Get Brochure

The CREATES (Creating and Restoring Equal Access to Equivalent Samples) Act is a U.S. federal law passed in 2019 designed to promote competition in the pharmaceutical industry by addressing anti-competitive practices that delay the entry of generic drugs and biosimilars into the market. The Act specifically targets situations where brand-name drug manufacturers refuse to provide the necessary samples of their products to generic and biosimilar developers, which are essential for conducting bioequivalence or biosimilarity testing required for FDA approval.

It also prevents brand companies from exploiting Risk Evaluation and Mitigation Strategies (REMS) programs as a pretext to deny access to these samples, ensuring that safety protocols are upheld without stifling competition. If the requested product is governed by a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU), one crucial step is obtaining a Covered Product Authorization (CPA) from the FDA. However, this requirement does not apply to products not subject to REMS with ETASU.

What are the key Features of the CREATES Act?

  • Addressing REMS Restrictions: Some brand-name manufacturers have used Risk Evaluation and Mitigation Strategies (REMS) as a pretext to deny generic developers access to product samples. The CREATES Act requires them to provide these samples under FDA-supervised safety protocols. It also prohibits manufacturers from leveraging REMS to obstruct generic drug development.
  • Litigation Mechanism: Generic developers can file lawsuits against brand-name manufacturers that fail to comply with sample-sharing requests within 31 days. Courts can order manufacturers to provide samples and impose penalties to deter future delays.
  • FDA Oversight: The act includes provisions for the FDA to review and approve safety protocols for the handling of restricted drug samples. This ensures patient safety during generic drug testing while facilitating fair access.
  • Market-Based Terms: Manufacturers must sell drug samples to generic developers on "commercially reasonable, market-based terms" without imposing additional restrictions.

What is the Significance of the CREATES Act?

  • Promotes Competition: Removing barriers that delay the entry of generics and biosimilars into the market helps foster a more competitive pharmaceutical market.
  • Reduces Drug Costs: Increased competition often leads to lower drug prices, benefiting consumers and healthcare systems.
  • Encourages Innovation: By curbing anti-competitive practices, the law creates a fairer environment for innovation by generics and biosimilar manufacturers.

DDReg’s Capability

The CREATES Act is a transformative step in promoting fairness and competition in the pharmaceutical industry. Addressing anti-competitive practices and facilitating the entry of generics and biosimilars brings affordable medications closer to those who need them most. At DDReg, we understand the intricacies of the CREATES Act and its impact on the global pharmaceutical landscape. Our seasoned experts assist in navigating the CREATES Act's provisions, ensuring compliance and strategic advantage.

How can we help you?
Contact our experts today !