Page 184 - CW E-Magazine (20-5-2025)

Special Report Special Report

President Trump signs Executive Order to increase program in India and China. While FDA agency and with other relevant agen- of relocating or building pharmaceuti-
inspections of domestic manufacturing cies to expedite the review and approval cal manufacturing capacity in the US.
US-based pharma manufacturing facilities are not announced, inspection of relevant permits. Dating back to 2020 and since then,
of foreign drug manufacturing facilities
are announced, a diff erential in inspec- Streamlining review of domestic policy makers and industry stakehol-
Seeking to streamline regulatory tive Order outlined several measures to PATRICIA VAN ARNUM tion practices that FDA is seeking to pharmaceutical manufacturing by ders have sought to address vulner-
processes be taken by the federal government to Editorial Director, (DCAT) change. FDA conducts approximately Army Corps of Engineers abilities in the supply of critical medi-
n May 5, 2025, President facilitate domestic pharmaceutical manu- 12,000 domestic inspections and 3,000 By November 5, 2025, the Execu- cines to the US that surfaced during the
Trump issued an Executive facturing in the US as outlined below.  Improving enforcement of data foreign inspections each year in more tive Order directs the Secretary of the COVID-19 pandemic. In 2020, the Associ-
OOrder to streamline the regulatory reporting, including publicly display- than 90 countries, according to the Army, acting through the Assistant Secre- ation for Accessible Medicines (AAM),
review by the US Food and Administra- Streamlining FDA review of ing the list of facilities, including agency. tary of the Army for Civil Works, to which represents US-based generic
tion of pharmaceutical manufacturing domestic manufacturing foreign facilities, that are not in review the nationwide permits issued drug companies and manufacturers,
facilities in the US, enhance the inspec- By November 1, 2025, the Execu- regulatory compliance; Streamlining review of domestic under the Clean Water Act and the issued a Blueprint for Enhancing the
tion process of foreign drug-manufac- tive Order directs the US Secretary of  Providing clearer guidance regard- pharmaceutical manufacturing Rivers and Harbors Appropriation Security of the US Pharmaceutical Supply
turing facilities, and streamline per- Health and Human Services, through ing the requirements or recommen- by the Environmental Protection Act to determine whether an activity- Chain, a six-element policy framework
mitting of manufacturing facilities by the FDA Commissioner, to review exis- dations for site changes, including Agency (EPA) specifi c nationwide permit is needed to for the federal government that would
the Environmental Protection Agency ting regulations and guidance that moving production from a foreign to By November 5, 2025, the Execu- facilitate the effi cient permitting of pharma- support the fi nancial feasibility of
(EPA). pertain to the development of domestic domestic facility, and validation of tive Order directs the EPA Administra- ceutical manufacturing facilities. increasing US domestic manufacturing
pharmaceutical manufacturing and to new or updated components neces- tor to update regulations and guidance of generic drugs. The blueprint laid
“One key area of concern is the take steps to eliminate any duplicative sary in manufacturing; and that apply to the inspection and appro- What’s next out actions that the federal government
length of time it takes to build pharma- or unnecessary requirements, maxi-  Updating any other relevant compli- val of new and expanded manufacturing The Executive Order lacks details could take to ensure a consistent supply
ceutical manufacturing facilities in the mize the timeliness and predictability ance policies, guidance documents, capacity of pharmaceutical products, on specifi c measures that would be of critical pharmaceuticals, which built
United States today,” said the Exe- of agency review, and streamline and and regulations. APIs, key starting materials, and associa- taken to realize the goal of streamlining upon the existing generics pharma-
cutive Order issued on May 5, 2025, accelerate the development of domestic ted raw materials in the US to eliminate the regulatory review process to facili- ceutical supply chain in the US, which in-
which cited estimates of 5 to 10 years pharmaceutical manufacturing. This in- Enhancing inspection of foreign any duplicative or unnecessary require- tate new and expanded pharmaceutical cluded among other measures, fi nancial
to build new manufacturing capa- cludes reviewing regulations and guid- manufacturing facilities ments and maximize the timeliness and manufacturing capacity in the US. Key incentives to increase domestic manu-
