Our colleagues at the Tan Sheet think the Consumer Healthcare Products Association, the trade group representing over-the-counter drug manufacturers, has a handle on the latter, given the timing of their announcement today that their members plan to relabel OTC pediatric cough cold products “do not use” in children under 4.The announcement garnered industry headlines like this: Drug companies: No cold medicines for kids under 4. The relabeled products including some in Novartis’ Triaminic Line, McNeil’s Tylenol line and and some from Procter & Gamble, Reckitt Benckiser and Wyeth Consumer Healthcare (a full list is here) will be on shelves within weeks, under a plan the association worked out with FDA's blessing - well before the agency's Part 15 hearing held last Thursday to gather information on the products.
Notably, both the agency and the association kept mum at the hearing about the relabeling plan.
As a result, petitioners seeking to have pediatric cough/cold products off the market for children under 6 didn’t get a chance to pick at the plan at the widely covered event, and industry is able to announce a public safety initiative that appears to address at least part of the program in the next news cycle.
Which had some reporters griping at FDA today when the agency held a press call on CHPA’s plan. “Why couldn’t you have brought this little tidbit up during the nine-hour meeting on exactly this topic last week?” was the gist of the complaint. FDA’s director of the Office of New Drugs, John Jenkins, and drug center head Janet Woodcock said they deferred to CHPA on the announcement and split a hair, saying the meeting was about proposed changes to the OTC monograph, not about short term industry efforts. Given FDA’s recent track record on public relations, this isn’t too surprising.
For an in depth look at FDA’s meeting and some clues to agency thinking about revising the OTC monograph for the products, see “The Tan Sheet” here.
--Chris Walker
*(timing.)
No comments:
Post a Comment