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Collaboration and Consensus: Pam Bailey Profile

By: Karen A. Newman
Posted: October 3, 2008, from the February 2006 issue of GCI Magazine.

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She points to AdvaMed’s collaborative process with the European, French and Japanese associations as an example, and said she has found the same opportunity in this industry. In meetings with her counterparts in Europe, China and Japan, she has found the same determination to work with the regulatory agencies in a collegial way to find a path toward rationalization of regulation. “Companies need consistency of regulation, they need transparency, they need to understand what the requirements are and, ideally, there should be minimal variation from market to market,” said Bailey. “In the device sector, we had a process in place and it worked very well.” CTFA has embarked on an analysis of that process, and, in January, hosted a meeting of industry counterparts from the associations outside the United States to review processes and select one to be put in place to allow similar achievements in this industry.

Another focus for Bailey at AdvaMed was making sure FDA had the resources it needed to do its job well, a challenge for the consumer personal care industry as well. Federal appropriations are limited and they are not increasing, said Bailey, yet this industry needs a strong FDA. She explained that the Cosmetics program at FDA is part of the Center for Food and Nutrition. The Federal budget is under so much stress that with the food safety program in need of new resources, Federal appropriations for the Cosmetics progam continue to weaken. In the past, CTFA lobbied the appropriations committee in Congress for additional funds for FDA, but that is not a feasible option in the current environment, according to Bailey.

At AdvaMed, she led the effort to enact legislation imposing user fees on medical technology companies, enabling FDA to approve their device applications sooner. The pharmaceutical industry enacted similar fees in the mid-1990’s. However, user fees are not an appropriate model for the cosmetic industry, she said. AdvaMed’s model may not be appropriate for the personal care industry, but Bailey believes the CTFA has a track record of innovation and thinking outside the box when it comes to solving problems such as this.

“I don’t know of any process that is as innovative as the Cosmetic Ingredient Review (CIR),” she said. “There is nothing else like that, and it is something that I think the industry has a very proud record of having developed 30 years ago.” CIR is the model open program for cosmetic industry self-regulation that subjects cosmetic ingredients to the scrutiny of an expert panel bent on ensuring product safety. The expert panel has reviewed more than 1,200 cosmetic ingredients in its 30 years. CIR safety assessments are published annually in the CIR Compendium and in monographs available to anyone who may be interested.

The challenge now, Bailey said, is to think outside the box in a similarly creative way to work with FDA in identifying the path toward providing resources while maintaining this industry’s strong record of self-regulation.

Setting the Standard