FDA Regulations to Improve Access to Investigational Drugs for People With HIV/AIDS, Other Illnesses
August 13, 2009
The FDA on Wednesday posted on its Web site "new regulations ... designed to provide broader access to experimental drugs for seriously ill people who have exhausted all other commercially available treatments," the Wall Street Journal reports (Corbett Dooren, 8/12). "The regulations spell out more clearly which patients are eligible for special access to experimental medicines, the [FDA] said. They also clarify when manufacturers can charge patients for the drugs," Reuters reports. According to the article, "Experimental medicines have been available to patients outside clinical trials under certain circumstances since the 1970s. Tens of thousands of patients with AIDS, cancer and other conditions have used medicines through those programs, the FDA said" (Reuters, Richwine, 8/12). Lynda Dee, a patient representative for the FDA's Antiviral Drugs Advisory Committee and a founding member of the AIDS Treatment Activist Coalition in Baltimore, said, "Anything FDA does to promote transparency is good for us," adding, "This will go far in helping people who need these new treatments" (Gardner, HealthDay/U.S. News & World Report, 8/12).
HIV/AIDS Update -- New Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily U.S. HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.