GPhA, IPEC Call on FDA to Establish Working Groups With Industry

As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions.

Speaking at an FDA public meeting on Friday, representatives of two trade groups — GPhA’s Senior Vice President for Sciences and Regulatory Affairs David Gaugh and David Schoneker, vice chair for scientific and regulatory affairs of the International Pharmaceutical Excipient Councils — stressed the importance of forming FDA-industry working groups to identify regulatory science priorities.

“GPhA and other stakeholders dialogue with the FDA to explore how best to broaden industry’s input into the development process,” Gaugh said. “But today, no action plans we have presented have been taken up. One public hearing is not considered to be enough.”

Schoneker echoed these comments, noting that the two groups have been working with the FDA since 2011 to improve the Inactive Ingredient Database and address its use in drug development. But five years later, several key decisions have yet to be made and implemented by the FDA.

He specifically called on the FDA to minimize reviews of “redundant” excipient toxicology information, adding that the current database and associated policies are problematic for proper drug development and approval.

Gaugh cited GPhA’s concerns with the transparency of FDA decisions, such as how the FDA considers projects and studies and the overall impact of the Regulatory Science Plan on access to generic medications.

He also called for the FDA to create new tools for assessing safety, effectiveness, quality and performance of generic products, but said that GPhA would require more collaboration with a working group before making specific recommendations. — Michael Cipriano

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