August 13th, 2009
Can I get an experimental drug?
One of the most heart-rending aspects of this blog is what happens after I write about some dread disease and an experimental treatment.
The e-mails are certain to follow. How can I get some? My (wife, husband, father, mother, son, daughter) will die if we don’t get help soon.
I never knew what to say before. Now I do.
The FDA today released final rules for both expanding the use of investigational drugs and charging for their use.
Put simply the answer is we hope so.
The agency’s press announcement on the new rules comes with new Web pages that detail, in fairly simple English, what family members can do.
Perhaps the most important information is this page, on Expanded Access. Not everyone can get access. You must have a serious or life-threatening illness. You must make special arrangements with the drug’s manufacturer. They might say no.
An Institutional Review Board will look at experimental drugs, requiring and then reviewing consent documents so that patients and their families know precisely what they’re in for. Not just the known knowns, but at least the known unknowns, and the fact there may be unknown unknowns as well.
The new rules don’t thrill everyone.
The Abigail Alliance, which has been doing battle with the FDA for nearly a decade, called the rules a “codifying of the status quo.” The group is named for Abigail Burroughs, a 21 year old who died of cancer in 2001. The group lost their legal battle for access to Erbitux in 2008, and sought a legislative solution.
Regardless of whether the new rules are good or bad, I think it’s good to see them clear, to see them published, and to see them accessible via the Web.
At least next time the e-mail flood comes in after a story on a new drug, there will be something I can tell them.
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
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