GAO Asked to Assess Viability of FDA’s Complex Generics Pathway

The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient.

Specifically, the committee sent a letter Dec. 10 asking the GAO to assess whether generic versions of nonbiologic complex drugs that are not fully characterized present challenges in meeting generic approval standards.

If the agency concludes that meeting approval standards presents challenges, then the GAO should consult with public and private groups to analyze the following questions:

  • What requirements should be established regarding the comparability of the manufacturing process?
  • What degree of characterization of the proposed generic version and the reference product should be required to determine safety and efficacy?
  • What degree of similarity should be required for the active ingredient of the generic version to be deemed the same as the active ingredient in the reference product?
  • What types of evidence should be required to demonstrate bioequivalence?
  • How much clinical evidence is needed?

Once those questions are answered, the agency should determine whether current ANDA pathways can address the use of reference products. The study also should make recommendations for the FDA, such as developing policy documents and establishing general principles on evidence needed.

Read the letter here: — Tamra Sami


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