The FDA is preparing two proposals that would make it easier for patients to obtain experimental drugs as a last resort. In one proposal, which has to be approved by the OMB, the agency is spelling out how doctors and patients can obtain unapproved therapies for dangerous ailments. And in another proposal, the FDA is spelling out how drug developers can sell the therapies on a nonprofit basis. Patient advocacy groups, particularly in oncology, have been clamoring for access to experimental drugs for years. These new draft proposals would clarify how that can be done. Experts caution, though, that patients should be protected from obtaining drugs that could pose serious safety risks.
- read The Wall Street Journal report [1] on the new draft proposals
Related Article:
New rules could relax standards for Phase I drugs. Report [2]
Links:
[1] http://online.wsj.com/article/SB116303337576517988.html?mod=health_home_stories
[2] http://www.fiercebiotech.com/story/new-rules-could-relax-standards-for-phase-i-drugs/2006-11-07