Lawmakers Question FDA on Complex Generic Approvals

A congressional committee may be planning to throw its weight behind “complex generics” as part of a push to increase generic options and lower drug costs.

The House Energy and Commerce Committee sent a letter to FDA Commissioner Stephen Hahn calling for details of how the agency has been approving generics that include a complex API, formulation, route of delivery or are part of a complex drug-device combination.

The committee noted that complex generics are considered important options for less costly treatment of such conditions as multiple sclerosis, schizophrenia, metastatic breast cancer, osteoporosis and chronic obstructive pulmonary disease, among others.

“The length of time leading to the approval of some recently approved complex generics raises questions of whether additional actions may be necessary to encourage the development of these products," the committee wrote.