Page 173 - CW E-Magazine (16-7-2024)

Special Report Special Report

Drugs shortages once again in the spotlight in the US manent discontinuances and interrup- advanced pharmaceutical quality input from 23 individuals/entities. The
tions in manufacturing and FDA’s own systems; technical excellence; and feedback will assist CDER in further
actions are helping to reduce the threat employee engagement and empower- developing its QMM program.
n June this year, the FDA published to increases in demand, according PATRICIA VAN ARNUM and impact of drug shortages. In 2023, ment. The paper provided examples of
its annual report to Congress to FDA’s report(1). Manufacturers Editorial Director, (DCAT) FDA said it worked with manufacturers elements within each practice area that In addition, in April 2023, FDA
Idetailing the level of drug short- are now not required to notify FDA to successfully avoid a large number of may be considered during an assess- issued a draft guidance document,
ages and efforts the agency is taking about shortages related to increases Low prices: Drug products, commonly drug shortages, helping to prevent 236 ment. Notifying FDA of a Discontinuance or
to mitigate them. In 2023, 55 new drug in demand, and FDA is seeking new older generics, with low prices have a shortages. For a comparison to recent Interruption in Manufacturing of
shortages were identifi ed by the FDA. authority to require notifi cation from higher risk of drug shortage years, FDA helped prevent 317 short- FDA also participated in a peer- Finished Products or Active Pharmaceu-
What products and areas were most manufacturers related to product USP’s analysis shows that in 2023, ages in 2021 and 222 in 2022. reviewed journal article(3), published tical Ingredients Under Section 506C of
prevalent and what is the impact on demand – related drug shortages. FDA product discontinuation increased by in January 2023, that shared lessons the FD&C Act, to assist applicants and
drug manufacturers? has put forth legislative proposals in 40% in one year, from 100 drug pro- FDA pointed to actions that it took learned from two QMM pilot programs manufacturers in providing FDA timely
its fi scal year 2025 proposed budget ducts in 2022 to 140 in 2023, suggesting in 2023 to address and prevent drug conducted with separate contractors and informative notifications about
Tracking drug shortages that would include authorities tightening margins forced manufactu- shortages, including among other to assess the QMM of drug manufac- changes in the production of certain
During calendar year 2023, 55 new intended to promote the agency’s rers to tap out of the market. The report things, incentivize drug manufacturing turers. One pilot program evaluated fi nished drugs, biological products, and
drug shortages were identifi ed by the response efforts, such as requirements also showed that the average price of establishments’ use of quality manage- seven establishments located within the certain APIs that may, in turn, help the
US Food and Drug Administration’s for manufacturers to notify FDA of sterile injectable medicines in shortage ment maturity (QMM) practices. FDA’s US that produce fi nished dosage form agency prevent and mitigate drug short-
(FDA) Center for Drug Evaluation an increase in demand that the manu- was nearly 8.5 times lower than those QMM program aims to encourage manu- products marketed in the US. A second ages. A revision of the draft guidance
and Research (CDER) and Center for facturer likely will be unable to meet not in shortage. facturers of CDER – regulated drugs to pilot program evaluated eight establish- document was issued in February 2024.
Biologics Evaluation and Research without meaningful shortfall or implement quality management prac- ments located outside the US that
(CBER), according to a recent FDA delay and to provide manufacturing Manufacturing complexity: Drugs tices that go beyond current good manu- produce APIs used in drug products REFERENCES
report on drug shortages(1). Although volume and supplier information. If with higher manufacturing complexity, facturing practice (cGMP) to support a marketed in the US. 1. US Food and Drug Administration,
the number of new drug shortages has enacted, FDA says these proposals such as sterile injectables, are more more reliable drug supply chain. Report to Congress: Drug Shortages
declined since a peak high reached in would greatly enhance its ongoing vulnerable to shortage In addition, following the commit- CY 2023, June 2024.
