Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 61

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 61
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 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 CMS Innovation Center continues to test the proposed models
and has started to roll out plans for access model testing of certain product types (e.g., cell and gene therapies) by states and manufacturers.
At the state level, state legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical
pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure
and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In December
2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit
managers, or PBMs, and other members of the health care and pharmaceutical supply chain, an important decision that may lead to further
and more aggressive efforts by states in this area. Then, in mid-2022, the Federal Trade Commission, or FTC, launched