Rx Economic Information-Sharing Concept Getting Renewed Push
This article was originally published in The Pink Sheet Daily
Payers join biopharma in seeking clarity around information-sharing provisions in FDAMA Sec. 114 – and in expanding the kind of off-label data that could be disseminated under the law.
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Sponsors and payers question guidances' scope and potential audiences, and wonder if the agency couldn't just perform some retrospective audits of off-label communication to speed things up.
US Academy of Managed Care Pharmacy is developing language to protect exchange of clinical and economic information on pipeline products between manufacturers and healthcare decision-makers; safe harbor could find a home in legislation reauthorizing FDA user fee programs.
Manufacturers should be allowed to talk to payer representatives involved in financial forecasting about a new drug well before FDA approval, group led by Academy of Managed Care Pharmacy says.