ImClone's Erbitux—Lung cancer, Rejected in 2001, Approved in 2004
AstraZeneca's Iressa—Lung cancer, Approved in 2003, FDA stopped additional patients in 2005
Biogen Idec's Tysabri—MS, Approved in Dec 2004, pulled two months later, reintroduced in 2006 after patients lobbied FDA
Dendreon's Provenge—Prostate cancer (experimental vaccine), unapproved, FDA asked for additional trials this May
Genta's Genasese—melanoma and leukemia, FDA Rejection Letter, company appealing
The Abigail Alliance for Better Access to Developmental Drugs filed suit against the FDA in 2003 seeking expanded access to experimental drugs for terminally ill people. The nonprofit group was founded by Frank Burroughs in 2001 after his 21-year-old daughter and only child, Abigail, died of head and neck cancer. She had been turned down for clinical trials for ImClone Systems' (IMCL) Erbitux and AstraZeneca's (AZN) Iressa, both of which went on to win FDA approval. After a long legal battle, a three-judge panel from the District of Columbia Circuit Court of Appeals ruled last year that the case could be heard in district court.
The FDA requested that the court's full, 10-judge panel consider the case, and its decision is widely expected this summer. Whichever side loses is sure to appeal to the Supreme Court. "This could be a landmark civil rights case," Burroughs says. That right, if the Abigail Alliance prevails, would let a terminally ill patient try any drug that has proven safe in early-stage human studies, even if there is no evidence of its efficacy.
More at BusinessWeek