Court Rules Against Potential FDA Reform

Published November 1, 2007

The Court of Appeals for the District of Columbia Circuit in early August ruled terminally ill patients do not have a constitutional right to use drugs not yet approved by the Food and Drug Administration (FDA).

Legislative Solution

The court’s decision doesn’t surprise–or deter–those who support FDA reform.

“We haven’t taken a position on whether patients have a constitutional right to gain access to experimental drugs, so this decision, while disappointing, doesn’t set back our effort at all,” explained Heartland Institute President Joseph Bast. “Our position is that it would be good public policy for such access to be granted, and that Congress could do so by authorizing the creation of a second track that goes around FDA, not through it, for people who are willing to accept some of the risks that come with using drugs that haven’t made it all the way through FDA’s drug approval process.

“We believe it is unrealistic to expect FDA to ever adopt policies that allow individual consumers to decide for themselves how much risk to accept in return for pain relief or potentially lifesaving drugs,” Bast continued. “People should be allowed to choose FDA’s very safe drugs–for which they will wait eight years for those drugs to be made available–or much faster access to drugs that have been shown to be safe but not yet shown to be more effective than existing drugs.”

Informed Consent

The idea of a two-track system, conceived by independent researcher Bart Madden and promoted by The Heartland Institute, would modify FDA’s drug approval process to allow terminally ill patients and others to use not-yet-approved drugs with informed consent.

Madden is convinced the two-track system would benefit everyone.

“The hidden result of excessively long FDA clinical trials is relentless suffering and death from delayed access to new, superior drugs,” Madden said.

Under Madden’s plan, one track would test drugs with conventional FDA trials. The other would allow patients and doctors to make informed decisions to use drugs not yet approved by FDA.

“All treatments and their outcomes would be made public,” Madden explained. “People would have the freedom to choose approved drugs or not-yet-approved, late-stage experimental drugs.”

The system would rely on informed consumers and doctors, primarily using an informed consent liability release and an online “Tradeoff Evaluation Database.” The database would publish real-time, continuous updates about the safety and efficacy of all experimental drugs.

Lengthy Trial

As Bast noted, FDA takes approximately eight years to test and study a drug before releasing it to the public–if it is released at all. According to the Kaiser Family Foundation, only one in five drugs that enter the clinical testing process ever gain FDA approval and enter the market.

Madden believes his proposal helps patients, crosses party lines, and encourages innovative pharmaceutical research.

“FDA supporters will argue that our freedom of choice damages their clinical trials, which they say benefit society in the future,” Madden said. “Unspoken is their assumption that the suffering and death of existing patients is a necessary cost.”

Marika Benko ([email protected]) writes from California.

For more information …

More Choices, Better Health–Free to Choose Experimental Drugs, by Bartley J. Madden, is available through PolicyBot™, The Heartland Institute’s free online research database. Point your Web browser to and search for document #21194.

“Health Care and the 2004 Elections: Prescription Drug Costs,” published by the Kaiser Family Foundation, is also available through PolicyBot™. Search for document #22022.