Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 210

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 210
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 from other healthcare reform measures, especially with regard to healthcare access, financing
or other legislation in individual states, could have a material adverse effect on the healthcare industry in the United States.

| 104 |

In addition, there has been
heightened governmental scrutiny over the manner in which biopharmaceutical manufacturers set prices for their marketed products. Such
scrutiny has resulted in several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to,
among other things, bring more transparency to medicine pricing, review the relationship between pricing and manufacturer patient programs,
reduce the cost of medicines under Medicare, and reform government program reimbursement methodologies for pharmaceutical products. Notably,
on December 20, 2019, the Further Consolidated Appropriations Act for 2020 became law (P.L. 116-94) and included a piece of bipartisan
legislation called the Creating and Restoring Equal Access to Equivalent Samples Act of 2019, or the CREATES Act. The CREATES Act aims
to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted
the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic and biosimilar
product developers access to samples of brand products. Because generic and biosimilar product developers need samples to conduct certain
comparative testing required by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry
of generic and biosimilar products. To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic
or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable,
market-based terms.” Whether and how generic and biosimilar product developments will use this new pathway, as well as the likely
outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on our future commercial
products are unknown.

More recently, in August 2022,
President Biden signed into the law the Inflation Reduction Act of 2022, or the IRA. Among other things, the IRA has multiple provisions
that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. Starting in
2023, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the
drug product’s price increases faster than the rate of inflation