House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics

Posted 15 December 2015 By Zachary Brennan

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Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs).

The request for GAO action follows the introduction of HR 1576 in March, which also calls on GAO to study the pathway for such generics, including sodium ferric gluconate, a treatment for iron deficiency anemia in kidney dialysis patients, and liposomal doxorubicin hydrochloride, which is a cancer treatment.

“Given the complex natures of these large molecule drugs, we seek GAO’s input on whether the current statutory pathway for generic NBCDs (nonbiologic complex drugs) is adequate to guarantee patient safety,” they say.

Complex drugs and biologics can be composed of large molecules that are more difficult to fully characterize than small molecules, which adds to the difficulty of demonstrating that the generics are identical to their reference products.

For the purposes of GAO’s study, the congressmen say, NBCDs should be not considered fully characterized if: the API has molecular diversity, scientific analytic methodologies are unable to fully identify the molecular structures and physiochemical properties of the active ingredient, and the nature of the active ingredient is not understood well enough to identify the mechanism of action that produces the drug’s therapeutic effect.

If the GAO determines that these generic drugs face significantly different challenges than their small-molecule counterparts, then the congressmen call on the GAO to determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended; and (3) whether FDA should develop a more robust policy on the evidence necessary to obtain approval for these generics.

House Letter to GAO

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Categories: Active pharmaceutical ingredients, Drugs, Crisis management, Compliance, Government affairs, Regulatory strategy, Submission and registration, News, US, FDA

Tags: GAO, complex generics, APIs, FDA ANDA approvals

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