FDAnews Drug Daily Bulletin


Nov. 29, 2005

The HHS Secretary's Advisory Committee on Human Research Protections (SACHRP) lauded a recent draft guidance on adverse event reporting at its recent meeting in Washington, D.C. SACHRP also grilled the FDA about when it could expect similar guidance from the agency.

The Office for Human Resource Protections (OHRP) guidance came as a result of a March 2004 SACHRP resolution that OHRP and the FDA should issue clear and consistent internal and external adverse event reporting guidance. The guidance is the first of several documents that will be published on this topic, said OHRP's Associate Director Michael Carome. The ultimate goal is to issue final guidance on reporting and analysis of adverse events and unexpected adverse events, he told a recent SACHRP meeting.

SACHRP Chairman Ernest Prentice asked Carome if the FDA was on board with OHRP's draft guidance. Carome said the agency had reviewed several drafts of the guidance and made multiple comments on it, which the revisions reflected. OHRP hopes to finalize the guidance by spring 2006, said Carome, adding his office would work closely with the FDA to publish harmonized guidance on adverse event reporting.

Another SACHRP member stressed the importance of the FDA's regulations shadowing OHRP's guidance. Otherwise, "SACHRP's work will have been for nothing," said Susan Kornetsky, director of clinical research compliance at Children's Hospital, Boston. She commended Carome on the document, and said she believed "this is the way to go."