25 December 2016 - Why the regulators at the FDA must think surgeons.

On a visit to her prenatal physician, Margaret Boeme and her husband received unwelcome news — their unborn baby had a spinal tumour. Several doctors recommended the Boemes terminate the pregnancy, but the couple refused to give up. Finally, they found doctors willing to perform a risky open foetal procedure to remove the tumour. Twelve weeks later, Mrs. Boeme gave birth to a beautiful baby girl.

When surgeons take these risks, it’s inspiring. But when the FDA does something similar — in particular, rethinking a new drug’s review pathway so that patients without any options can have one — some consider it scandalous.

That’s just wrong. Like a surgeon, the FDA should follow proper procedures, always. But those procedures should allow for advances in regulatory science — such as the patient voice.

Read Washington Times article