Company: SHPH
Filing Date: 2025-02-27
Form Type: 424B3
Source: 0001493152-25-008474
Chunk: 54

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-27
Form: 424B3
Chunk 54
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We believe that the efforts of governments and third-party payors to contain or reduce the cost of healthcare and legislative and regulatory proposals to broaden the availability of healthcare will continue to affect the business and financial condition of pharmaceutical and biopharmaceutical companies. A number of legislative and regulatory changes in the healthcare system in the U.S. and other major healthcare markets have been proposed in recent years, and such efforts have expanded substantially in recent years. These developments have included prescription drug benefit legislation that was enacted and took effect in January 2006, healthcare reform legislation enacted by certain states, and Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (the “ACA”), a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending and enhance remedies against fraud and abuse. The ACA also contains provisions that will affect companies in the pharmaceutical 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