city in the US for pharmaceuticals and ance that apply to the inspection and By August 3, 2025, the Executive predictability of agency review. items to watch for in the coming months facturing capacity as well as product
critical inputs. “New construction must approval of new and expanded manu- Order directs the FDA Commissioner are further executive or Congressional volume guarantees. In addition, in
navigate myriad Federal, State, and facturing capacity and emerging tech- to develop and advance improvements Centralized coordination of environ- action to realize the goals to facilitate 2023, AAM released a white paper to
local requirements ranging from build- nologies that enable the manufactur- to the risk-based inspection regime mental permits domestic manufacturing in the US. outline policy recommendations to
ing standards and zoning restrictions to ing of pharmaceutical products, active that ensures routine reviews of over- The Executive Order identifi es EPA mitigate generic drug shortages in the
environmental protocols that together pharmaceutical ingredients (APIs), key seas manufacturing facilities involved as the lead agency for the permitting of One issue not yet specifi cally ad- US, which included policy proposals
diminish the certainty needed to gene- starting materials, and associated raw in the supply of medicines to the US. pharmaceutical manufacturing facili- dressed is the cost of increasing or relo- to increase generic-drug manufacturing
rate investment for large manufactur- materials in the US. This will be funded by increased fees ties that require environmental impact cating pharmaceutical manufacturing to capacity in the US, including providing
ing projects…Even expanding existing on foreign manufacturing facilities and assessments unless that role is assumed the US and fi nancial incentives to do so. targeted federal grants or contracts, or
capacity or modifying existing produc- To achieve those goals, the Execu- would require the FDA Commissioner by another agency. The lead agency is While proposed tariff s under conside- other direct assistance, to generic manu-
tion lines to produce new or diff erent tive Order directs the FDA Commis- to publicly disclose the annual number directed to designate a single point of ration by the Administration create addi- facturers with excess manufacturing
products requires extensive permit- sioner to evaluate the current risk-based of inspections that the FDA conducts contact within the agency to coordinate tional costs for importing products into capacity to upgrade and update existing
ting and regulatory approval, making approach to prior approval of licensure on foreign facilities, with specifi c detail with permit applicants. Additionally, the US with a policy goal of increasing manufacturing lines, build new lines in
it more diffi cult to repurpose existing inspections, including when such ins- by country and by manufacturer. the Offi ce of Management and Budget domestic manufacturing, they do not existing facilities, or build new faci-
underutilized pharmaceutical manufac- pections are necessary, and improve the is directed to coordinate with the lead address the practical issues of the cost lities to provide additional capacity.
turing capacity available domestically.” inspection process to ensure that ins- In a separate action announced by
pections are prompt and effi cient. FDA on May 5, 2025, the agency an-
The Executive Order also pointed to nounced its intent to expand the use
a diff erential in the inspection process In addition, the FDA Commissio- of unannounced inspections at foreign Missed a copy !!!
of domestic pharmaceutical manufac- ners is directed to take action on other manufacturing facilities that produce For Digital Edition of this month’s issue & all other past issues
turing facilities and foreign drug-manu- measures relating to the inspection pro- foods, essential medicines, and other Visit www.hpicindia.com
facturing that creates barriers for cess and data reporting. These include: medical products for the US market. PDF copies available for download
domestic pharmaceutical manufacturing.  Expanding existing programs that This change builds upon the agency’s Register Now
provide early technical advice Offi ce of Inspection and Investigations Contact: For Subscription : Mrs. Usha S. - usha@hpicindia.com
To address those issues, the Execu- before a facility is operational; Foreign Unannounced Inspection Pilot For Advertising : Mr. Vijay Raghavan - vijay@hpicindia.com

184 Chemical Weekly May 20, 2025 Chemical Weekly May 20, 2025 185

Contents Index to Advertisers Index to Products Advertised