
exist: quality problems, the concentration of pro-
duction to just a few manufacturers or a restricted
geographical area, low prices and small margins,
and lack of transparency on quality.
Patel (Clarkston Consulting): With increased focus
from stakeholders in the value chain, including
patients and consumers, we will likely see sustain-
ability rising as a focus for supply chains moving
forward. Also, as the past 18 months have shown,
more and more businesses will begin to focus on
digitalization through data analytics, advanced
technological manufacturing, etc.
References
1. FDA, Report to Congress: Drug Shortages for Calendar Year 2020, Re-
port, www.fda.gov/media/150409/download, Feb. 21, 2020.
2. EMA, "Availability of Medicines," www.ema.europa.eu/en/human-
regulatory/post-authorisation/availability-medicines#impact-of-
covid-19-pandemic-section, accessed Aug. 4, 2021.
PT
"The rush to develop and
manufacture vaccines has
resulted in major raw material
shortages in the industry for
other drugs."
—Swati Patel,
Clarkston Consulting
