It takes the Food and Drug Administration an average of nearly seven years to approve promising new anti-cancer drugs. For most terminally ill patients, that's not nearly fast enough. Now patient advocates are taking the FDA to court in an effort to force the agency to streamline its approval process.
In late July, the Washington Legal Foundation sued the FDA and the Department of Health and Human Services in U.S. District Court on behalf of the Abigail Alliance for Better Access to Developmental Drugs, a Virginia-based advocacy group for terminally ill patients. The lawsuit contends that the FDA's tortuous drug-approval process effectively denies terminally ill cancer patients access to experimental anti-cancer drugs, thereby violating their constitutional rights.
Alliance founder Frank Burroughs named the group after his daughter Abigail, who two years ago succumbed to cancer at age 21 after trying unsuccessfully to obtain access to two experimental anti-cancer drugs. The group's lawsuit also details the struggles faced by other Alliance patients who were urged by their physicians to try experimental drugs after traditional therapies failed. None of the Alliance patients was able to get into the very limited group who participated in the drug companies' clinical trials.
The lawsuit calls on the FDA to give special initial approval to experimental drugs that show effectiveness and to permit their sale and distribution to patients with no other approved treatment options. The FDA was withholding comment pending review of the lawsuit.
Despite several lawsuits filed against the FDA seeking early access to experimental drugs, the agency still retains dictatorial power that results in needless suffering and death of millions of Americans each year.