Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 60

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 60
---
 in healthcare policies, laws and regulations, including legislative measures aimed at reducing health care costs, may impact our ability to obtain approval for or commercialize any of our future product candidates, if approved.

All aspects of our business,
including research and development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject
to extensive legislation and regulation. Changes in applicable U.S. federal and state laws and agency regulation, as well as foreign laws
and regulations, could have a materially negative impact on our business. In the United States and in some other jurisdictions, there
have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay
marketing approval of our product candidates or any potential future product candidates of ours, restrict or regulate post-approval activities,
or affect our ability to profitably sell any product candidates for which we obtain marketing approval. Increased scrutiny by the U.S.
Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent
product labeling and post-marketing testing and other requirements. Congress also must reauthorize the FDA’s user fee programs every
five years and often makes changes to those programs in addition to policy or procedural changes that may be negotiated between the FDA
and industry stakeholders as part of this periodic reauthorization process. Congress most recently reauthorized the user fee programs
in September 2022 without any substantive policy changes.

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Among policy makers and payors
in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of
containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a focus
of these efforts and has been significantly affected by major legislative initiatives. In March 2010, Congress passed the ACA, which substantially
changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical
industry. We expect that changes or additions to the ACA, the Medicare and Medicaid programs, and changes stemming from other health care
reform measures, especially with regard to health care access, financing or other legislation in individual states, could have a material
adverse effect on the health care industry in the United States.

The Drug Supply Chain Security
Act, or DSCSA, which will become fully effective and applicable in November 2024, imposes obligations on manufacturers of pharmaceutical
products related to product tracking and tracing. Furthermore, in February