Policy Documents

More Choices, Better Health

Bartley J. Madden –
May 1, 2007

More Choices, Better Health: Free to Choose Experimental Drugs shows the Food & Drug Administration’s lengthy drug approval process causes needless pain and suffering. The booklet presents an alternate solution that would give informed patients and their doctors easier access to experimental drugs.

Madden proposes a system he calls Dual Tracking. He writes, “the current one-track new-drug approval system, whereby all new drugs must be approved by FDA before they are available to the public, must be augmented by the creation of another track, creating a Dual Tracking system for experimental drugs. Dual Tracking gives patients the freedom to choose FDA-approved drugs or experimental drugs.”

Madden notes an effective Dual Tracking system relies heavily on informed doctors and consumers. Therefore, the booklet proposes an online Tradeoff Evaluation Database (TED) that would publish up-to-the-minute data from FDA clinical trials and non-clinical consumer experiences.

“Drug developers would have to promptly and fully report all outcomes from not-yet-approved drug treatments,” writes Madden, and “the government would have to ensure adequate information is available publicly.”

“The most powerful argument for Dual Tracking, one that has appeal across political affiliations,” Madden writes, “is that individuals and families ought to be free to improve or save a life, even if doing so incurs some risk.” The current regulatory regime, he says, “is profoundly at odds with this simple and compelling idea.”