October 24, 2024

In recent years, the U.S. Food and Drug Administration (FDA) has increased its focus on companies involved in the manufacturing and distribution of amniotic membrane and fluid-derived products. Widely used for wound healing and tissue regeneration, these products must adhere to stringent regulatory standards to ensure their safety, purity, and efficacy before reaching the market. However, many companies have faced significant compliance challenges in meeting these FDA requirements.

One such case involved an FDA inspection of a firm engaged in the production of amniotic-based products, including those intended for injection. These products, promoted for their anti-inflammatory, antimicrobial, and tissue-regenerative properties, were found to be in violation of several key regulatory standards.

Why Amniotic-Based Products Are Under FDA Scrutiny

Amniotic membrane and fluid-derived products are regulated as drugs or biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act). Products containing amniotic membrane are also classified as human cell, tissue, or cellular or tissue-based products (HCT/Ps), which must comply with specific regulatory criteria. To be regulated solely under section 361 of the PHS Act, a product must meet the criteria for minimal manipulation and homologous use, as specified in 21 CFR 1271.10(a).

During an FDA inspection, it was revealed that the firm’s products did not meet these criteria. The products were minimally manipulated but were marketed for non-homologous uses, exceeding the FDA's allowable scope under section 361. As a result, these products were classified as biological drugs, subjecting them to more stringent regulatory oversight, including premarket approval.

Additionally, the firm was found to be manufacturing and distributing these products without an approved Biologics License Application (BLA), a key regulatory requirement for the legal distribution of biological products in the U.S.

Key FDA Violations and Compliance Issues

The FDA’s inspection uncovered several critical violations, which serve as essential lessons for companies in this space:

  1. Failure to Validate Manufacturing Processes: The firm did not adequately validate its manufacturing processes to ensure product identity, strength, quality, and purity. Process validation is a core element of current good manufacturing practices (CGMP), ensuring that products are consistently produced to meet required quality standards.
  2. Insufficient Stability Testing: The firm assigned a two-year expiration date to its products without sufficient data to support their stability. Stability testing is essential to confirm that a product remains effective and safe throughout its shelf life.
  3. Inadequate Complaint Handling Procedures: The company failed to follow proper procedures for handling complaints, including not reporting an adverse event involving a communicable disease to the FDA within the required timeframe. Failing to report such incidents poses serious risks to patient safety and may lead to further regulatory penalties.
  4. Lack of an Approved BLA: Without an approved BLA or Investigational New Drug (IND) application, the firm’s products could not be legally marketed for human use outside of clinical trials. The FDA requires a rigorous review process to ensure the safety, efficacy, and potency of biological products before they are allowed on the market.

Impact on the Industry: Why Compliance Matters

This case serves as a stark reminder of the importance of regulatory compliance for companies working with amniotic-based and other biological products. Failure to meet FDA standards can jeopardize patient safety and expose companies to severe consequences, including product seizures, injunctions, fines, and other legal actions.

Given the heightened scrutiny, proactive compliance strategies are essential for companies seeking to bring amniotic-based products to market without facing costly penalties or delays.

Addressing Compliance Challenges: How Maven’s Toxicology and Regulatory Expertise Supports Your Success

Navigating the complex regulatory landscape of biological products is challenging, but with the right expertise, companies can successfully bring safe and effective products to market while avoiding compliance violations. Maven offers comprehensive toxicology and regulatory services to help companies meet FDA requirements and ensure the safety of their products.

Here’s how Maven’s services can help companies overcome the challenges highlighted by the FDA:

  • CGMP Consultation and Process Validation: Maven assists companies in validating their manufacturing processes, ensuring that products meet FDA standards for identity, strength, quality, and purity. Our experts make sure that your processes are robust, repeatable, and compliant with CGMP regulations.
  • Stability Testing Support: Maven helps establish rigorous stability testing protocols, ensuring that your products maintain their effectiveness and safety over time. Proper stability data is crucial for assigning accurate expiration dates and ensuring that products remain safe throughout their shelf life.
  • Regulatory Submissions and Licensing: Maven provides support in preparing and submitting the necessary regulatory documentation, including BLAs and IND applications. Our team ensures that your submissions meet FDA standards, facilitating a smooth regulatory approval process.
  • Adverse Event Reporting and Complaint Handling: We help companies establish comprehensive adverse event monitoring systems and complaint handling procedures. Ensuring that all adverse events are promptly reported to the FDA helps mitigate risks to patient safety and avoids potential penalties for non-compliance.
  • Toxicology Risk Assessments: Maven’s toxicology experts conduct thorough risk assessments to identify any potential hazards associated with your products. This includes evaluating the safety profile of amniotic-based products to ensure they meet FDA safety standards before entering the market.

Conclusion

As the FDA continues to prioritize the regulation of amniotic-based and other biological products, companies must remain vigilant about compliance with regulatory standards. The risks of non-compliance both to patient safety and to the business itself are too significant to ignore.

By partnering with Maven, companies can leverage expert toxicology and regulatory services to ensure that their products meet FDA requirements and are safe for patient use. Maven’s comprehensive services help companies avoid the pitfalls of non-compliance, ensuring smooth market entry and long-term success in a highly regulated industry.

Call Maven today to discuss how our team of experts can help you navigate the complex world of regulatory compliance and bring safe, effective products to market.