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Pharmaceutical Consulting Update on Smoking Cessation and Generic Pharmacovigilance

By Charles O Jaap, V, MBA, RAC

Pharmaceutical consulting related to smoking cessation and generic pharmacovigilance has been a topic of interest to PDG for several years. As such, we have monitored two proposed rules closely.

One is entitled Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; regulations on the sale and distribution of tobacco products and required warning statements for tobacco products ("Deeming Rule" 79 FR 23142). The other is entitled Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products ("Generic CBE Rule" 78 FR 67985).

The Deeming Rule was scheduled to be finalized in June 2015. According to the Unified Agenda at this writing (September 3, 2015), the status of the proposed rule as of June 2015 was "Final Action".

Should the rule be finalized as proposed, the American Vaping Association has stated that it believes that 99% of current vendors would be eliminated due to the premarket review requirements. It is interesting to note that in May 2015, after the comment period had been extended, senator Richard Blumenthal (D-Conn) gave the FDA until the end of the summer to finalize the rule .

One month later in June 2015, it was reported that the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA) and related agencies had approved a spending bill that would "prevent the FDA from regulating the vast majority of vapor products out of existence." Meanwhile, the proposed Deeming Rule remains proposed.

Proposed in November 2013, the Generic CBE Rule would allow generic drug sponsors to update safety warnings using the changes being effected process as set forth in 21 CFR 314.70(c)(6)(iii). However, more recently GPhA and PhRMA jointly proposed an alternative approach known as Expedited Agency Review ("EAR") that would require NDA/ANDA holders to submit new safety information to the FDA. The FDA would then review the information in light of information in its Sentinel System and require changes based on the review.

Quite a departure from the CBE, the proposal describes the EAR as its replacement. The proposal is described in a letter to the FDA Commissioner from PhRMA and GPhA dated November 14, 2014. The rule is currently scheduled to be finalized by the end of this month.

About the author

Charles Jaap is vice-president of Operations and Business Development for PDG. The opinions and statements in this article are solely those of Charles Jaap and do not necessarily reflect the views of PDG.


1. FDA has summer to finalize tobacco deeming regs, Senate Dem says. Lydia Wheeler, The Hill, May 14, 2015. ( Congress Moves to Protect the Vapor Industry from the FDA’s Deeming Ban. American Vaping Association, June 19, 2015.

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