Pharmaceutical Profit Limitation and Healthcare Access Act

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The purpose of this act is to address the issue of escalating healthcare costs, promote affordable access to essential medications, and ensure transparency and accountability in the pharmaceutical industry. This act seeks to regulate pharmaceutical company profits on medicines to protect the health and well-being of all Americans.

For the purposes of this act, the following definitions apply:

a. “Pharmaceutical Company” refers to any entity engaged in the research, development, manufacture, marketing, or sale of prescription medications in the United States.

b. “Total Cost of Production, Research, and Development” includes all expenditures directly related to the discovery, development, manufacturing, and distribution of medications, as determined by the Department of Health and Human Services (HHS).

c. “Medication” refers to prescription drugs and biologics approved by the Food and Drug Administration (FDA).

Pharmaceutical companies operating within the United States shall be subject to a profit limitation. The maximum allowable profit margin on the sale of medications shall be set at 20% of the total cost of production, research, and development, as calculated by HHS.

The Department of Health and Human Services (HHS) shall establish comprehensive regulations for the implementation and enforcement of this act. HHS shall have the authority to:

a. Conduct regular audits of pharmaceutical company financial records.

b. Issue subpoenas to collect relevant documents and testimony.

c. Investigate alleged violations and report findings to appropriate authorities.

d. Recommend penalties, including fines, suspension of product approvals, or other appropriate measures, to the relevant legislative bodies.

• All pharmaceutical companies subject to this regulation shall be required to submit annual financial reports to HHS. These reports shall include, but not be limited to:

a. Revenue and profit details for each medication.

b. Comprehensive breakdown of research and development expenditures.

c. Total manufacturing and distribution costs.

d. Expenses related to marketing and administration.

• HHS shall establish guidelines for the standardized format of these reports.

• All financial reports submitted by pharmaceutical companies shall be made publicly accessible through a government-designated platform, ensuring transparency in medication pricing.

• To protect proprietary information, sensitive details such as specific manufacturing processes and trade secrets shall be redacted from public reports.

Pharmaceutical companies found in violation of the profit limitation shall be subject to penalties, including but not limited to:

a. A fine equal to the excess profit amount, to be paid within 30 days of notification.

b. Suspension of product approvals, which may result in the removal of medications from the market.

c. Further legal actions as determined by relevant authorities.

HHS shall have the authority to provide regulatory flexibility and waivers to smaller pharmaceutical companies and startups to encourage innovation and competition in the pharmaceutical industry, provided they meet specific criteria and comply with the profit limitation.

• A designated governmental body shall conduct a comprehensive biennial review of this act’s effectiveness in achieving its intended purposes. This body shall evaluate:

a. The impact of profit limitations on medication pricing and access.

b. The financial health and sustainability of the pharmaceutical industry.

c. The overall affordability and accessibility of essential medications.

• Based on the findings of this review, the governmental body shall have the authority to recommend adjustments or amendments to this act to ensure its continued relevance and effectiveness.

In the event that any section or provision of this act is deemed unconstitutional or unenforceable, the remaining sections shall remain in full force and effect.

• This act shall take effect on [Effective Date]. Pharmaceutical companies shall be granted an initial transition period of [Implementation Period] to come into full compliance.

• Adequate funding shall be allocated to implement and maintain the regulatory framework, audits, and oversight mechanisms required for this act’s enforcement.

The relevant congressional committees shall have the authority to conduct oversight hearings and investigations related to the implementation and enforcement of this act.

HHS shall coordinate with relevant agencies, including the FDA and the Federal Trade Commission (FTC), to ensure consistent enforcement and oversight.

This act shall be subject to periodic legislative review to assess its impact and consider necessary amendments or improvements.

This Pharmaceutical Profit Limitation and Healthcare Access Act aims to address the issue of rising medication costs and promote healthcare affordability by regulating pharmaceutical company profits on essential medications. The Department of Health and Human Services shall oversee the implementation and enforcement of this comprehensive regulatory framework.