GAO Asked to Assess Viability of FDA’s Complex Generics Pathway
The FDA has begun approving generic versions of non-biologic complex drugs (NBCDs) using the same regulatory approval pathway used for small molecule drugs. However, the House Energy & Commerce Committee is asking the Government Accountability Office (GAO) to evaluate if this approach is sufficient.
Specifically, the committee sent a letter on December 10 asking the GAO to assess whether generic versions of NBCDs that are not fully characterized present challenges in meeting generic approval standards.
If the agency concludes that meeting approval standards presents challenges, the House Energy & Commerce Committee has asked GAO to make recommendations based on five key areas, which I outline in my full article on DrugWonks.com.
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Peter J. Pitts. Executive Partner for YourEncore, President - Center for Medicines in the Public Interest, Former FDA Associate Commissioner.