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Compassionate Use – And A Really Tough Decision

Posted Oct 28 2008 9:56pm
Earlier this week, the Abigail Alliance for Better Access to Developmental Drugs lost a Court of Appeals ruling that terminally ill patients do not have a constitutional right to early access (Phase I and II) to experimental medications that have not yet been approved by the U.S. FDA. Surely this one will go all the way to the Supreme Court.

While I do think that the FDA drags its heels unnecessarily with approvals to important cancer medications, giving patients compassionate use so early (Phase I) is problematic and provides patients with no guarantees to product safety. Interestingly, ASCO and the National Coalition for Cancer Survivorship (NCCS) both lined up behind the FDA on this one. A decision that I think of those organizations will probably regret in the coming years.

In the past, the FDA has completely botched the compassionate use priority. It has failed to enable access to lifesaving medications and surely thousands of patients could have lived (including Abigail, whom the Alliance was founded for after the FDA refused to allow access to Eribitux…which was eventually approved to treat Abigail’s tumor). Yet, enabling access too soon would likely cost even more lives. It’s a really tough decision, but it’s probably the right one.
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