[Source: Health and Life Sciences Law Daily, August 14, 2007]
Congressional Quarterly (8/13, Adams) reported that advocates for "terminally ill patients seeking treatments not yet approved by the Food and Drug Administration argue that a recent court ruling may amount to a virtual death sentence for some of their number." In that decision, the U.S. Court of Appeals for the District of Columbia "found that the Abigail Alliance for Better Access to Developmental Drugs had no legal basis to overlook FDA strictures on drugs not yet approved for the market." CQ continued, "FDA Commissioner Andrew von Eschenbach says that the agency is now considering expanding its policy on compassionate-use exemptions. ... Meanwhile, the FDA continues to crack down on cancer patients looking for alternative treatments beyond its regulatory reach. Earlier this summer, FDA officials forced Web sites to stop selling a chemical known as dichloroacetate that is not approved for treatment but that a Canadian researcher believes can mitigate -- and possibly cure -- the spread of lung and breast cancer without harming normal cells."
Abigail Alliance members call for Congress to pass the Access Act. In a commentary appearing in the Wall Street Journal (8/14, A17), Ronald Trowbridge and Steven Walker, both with the Abigail Alliance, write, "Last week, the full D.C. Circuit Court of Appeals reversed an earlier decision by its own three-judge panel and ruled 8-2 against a dying patient's right to pursue life by taking investigational -- but as yet FDA-unapproved -- drugs." They continue, "The FDA responded to our lawsuit by proposing 'new' regulations governing access to investigational drugs. They propose to change nothing." The two men conclude, "We will appeal the decision in Abigail Alliance v. Eschenbach (pdf) to the Supreme Court, and agree with only one thing in the majority opinion. Congress should pass our pending legislation, called the Access Act (pdf), now. It should be added to the FDA reauthorization bill headed for a vote in September. This is massive human tragedy, made even worse by the fact that it didn't and doesn't have to be this way. Looking at FDA automatons and the D.C. Circuit Court brings to mind T. S. Eliot's question, 'Where is the wisdom we have lost in knowledge?'"
Related Materials:
- S.1956 ("Access Act")
- See this post relating to the case mentioned above: "D.C. appeals court rules terminally ill lack constitutional right to experimental medicines"
