J&J/McNeil Consent Decree Prequel Tops OTC Stories, Switch Leads Topics In 2014
This article was originally published in The Tan Sheet
“The Tan Sheet” readers also made top stories of FDA’s rejection of Bayer’s petition for aspirin as primary prevention of heart attack stroke; advisors recommending FDA consider additional label warnings for OTC NSAIDS; and FDA seeking to overhaul its OTC drug monograph process to be “more agile and responsive.”
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McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.
An NIH-funded study shows 92% of older consumers have chronic conditions, the primary target of FDA’s Nonprescription Safe Use Regulatory Expansion initiative to facilitate more Rx-to-OTC switches. The agency also extends the comment period for its initiative on making more ingredients available through the OTC monograph process.
Merck will try to convince an FDA advisory committee May 2 to partially switch its blockbuster Rx drug Singulair to OTC for allergy relief in adults only. The firm will not seek to switch the Rx indications for asthma or allergy relief in children.