New spending bill looks to push FDA on generics naming guidelines

WASHINGTON —  The House Appropriations Committee on Friday released a new spending bill for the coming fiscal year, which provides additional funding for the FDA and contains language about how the Food and Drug Administration should finalize its guidance on generic drug and biosimilar naming. 

 

The guidance in question, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” in its draft form allows a generic drug sponsor to issue a label change for a product based on acquired information about safety, which would allow for difference between generics and the reference product on temporary basis. The rule saw a draft issued in 2013 and the FDA has been considering a final rule since then, with a plan to release the final version in July. But the spending bill includes language that looks to push the FDA into rewriting it to fit Congress’ expectations by withholding some funding. 

 

“None of the funds appropriated or otherwise made available by this Act may be used by [FDA] to finalize or implement the rule entitled 'Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products' … unless the final version of such rule requires that [FDA] — (1) approve in advance on a timely basis any change to the safety information in the labeling of a drug that is marketed pursuant to an abbreviated new drug application … or an application under section 351(k) of the Public Health Service Act … and (2) requires an identical change to be made on the same timetable to the safety information in the labeling” of the reference product.

 

Additionally, the bill contains 21st Century Cures language, emphasizing patient-focused development, modern trial design and FDA priority review for breakthrough devices. It would also ban the FDA from considering drugs developed in a way in which “a human embryo is intentionally created or modified to include a heritable genetic modification.”