Generic Industry Appears Positioned to Sue FDA Over Generic CBE Rule

25th November 2014

By Charles Jaap, MBA, RAC 

Pharmaceutical Development Group (PDG™), a pharmaceutical consultant, has published a chronology of events relating to FDA’s proposed rule that would allow generics to use the CBE process to update their labeling with new safety information.

In a new development, the Regulatory Affairs Professional Society (RAPS) recently reported ‘Generic Drug Industry Threatens FDA with Lawsuit over Drug Labeling Proposal’.

The rule is currently scheduled to be finalized in December 2014, according to the Federal Register Unified Agenda 0910-AG94.

However, this document also notes that the comment period closed on 13 January 2014, a date which was subsequently extended (see below). Sources at FDA have not provided additional information.

On 13 November 2013, FDA issued the notice of proposed rule ("Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products"), which would allow generics to add safety information to product labeling using the CBE process.

In December 2013, FDA announced an extension of the comment period for the proposed generic CBE rule from 13 January to 13 March 2014.

On January 22 2014, 28 members of Congress, including ten senators, wrote to FDA Commissioner Hamburg, expressing ‘grave concerns’ about the proposed rule allowing generics to ‘alter an abbreviated new drug application (ANDA) label without FDA approval.’

In February, the FDA responded to representative Joseph R Pitts, noting that ‘it is of course possible that FDA might adopt an alternative regulatory approach or that the final rule may differ in some respects from the proposal to reflect points made in the comments.’

The comment period closed on 13 March with at least 64 public submissions from a variety of stakeholders including industry representatives, Generic Pharmaceutical Association (GPhA), National Conference of State Legislators and Public Citizen.

Janet Woodcock, MD director of Center for Drug Evaluation and Research (CDER) FDA issued a statement on April 1 before the Subcommittee on Health, Committee on Energy and Commerce and the US House of Representatives.

It was entitled ‘Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling.’ Dr. Woodcock outlined the purpose and summary of the proposed rule, citing recent court decisions and legal authority.

In her closing statement, she said: "This proposed rule, if finalized, is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients."

PDG continues to monitor developments related to the generic CBE rule and will issue additional updates as events unfold.

About PDG

PDG delivers strategic pharmaceutical and FDA regulatory consulting, scientific support and US pharmaceutical registration assistance spanning proof of concept through to commercialization.

PDG’s integrated team of professionals have years of industry experience addressing FDA submission, approval and post-marketing assignments across a variety of dosage forms and therapeutic areas.

Expertise spans prescription and nonprescription (OTC) drugs, both NDA and monograph. PDG was founded in 1999 by Dr Cheryl Blume, is headquartered in Tampa, Florida, and provides regulatory consulting services to organizations of all sizes, both foreign and domestic.

Please feel free to contact us.

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