Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 66

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 66
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industry and other healthcare related industries by imposing additional costs and changes to business practices. Provisions affecting
pharmaceutical companies include the following:

    ●
    mandatory
    rebates for drugs sold into the Medicaid program have been increased, and the rebate requirement has been extended to drugs used
    in risk-based Medicaid managed care plans;

    ●
    the
    340B Drug Pricing Program under the Public Health Services Act has been extended to require mandatory discounts for drug products
    sold to certain critical access hospitals, cancer hospitals and other covered entities;

    ●
    pharmaceutical
    companies are required to offer discounts on brand-name drugs to patients who fall within the Medicare Part D coverage gap, commonly
    referred to as the “Donut Hole”; and

    ●
    pharmaceutical
    companies are required to pay an annual non-tax deductible fee to the federal government based on each company’s market share
    of prior year total sales of branded products to certain federal healthcare programs, such as Medicare, Medicaid, Department of Veterans
    Affairs and Department of Defense. Since we expect our branded pharmaceutical sales to constitute a small portion of the total federal
    health program pharmaceutical market, we do not expect this annual assessment to have a material impact on our financial condition.

Moreover,
we cannot predict what healthcare reform initiatives may be adopted in the future. Further federal and state legislative and regulatory
developments are likely, and we expect ongoing initiatives in the U.S. to increase pressure on drug pricing. Such reforms could have
an adverse effect on anticipated revenues from product candidates that we may develop and for which we may obtain regulatory approval
and may affect our overall financial condition and ability to develop product candidates.

Our
ability to obtain services, reimbursement or funding from the federal government, including the ability to obtain grants from the
NIH, may be impacted by possible reductions in federal spending or changes in regulations or the regulatory
environment.

U.S.
federal government agencies currently face potentially significant spending reductions. Under the Budget Control Act of 2011, the
failure of Congress to enact deficit reduction measures of at least $1.2 trillion for the years 2013 through 2021 triggered
automatic cuts to most federal programs. These cuts would include aggregate reductions to Medicare payments to providers of up to
two percent per fiscal year, starting in 2013. Under the American Taxpayer Relief Act of 2012, which was enacted on January 1, 2013,
the imposition of these automatic cuts was delayed until