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FDA offers advice to streamline drug development
WASHINGTON — In an attempt to streamline the process between drug discovery and availability to patients, the Food and Drug Administration released two guidance documents, the agency said in a press release.
The two documents, “Exploratory IND studies” and “INDs — Approaches to complying with CGMP during phase 1,” are part of a larger initiative introduced by the FDA in 2004.
“One of the biggest barriers research and academic institutions face is the ability to get discoveries made in the lab into clinical testing. The new Exploratory IND guidance emphasizes the flexibility available to researchers when conducting early clinical testing of these cutting-edge treatments,” said Andrew von Eschenbach, MD, acting FDA commissioner of food and drugs, in the release.
With those instructions comes a “suggested approach” to complying with current good manufacturing practice requirements for drugs used only in phase 1 studies.
“The problem is that researchers conducting very early studies were required to follow the same manufacturing procedures as those companies that mass produce products for broad-scale distribution," said Janet Woodcock, MD, FDA deputy commissioner for operations.
"These requirements are so burdensome for early phase 1 studies that many leading medical research institutions have not been able to conduct these studies of discoveries made in their laboratories,” she said in the release.
The FDA said the aims of these guiding documents and its Critical Path Initiative are to speed up the process of approving much-needed drugs and reduce the amount of time and money spent on unsuccessful ventures.
“Currently, nine out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Health and Human Services Secretary Mike Leavitt. He hopes the announced recommendations will help more researchers conduct earlier, more-informed studies of promising treatments.