FDA works with outdated IT Systems
USA - Outdated and broken IT systems are blamed for slowness of the Federal Drugs Administration (FDA) reviews of foreign drugs, said former FDA officials and the Government Accountability Office (GAO) during a House Energy and Commerce Oversight Investigations Subcommittee hearing.
Former FDA regulatory counsel, Benjamin England, said that, although lawmakers were told that the FDA’s drug import programmes and IT systems were broken eight years ago, they still remain broken.
Reports vary on the number of non-US establishments that are subject to FDA inspection; one estimate showed around 3,000; another 6,800, according to Marcia Crosse, GAO’s healthcare director.
Former FDA Associate Commissioner William Hubbard pointed out that a relatively small investment in IT could make oversight more effective.
In a written testimony for the hearing, FDA Commissioner Andrew von Eschenbach said that upgrading the FDA’s IT systems has been one of his top priorities. The agency, he wrote, has created a board to address data accuracy and also that FDA’s IT chief is drafting a two-year plan to modernise the agency’s IT infrastructure.
15.11.2007
