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Can This Boy’s Life Be Saved?

The answer may depend on President Obama.

Mar 24, 2014, Vol. 19, No. 27 • By MICHAEL ASTRUE
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What’s worse is that compassionate use has become an entitlement of the Washington elite; for instance, if you are a relative of a member of Congress seeking a compassionate use exemption, you can expect that an FDA official will immediately call the company in question to demand that it submit and support an application for compassionate use. I was on the receiving end of those calls several times in the 1990s when my employer was in a final trial for an experimental anticoagulant, which at that time was uniquely life-saving for certain surgery patients allergic to heparin.

At any given point of time, there are thousands of patients like Jack Fowler who need a drug based on a clear mechanism of action that has a clean safety trial prior to a pivotal trial. Jack’s parents have declared that they would do what any decent parents would do, and they would sign a waiver of liability that would shield Shire from any lawsuit. A hospital ethics review board would have to review Jack’s particular case and determine that it is ethical for Jack’s doctor to prescribe the drug for him. If those things happen, there is a real chance Jack will live. If those things don’t happen, it is all but certain that Jack will die what all constitutional lawyers would consider a “cruel and unusual” death.

President Obama should end this standoff right now. First, he needs to call FDA commissioner Margaret Hamburg and make sure that there are no facts outside of the public domain that would make Jack Fowler a poor risk for a compassionate use exemption. Second, assuming that conversation goes as it most probably will, President Obama should ask Commissioner Hamburg to pick up the phone and call Shire’s new CEO, Dr. Flemming Ornskov, and tell him that whatever his nervous regulatory executives are telling him is untrue, and that the FDA would genuinely welcome their support of a compassionate use application for Jack Fowler.

Almost surely, that phone call will save Jack from a death penalty that is the indirect product of a nontransparent and unpredictably administered regulatory process. It is important, though, that President Obama not stop there; his time is too valuable to keep making these kinds of calls.

President Obama should have his lawyers draft an executive order that will keep sick children off Death Row. In that order he should direct the FDA to convene an advisory committee with several ethicists and a hefty dose of patient advocates to advise the FDA on a public list of experimental drugs presumptively approvable under the compassionate use exemption. The current compassionate use rules, which were thoughtfully revised under this administration, are fine as far as they go, but they do not address the nontransparency that enables unpredictable decisions that cause unnecessary deaths.

President Obama can do something heroic if he simply shows his respect for human life by directing that life-and-death decisions under his control are made openly, honestly, and compassionately. He does not need new legislation—it is just a question of using the authority he already has.

Surely, even with all our political divisions, every decent person in Washington can get behind saving the Jack Fowlers of our nation.

Michael Astrue served as HHS general counsel (1989-1992) and commissioner of Social Security (2007-2013). He was a senior vice president and then CEO of the rare disease company Transkaryotic Therapies from 2000-2005. He has not spoken directly or indirectly with Shire, the FDA, or the Fowlers about this case.

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