The U.S. Food and Drug Administration (FDA) is often praised for establishing the “gold standard” for drug approval where adherence to regulations and policy is strict and absolute. All FDA approved drugs have been rigorously shown to be safe and effective through years of careful review.
However, some critics charge that the FDA has failed to keep up with the fast pace of cancer research in ways that might allow thousands of patients to benefit from promising new cancer medications that are still in the approval process. For instance, about 57,000 people die of colon cancer each year. There are two drugs that might benefit some colon cancer patients, but approval is not expected until 2004.
Prior to approval, only the small number of patients able to sign up for clinical trials will benefit from them. Companies shepherding drugs through the approval process cannot legally sell drugs to desperate patients wishing to participate (but unable to enrol) in clinical trials. Neither can drug companies afford to donate drugs free of charge to thousands of patients not officially participating in the expensive, closely monitored drug trails.
The Abigail Alliance for Better Access to Developmental Drugs thinks it has a solution called “Tier 1 Initial Approval.” This would allow patients limited access to experimental drugs that have initially shown to be effective but are possibly months away from “full” FDA approval.
Source: Steven Walker, S.O.S. to the FDA, Wall Street Journal, August 26, 2003.
For text http://online.wsj.com/article/0,,SB106185410295150100-search,00.html
For more on Health Issues (FDA Reform) http://www.ncpa.org/iss/hea/
FMF Policy Bulleti\9 September 2003
