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FDA Details Access to 'Investigational' Drugs
WEDNESDAY, Aug. 12 (HealthDay News)
By clarifying rules governing patient access to so-called investigational drugs, U.S. health officials said Wednesday that they hope to expand the number of people who might benefit from these not-yet-approved medications.
Investigational 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.