Hamburg: Society needs to weigh in

April 10, 2014 – 6:10 pm | By Mari Serebrov | No comments yet

Blog 4-10-14Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader societal discussion, FDA Commissioner Margaret Hamburg said.

Speaking at the annual meeting of the Pharmaceutical Research and Manufacturers of America, Hamburg ticked off a few issues that we as a society must address. For instance, in the absence of a cure, patients with chronic or terminal diseases want a better quality of the life they have left. But the FDA tends to judge a potential drug’s merits on survival endpoints rather than quality-of-life factors.

Are we willing to invest in drugs that improve a dying patient’s life or make life easier for someone with a chronic condition? If we answer yes, how does the FDA, which is so used to weighing objective scientific data, quantify subjective patient-reported outcomes as a component in the assessment of a drug candidate?

This isn’t the only conversation we should be having, Hamburg said. We need to be shaping a national strategy seizing the potential of personalized medicine. Again, that discussion is much broader than the FDA alone, she said. It needs to consider intellectual property, economic policies, scientific investment and reimbursement issues.


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