Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 157

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 157
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 States
and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing 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 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.

The DSCSA, which became fully effective and applicable
in November 2024 (except for certain trading partner-specific exemptions through specified dates in 2025 to accommodate additional time
needed in order to fully implement DSCSA requirements for electronic drug tracing at the package level), 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 pharmaceutical 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.

62

At the state level, 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