A case working its way through the legal system may end up forcing the FDA to give super-sick patients the right to buy and use unapproved experimental drugs. The case was spearheaded by a group called the Abigail Alliance, which works to break down barriers to accessing experimental drugs. Last year, a court ruled that dying patients have a constitutional right to purchase such drugs, at least if their doctors say there are no other options, but the FDA appealed. The ruling, if it stands, will allow patients to take drugs after small Phase I trials, something the FDA says would create far too many risks to patients, given that nearly 90 percent of Phase I drugs are abandoned due to ineffectiveness or safety concerns.
The next step in the legal fight moves to the U.S. Court of Appeals for the District of Columbia, where attorneys will re-argue the matter on March 1. The FDA, for its part, is fighting for all its worth, arguing that the appeals court decision would prevent the agency from offering the basic patient protections it exists to provide.
To get more information on the controversy:
- read this Newark Star-Ledger article