New drug sponsors cause FDA chaos

“Emerging sponsors” or companies that have never had an approved application to market a drug are wreaking havoc on review activities at FDA's drugs center, says Office of New Drugs director John Jenkins.

“We are seeing a rapid shift in the drug development paradigm from big pharma research and development to small companies with venture capital-backed drug development programs,” he told an FDA/CMS Summit in Washington, DC in December.

There have been meaningful approvals from emerging sponsors during the past year, Jenkins noted, such as Seattle Genetics' brentuximab for Hodgkins Disease and anaplastic large cell lymphoma, Shire Orphan's icatibant for hereditary angioedema, and Incyte's ruxolitinib for myelofibrosis.

However, he said this paradigm shift “impacts on CDER's workload and interactions with sponsors, and we are working to catch up to the new model.”

“Inexperienced sponsors,” Jenkins continued, “need more advice and meetings with FDA and require greater clarity from us in the advice we provide.”

These venture capital-backed sponsors are more “transparent” in publicizing information about their interactions with FDA. “I refer to it as ‘drug development by press release,'” Jenkins said. “These statements are often overly optimistic on their characterization of their interaction and do not capture the nuances of FDA advice.”
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