Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 300

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 300
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 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. In December 2020, the U.S. Supreme Court held unanimously
that federal law does not preempt the states’ ability to regulate PBMs, and other members of the healthcare 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 FTC launched
sweeping investigations into the practices of the PBM industry that could lead to additional federal and state legislative or regulatory
proposals targeting such entities’ operations, pharmacy networks, or financial arrangements. In addition, in the last few years,
several states have formed prescription drug affordability boards (“PDABs”), with the authority to implement upper payment
limits