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Comments on Notice, “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication” (Doshi et al.)

Doshi P, Herder M, Alexander GC, Bero L, Bijl D, Bourgeois FT, Cassels A, Chirac P, Darrow JJ, Dickersin K, Erviti J, Gøtzsche PC, Healy D, Helfand M, Hemkens LG, Heneghan C, Jefferson T, Jones M, Jørgensen L, Jureidini J, Kapczynski A, Kesselheim AS, Kirsch I, Krumholz HM, Leache L, Lexchin J, Li T, Lurie P, Marciniak T, Mayo-Wilson E, McDonagh M, McHenry LB, Mello MM, Miller JE, Mintzes BJ, Moore TJ, Morten CJ, Naci H, O'Sullivan C, Perry TL, Powers JH, Prasad V, Puhan M, Puil L, Redberg RF, Ross JS, Saiz LC, Sarpatwari A, Seife C, Turner EH, Vitry A, Wallach JD, Woloshin S, Zarin DA - Food and Drug Administration (FDA)

Policy Interactions

| August 2019

Regulation and Clinical Evidence

Summary:

The commenters oppose the FDA’s plan to replace individual discipline-specific drug reviews with a single “integrated review,” arguing this would reduce transparency by eliminating detailed reviewer analyses, dissenting opinions, and granular safety data that researchers and the public rely on to understand FDA decision-making.

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