2011, when 251 new drug shortages work to address potential drug short- Manufacturing complexity can also Among the actions taken by FDA ment made at FDA’s Pharmaceutical 2. US Food and Drug Administration,
were reported, drug shortages continue ages. be seen in certain therapeutic classes, in 2023 relating to QMM include the Science and Clinical Pharmaco- “CDER’s Quality Management
to be a problem. The 55 new shortages such as certain antibiotics needing dedi- publishing of a white paper on QMM, logy Advisory Committee in November Maturity (QMM) Program: Practice
in 2023 were an increase over the 49 In a separate analysis, the U.S. cated facilities – and in certain active CDER’s Quality Management Maturity 2022, CDER engaged with over 10 Areas and Prototype Assessment
new drug shortages reported in 2022 Pharmacopeia (USP), an independent ingredients that require complex chemi- (QMM) Program: Practice Areas and stakeholder groups in 2023 through Protocol Development.”
and the 41 new drug shortages reported scientific organization, released its cal synthesis. Prototype Assessment Protocol Deve- facilitated discussions to solicit their 3. J. Maguire et al., “Lessons from
in 2021. inaugural Drug Shortage Report in June lopment(2). The paper introduced fi ve input on the perceived benefi ts of the CDER’s Quality Management
2024, which encompasses trends up Geographic concentration practice areas in the prototype assess- QMM program. FDA’s CDER also Maturity Pilot Programs,” The AAPS
Although there has been a levelling to the end of 2023 in the US. The Drugs in which the active pharma- ment protocol: management commit- established a public docket (September Journal, January 10, 2023, doi:
off of new shortages over the past report showed that shortages are lasting ceutical ingredient (API) and/or fi ni- ment to quality; business continuity; 15 to December 14, 2023) that garnered 10.1208/s12248-022-00777-z.
decade, 2023 has been a challenging year longer – the average drug shortage shed dose are made in a single or few
for shortages. One data point of note is lasts for over three years compared to locations are more susceptible to Target Your Market More Effectively
the number of ongoing shortages yet to about two years in 2020 – and impact shortage. IndiaChemTrade
be resolved from previous years. As of a wide range of therapeutic classes. Free for subscribers of Chemical Weekly
December 31, 2023, FDA had identi- More than half, 53%, of new drug Quality concerns IndiaChemTrade provides consolidated trade statistics of India. The information provided here is based on
fi ed 98 ongoing CDER-and CBER- shortages were generic sterile inject- Quality-related issues that surface the annual trade data published by the Directorate General of Commercial Intelligence and Statistics,
tracked shortages, which included 94 able medicines. in regulatory agency inspection out- Government of India. The database can be searched by: Chemical Name/Harmonised Code to obtain the
drug shortages identifi ed by CDER and comes and manufacturer recalls can consolidated trade (import or export) in that item; or by Country to obtain the trade (import or export) in all chemicals
four by CBER. Through its USP’s Medicine Sup- also inform drug shortage risk but must and related products between India and that country.
ply Map, a tool that identifi es, charac- be used along with other information
Although the majority of drug terizes, and predicts risk in the supply to be meaningful. ChemXchange
shortages have historically been chain, the report highlights four factors Open to all – no subscription required
linked to quality and GMP is- that singularly, or in combination, can Impact on drug manufacturers ChemXchange – the chemical exchange with a difference – is where you can identify your buyers and
sues, in 2023, drug shortages also leave a drug more vulnerable to short- In its report, FDA says that based on supplyers on-line, any time. Listing in this unique platform is free to all advertisers in the print version of Chemi-
occurred as a result of increased age: low prices, manufacturing com- its experience and its data on drug short- cal Weekly for a period of 12 months.
demand. More than half of the short- plexity, geographic concentration, and ages it believes that the requirements For more information contact: 022-24044471 / 72
ages seen in 2023 were due, in part, quality concerns. related to the early notifi cation of per- Email: corporate@chemicalweekly.com or log on to chemicalweekly.com

172 Chemical Weekly July 16, 2024 Chemical Weekly July 16, 2024 173

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