Will Congress Force FDA to Revise & Delay Proposed Generic Drug Labeling Rule? | Pharma Industry Regulation | Scoop.it

As Congress looks to pass a spending bill for FY 2017 by Friday, the House Appropriations Committee has released a new bill with a modest amount of new funding for the US Food and Drug Administration (FDA) and new demands on how FDA should write a controversial and major final rule on generic drug labels.

The rule, which FDA has said it will finalize in July, would allow generic drug companies to update their labels with new safety information when that information becomes available, like their reference product counterparts have done for almost 30 years.

Under current FDA regulations, generic drug companies with abbreviated new drug applications (ANDAs), unlike companies with new drug applications (NDAs) and biologics license applications (BLAs), cannot independently update product labeling with newly acquired safety information.

If finalized, the rule as currently written would permit a sponsor of a generic drug to immediately issue a labeling change for any safety-related change (prior to FDA approving such a change), which begins a process intended to allow differences to exist between the generic drug, the brand-name reference product and other approved generic drugs on a "temporary basis."

Congressional Demands
Buried in the spending bill is a major roadblock for FDA’s proposal to finalize this rule allow generic drugmakers to make labeling changes when safety events arise and without initial FDA approval.

The bill makes clear: “None of the funds appropriated or otherwise made available by this Act may be used by the Food and Drug Administration 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 the Food and Drug Administration — (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.

Rep. Rosa DeLauro (D-CT) took issue with the wording of this provision at a hearing on Wednesday. She also criticized the bill for including 21st Century Cures provisions and said she cannot support the bill.

The 21st Century Cures provisions are focused on three subsections of the House-passed bill: Patient-focused drug development, which calls on FDA to develop and use patient experience data; Modern trial design and evidence development, which would allow FDA to review drug data "derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use"; and FDA priority reviews for breakthrough devices.