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FDA Details Access to 'Investigational' Drugs
Date:8/12/2009

tigational drugs are ones that are in the process of being approved by the FDA for use but are still being tested for safety and effectiveness. "We don't know as much about these drugs as we do approved drugs," Woodcock said.

The new rules will not interfere with the drug-approval process, officials said.

"We want to achieve a balance between the need to gather information to demonstrate whether drugs work and the fact that critically ill patients urgently want access and may be willing to take greater risks if they have no reasonable alternatives," said FDA Commissioner Dr. Margaret A. Hamburg. "The expanded access procedures will allow patients to get access without disrupting the gathering of information."

Under the new protocol, single patients as well as intermediate- and large-sized groups could gain access to experimental drugs.

The second rule published Wednesday details the circumstances under which manufacturers can actually charge patients for use of investigational drugs.

"Making these drugs available outside of a clinical trial can be costly to manufacturers," Woodcock said. "By permitting charging for expanded access we hope to stimulate more companies to provide investigational drugs."

According to Woodcock, deciding which companies will be allowed to recover part of their costs this way will be a "judgment call" on the part of the FDA. "They will have to give us financial information and they will have to convince us that the drug would not be developed absent this charging," she said. The company could also charge for administrative costs and for the cost of monitoring the patient, she added.

It's possible that some patients could get access to investigational drugs as early as late-stage Phase I trials, the earliest types of trials, Woodcock said.

"Together, the two final rules announced will make wider availability of investigational drugs possible by providing c
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