Monday, December 11, 2006
Article in the Washington Post -- FDA Reveals Plan for Wider Access to Experimental Drugs, by Rob Stein:
The Food and Drug Administration yesterday unveiled a proposal designed to give thousands of seriously ill patients easier access to experimental treatments.
The proposal would clarify how patients can become eligible to get drugs that are showing promise but have not been fully tested to determine their safety and effectiveness, officials said. The plan would make it easier for researchers, drug companies and research institutes to determine how much they could charge patients getting drugs early, they said.
"People feel like there's a need to have access earlier," the FDA's Janet Woodcock said. "We're simplifying the process."
The FDA has allowed some patients access to experimental drugs since the 1970s, a practice that began to expand under pressure from AIDS activists in the early days of the epidemic. Since then, advocates for patients suffering from cancer and many other diseases have pressed the agency to further relax its requirements.