Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 59

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 59
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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 2022, FDA released proposed regulations to amend the national
standards for licensing of wholesale drug distributors by the states; establish new minimum standards for state licensing third-party
logistics providers; and create a federal system for licensure for use in the absence of a state program, each of which is mandated by
the DSCSA. Other legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional
activities for pharmaceutical products. We are unsure whether additional legislative changes will be enacted, or whether the current regulations,
guidance or interpretations will be changed, or whether such changes will have any impact on our business.

Additionally, there has been
heightened governmental scrutiny in the United States of biopharmaceutical pricing practices considering the rising cost of prescription
drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation
designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer
patient programs, and reform government program reimbursement methodologies for products. For example, President Biden's Executive Order
14087, issued October 2022, called for CMS to prepare and submit a report to the White House on potential payment and delivery modes that
would complement the Inflation Reduction Act of 2022, or IRA, lower drug costs, and promote access to innovative drugs. In February 2023,
CMS published its report which described three potential models focusing on affordability, accessibility and feasibility of implementation
for further testing by the CMS Innovation Center. As of February 2024, the