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Future OTC Technologies Will Bring Regulatory Challenges – Gottlieb

This article was originally published in The Tan Sheet

Executive Summary

Technological changes in the OTC drug marketplace will prompt changes in the approval process for nonprescription products, according to FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb, MD

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Drug sponsors should work with insurers in advance of nonprescription switches to develop reimbursement plans to benefit consumers, particularly when considering a behind-the-counter switch, former FDA Deputy Commissioner Scott Gottlieb advises

Deputy commissioner leaving FDA

Scott Gottlieb, MD, the agency's Medical & Scientific Affairs exec, announces Dec. 12 he will leave to return to the American Enterprise Institute think tank, where he was a resident fellow before joining FDA 18 months ago. He has worked on FDA policy initiatives, including improving the advisory committee process and improving the effectiveness of the agency's approaches to communicating risk information to the public. Gottlieb, who practiced internal medicine during his tenure as a public official, also helped facilitate implementing new regulations and policies, including drug and biologic products labeling and expanded access to drugs under development. Gottlieb, who is leaving FDA effective Jan. 16, 2007, commented this year that technological changes in the drug marketplace will prompt changes in the approval process for nonprescription products and will lead to opportunities for development of new OTCs, particularly for chronic conditions (1"The Tan Sheet" May 8, 2006, p. 4)...

SPL for OTCs

The Center for Drug Evaluation & Research will focus on structured product labeling (SPL) requirements for OTC drugs once it gets past the initial launch of SPL for Rx drugs in late October, CDER Office of Business Project Support Program Manager Lisa Stockbridge stated. Starting Oct. 31, manufacturers must submit label changes in electronic format using structured product labeling for all NDAs and ANDAs. Focus on SPL for OTCs is targeted for August 2006, she said during the Regulatory Affairs Professional Society annual meeting in Baltimore, Md., Oct. 17. Transition to SPL has been delayed several times since FDA's release of draft guidance on the topic in February 2004; the final guidance was issued in April. Implementing SPL places a "larger workload" on CDER, with the biggest burden on generic drugs due to a higher volume of labeling, Stockbridge said. The FDAer urged patience as the agency begins to adapt to the new system...

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