Updated: Congress Looks to Force FDA Into Rewriting Major Generic Drug Labeling Rule

Regulatory NewsRegulatory News
| 13 April 2016 | By Zachary Brennan 

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.

That means that when a generic company notices a safety issue that has yet to either crop up or be indicated on its reference product’s label (or the reference product is no longer even produced), the generic company cannot do anything to notify the public of an imminent concern, which raises serious liability issues.

FDA first unveiled the proposed rule in November 2013, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, but has been deliberating, holding public meetings and reopening the federal docket for more comments (the last comment period closed last April).

As the proposed rule notes, the current regulatory difference between ANDA holders and NDA and BLA holders means that an individual can bring a product liability action for "failure to warn" against an NDA holder, but generally not an ANDA holder.

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."

Some in the generic industry oppose the rule (to the point of suing FDA) and claim it would expose companies to billions of dollars in new legal liabilities, though patient advocacy groups are angered by the delay in finalizing it.

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

In addition, the bill would ban FDA from considering any new drug or biologic application that relies on research in which “a human embryo is intentionally created or modified to include a heritable genetic modification.”

And the bill aims to stop FDA from finalizing, implementing, administering or enforcing another FDA rule on tobacco, “if such rule would apply to traditional large and premium cigars,” which DeLauro and Rep. Nita Lowey (D-NY) also contested.

FDA Funding

Overall, the bill would provide FDA with $2.7 billion in discretionary funding, a small increase of $33 million over FY 2016, though thanks to user fee revenue, total funding for the agency would be $4.78 billion – $97.4 million above FY 2016. Within this total, funds for medical product safety activities are increased by $9.4 million. 

The bill also provides $10 million in funding to combat Zika and Ebola virus outbreaks by helping to fund ongoing response activities, and to expedite the development and availability of medical products to fight the viruses. 

The bill passed by voice vote on Wednesday and heads to the full committee for consideration.

This story was updated on 4/14/16 to include more information on the 21st Century Cures language included in the spending bill.

Bill Text


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