Partner David Rosen was quoted in a Pink Sheet article, “Clinical Study Disclosures Will Make Drug Reviews More Efficient- Gottlieb,” about the implications of a new FDA program linking drug approval documents to sponsors’ clinical study reports.
Rosen said the opening the clinical study reports could help sponsors on the reimbursement end. “Third-party payers want to understand a lot of the underlying data that went into FDA’s decision-making process for new products that are coming into the marketplace because they have tough choices on reimbursement,” he said.
Rosen also told Pink Sheet that the willingness of sponsors to participate in the new program may depend on how much of the data will be made public. “I do really like the idea that more of the data…on which FDA has conducted their analysis to confirm safety and efficacy would be open to the public for examination,” he said. “I don’t think it’s meant to be a second-guess situation, too, but I think you’ll see a lot of people looking at this to do some comparative analyses of their product versus other products. It should be very interesting.”
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